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The LightSheer pulsed diode array laser systems are indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer pulsed diode array laser systems are intended for use on all skin types (Fitzpatrick skin types I – VI), including tanned skin.

The LightSheer Desire Light Laser System with LightSheer ET/XC Laser Handpiece is indicated for the treatment of vascular lesions, including angiomas, telangiectasia and other benign vascular lesions, the treatment of Pseudofolliculitis Barbae (PFB). The LightSheer Desire Light Laser System with LightSheer ET/XC Laser Handpiece is also indicated for hair removal, permanent hair reduction* and the treatment of benign pigmented lesions and leg veins.

• Note: 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 modified LightSheer Desire Light Laser System is a non-invasive aesthetic laser system that delivers pulsed infrared laser light with a wavelength ranging from 790-830 nm (805 nm nominal). The system consists of a laser console and two optional handpieces, ET or XC, which can be connected to the console, one at a time, via a universal plug-in connector and an umbilical cable.

The ET handpiece; delivers laser energy through a 9mm tip up to 81 J maximum. The settings for this handpiece are selectable pulse duration from 5-400 ms, selectable fluency from 10-100 J/cm² and a pulse repetition rate up to 3 Hz maximum. The XC handpiece; delivers laser energy through a 12mm x 12mm tip up to 58 J maximum. The settings for this handpiece are selectable pulse duration from 5-400 ms, selectable fluency from 10-40 J/cm² and a pulse repetition rate up to 3 Hz maximum

The laser system delivers pulsed infrared laser light from the diode array in the ET or XC handpiece to the treatment area. In standard use, the handpiece is pressed against the patient's skin and a pulse of light is delivered. To initiate energy output, the system requires redundant activation of the handpiece enable button and the handpiece trigger button while the system is in the Ready mode.

The ET and XC handpieces include a chilled sapphire tip that is water-cooled to provide active skin cooling. The physician is able to control the settings of laser energy from the LCD display on the main console.

The provided text describes the 510(k) premarket notification for the "LightSheer Desire Light Laser System." This document establishes substantial equivalence to a predicate device rather than focusing on specific performance metrics against pre-defined acceptance criteria for a new device. Therefore, it does not contain the detailed information necessary to fully answer all aspects of your request as it pertains to acceptance criteria and a study proving those criteria.

However, based on the information provided, here's what can be extracted and inferred:

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

The document does not present specific quantitative acceptance criteria or a table of performance metrics in the way one might expect for a study proving device performance against such criteria. Instead, it states that "Test results indicated that the subject LightSheer Desire Light Laser System performs in accordance with its requirements and specifications, in similarity to its predicate device."

The "performance" in this context refers to demonstrating that the modified device functions comparably to its predicate and meets safety standards. The categories of testing performed are:

The ultimate "acceptance criterion" for this 510(k) submission is that the device is "substantially equivalent" to the predicate device in terms of safety and effectiveness, and the document concludes that it meets this.

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

The document does not specify a "test set" in the context of clinical data for performance evaluation. The testing described (electrical, software, environmental, system) suggests a regulatory/engineering testing approach rather than a clinical study with a patient sample size. There is no mention of country of origin of data or whether it was retrospective or prospective, as no clinical data set is referenced.

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

Not applicable. This type of information is generally relevant for clinical studies involving expert interpretation of medical images or outcomes, which is not the primary focus of the performance testing described here. The "ground truth" for electrical safety, software function, etc., is based on engineering specifications and regulatory standards.

4. Adjudication method for the test set

Not applicable, as no human-reviewed data sets or adjudications are 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 a laser 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

This refers to the performance of the device itself as a physical system, rather than an algorithm. The "System testing" mentioned (e.g., energy measurements, handpiece cooling, safety controls) represents the standalone performance evaluation of the device's functional aspects. The document implies these tests were performed to ensure the device operates according to its specifications.

7. The type of ground truth used

The "ground truth" for the tests performed are primarily the engineering specifications, design requirements, and international safety standards (e.g., EN 60601-1, EN 60825-1, ISO 14971) against which the device's electrical, laser, mechanical, and software functionality were evaluated. For example, for "energy measurements," the ground truth would be the expected energy output within a specific tolerance, as defined by the device's design specifications.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this device is not an AI/machine learning system that requires training data.

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

Not applicable for the same reason as #8.

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