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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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The MC-Subtalar™ II screw system is for the correction of flexible flat feet in children (6 to 6 years, after conservative treatment did not result in a flat foot correction,

• Age

The MC-Subtalar™ II screws are partly threaded, cannulated and self-tapping screws. They are designed to be implanted into the calcaneus bone of the foot for subtalar extra-articular arthroeresis. A hexagonal shaped shaft end allows easy adjustment while operation. The screws are made of X2CrNiMo 18-15-3 stainless steel and are also available made of Ti6Al4V titanium alloy. The MC-Subtalar™ II is offered in sizes of 25 mm, 30 mm and 35 mm and with different head diameter of 6 mm, 8 mm and 10 mm to meet the specific anatomical requirements for various age groups.

The provided text is a 510(k) premarket notification for a medical device called MC-Subtalar™ II. This document describes the device, its indications for use, and its equivalence to legally marketed predicate devices. However, it explicitly states: "Clinical Data were not needed for these devices to show substantial equivalence."

Therefore, based on the provided text, a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical or analytical performance study with specific acceptance criteria related to accuracy, sensitivity, or specificity, and human reader performance against an AI, was not performed or required for this 510(k) submission.

The "acceptance criteria" and "device performance" described are mechanical and biomechanical in nature, rather than diagnostic or clinical effectiveness outcomes that would involve complex statistical analyses of sensitivity, specificity, or reader studies.

Here's a breakdown of what is available in the document regarding the device's assessment:

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

The document does not present a formal table of acceptance criteria with corresponding performance metrics in the way one might expect for a diagnostic or AI-driven device. Instead, it describes mechanical and biomechanical testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly stated in terms of patient data. The "test set" refers to the physical devices subjected to mechanical and biomechanical testing. The number of devices tested is not specified, but such tests typically involve a statistically relevant number of samples to ensure robust results.
• Data Provenance: The tests were conducted by Merete Medical GmbH, a German company (Alt-Lankwitz 102, 12247 Berlin, Germany). The origin of the data (i.e., the conditions under which the mechanical tests were performed) would be laboratory-based and controlled, rather than patient data from a specific country or collected retrospectively/prospectively.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The "ground truth" here is based on engineering standards (ASTM F543-13) and mechanical testing results, not expert interpretation of medical images or clinical outcomes. The evaluation relies on standardized physical tests and measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are typically used in clinical studies or expert consensus for ground truth establishment. For mechanical testing, the results are objectively measured against pre-defined engineering specifications.

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

No, an MRMC comparative effectiveness study was not done. This device is a surgical implant (Subtalar Arthroereisis Implant), not an AI-driven diagnostic or image analysis tool. There is no "human reader" component in its assessment for this 510(k) submission.

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

No, a standalone algorithm performance study was not done. This is not an algorithm or software device.

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

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

• Adherence to engineering standards (ASTM F543-13).
• Mechanical and biomechanical test results demonstrating the physical properties (e.g., strength, durability) of the implant.

8. The sample size for the training set

This is not applicable as there is no "training set" for an algorithm. The device is a physical implant.

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

This is not applicable as there is no "training set" for an algorithm.

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