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510(k) Data Aggregation

    K Number
    K113071
    Device Name
    SYNTHECEL DURA REPLACEMENT DEVICES
    Manufacturer
    SYNTHES
    Date Cleared
    2012-01-09

    (84 days)

    Product Code
    GXQ,GXO
    Regulation Number
    882.5910
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K950956,K973706,K982282,K982180,K021477
    Predicate For
    K131792,K212943
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SyntheCel® Dura Replacement Devices are intended for use as a dura replacement for the repair of dura mater. SyntheCel® Dura Onlay is indicated for use in adults for the repair of dural defects and it can be placed without sutures. SyntheCel® Dura Substitute is indicated for use in adults for the repair of dural defects and it can be sutured into place.

    Device Description

    SyntheCel® Dura Replacement Devices (Onlay and Substitute) are composed of biosynthesized cellulose and water with a unique construction of non-woven, interconnected cellulose fibers. SyntheCel® Dura Replacement Devices function as a mechanical layer which protects and repairs the dural defect while preventing further CSF leakage. SyntheCel® Dura Replacement Devices are immunologically inert and have demonstrated minimal foreign body response. They are non-resorbable.

    AI/ML Overview

    The provided text describes the SyntheCel® Dura Replacement Devices and the studies performed to demonstrate their safety and effectiveness for FDA clearance.

    Here's an analysis of the acceptance criteria and the studies, based on the information provided:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Primary Efficacy Endpoint)Reported Device Performance
    Absence of CSF fistula (drainage from wound or sinus) and pseudomeningocele within 6 months post-operatively, confirmed by radiographic evaluation and physical examination of the surgical site.The results of overall success analyses indicate that the SyntheCel® is non-inferior to the dura replacement control group.
    Non-Clinical Acceptance CriteriaReported Device Performance
    Tensile strength comparable to predicatesSyntheCel® Dura Replacement Device performance was found to be comparable in tensile strength.
    Burst strength comparable to predicatesSyntheCel® Dura Replacement Device performance was found to be comparable in burst strength.
    Suture pull-out strength comparable to predicatesSyntheCel® Dura Replacement Device performance was found to be comparable in suture pull-out strength.
    No meningitis, CSF leakage, infection, hydrocephalus, device vascularization, nor significant hemorrhage in animal study.Results noted at necropsy show no meningitis, CSF leakage, evidence of infection, hydrocephalus, device vascularization, nor significant hemorrhage in any of the animals regardless of the implant type.
    No evidence of a toxic leachable or local adverse effect in animal study.SyntheCel® Dura Replacement Devices showed no evidence of a toxic leachable or local adverse effect.
    Non-irritating, non-sensitizing, non-mutagenic, non-mutagenic, non-cytotoxic, non-hemolytic, and non-pyrogenic (Biocompatibility).Demonstrated that the material is non-irritating, non-sensitizing, non-mutagenic, non-cytotoxic, non-hemolytic, and non-pyrogenic.
    Pyrogenicity < 0.06 EU/ml.Pyrogenicity was evaluated using the Limulus Amebocyte Lysate (LAL) test and found to be less than 0.06 EU/ml.

    2. Sample Size Used for the Test Set and Data Provenance

    • Clinical Study:

      • Total Patients Enrolled: 99
      • Test Set (Investigational SyntheCel® group): 62 patients
      • Control Group: 37 patients
      • Data Provenance: Not explicitly stated, but clinical studies for FDA submission are generally multi-site, and often international, though specific countries aren't mentioned. The study was prospective, with patients randomized and treated at 8 clinical sites.

    • Non-Clinical (Mechanical Testing):

      • Sample Size: "samples" of SyntheCel® Dura Replacement Devices and predicates (DuraGen and Dura-Guard) were used. Specific numbers are not provided.
      • Data Provenance: Not specified, likely internal lab testing.

    • Animal Studies (Rabbit Durotomy Implant Studies):

      • Sample Size: Not explicitly stated, but "any of the animals" implies a group of animals were studied. One study was conducted "following GLPs" (Good Laboratory Practices).
      • Data Provenance: Not specified, but animal studies are typically conducted by contract research organizations or internal labs.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

    • Clinical Study: The text mentions "physical examination of surgical site" and "radiographic evaluation," which implies assessment by medical professionals. However, the exact number of experts (e.g., surgeons, radiologists) and their specific qualifications used to establish the "ground truth" (i.e., whether CSF fistula or pseudomeningocele was present) are not explicitly stated.

    4. Adjudication Method for the Test Set

    • The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the clinical outcomes (CSF fistula, pseudomeningocele) in the test set.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • No, an MRMC comparative effectiveness study was not done. The clinical study was a direct comparison of the SyntheCel® device to a control group of other dura replacement products, evaluating patient outcomes. It was not a study assessing how human readers (e.g., radiologists) improve with or without AI assistance.

    6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

    • No. This device is a surgical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable. The studies evaluated the physical device's performance in humans and animals.

    7. Type of Ground Truth Used

    • Clinical Study: The ground truth for the clinical study was based on clinical outcomes data obtained through "radiographic evaluation and physical examination of surgical site" at 6 months post-operatively.
    • Mechanical Testing: The ground truth was based on physical measurements of tensile strength, burst strength, and suture pull-out strength using standardized test methods.
    • Animal Studies: The ground truth was established through necropsy findings and histological/toxicological evaluations in animal models.
    • Biocompatibility: The ground truth was based on laboratory test results from standardized ISO 10993 tests and LAL test for pyrogenicity.

    8. Sample Size for the Training Set

    • Not applicable. This device is a medical implant, not an AI or machine learning model that requires a training set. The studies described are for regulatory clearance of the physical device.

    9. How the Ground Truth for the Training Set Was Established

    • Not applicable, as there is no training set for this type of device.
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