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The GME ExSys 308 System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.

The ExSys 308 is an ultratraviolet light system designed to be used in Dermatological practice for the treatment of psoriasis and vitiligo. The ExSys 308 System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button, speaker), which controls an applicator unit. The applicator unit contains the UV light source. The model number is ExSys 308. The ExSys 308 System includes the following accessories: Power cord, optional foot switch, laser protective goggles, applicator holder, and set of treatment tips. The treatment tip (a distance spacer) is the only patient contacting part of the system. There are no single use parts in the ExSys 308 System.

This document is a 510(k) premarket notification for the GME ExSys 308 System, an ultraviolet light device for dermatological disorders. It aims to demonstrate substantial equivalence to a predicate device, the Quantel 308 Dermatological Excimer System. The information provided focuses on the device's technical specifications and safety testing, typical for a substantial equivalence claim under 510(k) for a Class II device. It does not contain a clinical study with acceptance criteria and device performance as typically understood for AI/ML device evaluations.

Therefore, the following points address what can be extracted from the provided text, and explicitly states where information is not available given the nature of this submission.

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission is for a physical medical device (UV lamp) and focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and safety standards, rather than clinical performance metrics typically associated with AI/ML systems (e.g., sensitivity, specificity, accuracy).

Note: For devices subject to 510(k), "acceptance criteria" are generally derived from demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through comparison of technical specifications and adherence to recognized standards. Clinical performance metrics like sensitivity/specificity are not typically required for this type of device.

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

• Sample Size for Test Set: Not applicable. This submission does not involve a "test set" in the context of an AI/ML algorithm evaluation using patient data. It describes nonclinical safety and performance testing of a physical device.
• Data Provenance: Not applicable. The testing described is nonclinical (e.g., electrical safety, optical performance).

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

• Number of Experts & Qualifications: Not applicable. Ground truth, in the context of clinical expert consensus, is not relevant to the nonclinical testing described for this device.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set or adjudication process is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with evaluating AI interpretation or diagnostic assistance systems used by human readers, which is not the nature of this physical device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: No, a standalone study (in the context of an algorithm's performance) was not done. The device is a direct treatment tool, not an AI/ML diagnostic or interpretive algorithm. The reported performance refers to the physical output and safety of the UV light system itself.

7. Type of Ground Truth Used

• Type of Ground Truth: For the nonclinical performance and safety testing, the "ground truth" refers to established engineering standards (e.g., IEC 60601-2-57, EN 60601-1, EN 60601-1-2) and the known specifications and performance of the predicate device. The illumination homogeneity and treatment tip transmission were evaluated against defined technical limits.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not employ an AI/ML algorithm that requires a "training set."

9. How Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.

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The GME LinScan System with the applicators LinScan 808 and LinScan 980 is indicated for hair removal and permanent hair reduction defined as the stable, long term reduction in hair counts at 6, 9,or 12 months following a treatment regime.

The LinScan is a diode laser system designed to be used in Dermatological practice for stable, long term hair reduction. The LinScan System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button), which controls an applicator unit. The applicator unit contains the diode laser and scanner. The unit comes in two models: the LinScan 808 has an applicator with a 808 nm diode laser. The LinScan 980 has an applicator with a 980 nm diode laser. The LinScan System includes the following accessories: Power cord, foot switch, laser protective goggles, applicator holder, and coolant refill kit. A cooled sapphire is the only patient contacting part of the system. There are no single use parts in the LinScan System. Principle of Operation: The laser light is converted to heat when it strikes a chromophore (pigment). The hair follicle contains pigment and reacts to laser light by heating. Heating denatures proteins in the hair follicle, retarding hair growth.

The provided document, K141063 does not contain information on testing results that demonstrate the device meets acceptance criteria. The document is primarily a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.

Key observations:

• No Acceptance Criteria Table: The document does not include a table outlining specific acceptance criteria for device performance.
• No Reported Device Performance: While the document lists device specifications (e.g., fluence, pulse widths, wavelength), it does not present performance data from a study to show how the device actually performed against any predefined acceptance criteria.
• Focus on Substantial Equivalence: The "Performance Data" section ([4] K141063, H. Performance Data) exclusively mentions adherence to IEC standards (IEC 60825-1 and IEC 60601-2-22) for electrical and laser safety, which are general safety and performance standards for laser products, not specific clinical or technical performance acceptance criteria for hair reduction.
• No Clinical Study Details: There is no mention of a human clinical study, sample sizes, data provenance, ground truth establishment methods, or expert involvement for evaluating the device's efficacy in hair removal or permanent hair reduction. The indications for use mention "stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime," which implies a need for clinical data to substantiate, but such data is not provided in this summary.

Therefore, many parts of your request cannot be fulfilled based on the provided input.

However, I can provide a general understanding of what such a table would look like and address the limited information available:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the provided document does not include specific acceptance criteria or performance data for hair removal/reduction efficacy. If it did, a table might look something like this (hypothetical example):

Information Not Found in the Document:

• 2. Sample size used for the test set and the data provenance: Not mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not 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, as this is a laser device, not an AI diagnostic tool, and no MRMC study is mentioned.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a laser device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
• 8. The sample size for the training set: Not applicable, as this is a laser device, not an AI/algorithm-based system requiring a training set in the conventional sense.
• 9. How the ground truth for the training set was established: Not applicable.

Summary of Device Performance Information Available in the Document:

The document ([3] K141063, H. Performance Data) states that the device demonstrated conformance with the following safety and general performance standards:

• IEC 60825-1: General safety standard for laser products.
• IEC 60601-2-22: Specific safety standard for surgical, cosmetic, therapeutic, and diagnostic laser equipment.

The submission is a 510(k) for substantial equivalence. The primary "proof" meeting acceptance criteria for this type of submission is the demonstration that the device's technical specifications and safety profile are comparable to a legally marketed predicate device, and that it conforms to relevant recognized safety standards. The document asserts that the LinScan System "was found to be substantially equivalent to the predicate device, the LEDA from Quantel Derma, in terms of technology, function and intended use" and that "there are no new questions of safety or efficacy raised" ([4] K141063, I. Conclusion).

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