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The Smith & Nephew TFCC FAST-FIX Kit is intended for use as a suture retention device to facilitate Triangular Fibrocartilage Complex (TFCC) repair procedures.

The TFCC FAST-FIX Kit is an all-inside Triangular Fibrocartilage Complex (TFCC) repair system. The kit consists of the delivery device pre-assembled with a disposable split cannula and also packaged with a knot pusher/ suture cutter. The delivery device includes two non-absorbable polymer implants (Polyetheretherketone (PEEK)), pre-tied with #2-0 non-absorbable suture (Ultra High Molecular Weight Polyethylene (UHMWPE)) and preloaded into a needle delivery system.

The provided text describes a 510(k) submission for the Smith & Nephew TFCC FAST-FIX Kit, a medical device for suture retention during Triangular Fibrocartilage Complex (TFCC) repair. This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing. It does not involve an AI component, clinical studies with human participants, or the use of AI-specific metrics like AUC, sensitivity, or specificity. Therefore, many of the requested fields related to AI performance, clinical study design, and human reader involvement are not applicable/reported in this document.

Here's the information derived from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated in terms of number of devices tested. The document mentions "Mechanical testing was conducted," but does not provide specific sample quantities for the tests (e.g., how many kits were used for tensile strength testing).
• Data Provenance: Not applicable in the context of clinical data. For mechanical testing, the testing would have been conducted in a laboratory setting, likely in the US by the manufacturer, Smith & Nephew. The document does not specify the location or provide details on the generation of the mechanical test data beyond stating "Mechanical testing was conducted."
• Retrospective/Prospective: Not applicable, as this refers to mechanical testing, not a clinical study.

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. This device is a surgical implant, and its acceptance criteria were met through mechanical testing against predicate devices, not through expert-based ground truth establishment for diagnostic or interpretive tasks.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. There was no adjudication needed as it was a comparison of mechanical properties, not expert interpretations.

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 submission is for a physical medical device (suture retention system), not an AI-powered diagnostic tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. There is no algorithm or AI component to this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Comparative Mechanical Performance: The "ground truth" for the mechanical testing was the established performance of legally marketed predicate devices. The subject device's mechanical properties (ultimate tensile strength and load at 2mm elongation) were compared directly to those of the predicate devices. The goal was to demonstrate that the subject device's performance was "at least equivalent."

8. The sample size for the training set

• Not applicable. There is no AI model, and therefore no training set.

9. How the ground truth for the training set was established

• Not applicable. There is no AI model or training set.

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