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The Diode Laser Therapy System (Model: FG2000-B/FG2000-B Pro) is indicated for temporary hair reduction.

The Diode Laser Therapy System(Model: FG2000-D+Pro/FG2000-D) is indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. It is suitable for all skin types (Fitzpatrick skin type I-VI), including tanned skin.

The Diode Laser Therapy System consists of main unit, handpiece, and its accessories. Diode Laser Therapy System is intended for hair removal, mainly based on the principle of selective photothermal interaction, which means that lasers of specific wavelengths can only be selectively absorbed by the target color base.

The Diode Laser Therapy System(Model: FG2000-B/FG2000-B Pro) are desktop devices, which combines 3 wavelengths (755+808+1064 nm) into a single handpiece to achieve purpose for temporary hair reduction.

The Diode Laser Therapy System (Model: FG2000-D+Fro/ FG2000-E) are vertical device, which is a single wavelength (808 nm only) device.

This document describes the FDA's 510(k) premarket notification for the "Diode Laser Therapy System" by Beijing ADSS Development Co., Ltd. A 510(k) submission aims to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness de novo through clinical trials, as would be required for a PMA (Premarket Approval) device.

Therefore, the provided document does not contain information typically found in a study proving a device meets acceptance criteria derived from a clinical trial for AI/ML-based medical devices. The device in question is a laser therapy system, not an AI/ML-based device that would require complex performance metrics like sensitivity, specificity, or AUC, nor would it involve human readers, expert ground truth adjudication, or MRMC studies.

The "acceptance criteria" discussed in this document relate to the substantial equivalence to predicate devices and compliance with relevant performance and safety standards for laser devices.

Here's an analysis based on the provided text, addressing the points you raised where applicable to a non-AI/ML device:

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

The document does not present a formal table of "acceptance criteria" in terms of performance metrics like sensitivity/specificity for an AI/ML device. Instead, "acceptance criteria" are implied by the demonstration of "substantial equivalence" to predicate devices and compliance with recognized international standards for medical electrical equipment and laser products.

The tables provided in Section 6, "Summary of technological characteristics of device compared to the predicate device," serve as the primary comparison metrics to show substantial equivalence.

Acceptance Criteria (Implied by Substantial Equivalence and Standards Compliance) and Reported Device Performance:

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

• No clinical test set was used. Section 8 explicitly states: "There was no clinical testing performed."
• The "test set" for this submission consists of non-clinical bench testing for performance and compliance with relevant standards. The data provenance is implied to be from Beijing ADSS Development Co., Ltd. (China), given their location and the submission coming from them.

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. As there was no clinical testing or AI/ML component, there was no need for experts to establish ground truth in the context of diagnostic or treatment efficacy. The "ground truth" for substantial equivalence is the predicate device's proven characteristics and compliance with recognized standards.

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

• Not applicable. No clinical data requiring adjudication was generated.

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 relates to AI/ML device assessment, which this product is not.

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

• Not applicable. This relates to AI/ML device assessment, which this product is not.

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

• The "ground truth" in this context is the established safety and performance of the legally marketed predicate devices and compliance with internationally recognized performance and safety standards (e.g., IEC 60601 series, ISO 10993 series for biocompatibility, IEC 60825-1 for laser safety).

8. The sample size for the training set

• Not applicable. This device does not use a training set as it is not an AI/ML device.

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

• Not applicable. No training set was used.

In summary:

This document is a 510(k) clearance letter for a diode laser therapy system. The "study" proving the device met "acceptance criteria" was primarily a non-clinical assessment based on:

• Bench testing: To confirm the device's technical specifications and performance (e.g., laser wavelength, pulse characteristics, energy fluence).
• Comparison to predicate devices: Demonstration of "substantial equivalence" in terms of intended use, technological characteristics, and safety features to legally marketed devices.
• Compliance with recognized standards: Adherence to national and international safety and performance standards for medical electrical equipment, laser devices, and biocompatibility.

The "acceptance criteria" are implied by meeting these requirements and showing that any differences from predicate devices do not raise new questions of safety or effectiveness. Clinical testing, human reader studies, and AI/ML specific evaluations (like those mentioned in your prompt) were not part of this clearance process for this type of device.

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