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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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