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The TARSA-LINK Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as:

· Opening wedge osteotomies of Hallux Valgus

· Evans lengthening osteotomies

· Metatarsal/cuneiform arthrodesis

The TARSA-LINK Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot. The implant is available in a range of sizes and footprints to suit the individual anatomical conditions of the patient. Additionally, the wedge is fabricated and manufactured with two different materials: 1) Polyetheretherketone (PEEK) with tantalum markers and titanium pins (Ti 6Al-4V ELI). 2) Titanium (Ti 6Al-4V ELI).

The implant is hollow to permit packing with autogenous bone graft to help fusion. A C-Shape footprint of the device is also offered for use in procedures where bone graft is not required. The implant has two pockets to permit placement of titanium bone screws (Ti 6Al-4V ELI) through the wedge to provide internal fixation. Devices are offered with either midline or offset screw pockets.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the TARSA-LINK Stand-Alone Wedge Fixation System components with components from any other system or manufacturer. The TARSA-LINK Stand-Alone Wedge Fixation System components should never be reused under any circumstances.

This document is a 510(k) Premarket Notification from the FDA regarding the "TARSA-LINK Stand-Alone Wedge Fixation System." It's for a medical device that provides internal bone fixation. Therefore, the "acceptance criteria" and "study" refer to engineering and benchtop tests to demonstrate substantial equivalence to predicate devices, not clinical studies with human participants or AI performance metrics.

Here's the breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not describe a test set in the context of clinical data for AI or human reader performance. Instead, it refers to benchtop testing and Finite Element Analysis (FEA) for a physical medical device. Therefore:

• Sample Size: Not specified in terms of number of "samples" in a clinical or AI dataset. For benchtop testing, typically a certain number of devices would be tested, but the exact quantity is not detailed here. For FEA, it's a computational simulation.
• Data Provenance: Not applicable in the context of country of origin or retrospective/prospective data as this is a physical device and engineering tests. The data comes from internal testing and analysis performed by the manufacturer, Life Spine.

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

This information is not applicable to this type of submission. "Ground truth" in this context would refer to the expected mechanical performance, material properties, and design specifications, which are established through engineering standards and internal design verification, not through expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers (e.g., radiologists) when establishing ground truth for diagnostic studies. The evaluation for this device involves engineering tests, not human interpretation of data requiring adjudication.

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

This is not applicable. This document is for a physical medical implant, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted or mentioned.

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

This is not applicable. This device is a physical implant, not an algorithm.

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

The "ground truth" for evaluating this device's performance is based on:

• Engineering Standards: Adherence to material specifications (e.g., ASTM F2026, F136, F560) and mechanical performance criteria derived from established biomechanical principles for bone fixation.
• Comparison to Predicate Devices: The reference point for "truth" is the known performance and safety profile of the legally marketed predicate devices. The new device must demonstrate "substantial equivalence" in design, materials, and performance.

8. The sample size for the training set

This is not applicable. This device is not an AI algorithm, so there is no "training set."

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

This is not applicable. As there is no training set, there is no ground truth established for it.

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