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The Diode Laser Hair Removal Device (Model: EVOLUTION MEDICAL, M-I-X MEDICAL, GENESIS, Lotus and Ultimate) 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 Hair Removal Device is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a diode laser as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a foot switch and a laser handpiece. There are five models included, EVOLUTION MEDICAL, M-I-X MEDICAL, GENESIS, Lotus, and Ultimate, the five models have same mechanism of action, principle and specification, with only one difference: the adjustable range of Energy density is different, EVOLUTION MEDICAL (1-77 J/cm^2), M-I-X MEDICAL (1-70 J/cm^2), GENESIS (1-74 J/cm^2), Lotus(1-67 J/cm^2), and Ultimate(1-65 J/ cm^2).

Changes to the device include the addition of a remote link to the device to obtain and back up the device's usage data, a remote upgrade function, and the ability to provide a URL for users to download the device's usage data, as compared to previously listed devices.

The provided text describes a 510(k) premarket notification for a Diode Laser Hair Removal Device. This document focuses on establishing substantial equivalence to a predicate device rather than detailing a clinical study with acceptance criteria for a new device's performance.

Therefore, the sections below requiring information about acceptance criteria and a study proving the device meets them cannot be fully populated as they would for a de novo or PMA submission. The document primarily discusses non-clinical tests to verify design specifications and compliance with standards.

Here's the information that can be extracted or inferred from the provided text, with clarifications where details are not present:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a table of explicit acceptance criteria with corresponding device performance metrics for efficacy (e.g., specific hair reduction percentages) as would be found in a clinical study report for a new device.

Instead, the document focuses on demonstrating that the device meets safety and performance standards and is technologically equivalent to its predicate. The "performance" discussed primarily relates to meeting design specifications and regulatory standards.

2. Sample Size Used for the Test Set and Data Provenance

The document primarily refers to non-clinical tests for compliance with standards and design specifications. It does not describe a clinical test set with human subjects.

• Test Set Sample Size: Not applicable as a clinical test set is not described. The tests are for device components and system performance.
• Data Provenance: The tests are non-clinical, related to device manufacturing and engineering compliance. No country of origin for clinical data is applicable. The tests are prospective in the sense that they are conducted on the new device to demonstrate compliance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the document describes non-clinical engineering and compliance testing, not a clinical study requiring expert ground truth assessment.

4. Adjudication Method for the Test Set

Not applicable, as this refers to a clinical study with human observers or interpreters, which is not described here.

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 hair removal system, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in a diagnostic context.

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

Not applicable. This device is a physical laser system, not an algorithm, and the concept of "standalone performance" for an algorithm is not relevant here.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is defined by the requirements outlined in the cited international and national standards (e.g., IEC 60601-1, ISO 10993) and the device's design specifications. These standards provide benchmarks and methodologies against which the device's performance is measured.

8. The Sample Size for the Training Set

Not applicable. As this document details hardware medical devices, there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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