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The First Ray Flip Button Suture Anchor is intended to be used for suture or tissue fixation in the foot, ankle, hand, and wrist. Specific indications are listed below:

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP Joints for All Digits, Digital Tendon Transfers

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-Foot Reconstruction

The Flip Button Suture Anchor is a device which is preloaded with suture and is designed to attach soft tissues to bone. The device is deployed through a bicortical drill hole and secured on the far cortex.

The provided document is a 510(k) summary for a medical device (Flip Button Suture Anchor) and does not describe a study involving an AI/software device that generates performance metrics for acceptance criteria. Instead, it describes a non-clinical testing approach to demonstrate substantial equivalence to predicate devices. Therefore, most of the requested information regarding AI/software performance metrics and ground truth establishment is not applicable.

However, I can extract information related to the acceptance criteria and the study performed for this specific device:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document states "All necessary testing has been performed for the worst-case Flip Button Suture Anchor". It does not specify the exact sample size used for the test set (different units of the Flip Button Suture Anchor tested) nor details on data provenance (e.g., country of origin, retrospective/prospective).
• The testing was non-clinical, conducted on "test units representative of finished devices" and "bone analog material".

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

• Not applicable. This was a non-clinical, mechanical performance study, not one requiring expert human interpretation of data for ground truth.

4. Adjudication Method for the Test Set:

• Not applicable. This was a non-clinical, mechanical performance study.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study was a non-clinical, mechanical performance comparison.

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

• Not applicable. This device is a physical medical device (suture anchor), not an algorithm or software. The study evaluated its mechanical performance.

7. Type of Ground Truth Used:

• For the non-clinical testing, the "ground truth" was established by measured mechanical properties (static pullout strength) compared against the performance of a predicate device in a controlled laboratory setting using bone analog material.

8. Sample Size for the Training Set:

• Not applicable. This was a non-clinical performance study of a physical device, not an AI/software requiring a training set.

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

• Not applicable. No training set was used.

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