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Phoenix Sinus Tarsi Stent is an implant stabilization device used in the treatment of talotarsal joint instability in adult and pediatric patients four years of age and older. The stent is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion.

The Phoenix Sinus Tarsi Stent is a non-pyrogenic type IIB extra-osseous talotarsal stabilization (EOTTS) device used in the treatment of talotarsal joint instability per Graham Et al. EOTTS classification system. The stent system consists of an implant designed to be inserted into the sinus tarsi and has corresponding instrumentation to facilitate the insertion. All stents are manufactured from Ti6Al-4V ELI per ASTM F136 and have 5 sizes with varying diameter.

The Phoenix Sinus Tarsi Stent System is a medical device, and the provided FDA 510(k) clearance letter focuses on its substantial equivalence to predicate devices based on non-clinical performance testing. This type of submission does not typically involve the kind of AI/ML performance evaluation criteria and studies that would address human-in-the-loop performance, multi-reader multi-case studies, or detailed ground truth establishment as requested.

The provided document describes non-clinical performance testing to demonstrate the device's physical and biological properties. It does not involve AI or algorithms, nor does it refer to human interpretation of medical images or data. Therefore, many of the requested categories (such as human readers, AI assistance, ground truth for AI, etc.) are not applicable to this specific device and its regulatory submission.

However, I can extract the acceptance criteria and study information that is present in the document regarding the device's physical and material performance.

Acceptance Criteria and Study for the Phoenix Sinus Tarsi Stent System (Non-Clinical Performance)

The Phoenix Sinus Tarsi Stent System's acceptance criteria and performance are established through a series of non-clinical tests designed to demonstrate its safety and functionality as a physical implant. These tests do not involve AI/ML components or human interpretation studies.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states: "All testing showed the subject device performed as intended. All testing met applicable predetermined acceptance criteria."

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

• Sample Size: Not explicitly stated for each test (e.g., number of stents tested for pullout, bending, etc.). For physical and material tests, sample sizes are typically determined by relevant ISO/ASTM standards.
• Data Provenance: The tests are non-clinical, implying laboratory-based testing of the device itself (e.g., physical specimens of the stent and its materials), not patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" studies are not applicable in this context.

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

• Not Applicable. For non-clinical performance testing of a physical implant, "ground truth" is established by adherence to recognized international standards (e.g., ASTM, ISO, AAMI, USP) and predefined pass/fail criteria for material and mechanical properties. There are no human "experts" establishing ground truth in the sense of medical diagnosis or interpretation for this type of testing.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation of data where consensus on ground truth is required. For the non-clinical tests described, outcomes are typically objectively measured against predefined criteria specified in the test standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is designed to evaluate the performance of diagnostic devices, especially those involving human interpretation (e.g., radiologists reading images), often with and without AI assistance. The Phoenix Sinus Tarsi Stent System is a physical implant, not a diagnostic device involving human interpretation; thus, MRMC studies are not applicable.

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

• No. This device does not incorporate any AI or algorithm component. Its performance is purely based on its physical and material properties.

7. The Type of Ground Truth Used:

• Scientific Standards and Predetermined Criteria: For mechanical tests (e.g., screw pullout, cantilever bending), ground truth is defined by the requirements and methodologies outlined in the applicable ASTM standards (e.g., ASTM F543, ASTM 2193), with specific performance thresholds (e.g., minimum pullout strength, maximum deflection).
• Biological/Material Standards: For biocompatibility (Endotoxin, Cytotoxicity) and sterilization, ground truth is based on meeting the specifications and acceptable limits defined by international standards (e.g., AAMI ST72, USP , ISO 10993-5, ISO 11137-1/2).
• Packaging Integrity: For shelf-life, ground truth is meeting parameters defined by ISO 11607-1 and relevant ASTM standards regarding package integrity.

8. The Sample Size for the Training Set:

• Not Applicable. This device does not use AI/ML, therefore, there is no "training set."

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

• Not Applicable. There is no training set for this device.

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