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TIGR™ Matrix Surgical Mesh is indicated for use in reinforcement of soft tissue where weakness exists.

TIGR Matrix Surgical Mesh is knitted from two different synthetic resorbable fibers, possessing different degradation characteristics. The first fiber, making up 40% of the matrix by weight, is a copolymer of polyglycolide, polylactide, and polytrimethylene carbonate. The second fiber, making up 60% of the matrix by weight, is a copolymer of polylactide, and polytrimethylene carbonate. Both fibers degrade by bulk hydrolysis once implanted, resulting in a decreasing strength retention followed by mass loss of the fibers.

The provided text describes a 510(k) summary for the TIGR Matrix Surgical Mesh, which is a medical device. The information is related to demonstrating substantial equivalence to predicate devices, not establishing new performance criteria through a study with acceptance criteria in the typical sense of AI/software performance. Therefore, many of the requested fields are not applicable.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number. The document mentions "in vivo studies in the abdominal wall of sheep" and "a Sheep hernia repair model." It does not specify the number of sheep used in these studies.
• Data Provenance: Prospective animal studies (sheep). The country of origin is not specified but the submitter is based in Singapore.

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

• Not Applicable: This type of information is relevant for AI/software performance studies where ground truth is established by human experts (e.g., radiologists interpreting images). For a surgical mesh, the "ground truth" for performance is based on direct observation in animal models and histological analysis, not human expert consensus on interpretations.

4. Adjudication Method for the Test Set

• Not Applicable: Similar to point 3, adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations in diagnostic studies, not for evaluating the direct physical and biological performance of a surgical mesh in an animal model.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No: An MRMC comparative effectiveness study is specific to evaluating the impact of a diagnostic AI tool on human reader performance. This device is a surgical mesh, not a diagnostic tool, and the studies performed are direct comparisons in animal models.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable: This concept is for AI algorithms. The device is a surgical mesh, not an algorithm.

7. The Type of Ground Truth Used

• Animal Studies / Histopathology / Direct Observation: The studies described rely on direct observation in live animal models (sheep hernia repair), tissue integration, local tolerance, and potentially histological examination to determine absorption rates and tissue response. Pathology would be involved in analyzing tissue samples.

8. The Sample Size for the Training Set

• Not Applicable: There is no "training set" in the context of demonstrating substantial equivalence for a physical medical device like a surgical mesh. This term applies to machine learning models.

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

• Not Applicable: As there is no training set, this question is not relevant.

Summary of Device Performance and Equivalence Claim:

The TIGR Matrix Surgical Mesh demonstrates substantial equivalence to predicate devices (Prolene Mesh, Mersilene Mesh, Ultrapro Mesh) by showing:

• Similar Technological Characteristics: Physical and mechanical properties like mesh thickness, density, pore diameter, knit characteristics, suture retention strength, tear strength, and burst strength are similar to predicates.
• Biocompatibility and Safety: The mesh passed ISO 10993 tests (conducted under 21 CFR, Part 58, Good Laboratory Practices) and was determined to be non-toxic, non-mutagenic, non-sensitizing, biocompatible, and safe.
• Equivalent Effectiveness (In Vivo): In a sheep hernia repair model, the overall performance, including tissue integration and local tolerance, was equivalent to the Prolene Mesh predicate device.
• Degradation/Absorption Profile: The two fibers in the mesh have distinct degradation characteristics, with the first fiber absorbing within 4 months and the second within approximately 36 months in sheep models.

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