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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 Irradiation Cosmetic Device (Model: HairPro Plus) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II and males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV

Irradiation Cosmetic Device (Model: HairPro Plus) consists of laser diodes that are spread throughout the cap. The device uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. In the process of the cap working, the indicator blinks red based on the working frequency of the laser diodes. Built-in timing function, the cap can record the time per treatment, and the cap can stop working automatically after each 30 minutes treatment. When the built-in IR detected the cap is not worn on the head, the laser light output will be automatically suspended immediately and the cap will automatically shut down after 10 minutes.

The provided FDA 510(k) summary for the "Irradiation Cosmetic Device (Model: HairPro Plus)" describes a device clearance based on substantial equivalence to predicate devices, rather than a study demonstrating clinical performance against established acceptance criteria for a new clinical claim.

Therefore, the information requested regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for studies supporting novel clinical claims for AI/ML-driven devices, is largely not applicable to this submission. This device is cleared based on demonstrating that it is as safe and effective as existing legally marketed predicate devices, primarily through engineering and biocompatibility testing.

Here's an breakdown based on the provided document:

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

The submission does not present a table of specific clinical acceptance criteria with corresponding performance metrics for hair growth promotion. Instead, the "acceptance criteria" are implied by compliance with various safety and performance standards for medical electrical equipment and biocompatibility, as well as demonstrating substantial equivalence to predicate devices in their design, intended use, and specifications.

The table in the document (pages 5-6) is a comparison table to predicate devices, not a performance table against clinical acceptance criteria for the subject device itself. It indicates that the subject device's specifications (e.g., wavelength, energy, treatment time, irradiance, fluence) are comparable to those of the predicate devices. The "Verdict" column indicates "SE" (Substantial Equivalence) rather than a specific performance measure.

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

No clinical test set of patients or medical images is described for this submission. The tests performed are laboratory bench tests and comparisons to predicate device specifications. Therefore, information about sample size and data provenance for a test set is not provided.

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 test set requiring expert ground truth establishment was conducted for this 510(k) submission.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring adjudication was conducted.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The submission relies on substantial equivalence to predicate devices, supported by engineering and biocompatibility testing, not human-in-the-loop performance studies comparing AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Based on the provided document, the "Irradiation Cosmetic Device" is a hardware device (laser cap) for promoting hair growth. It does not appear to be an AI/ML algorithm or software device that would have "standalone performance" in the typical sense of AI/ML. The performance demonstrated is related to its physical specifications, safety, and biocompatibility, as compared to predicate devices.

7. The type of ground truth used

For the safety and performance evaluations, the "ground truth" is implied by compliance with international standards (IEC, ISO) for electrical safety, electromagnetic compatibility, laser safety, and biocompatibility. For the substantial equivalence claim, the "ground truth" is the established safety and effectiveness profile of the predicate devices. There is no mention of a ground truth established from expert consensus, pathology, or outcomes data related to hair growth efficacy for the subject device within this 510(k) summary. Efficacy for hair growth is assumed due to the substantial equivalence to predicate devices that have prior clearance for this indication.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device that requires a training set.

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

Not applicable, as this is not an AI/ML device that requires a training set.

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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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The Irradiation Aesthetic Device (Model: HairPro) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II and males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Classification of Skin Phototypes I to IV

Irradiation Aesthetic Device (Model: HairPro) consists of laser diodes that are spread throughout the cap. The device uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. In the process of the cap working, the indicator blinks red based on the working frequency of the laser diodes. Built-in timing function, the cap can record the time per treatment, and the cap can stop working automatically after each 30 minutes treatment. When the built-in IR detected the cap is not worn on the head, the laser light output will be automatically suspended immediately and the cap will automatically shut down after 10 minutes.

The provided text is a 510(k) Summary for the "Irradiation Aesthetic Device (Model: HairPro)". This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing de novo clinical efficacy or safety through a separate performance study with acceptance criteria.

Therefore, the document does not report on a study that proves the device meets specific performance acceptance criteria in the way you've described (e.g., in terms of clinical accuracy, sensitivity, specificity, etc., for a diagnostic AI device). This is a marketing clearance for a device like an "Infrared Lamp" which generally relies on established safety and performance standards for similar devices already on the market.

Here's why the requested information cannot be fully provided from this document:

• Acceptance Criteria & Device Performance Table: The document provides "Comparison to Predicate Device" (Section 7) which lists various technical specifications and their values for the subject device and predicate devices. This is a comparison for substantial equivalence, not a list of acceptance criteria for a new performance study. The "Verdict" column indicates "SE" (Substantially Equivalent) rather than a pass/fail against a quantitative criterion.
• Sample Size and Data Provenance: This document describes bench testing against electrical safety, electromagnetic compatibility, laser safety, and biocompatibility standards (Section 6). It does not mention any clinical study involving patients or a "test set" of patient data for performance evaluation. The "Attachment 9" and "Attachment 10" are references to reports for these technical tests, not clinical data.
• Experts for Ground Truth/Adjudication Method: Since no clinical performance study involving an AI component or diagnostic capability is mentioned, there's no discussion of ground truth establishment or expert adjudication.
• MRMC Comparative Effectiveness Study: No such study is mentioned. The device is a "Irradiation Aesthetic Device" (likely a low-level laser therapy device for hair growth), not a diagnostic AI.
• Stand-alone Performance: Not applicable as it's not a diagnostic AI device.
• Type of Ground Truth: Not applicable, as no clinical performance study for an AI or diagnostic function is described. The ground truth refers to established standards for the material and electrical properties of the device.
• Training Set Sample Size and Ground Truth Establishment (for training set): Not applicable, as this is not an AI/machine learning device that requires a training set of data.

In summary, based solely on the provided 510(k) summary, the device is cleared based on its substantial equivalence to predicate devices, supported by bench testing conforming to relevant safety and performance standards, rather than a clinical study with new performance acceptance criteria.

The "acceptance criteria" for this clearance are implicitly met if the device demonstrates (through engineering specifications and bench testing) that it is as safe and effective as the predicate devices, and that any differences do not raise new questions of safety or effectiveness.

If this were an AI/ML medical device, the 510(k) summary would typically include a "Clinical Performance" section detailing studies with specific endpoints and criteria. This document does not contain such a section.

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