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The HEALIX TiTM Anchors with DYNACORD™ is intended for:

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromioclavicular; Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction:

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair:

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;

Hip: Capsular repair, Acetabular Labral Repair.

The HEALIX TiTM Anchor with DYNACORDTM Suture is a threaded suture anchor preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. HEALIX TiTM Anchors with DYNACORDTM Suture is available in Titanium material, which is a common material used on existing Depuy Mitek devices. Devices with needles will be offered to facilitate suture passage through tissue. The HEALIX TiTM Anchor with DYNACORDTM Suture is provided sterile and is for single use only.

This document is a 510(k) premarket notification for a medical device called the HEALIX Ti™ ANCHOR with DYNACORD™. It establishes substantial equivalence to a predicate device, meaning it does not require a new study to prove its safety and effectiveness in the same way a novel device would. Therefore, the information typically found in an AI/Software as a Medical Device (SaMD) submission regarding acceptance criteria, training/test sets, expert adjudication, and MRMC studies is not applicable here.

The provided text focuses on the non-clinical testing performed to demonstrate the device's substantial equivalence to a predicate, rather than a clinical study evaluating the performance of an AI/SaMD.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance:

The document describes non-clinical testing, not performance against specific clinical acceptance criteria of an AI/SaMD. The "acceptance criteria" here relate to engineering and material performance for a physical implant.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in terms of number of anchors tested, but general non-clinical testing was conducted.
• Data Provenance: Not applicable in the context of clinical data for AI/SaMD. This refers to lab-based testing of physical properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is not an AI/SaMD and does not involve human expert labeling of data. The "ground truth" for these tests would be the established engineering and materials science standards.

4. Adjudication method for the test set:

• Not applicable for non-clinical engineering tests.

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 is a physical medical device, not an AI/SaMD.

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

• Not applicable. This is a physical medical device, not an AI/SaMD.

7. The type of ground truth used:

• For the non-clinical testing, the "ground truth" is defined by established engineering standards, USP specifications for suture materials, and biological safety standards (e.g., ISO standards for biocompatibility, endotoxin limits).

8. The sample size for the training set:

• Not applicable. This is not an AI/SaMD.

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

• Not applicable. This is not an AI/SaMD.

In summary, the provided document is a regulatory submission for a physical medical device (suture anchor) based on demonstrating substantial equivalence to an existing predicate device through non-clinical performance and safety testing, not through clinical trials or evaluations of an AI/SaMD.

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