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The Diode Laser Treatment System 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 Diode Laser Treatment System consists of the main unit and a hand piece. The system uses a diode laser as an active medium placed in an optical cavity to produce amplified beam at the wavelength of 808 nm. A microprocessor is used to control electronics for the front panel. A self-contained water cooling system is built into the power supply unit. The device provides 36 working modes, which are six modes for men and six modes for women. The men or women mode includes face, armpit, arm, body, bikini, leg mode respectively for different treatment part. The diode laser operates in a pulsed mode with a fixed pulse width and fixed pulse duration of the pulse train for each mode. The number of pulses can be adjusted within the preset range.

This document describes a 510(k) premarket notification for the Weifang KM Electronics Co., Ltd. Diode Laser Treatment System. The notification aims to demonstrate substantial equivalence to legally marketed predicate devices for hair removal and permanent hair reduction.

Based on the provided text, a clinical study proving the device meets specific performance-based acceptance criteria for hair reduction was not described. The document focuses on demonstrating substantial equivalence primarily through technological characteristics and non-clinical performance data (biocompatibility, electrical safety, EMC, and laser safety).

Here's an analysis based on your requested information:

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

The provided text does not explicitly state performance-based acceptance criteria for hair reduction (e.g., a percentage of hair reduction required) or reported device performance in terms of clinical efficacy. Instead, it defines "Permanent hair reduction" 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." This is a definition rather than an acceptance criterion with a specific threshold.

The document does include acceptance criteria and reported performance for non-clinical testing:

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

There is no information provided in the document about a clinical test set, its sample size, or data provenance related to hair reduction efficacy. The non-clinical tests mentioned (biocompatibility, electrical safety, EMC, laser safety) do not typically involve a patient sample size or data provenance in the context of clinical efficacy.

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)

Since no clinical test set for assessing hair reduction efficacy is described, there is no information provided regarding experts used to establish ground truth.

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

Since no clinical test set for assessing hair reduction efficacy is described, there is no information provided regarding an adjudication method.

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

The device is a Diode Laser Treatment System for hair removal and not an AI-assisted diagnostic or interpretation device that would typically involve a multi-reader multi-case (MRMC) study or human readers. Therefore, no such study was done or reported in this document.

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

This point is not applicable to a laser treatment system that performs a physical action (hair removal). The "standalone" performance for such a device would refer to its inherent operational capabilities, which are covered by the non-clinical tests (electrical safety, laser safety, etc.) but not in the context of algorithm-only performance.

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

For the non-clinical tests, the "ground truth" is defined by the requirements of the specific international standards (ISO, IEC). For example, for biocompatibility, the ground truth is whether the device materials elicit a toxic, irritant, or sensitizing response according to the defined test methods. As no clinical efficacy study is described, no clinical ground truth (like pathology or outcomes data for hair reduction) is mentioned.

8. The sample size for the training set

The document describes a physical medical device (Diode Laser Treatment System), not an AI/ML algorithm that would require a "training set." Therefore, this is not applicable, and no information is provided.

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

As the device is not an AI/ML algorithm requiring a training set, this is not applicable, and no information is provided.

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