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

The proposed device, 308nm Excimer System is a new type of ultraviolet light therapy instrument, which could emit high levels of UV light. It has the following features:

• High intensity UV light.
• The instrument is suitable for small area treatment with good targeting.
• 8 inches Super Large color touch LCD screen which make the operation display more convenient;
• Manual MED tests can also be performed according to the skin characteristics of the patient.
• One-click Control light source Output.
• Powerful user management capabilities.
• Can realize the export and view of user information;
• Multi-spec treatment handle light filter. The user can choose filter according to the size of the treatment area. Avoid excess radiation output.
• Fingerprint entry makes it easy for doctors to quickly access patient information (for KN-5000D):
• Accurate calibration system. Enhanced reliability of instrument dose output (KN-5000D applicable).

Here's a breakdown of the acceptance criteria and study information for the 308nm Excimer System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative sense for performance as one might expect for an AI/diagnostic device. Instead, it relies on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with relevant safety and performance standards. The "performance" being evaluated is the device's adherence to these standards and its operational characteristics being comparable to legally marketed devices.

Note on "Analysis 1, 2, 3, 4" from the document: These sections discuss slight differences in specifications like Max Power Output, Treatment Area, Treatment Time, Maximum Dose, Power Source, MED Dose Determination, and Operating/Storage Environment. The conclusion for each is that these differences fall within the range of predicate devices or comply with relevant standards, and therefore do not raise any safety or effectiveness issues, thus meeting the implicit acceptance criteria of being substantially equivalent.

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

• No clinical test set was used for this submission. The document explicitly states: "No clinical study is included in this submission."
• The device's substantial equivalence was determined based on non-clinical (lab bench) testing and comparison to predicate devices' specifications and compliance with international standards.

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

• Not applicable. As no clinical studies were performed and the evaluation relied on non-clinical testing and comparison to predicate devices, there was no ground truth for a test set established by experts in the context of diagnostic performance.

4. Adjudication method for the test set:

• Not applicable. No clinical test set.

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 medical equipment (ultraviolet lamp) for treatment, 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:

• Not applicable. This is a medical device, not an algorithm. Its performance is evaluated based on its physical and operational specifications and compliance with safety standards, not an algorithm's output.

7. The type of ground truth used:

• For non-clinical tests: The "ground truth" implicitly refers to the specified values, ranges, and requirements outlined in the international standards (e.g., IEC 60601-1, IEC 60601-2-57, IEC 60601-1-2, IEC 62471, ISO 10993-5, ISO 10993-10) that the device was tested against. Compliance with these standards served as the "truth" for safety and basic performance characteristics.
• For substantial equivalence: The "ground truth" is the established safety and effectiveness of the legally marketed predicate devices, which the proposed device aims to demonstrate equivalence to based on technological characteristics and compliance with standards.

8. The sample size for the training set:

• Not applicable. This device is a physical medical equipment, not an AI model that requires a training set.

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

• Not applicable. No training set was used.

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The 308nm Excimer System (model: XECL-308E) is an Ultraviolet Light Emitting Medical Device. It is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. It is to be used on intact skin only.

The 308nm Excimer System (model: XECL-308E)is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, and leukoderma on all skin types (I-VI). The system including a main body, power line, handpiece holder, XeCl lamp, handpiece, and output light window adapter. The handpiece includes a contains light emitting diodes (LEDs), which create an array of narrowband UVB light centered at a wavelength mainly between 308±2 nm. The device should be operated by a professional doctor in the hospital for the treatment.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of an AI/ML-driven medical device.

The document is a 510(k) summary for the "308nm Excimer System" (model: XECL-308E), which is an Ultraviolet Light Emitting Medical Device. It describes the device's indications for use, its comparison to predicate devices, and lists various electrical safety and electromagnetic compatibility standards it complies with (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, and IEC 62304 for software).

However, none of the details you requested regarding acceptance criteria, device performance, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information for an AI/ML device are present. The device described here is a physical medical device (an excimer lamp), not an AI/ML software device.

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

308nm Excimer System is an ultratraviolet light system designed to be used in Dermatological practice for the treatment of psoriasis and vitiligo. The lamp is axenon-chloride excimer lamp which utilizes a XeCl gas mixture to generate specific ultraviolet light at wavelenath of 308 nm. It displays the treatment parameters. Users can set the device and fluence on the control touch screen and determine the machine's state and function under the help of colour-coded indicator light.

The provided document is an FDA 510(k) premarket notification for a medical device (308nm Excimer System) and does not contain information about acceptance criteria or a study proving the device meets specific performance metrics typically associated with AI/ML-based medical devices or diagnostic tools.

This document primarily focuses on establishing "substantial equivalence" of the 308nm Excimer System to a legally marketed predicate device (GME ExSys 308) for treating psoriasis and vitiligo. The "tests" mentioned are bench testing for electrical safety, electromagnetic compatibility, and general safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57) and software lifecycle processes (IEC 62304). These are regulatory compliance tests, not performance studies as would be conducted for a diagnostic device's accuracy or an AI algorithm's effectiveness in a clinical context.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance in the context of accuracy, sensitivity, specificity, or clinical utility as would be applicable to an AI device. The document does not describe such a study.

The questions you asked are relevant for AI/ML medical devices where performance benchmarks and clinical validation studies are crucial. This document, however, describes a light therapy device where the primary regulatory hurdle is demonstrating equivalence to an existing device, not proving a new clinical efficacy or diagnostic accuracy.

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