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The IFS Subtalar Implant is intended to treat hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

The IFS Subtalar Implant is a one-piece device made of Ti 6Al-4V ELI intended to be implanted into the sinus tarsi of the foot. The implant is designed in 6 diameter and length sizes (7mm through 12mm and 13mm through 18mm, respectively). The implant which is used in the treatment of excessive motion of the talus relative to the calcaneus acts as a spacer for the joint, maintaining the joint space, allowing for range of motion, but limiting excessive pronation.

The provided text, a 510(k) summary for the IFS Subtalar Implant, focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed performance metrics for the device itself. Therefore, detailed information required by your request about acceptance criteria, study design, expert involvement, and ground truth establishment is not available in the provided document.

Here's a breakdown of what can and cannot be extracted from the text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Available. This document describes the device's design, material, and intended use, and compares it to predicate devices. It does not contain a table of performance metrics (e.g., accuracy, sensitivity, specificity) against predefined acceptance criteria for the device itself. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence, not to statistical performance of an AI or diagnostic device.

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

• Not Applicable/Not Available. The provided document is a 510(k) submission for a medical implant (bone fixation fastener), not a study evaluating an AI or diagnostic device. There is no "test set" in the context of evaluating an AI's performance. The review focuses on the device's design, materials, and intended use as compared to existing devices.

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

• Not Applicable/Not Available. Same as above, there is no "test set" or "ground truth" establishment in the context of typical AI/diagnostic device evaluation. The "experts" involved are likely the FDA reviewers assessing the 510(k) submission and the engineers/clinical staff from Internal Fixation Systems, Inc. who designed, developed, and documented the device.

4. Adjudication Method for the Test Set:

• Not Applicable/Not Available. No test set as described for an AI/diagnostic device.

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/Not Available. This is a hardware implant, not an AI-powered diagnostic tool. MRMC studies are irrelevant here.

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

• Not Applicable/Not Available. This is not an algorithm.

7. The Type of Ground Truth Used:

• Not Applicable/Not Available. No ground truth in the context of an AI/diagnostic device evaluation. The "ground truth" for this device would be its physical properties, biocompatibility, and mechanical performance, which are assessed through engineering tests and material analysis (though details are not in this summary).

8. The Sample Size for the Training Set:

• Not Applicable/Not Available. This is a physical implant, not an AI model. There is no concept of a "training set."

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

• Not Applicable/Not Available. No training set.

Summary based on the provided document:

The IFS Subtalar Implant's acceptance criteria for market clearance (510(k)) were based on demonstrating substantial equivalence to existing legally marketed predicate devices, specifically:

• Nexa Subtalar Arthrorisis Implant (K032902)
• Osteomed Subtalar Implant System (K031155)

The study proving this involved a comparison of technological characteristics, focusing on:

• Design: Similar overall diameters and lengths.
• Function: Intended to treat hyperpronated foot, stabilize the subtalar joint, and block excessive pronation, acting as a spacer.
• Material: Made of Ti 6Al-4V ELI, which is a common material for such implants and likely comparable to the predicates.
• Intended Use: Identical or very similar to the predicate devices (treating hyperpronated foot and stabilizing the subtalar joint).

The document explicitly states: "The IFS Subtalar Implant is substantially equivalent to the predicate devices with respect to the design, function, and material. The implants have the same overall diameters, lengths, and material composition. ... There are no significant differences between the subtalar implant and the other implants as listed in the Substantially Equivalent Devices. The IFS Subtalar Implant and the predicate devices have similar design attributes, material, and intended use thus is substantially equivalent."

This is a regulatory pathway for medical devices that are similar in technology and intended use to devices already on the market, meaning a full clinical trial demonstrating novel safety or effectiveness might not be required. The "study" in this context is the detailed comparison and justification provided in the 510(k) submission to the FDA.

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