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The STS screw is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela.

• Severely pronated foot;
• Walking intemperance;
• Calcaneal stance position greater than 50;
• Manually correctable deformities;
• Mid-tarsal breech (arch pain);
• Forefoot varus greater than 10°.

The Subtalar Spacer System (STS) a threaded implant designed to be inserted between the posterior and middle facets of the subtalar joint. It is manufactured from Ti-6A1-4V per ASTM F136 and is available in 6 sizes. STS has a center cannula design for use with a guide wire to facilitate proper placement.

This FDA 510(k) summary (K150213) is for a medical device called the Subtalar Spacer System (STS). Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present explicit acceptance criteria in the typical format of a table with quantitative metrics (e.g., sensitivity, specificity, accuracy, or specific mechanical performance thresholds).

Instead, the submission relies on demonstrating substantial equivalence to predicate devices. This means the primary "acceptance criterion" is that the new device is as safe and effective as a legally marketed predicate device. The performance is assessed by comparing the new device's technological characteristics and showing no new questions of safety or effectiveness are raised.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. This submission does not detail a "test set" in the sense of a clinical trial or a performance study with a specific number of cases/patients. Instead, it relies on non-clinical (bench) testing and comparison to predicate devices.
• Data Provenance: The data provenance is primarily from non-clinical evidence (bench testing and technical characteristic analysis) supporting the comparison to predicate devices. No human data (clinical or retrospective/prospective study) is described.

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

Not applicable. As no clinical "test set" with ground truth determination is described, there's no mention of experts for this purpose.

4. Adjudication Method for the Test Set

Not applicable. No "test set" requiring adjudication is described.

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

No. This document explicitly states "N/A" under "Substantial Equivalence - Clinical Evidence," indicating that a clinical study, including an MRMC study, was not performed or deemed necessary for this 510(k) submission.

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

Not applicable. This device is a physical implant (Subtalar Spacer System), not an algorithm or AI-driven system.

7. The Type of Ground Truth Used

Not applicable in the conventional sense of clinical ground truth (e.g., pathology, outcomes data). For a 510(k) based on substantial equivalence, the "ground truth" is established through:

• Predicate Device Performance: The safety and effectiveness profile of the legally marketed predicate devices.
• Engineering/Bench Test Data: Non-clinical testing data to ensure mechanical integrity and comparable performance to the predicate, often against established standards (e.g., ASTM F136 for material).

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant, not an AI/ML model that requires a training set.

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

Not applicable. No training set is involved.

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