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The 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 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 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.

The Laser Treatment System includes two (2) models, NYX and Grace, the differences between them are the external shape and the numbers of the handpiece connectors, NYX is the desktop type with one handpiece connector, and Grace is vertical stand type with two handpiece connectors.

This FDA 510(k) summary describes a Laser Treatment System (Models: NYX and Grace) intended for hair removal and permanent hair reduction. The document focuses on demonstrating substantial equivalence to a predicate device (Diode Laser Treatment System, K182924) through non-clinical performance testing.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not explicitly present a table of "acceptance criteria" for clinical effectiveness in the context of hair removal/permanent hair reduction and corresponding "reported device performance." Instead, the acceptance criteria are largely implied by compliance with recognized standards for safety and the demonstration of equivalent technological characteristics to the predicate device.

The closest we get to performance criteria are the "Indications for Use":

• "The 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."

However, the provided text does not contain data or study results demonstrating that the device meets this specific performance definition (i.e., measured hair reduction at 6, 9, and 12 months). The summary only describes non-clinical performance testing for safety and software.

Table summarizing implied acceptance criteria (primarily safety and technical equivalence) and their reported fulfillment:

Important Note: This 510(k) primarily demonstrates substantial equivalence to a predicate device, meaning it is as safe and effective as a device already on the market. It is not a de novo submission that requires extensive clinical trials to prove efficacy for the first time. The efficacy of laser hair removal devices is generally well-established in the medical literature, and clearance often relies on demonstrating that a new device operates similarly and safely.

The subsequent questions relate to clinical studies and ground truth establishment, which are not explicitly detailed in this 510(k) summary for the subject device. The document primarily focuses on non-clinical testing for safety and technical characteristics to demonstrate substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data for efficacy is provided for the subject device in this document, as the submission relies on substantial equivalence. The testing mentioned (biocompatibility, electrical safety, EMC, software) are non-clinical, controlled tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set for efficacy requiring expert ground truth is described for the subject device.

4. Adjudication method for the test set: Not applicable. (See #3)

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 device is a laser treatment system, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. (See #5)

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for clinical efficacy data for the subject device. For the non-clinical tests, the "ground truth" is defined by the standards (e.g., ISO 10993-1 for biocompatibility, IEC 60601 series for safety) and the device's design specifications for energy output and software functionality.

8. The sample size for the training set: Not applicable. This document does not describe a machine learning algorithm that requires a training set. The "software verification and validation" refers to traditional software engineering testing.

9. How the ground truth for the training set was established: Not applicable. (See #8)

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