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Indications for use for Leaseir MHR Xcell diode laser hair removal system with 810nm applicator includes:
· Hair Removal with Static and Dynamic modes intended 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 regime.
· Treatment of Pseudofolliculitis barbae (PFB)
· Use on all skin types (Fitzpatrick I-VI)

The Leaseir MHR Xcell is a surgical laser instrument for use in general and plastic surgery and dermatology, intended for hair removal and treatment of pseudo folliculitis barbae on all skin types (Fitzpatrick I-VI).
The process implies the generation of intense light pulses at specific wavelengths. The specific nature of the energies and pulse durations cause the desired effect (in the hair follicles and oxyhemoglobin in the blood) heating them sufficiently and destroying them without unnecessary damage to surrounding tissue. This is achieved by controlled emission of laser radiation to the target tissue.
The system consists of a main console and two interchangeable applicators that delivers pulsed light in the range of 800-820nm with a peak in the 810nm in different spot sizes. Two of the applicators emitting radiation at 810 nm wavelength for two areas 13.5×15 mm² and 14.5×25.5 mm². Two different operation modes are available: static mode and dynamic mode, which are differentiated basically by the frequency range defined for each mode (1-4 Hz for static and 10 Hz for dynamic).
The principle of operation consists in the photons travel along the axis and reflected again back into the crystal, continuing the chain reaction, while photons travelling in different directions leave the crystal. In one of the two mirrors, a tiny hole allows a small amount of light to leak out and the resulting beam is focused with lenses and is emitted from the laser. The total energy emitted by the Leaseir MHR Xcell is produced by an array of diodes.
The laser emission is activated by the hand piece trigger, deliver a continuous pulse pattern while the button is pressed.

This FDA 510(k) summary is for a medical device called "Leaseir MHR Xcell," which is a diode laser hair removal system. The document establishes substantial equivalence to a predicate device ("ELYSION-PRO") rather than presenting results from a de novo clinical trial with specific acceptance criteria as you might find for a novel device or software. Therefore, the information provided focuses on comparative effectiveness and safety based on existing standards and similarities to the predicate device, rather than detailed performance metrics against specific criteria.

Let's break down the information based on your request, noting where the provided text doesn't directly address certain points:

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

The document does not explicitly state acceptance criteria in the format of "X metric must be greater than Y value." Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device. The performance is assessed by comparing the technological characteristics of the Leaseir MHR Xcell with the predicate device, ELYSION-PRO, and showing that any differences do not raise new questions of safety or effectiveness.

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

The document does not describe a clinical study with a test set of data or human subjects for evaluating the device's performance. The provided information is entirely based on non-clinical testing (bench testing) and comparison to a legally marketed predicate device to demonstrate substantial equivalence.

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 or ground truth established by experts is mentioned in this 510(k) summary.

4. Adjudication method for the test set

Not applicable. No clinical test set or adjudication process is mentioned.

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 not an AI-assisted diagnostic device, and no MRMC study was conducted or described in this submission.

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

Not applicable. This device is a laser system, not an algorithm, and its performance is evaluated through non-clinical bench testing and comparison to a predicate, not standalone algorithm performance.

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

Not applicable in the context of a clinical study. For the purposes of this 510(k) submission, the "ground truth" for demonstrating safety and effectiveness relies on:

• Compliance with recognized industry standards (e.g., IEC, ISO).
• Bench testing results demonstrating the device meets its own specifications and safety parameters.
• The established safety and effectiveness of the legally marketed predicate device.

8. The sample size for the training set

Not applicable. This document pertains to a physical laser device, not an AI algorithm requiring a training set.

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

Not applicable for the same reason as above.

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