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The GORE SYNECOR Biomaterial device is intended for use in the repair of hernias and abdominal wall or thoracic wall soft tissue deficiencies that may require the addition of a non-absorbable reinforcing or bridging material.

GORE® SYNECOR Biomaterial is a composite mesh intended for use in the repair of hernias and abdominal wall or thoracic wall soft tissue deficiencies that may require the addition of non-absorbable reinforcing or bridging material. The device incorporates three distinct functional layers comprised of 1) a polytetrafluoroethylene (PTFE) knit mesh, laminated between 2) a non-porous synthetic bioabsorbable PGA:TMC film layer, and 3) a porous synthetic bioabsorbable PGA:TMC web layer. The permanent PTFE knit layer functions to provide strength when bridging a hernia or soft tissue defect. The non-porous bioabsorbable film layer is designed to limit cellular penetration which serves to minimize visceral adhesion formation to the material. The porous bioabsorbable web layer provides a scaffold for cellular infiltration and vascularization. The GORE® SYNECOR Biomaterial is for single use only.

This document describes the GORE® SYNECOR Biomaterial, a surgical mesh. The provided text is a 510(k) premarket notification summary and does not contain information about studies proving a device meets acceptance criteria using a test set that generates performance metrics for AI/ML algorithms. Instead, it focuses on the substantial equivalence of the GORE® SYNECOR Biomaterial to predicate devices based on pre-clinical (bench and animal) testing.

Therefore, many of the requested categories related to AI/ML device performance and testing (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details, and ground truth for training set) cannot be answered from the provided document.

However, I can extract information regarding preclinical performance testing.

Acceptance Criteria and Reported Device Performance (Bench Study)

Study Details (Pre-clinical)

• 1. A table of acceptance criteria and the reported device performance: See table above.
• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
  • Bench Study: Not specified.
  • Animal Study: A rabbit model was used. The number of animals or specific details of their use are not provided. Data provenance is not specified beyond "Pre-Clinical."
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as this is pre-clinical testing, not expert-based ground truth for interpretation. Histopathology would have been assessed by a pathologist, but specific numbers or qualifications are not mentioned in this summary.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to pre-clinical bench and animal studies in this context.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document does not describe the use of AI/ML.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document does not describe the use of AI/ML.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
  • Bench Study: Engineering and material science measurements (e.g., strength, suture retention, burst strength).
  • Animal Study: Histopathology and direct observation (for adhesions).
• 8. The sample size for the training set: Not applicable. This document does not describe the use of AI/ML.
• 9. How the ground truth for the training set was established: Not applicable. This document does not describe the use of AI/ML.

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