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The device FlexSys is a multi-modality skin surface treatment system. Depending on the chosen modules the intended use and the mode of operation varies.

Modules UVB EPL 308 and UVB EPL 308 lite:
The GME FlexSys System with module UVB EPL 308 or UVB EPL 308 lite is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.

Module Infrared 1550:
The GME FlexSys System with Infrared 1550 module is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.

The device FlexSys consists of a base unit with up to two installed internal laser modules, handpieces and/or scanners for these modules and attachable applicators. All applicators, handpieces, and scanners are connected by an electrical cable.

The base unit contains most of the controls, such as the touch-screen, the on / off switch or the emergency stop button. In addition, the power cord, foot switch, and the door plug are connected there. The touch-screen serves as the main control panel.

The applicators, handpieces, and scanners direct the light onto the skin. Some applicators contain a hand switch on the front of the handle by which light emission can be triggered.

The scanners and handpieces of the internal modules are connected to the base unit by an electric signal cable and by an optical fiber which guides the aiming beam and working beam laser light to the handpiece/scanner in its core. The light is then guided onto the skin via several mirrors and lenses. Due to the round shape of the fiber core the resulting laser spot on the skin is circular. The size of the working beam spot corresponds to the nominal value when the distance tip touches the skin. For larger distances the spot size will increase, i.e. the laser beam is divergent.

The provided text is a 510(k) Summary for a medical device (FlexSys). This type of document is for demonstrating substantial equivalence to a predicate device, not typically a full clinical study with acceptance criteria and performance metrics in the way a diagnostic AI device would be evaluated. Lasers are hardware devices, and their performance is primarily assessed through compliance with safety and performance standards, not diagnostic accuracy metrics like sensitivity or specificity.

Therefore, many of the requested points are not applicable or cannot be extracted from this document, as it describes a laser system for dermatological procedures, not a diagnostic AI device.

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) or not provided:

1. Table of acceptance criteria and reported device performance:

This document focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and safety standards, rather than specific performance metrics against clinical acceptance criteria for a diagnostic purpose. The "performance" for a laser device often refers to its safety and specified output parameters (e.g., wavelength, power, pulse duration), which are generally demonstrated through engineering and electrical/laser safety testing reports rather than clinical outcome measures with predefined acceptance thresholds.

2. Sample size used for the test set and the data provenance:
N/A. This is a laser device, not a diagnostic AI device that would typically have a "test set" of clinical data to evaluate algorithms. Its performance is evaluated through engineering and safety testing. The document states "Testing reports were submitted for the following standards," implying laboratory/bench testing rather than clinical data from a "test set."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
N/A. As this is not a diagnostic AI device, there is no "ground truth" in the context of expert diagnosis or interpretation of images/data for a test set. The validation revolves around engineering specifications and safety compliance.

4. Adjudication method for the test set:
N/A. Not applicable for a laser device's regulatory submission focused on engineering and safety standards.

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:
N/A. This device is a laser system, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
N/A. Not applicable to a laser device.

7. The type of ground truth used:
N/A. The "ground truth" for a laser device would be its physical properties and measured output (e.g., wavelength accuracy, power output, beam profile) confirmed against engineering specifications, and its safety compliance proven through adherence to international standards (IEC 60825-1, IEC 60601-2-22, IEC 60601-1, IEC 60601-1-2).

8. The sample size for the training set:
N/A. This is a hardware device; there is no "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:
N/A. Not applicable to a hardware device.

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