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The Medical Diode Laser Hair Removal Device (PZ-606VI, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The proposed device, Medical Diode Laser Hair Removal Device (PZ-606VI、PZ-BDT68-01、PZ-BDT68-02、PZ-BDT68-03、PZ-BDT68-04), is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

The device incorporates a diode laser that emits invisible infrared laser radiation centered on a wavelength of 808 nm. According to the selective light absorption theory, the laser can be preferentially absorbed by the melanin in the hair follicle, thus achieving the purpose of permanent hair removal. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. Hair growth must remain stable for a certain amount of time and must exceed the entire growth cycle of the hair follicle. Permanent hair removal does not mean that all hair in the treated area is completely lost. Special cooling technology is applied simultaneously during treatment to cool the skin and protect skin.

There are 5 models included, PZ-606VI, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03 and PZ-BDT68-04, the five models have the same intended use, mechanism of action and principle, only the minimum values of energy density and pulse duration are different.

The provided FDA 510(k) clearance letter and synopsis are for a Medical Diode Laser Hair Removal Device. This document is a regulatory submission for a physical medical device, not an AI/software as a medical device (SaMD). Therefore, the information requested in your prompt regarding acceptance criteria and studies for AI/SaMD (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not applicable to this device submission.

The document describes the device, its intended use, a comparison to a predicate device, and the non-clinical tests performed to demonstrate substantial equivalence for a hardware device. It explicitly states: "No clinical study is included in this submission."

Therefore, I cannot provide a table of AI acceptance criteria or details about AI-specific studies as requested, because this information is not present in the provided document and is not relevant to the type of device being cleared.

However, I can extract the acceptance criteria and performance information that is relevant to this type of physical device, based on the non-clinical testing mentioned:

Acceptance Criteria and Reported Device Performance (Non-Clinical for a Physical Device)

Regarding the AI/SaMD specific questions from your prompt:

1. Sample size used for the test set and the data provenance: Not applicable. No AI/SaMD test set described.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No AI/SaMD ground truth described.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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The Venus Velocity is intended for all Fitzpatrick skin types, including tanned skin, for use in dermatology, general and plastic surgery applications for:

• Hair removal;
• o Permanent hair reduction (defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen); and
• . Treatment of pseudofolliculitis barbae.

The Venus Velocity consists of a console, a detachable diode laser applicator, and three interchangeable sapphire light quides/tips (small, medium, and large sizes). A water system and pump in the console distribute water to cool the handpiece and tips during device use, decreasing the likelihood of burns, discomfort, or pain during treatment. The system is also provided with a water filling kit.

The device incorporates several safety features, including an emergency laser stop button, user login and password protection, and other software and hardware settings to mitigate the risk of improper energy release and ensure that system outputs are within specifications. The device also comes with goggles and patient eye protectors.

This document is a 510(k) Summary for the Venus Velocity device. It describes the device's technical characteristics, intended use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices. However, this document does not contain a detailed study proving the device meets acceptance criteria in the way typically expected for a clinical performance study. Instead, it relies on demonstrating that the device's technical specifications and safety profile are similar to existing, cleared devices.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of "acceptance criteria" for clinical performance. Instead, it implicitly defines acceptance by demonstrating that the device's technical parameters are within the ranges of predicate devices and that various safety and engineering tests passed.

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

The document does not describe a clinical test set with human subjects. The "performance data" refers to engineering, safety, and software verification tests. Therefore, information about sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided.

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

This information is not applicable as no clinical test set with ground truth established by experts is described in this document. The "tests" described are primarily engineering and technical validations against standards.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical test set requiring expert adjudication is described in this document.

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

This information is not applicable. The Venus Velocity is a laser surgical instrument, not an AI-assisted diagnostic or interpretative device that would involve human readers or AI assistance in that context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The Venus Velocity is a physical medical device (laser system) and does not involve AI algorithms in the sense of a standalone diagnostic or interpretative tool.

7. The Type of Ground Truth Used

For the engineering and safety tests, the "ground truth" was adherence to established international standards (e.g., IEC 60601 series, ISO 10993 series) and the specified technical parameters of the device. For software, it was "demonstrating that the software is appropriate for release."

8. The Sample Size for the Training Set

This information is not applicable. The Venus Velocity is a physical medical device, not an AI/machine learning model that requires a training set of data.

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

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

In summary:

This 510(k) summary focuses on demonstrating "substantial equivalence" to legally marketed predicate devices through a comparison of technological characteristics, intended use, and by showing the device meets relevant engineering, electrical safety, biocompatibility, and software validation standards. It does not present a clinical study with human subjects to establish specific performance metrics like sensitivity, specificity, or permanent hair reduction rates against predefined acceptance criteria for a new clinical claim. Instead, the claim of "permanent hair reduction" is tied to the predicate devices and general understanding of "laser surgical instrument" performance, and the device's technical specifications are verified to be safe and effective within those established ranges.

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