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The Ortho-Pro CSTS 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 talus, thus allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela. It is appropriate for the following conditions:

• Severely pronated foot .
• Calcaneal stance position greater than 5° .
• Manually correctable deformities .
• . Mid-tarsal breech (arch pain)
• Forefoot varus greater than 10° .

The Ortho-Pro CSTS Screw 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 implant is conical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. External flattened threads increase ease of insertion. It is available in five sizes, Ø8mm to Ø12mm in 1mm increments.

The provided document describes the 510(k) summary for the CSTS Screw, a medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical trials to establish new safety and effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" and "reported device performance" are typically framed in terms of demonstrating substantial equivalence to a predicate device through non-clinical testing and comparing design features. There isn't a direct "acceptance criteria" in the sense of a numerical diagnostic performance target as would be seen in an AI/diagnostic device study. Instead, the "acceptance criteria" are implied by demonstrating that the new device is as safe and effective as the predicate.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is primarily a non-clinical bench testing study combined with a comparison to predicate devices.

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

• Test Set Sample Size: Not explicitly stated as a "sample size" in the conventional sense of a clinical trial. The "test set" here refers to the samples of the CSTS Screw that underwent compressive testing. The exact number of screws tested is not provided in the summary.
• Data Provenance: The testing appears to be prospective bench testing conducted specifically for this submission. There is no mention of country of origin for data as it's a bench test, not clinical data from patients.

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

Not applicable. For a device like the CSTS Screw, "ground truth" and expert adjudication are typically associated with clinical outcomes, image interpretation, or pathological diagnosis. This submission relies on substantial equivalence and non-clinical engineering tests. There's no mention of experts establishing a "ground truth" for the non-clinical tests described.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert opinions, typically in diagnostic studies. This document describes non-clinical mechanical testing, where results are objective measurements rather than subjective interpretations requiring adjudication.

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 a subtalar screw, a physical implant, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and "human readers improving with AI assistance" are irrelevant to this 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, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

For the non-clinical testing: The "ground truth" would be the objective measurements obtained from the compressive testing (e.g., force at failure), and the engineering specifications/standards (e.g., ASTM F136 for materials). The "truth" of substantial equivalence is established by comparing these test results and design features to those of the predicate devices, which have already been deemed safe and effective.

8. The Sample Size for the Training Set

Not applicable. Training sets are relevant for machine learning algorithms. This is a physical medical device.

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

Not applicable. Training sets and their ground truth are not relevant for this type of device submission.

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