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The Milesman Premium Pulsed Diode Array Laser System is intended for use in general and plastic surgery and dermatology procedures for the treatment of vascular lesions, such as angiomas, hemangiomas, telangiectasia and other benign vascular lesions and treatment for pseudofolliculitis barbae.

The Milesman Premium is also used for removal of unwanted hair, permanent hair reduction and the treatment of benign pigmented lesions and leg veins in all skin types (Fitzpatrick I-VI), including tanned skin.

The Milseman Premium Pulsed Diode Array Laser System delivers pulsed laser light at 800 nm wavelength. The device consists of three interconnected sections: the system console, the handle hose (umbilical cord) to the handpiece, and the handpiece. The laser pulsed energy is delivered through the handpiece. A user is able to select specific laser parameters from the touch screen on top of the console.

The provided document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. Instead, it is a 510(k) summary indicating substantial equivalence to a predicate device.

Here's a breakdown of why the requested information is not available in the given text:

1. Acceptance Criteria and Reported Device Performance: This information is missing entirely. The submission states that "performance data are not required" because the device has "very similar specifications and indications for use" to its predicate.

2. Sample Size and Data Provenance (Test Set): Not applicable, as no performance study was conducted.

3. Number of Experts and Qualifications (Ground Truth for Test Set): Not applicable, as no performance study was conducted.

4. Adjudication Method (Test Set): Not applicable, as no performance study was conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study was done, as per the statement that "Performance Data: The Milseman Premium Pulsed Diode Array Laser System and the predicate LightSheer Pulsed Diode Array Laser System have very similar specifications and indications for use and as such, the performance data are not required." Therefore, there's no reported effect size of human readers improving with AI vs. without AI assistance.

6. Standalone Performance Study: No standalone (algorithm only without human-in-the-loop performance) study was done, as indicated by the lack of performance data requirement.

7. Type of Ground Truth Used: Not applicable, as no performance study was conducted.

8. Sample Size for Training Set: Not applicable, as this is a medical device (laser system), not an AI algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established: Not applicable, as the device is not an AI algorithm requiring a training set with ground truth.

In summary, the provided 510(k) summary for the Milesman Premium Pulsed Diode Array Laser System is based on demonstrating substantial equivalence to a predicate device (LightSheer™ Pulsed Diode Array Laser System), rather than on new performance data or clinical studies for the Milesman device itself.

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