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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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The OsteoSpring FootJack™ Subtalar Implant System is indicated for use in the treatment of hyperpronated foot and stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion but limited excessive pronation and resulting sequela. The OsteoSpring FootJack Implant System . implants are intended for single patient use only.

The OsteoSpring FootJack™ subtalar implant is intended to be implanted into the sinus tarsi of the foot. It will be available in a range of sizes. The implant is a solid, one-piece, conical, thread shaped and cannulated design.

Acceptance Criteria and Study for the OsteoSpring FootJack™ Subtalar Implant System

Based on the provided 510(k) summary (K112658), the OsteoSpring FootJack™ Subtalar Implant System did not undergo clinical studies to prove its acceptance criteria. Instead, it relied on non-clinical testing and claims of substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. No clinical test set involving patient data was used. The testing was non-clinical.
• Data Provenance: Not applicable. The data comes from in-vitro (Finite Element Analysis and Static Compression Testing) studies, not from human subjects or clinical settings, hence no country of origin or retrospective/prospective classification applies.

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

Not applicable. The non-clinical tests (Finite Element Analysis and Static Compression Testing) assess physical and mechanical properties, not interpretations of clinical data that would require expert consensus.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an implant, not an AI or imaging diagnostic tool that would typically involve human readers.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This device is a physical implant, not an algorithm. Therefore, "standalone performance" in the context of an algorithm does not apply.

7. Type of Ground Truth Used

For the mechanical performance, the "ground truth" was established by the physical and engineering properties of the device as measured by the static compression testing and simulated by the Finite Element Analysis. For the claim of substantial equivalence, the "ground truth" was the characteristics and performance data of the identified predicate devices against which the new device was compared.

8. Sample Size for the Training Set

Not applicable. This device did not involve any machine learning algorithms or AI that would require a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable. As there was no training set for an algorithm, no ground truth needed to be established for it.

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The Metasurg subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

The Metasurg subtalar implants are intended for single use only.

The Metasurg Subtalar Implant is a one-piece device made of titanium intended to be implanted into the sinus tarsi of the foot. The implant is offered in 6 sizes ranging from 7mm - 12mm in diameter. The implant is used in the treatment of excessive motion of the talus relative to the calcaneus.

This is a 510(k) summary for the Metasurg Subtalar Implant, a metallic bone fixation fastener. The document establishes substantial equivalence to other legally marketed devices and outlines the intended use and device description.

It's important to note that this document states substantial equivalence to legally marketed devices, but does not provide specific acceptance criteria or an analytical study proving the device meets those criteria. The provided text is a regulatory clearance document, not a performance study report.

Therefore, many of the requested details about acceptance criteria, device performance, and study methodology cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. This document does not detail specific acceptance criteria for performance (e.g., mechanical strength, wear resistance, biocompatibility thresholds) nor does it report the Metasurg Subtalar Implant's direct performance against such criteria in a test setting. The 510(k) process relies on demonstrating substantial equivalence to a predicate device, which implies the new device is as safe and effective as the predicate, but doesn't necessarily require reporting new performance data against specific, quantifiable acceptance criteria in this summary.

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

• Cannot be provided. This document does not describe any specific test set or clinical study conducted for the Metasurg Subtalar Implant.

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. There is no test set or ground truth described in this regulatory clearance document.

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

• Not applicable. There is no test set or adjudication process described.

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

• Not applicable. This device is an implant, not an AI-assisted diagnostic tool, and this document does not describe any MRMC studies.

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

• Not applicable. This device is an implant, not an algorithm.

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

• Not applicable. No specific ground truth is mentioned as this is a regulatory submission based on substantial equivalence, not a clinical trial report.

8. The sample size for the training set

• Not applicable. This involves an implant, not a machine learning model with a training set.

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

• Not applicable. This involves an implant, not a machine learning model, and therefore no training set or its ground truth establishment is discussed.

Summary of Device Information from the Document:

• Device Trade Name: Metasurg Subtalar Implant
• Classification Name: Smooth & threaded metallic bone fixation fasteners (21 CFR 888.3040, Product Code HWC, Class II)
• Common Name: Subtalar Arthrorisis Implant
• Device Description: A one-piece device made of titanium, implanted into the sinus tarsi of the foot. Offered in 6 sizes (7mm - 12mm diameter).
• Intended Usage/Indications for Use: Treatment of the hyperpronated foot and stabilization of the subtalar joint. Designed to block forward, downward, and medial displacement of the talus, allowing normal subtalar joint motion but blocking excessive pronation and its sequela. Intended for single use only.
• Material: Titanium Alloy (Ti-6AL-4V ELI)
• Substantial Equivalence: Documentation was provided to demonstrate substantial equivalence to other legally marketed devices. This is the primary "proof" used for 510(k) clearance, implying the device is as safe and effective as its predicate.

This 510(k) summary focuses on demonstrating that the Metasurg Subtalar Implant is substantially equivalent to devices already on the market. It does not provide detailed performance study data against specific acceptance criteria for the new device itself. Such data would typically be found in engineering testing reports (e.g., for mechanical properties) or clinical study reports, which are not included in this summary.

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