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The Normed® Vario Subtalar Screw System is indicated for adult, children and adolescent patients.

The screws are intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

Adult - additive subtalar alignment for flat foot.

Children - flexible flat foot treatment in children and adolescents.

The Normed Vario Subtalar Screw is a conical, threaded cannulated screw. It is designed to be inserted into the sinus tarsi of the foot for subtalar arthoroereisis. It is made from medical grade titanium alloy, Ti-6Al-4V (ASTM F136). The implant is offered in 2 sizes: Small (10mm - 13mm) and Large (13mm -16mm). The implants are provided nonsterile and single-use only. The instruments are non-sterile and reusable.

This document describes the Normed Vario Subtalar Screw, a medical device. The provided text is a 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to previously cleared devices rather than extensive clinical studies with specified acceptance criteria and detailed performance metrics. Therefore, many of the requested categories for a study proving acceptance criteria will not be directly applicable or available in this type of submission.

Here's an analysis based on the provided text:

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

The submission does not explicitly state quantitative acceptance criteria in a table format with corresponding reported performance values for each criterion. This type of detail is more common in PMA submissions or in reports of clinical trials designed to prove efficacy and safety against predefined endpoints.

Instead, the document states:
"Non-clinical testing demonstrated for the Normed Vario Subtalar Screw System meets performance requirements as defined by Design Control activities and are substantially equivalent to the predicate devices in terms of safety and efficacy."

The testing mentioned is:

Since this is a 510(k) submission, the "acceptance criteria" are implicitly met if the device performs comparably to the predicate devices and adheres to relevant standards (like ISO 10993-5 for biocompatibility). The specific "performance requirements" defined by Design Control activities are not detailed in this public summary.

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

The document primarily describes non-clinical testing. For the "Vario Screws Static Compression Load" and "Sterility validation," details on sample size, data provenance, and study design (retrospective/prospective) are not provided in this summary. These would typically be found in detailed test reports, not the 510(k) summary. For "In-vitro cytotoxicity" (ISO 10993-5), the standard specifies methodologies, but the sample size used in the specific test for this device is not reported here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the submission focuses on non-clinical engineering and biocompatibility testing, not clinical studies requiring expert ground truth establishment for diagnostic or treatment outcomes.

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

This information is not applicable for the non-clinical testing described. Adjudication methods are typically used in clinical studies when multiple experts assess patient data or outcomes.

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

An MRMC comparative effectiveness study was not done. This device is a medical implant (subtalar screw), not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable as the 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 tests:

• Vario Screws Static Compression Load: "Ground truth" would be engineering specifications and mechanical properties expected for the materials and design, compared against predefined failure limits or performance benchmarks.
• In-vitro cytotoxicity (ISO 10993-5): Ground truth is established by the standard itself, which defines acceptable levels of cytotoxicity based on cellular response to extracts from the material.
• Sterility validation: Ground truth is the absence of viable microorganisms, confirmed through standard microbiological testing methods.

8. The sample size for the training set

This information is not applicable as the device is a physical implant and does not involve machine learning algorithms that require a training set.

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

This information is not applicable as the device does not involve machine learning and therefore has no training set.

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