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The PathFormer device is intended for use in relieving pressure from subungual hematomas (including black toe). It cuts through finger and toe nails to release fluid accumulated in the underlying nail bed.

The Path Scientific, LLC. PathFormer is a battery-powered hand-held drill that cuts holes in fingernails and toenails using mesoscissioning technology. It cuts the nail with a microcutting tool, using skin impedance as the feedback mechanism for stopping the cutting intervention.

This document describes the PathFormer device, a battery-powered hand-held drill for relieving pressure from subungual hematomas (including black toe) by cutting holes in nails. The 510(k) summary provides a high-level overview, but a detailed study proving the device meets specific acceptance criteria is not present in the provided text.

Based on the information provided, here's what can be extracted and what is not available:

1. Table of acceptance criteria and reported device performance:

The provided text does not include a formal table of acceptance criteria or specific reported device performance metrics. The "Discussion of tests and test results" section merely states: "A variety of tests to fully demonstrate the PathFormer's mechanical, electrical, safety and performance characteristics have been provided in the 510(k) documentation." This is a general statement and does not provide quantifiable acceptance criteria or the results of those tests.

2. Sample size used for the test set and the data provenance:

This information is not available in the provided text. The document refers to "tests" but does not specify the sample size or the origin of any data (e.g., country of origin, retrospective or prospective).

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

This information is not available in the provided text. Given the device's function involves a physical intervention (cutting nails), the concept of "ground truth" established by experts in the context of diagnostic accuracy is not directly applicable in the same way as for an imaging or AI diagnostic device. However, if performance tests involved expert assessment of the cutting process or outcome, this detail is missing.

4. Adjudication method for the test set:

This information is not available in the provided text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable to the PathFormer device. The PathFormer is a tool for a physical procedure, not an AI-assisted diagnostic or interpretative device that augments human "readers."

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

This is not applicable to the PathFormer device. The PathFormer is a physical device operated by a human, not an algorithm.

7. The type of ground truth used:

This information is not explicitly available in the provided text. For a device like PathFormer, "ground truth" would likely relate to objective measurements of its cutting ability, safety features (e.g., stopping when skin is detected), and effectiveness in relieving pressure without causing harm. These would be established through engineering and performance testing rather than expert-derived diagnostic labels.

8. The sample size for the training set:

This is not applicable to the PathFormer device in the context of machine learning. The device is a mechanical tool, not an AI algorithm that requires a "training set."

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

This is not applicable for the same reason as point 8.

In summary:

The provided 510(k) summary indicates that various mechanical, electrical, safety, and performance characteristics were tested for the PathFormer device. However, it does not provide the specific details requested regarding acceptance criteria, sample sizes, data provenance, expert involvement, or adjudication methods that would be typically found in a detailed study report for diagnostic or AI-powered devices. The focus of the 510(k) summary is to state that these tests were conducted and that based on them, the device is considered safe and effective and substantially equivalent to a predicate device.

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