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The JOULE ClearSense Laser System is indicated for ablation, vaporization, incision, excision and coagulation of soft tissue, including:

• Matrixectomy
• Periungual and subengual warts
• Planter warts
• Radical nail excision
• Neuromas

It is also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

The JOULE ClearSense Laser System is a transportable medical device used for the treatment of temporary increase in clear nail in patients with onychomycosis. It uses Nd:YAG laser with a wavelength of 1064 nm.

ClearSense uses the laser energy to heat the target to a temperature that is sufficient to destroy it, but not to the point that the heat damages skin and surrounding tissue.

The ClearSense system consists of a control console, a foot switch, articulated. arm and a handpiece with a stainless steel guide tip (spacer) attached at its end.

Control Console houses the power supply, control electronics, cooling system and optics to direct the laser beam to the input of the articulated arm.

The provided text is a 510(k) summary for the JOULE ClearSense Laser System. It focuses on demonstrating substantial equivalence to predicate devices for its intended uses, particularly for the temporary increase of clear nail in patients with onychomycosis, and other soft tissue procedures.

However, the document does not contain specific acceptance criteria or details of a study designed to prove the device meets such criteria in terms of performance metrics (like sensitivity, specificity, accuracy, or quantitative clinical outcomes). The document primarily outlines the device's technical specifications and compares them to predicate devices to establish substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study proving it meets those criteria, as this information is not present in the provided text.

Based on the nature of the document (a 510(k) summary for a laser system), the "study" described is a declaration of substantial equivalence, not a clinical trial proving specific performance metrics against pre-defined acceptance criteria.

Here's an analysis of the requested information based on what is available:

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

• Not available. The document does not specify quantitative acceptance criteria for performance (e.g., successful treatment rates, clearance percentages, or specific diagnostic accuracy metrics). It focuses on substantial equivalence of technological characteristics and indications of use to predicate devices.

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

• Not applicable/Not available. No "test set" in the context of a performance study for AI/imaging devices is mentioned. The document is for a laser system.

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/Not available. This data is irrelevant for a laser device 510(k) submission.

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

• Not applicable/Not available.

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/Not available. This type of study is relevant for AI-powered diagnostic devices, not a therapeutic laser system like the JOULE ClearSense.

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

• Not applicable/Not available.

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

• Not applicable/Not available.

8. The sample size for the training set

• Not applicable/Not available.

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

• Not applicable/Not available.

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