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510(k) Data Aggregation

    K Number
    K160493
    Device Name
    Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm
    Manufacturer
    Salvin Dental Specialties
    Date Cleared
    2016-09-08

    (199 days)

    Product Code
    NPK
    Regulation Number
    872.3930
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K012144
    Predicate For
    K222549
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Salvin CytoSurg™ Non-Resorbable PTFE Membrane is a temporarily implantable material (nonresorbable) for use as a space-making barrier in the treatment of periodontal defects.

    Device Description

    The Salvin CytoSurg™ Non-Resorbable PTFE Membrane is composed of microporous PTFE material. It has a nominal thickness of 250 microns and is supplied in two sizes (25mm x 30mm and 12mm x 24mm). The membranes are single use and are supplied in sterile sealed pouches.

    AI/ML Overview

    The provided document is a 510(k) Premarket Notification for a medical device called the Salvin CytoSurg™ Non-Resorbable PTFE Membrane. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study proving performance against specific acceptance criteria in the context of an AI/ML device.

    Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details for an AI/ML device cannot be extracted from this document.

    However, I can extract the performance data and the conclusion related to the device's substantial equivalence to its predicate, as presented in the document.

    Acceptance Criteria and Reported Device Performance (as related to substantial equivalence):

    Acceptance Criteria CategorySpecific Tests PerformedReported Device Performance
    Physical PropertiesTensile StrengthBench testing demonstrated substantial equivalence to the predicate device
    Tear ResistanceBench testing demonstrated substantial equivalence to the predicate device
    Geometric ComparisonsDemonstrated substantial equivalence to the predicate device
    BiocompatibilityISO 10993-5 / Tests CytotoxicityMet their acceptance criteria
    ISO 10993-6 / Tests Local Effects After ImplantationMet their acceptance criteria
    ISO 10993-10 / Tests for irritation and skin sensitizationMet their acceptance criteria
    ISO 10993-11 / Tests for Systemic ToxicityMet their acceptance criteria
    Other ValidationsPackaging ValidationMet their acceptance criteria
    Sterilization ValidationMet their acceptance criteria

    Since this is not an AI/ML device, the following information is not applicable and cannot be extracted from the provided text:

    1. Sample size used for the test set and the data provenance
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
    3. Adjudication method for the test set
    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
    7. The sample size for the training set
    8. How the ground truth for the training set was established
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