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The Disco Subtalar Implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is intended to block the forward, and medial displacement of the talus, thus allowing normal subtalar joint motion but limiting excessive pronation.

The Disco Subtalar Implant consists of a threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, and corresponding instrumentation to facilitate insertion. The leading end of the implant is cylindrical in shape and is approximately half of the overall length of the device, with the remaining length being spherical. The full length of the implant incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. Internal threads are machined in the spherical end of the implant and are for use with a removal tool.

The Disco Subtalar Implant's 510(k) summary does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria in the manner typically understood for AI/ML-based medical devices (e.g., performance metrics like sensitivity, specificity, or AUC against a ground truth). This is a traditional medical device, not an AI/ML diagnostic tool.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance and design characteristics, rather than clinical efficacy studies.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. The "tests" mentioned are non-clinical (static compression and pull-out testing on the device itself), not studies on a test set of patient data.
• Data Provenance: Not applicable. The data comes from mechanical testing of the device.

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

• Not applicable. Ground truth, in the context of diagnostic AI/ML devices, relates to patient outcomes or expert interpretations. For this mechanical device, "ground truth" relates to engineering specifications and material properties, which are verified through standard engineering tests.

4. Adjudication Method for the Test Set

• Not applicable. There was no 'test set' of patient data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No. The document explicitly states: "No clinical studies were performed." This is a mechanical implant device, not a diagnostic tool typically evaluated with MRMC studies.

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

• Not applicable. This is a physical medical implant, not an algorithm or software device.

7. The Type of Ground Truth Used

• For mechanical properties: Engineering standards and specifications (e.g., ASTM F136 for material, established benchmarks for static compression and pull-out strength based on predicate devices).
• For intended use/function: Clinical consensus on the biomechanics of subtalar joint stabilization and correction of hyperpronation, as embodied by the predicate devices.

8. The Sample Size for the Training Set

• Not applicable. There is no training set as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. There is no training set.

Summary of Device Acceptance:

The acceptance of the Disco Subtalar Implant by the FDA (as indicated by the 510(k) clearance K111834) was based on its successful demonstration of substantial equivalence to already legally marketed predicate devices (Trilliant Twist Subtalar Implant - K103183 and ProStop - K071456).

The study that "proves the device meets the acceptance criteria" in this context is the non-clinical testing summary where:

• Static compression and pull-out testing was performed.
• The results indicated that the Disco Subtalar system is equivalent to predicate devices in these mechanical properties.
• The device's materials (Ti-6Al-4V alloy per ASTM F136), function, intended use, and design (despite a geometry change from the predicate) were also considered substantially equivalent.

The FDA's decision letter confirms this equivalence, allowing the device to be marketed. No clinical studies were required or performed for this 510(k) submission, as per standard regulatory pathways for certain types of mechanical implants claiming substantial equivalence.

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

The SubFix Arthroereisis Implants are intended for single use only.

The Memometal Implant is a one-piece device made of medical grade Titanium Alloy, Ti6A14V. The implant is available in 5 sizes ranging from 6.5 mm to 11.5 in diameter. No new materials or processes are used in the development of this implant.

The provided text is a 510(k) summary for the SubFix Arthroereisis Implant. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies in the same way a PMA (Pre-Market Approval) submission would.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, as it relies on a different regulatory pathway.

Specifically, it states: "An engineering analysis and a material comparison to various predicate devices were used to help demonstrate equivalence." This indicates that the primary "study" for this 510(k) was a comparison to existing devices, not a new performance study with specific acceptance criteria.

Let me address each point based on the information available and not available in the provided text:

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

• Not available. The document does not define specific acceptance criteria or report performance data against such criteria in the context of a new efficacy study. The document focuses on demonstrating substantial equivalence to predicate devices through design characteristics, intended use, engineering analysis, and material comparison.

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

• Not applicable / Not available. Since no performance study demonstrating efficacy against acceptance criteria is described, there is no "test set" in that context. The "test" for this 510(k) was an engineering and material comparison to existing predicate devices.

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)

• Not applicable / Not available. No ground truth establishment by experts is mentioned, as the submission relies on comparison to predicate devices, not on a new clinical study requiring ground truth.

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

• Not applicable / Not available. No adjudication method is mentioned as there's no clinical test set requiring it.

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. This is a medical implant, not an AI-assisted diagnostic tool. An MRMC study is not relevant here.

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

• No. This is a medical implant, not a standalone algorithm.

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

• Not applicable / Not available. No ground truth is established for a new clinical study. The "ground truth" for this 510(k) is implicitly the established safety and effectiveness of the existing predicate devices.

8. The sample size for the training set

• Not applicable / Not available. This is a medical implant, not a machine learning model, so there is no training set.

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

• Not applicable / Not available. As above, no training set for a machine learning model is involved.

Summary of the "Study" provided in the document:

The submission for the SubFix Arthroereisis Implant is a 510(k) Premarket Notification based on substantial equivalence to legally marketed predicate devices. The "performance data" section states:

• "An engineering analysis and a material comparison to various predicate devices were used to help demonstrate equivalence."

This indicates the study was a technical comparison, not a clinical trial with specific performance metrics and acceptance criteria for the new device's efficacy. The relevant aspect explored was the similarity in design, materials, and intended use to existing, approved devices.

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