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Appendix to Clinical Evaluation ReportClinical Data Identification Reportin accordance with MEDDEV 2.7/1 revision 4BackgroundProduct//Product nameImportance of review to risk management process//justificationPrevious literature searches conducted by the manufacturer//elaborate if applicableEquivalenceData for equivalent devices will be used to show safety and performance of the device under evaluation. All information concerning equivalence is available in Appendix “Demonstration of Equivalence”.In addition to data from equivalent devices, some performance aspects will be covered by pre-clinical data from the device under evaluationObjectiveThe objective of the literature search is in line with the scope of the clinical evaluation. This document covers both, the literature search strategy and the documentation of the actual search that was performed. This approach was chosen, because experience shows that the strategy evolves during the search. A common approach is therefore, to document the objective and make iterations along the way in order to retrieve a maximum of relevant data. The following research questions will be covered.Population(s)/disease(s) or condition(s)//elaborate if applicableIntervention(s)//elaborate if applicableComparator group(s)/control(s)//elaborate if applicableOutcome(s)/endpoint(s)//elaborate if applicableMethodsStrategy for data identificationAll publications containing clinical data obtained in the course of clinical evaluation are classified as either relevant or non-relevant. All relevant data identified is pursued and included in the overall evaluation of clinical safety and performance of the product under evaluation, as well as for the risk-benefit analysis.The manufacturer assures that all relevant clinical data, both published and unpublished, favourable or unfavourable for the device has been made available for inclusion in this evaluation. A systematic approach using the below mentioned predefined inclusion and exclusion criteria is performed. The data obtained in a search is screened in a first step and non-relevant data is excluded. In cases where no decision can be made based on the screening (e.g. of abstracts) of publications, the full text is reviewed and classification with regard to relevance is performed thereafter. The most important medical literature databases are included in the data identification process, leading to a high number of data from recognized scientific sources. The search algorithm is developed with no distinction between data with favourable or unfavourable results for the device under evaluation.As a result, at the time the evaluation is compiled, it can be assumed that sufficient sources were identified in order to allow for evaluation of safety and clinical suitability of the device.Sources for data identificationIn order to be able to determine the best data sources for the identification of clinical data with the product, a product dependent approach is applied. Whereas for most products, detailed literature will be available on Pubmed (), there might be some products where publications are mostly available in a language other than English and may therefore not be found on Pubmed. In those cases, other databases should be considered and included in the search. Moreover, data relevant for the European population may primarily be found in databases with European journals.. Sources of dataPubmed ()WorldCat ()Cochrane ()Manufacturer data and websites//add if furtherBackground data and clinical data in general are searched primarily in Pubmed. Product specific data is searched in all databases. Additionally, the safety databases MAUDE at the FDA and “Ma?nahmen von Herstellern” at the BfArM are searched for product specific reports from manufacturers. For identification of background data and data on the state-of-the-art, distinct searches are carried out. The searches are documented in Section REF _Ref467186221 \r \h \* MERGEFORMAT 4. Criteria for data selectionRating of EquivalenceCompetitor products and other relevant products are rated according to their equivalence to the device under evaluation. The rating of equivalence is performed using the following scheme.RatingDescription0No equivalence, not comparable1Low equivalence, slightly comparable2Medium equivalence, comparable3High equivalence, comparable in most aspectsThe following definitions of MEDDEV 2.7/1 revision 4 are considered for rating the aspects of clinical, technical and biological equivalence:AspectDescriptionClinical (C)-used for the same clinical condition (including when applicable similar severity and stage of disease, same medical indication), and- used for the same intended purpose, and- used at the same site in the body, and- used in a similar population (this may relate to age, gender, anatomy, physiology, possibly other aspects), and- not foreseen to deliver significantly different performances (in the relevant critical performances such as the expected clinical effect, the specific intended purpose, the duration of use, etc.).Technical (T)- be of similar design, and- used under the same conditions of use, and- have similar specifications and properties (e.g. physicochemical properties such as type and intensity of energy, tensile strength, viscosity, surface characteristics, wavelength, surface texture, porosity, particle size, nanotechnology, specific mass, atomic inclusions such as nitrocarburising, oxidability), and- use similar deployment methods (if relevant), and- have similar principles of operation and critical performance requirements.Biological (B) - use the same materials or substances in contact with the same human tissues or body fluids.The rating is performed for each aspect separately and the sum is calculated in order to obtain an overall measure for equivalence. Only data from products with a substantial equivalence will be considered for evaluation of performance. However, where safety issues are concerned, data from less equivalent products may also be considered.The rating of equivalent devices is documented in Appendix “Demonstration of Equivalence”.Inclusion criteria Data from products with a high equivalence to the product under evaluation are included in the evaluation.Inclusion criteria//describeExclusion criteria Data from products with low equivalence or other criteria described below were excluded. Exclusion criteria//describeHandling of duplicate dataUse of a structured publication database (e.g. Endnote, ReferenceManager or Zotero) allows exclusion of duplicate publications. Publications with a similar set of authors are scrutinized for potential overlaps with regard to the evaluated patient population (e.g. similar periods of recruitment or identical locations). Criteria for data appraisalQuality of dataAll clinical data for safety and performance are rated according to their level of evidence in order to determine their contribution to the overall evaluation. The scheme for rating is derived from the system developed by Howick et al. (see Table ?Level of Evidence from ). Usually, case series (level 4) and expert opinions (level 5) are classified to provide only limited evidence, which may not be used to confirm safety and performance of the medical device in question appropriately. However, some level 4 and 5 data may contain information of interest, especially on safety issues..Level of EvidenceDescriptionLevel 1Randomised controlled study with effective blinding and with statistically significant difference or no statistically significant difference but narrow confidence intervalsCohort study complying with the above criteriaSystematic review of Level-1 randomised controlled clinical investigations and homogeneous study resultsLevel 2Randomised controlled study, with a sound statistical evaluation of study results, however without effective blindingCohort study complying with the above criteriaSystematic review of Level-2 studies or with Level-1 studies with inconsistent resultsLevel 3Open label case control study with a sound statistical evaluation, however no randomisation or blindingRetrospective study based upon available patient dataSystematic review of Level-3 studiesLevel 4Case series without statistically justified study populationCase reports: Documentation of one or more single patient treatmentsLevel 5Expert opinion (without explicit critical appraisal of clinical study results)Number of patientsThe number of patients (n) in a study may play an important role in determining the value of a set of clinical data, especially in studies with a lower level of evidence. . Therefore, patient numbers are always stated. In case of systematic reviews or meta-analyses the number of studies evaluated is included.ContributionAll data is clustered into categories relevant to the aspects of product performance, product safety or the medical background including state-of-the art treatment and medical alternatives. P | PerformanceData concerning the product performanceS | SafetyData concerning the product safetySoA | State-of-the-artData concerning the medical background and current state-of-the-artTendencyWith regard to the outcomes of data evaluation these can be either supportive (favourable) for the product under evaluation, show that the product is not appropriate (negative) for its intended use due to performance and/or safety issues or show neither a positive nor a negative (indifferent) tendency:F | FavourableSupports appropriateness for clinical useI | IndifferentNo statement as to appropriateness for clinical use can be derived N | NegativeDoes not support appropriateness for clinical useSearch DocumentationSearch algorithmThe following flow chart shows the development of search terms that allow the retrieval of key data. //flow chart if possibleSearch DocumentationThe following tables list all searches conducted to identify potentially relevant data- Search terms and limits are stated in the tables. The search is performed by:NameDatabase:PubmedSearched in//dateSearch No.Search term (with limits)ResultsPotentially relevantDatabase:WorldCatSearched in//dateSearch No.Search term (with limits)ResultsPotentially relevantDatabase:CochraneSearched in//dateSearch No.Search term (with limits)ResultsPotentially relevantDatabase:MAUDESearched in//dateSearch No.Search term (with limits)ResultsPotentially relevantDatabase:BfArMSearched in//dateSearch No.Search term (with limits)ResultsPotentially relevant ................
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