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The Diode Laser Therapy Device (Model: DF-DIODE LASER-S1) 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.

Diode Laser Therapy Device adopts semi-conductor laser, based on selective photothermolysis principle, through specific wavelength, penetrate epidermis, optical energy was absorbed and translated into heat energy with restraining hair follicle tissues, and produce photothermal effect. It takes laser energy in hair follicle with rich in melanin, surrounding tissues absorb less even no energy, reach to restrained melanin of hair follicles and remove hair. The Diode Laser Therapy Device utilize a semiconductor diode with invisible infrared radiation as a laser source to emit 808nm wavelength laser which is absorbed by melanin. The laser power is delivered to the treatment area via laser handpiece. The emission laser is activated by a foot-switch.

This document is a 510(k) summary for a Diode Laser Therapy Device. Such summaries often focus on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than reporting on extensive clinical studies with detailed acceptance criteria and performance metrics typically seen for novel AI/ML-based devices.

Based on the provided text, the device in question is a Diode Laser Therapy Device (DF-DIODE LASER-S1), intended for hair removal and permanent hair reduction.

Here's an analysis of the requested information, specifically noting what is not present, as this is a traditional medical device submission, not an AI/ML device:

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

The document doesn't present a table of specific acceptance criteria in the way one might expect for an AI/ML device (e.g., minimum sensitivity, specificity, or AUC). Instead, it relies on demonstrating substantial equivalence to a predicate device (K211335) through non-clinical performance and safety testing. The "acceptance criteria" are implicitly met by successful compliance with various international standards.

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

• Sample Size: Not applicable. This submission relies on performance testing (e.g., electrical, EMC, laser safety, biocompatibility) against established standards rather than a clinical test set with a "sample size" of patients/studies.
• Data Provenance: Not applicable for the type of testing described (non-clinical).

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

Not applicable. There is no "ground truth" establishment in the context of clinical images or patient data for this type of device submission. The device's performance is assessed against technical safety and performance standards.

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

Not applicable. No adjudications of clinical data were performed.

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 is a laser therapy device, not an AI/ML diagnostic or assistive device for human readers. No MRMC study was conducted.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable. The "ground truth" for this device exists in compliance with international safety and performance standards (e.g., IEC 60601 series, ISO 10993 series) and the demonstrated equivalence of its technical parameters to a legally marketed predicate device.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. No training set.

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