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The ClearLink Controlled Phototherapy Equipment are medical ultraviolet devices, which are intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet radiation for diagnosed skin disorders. When equipped with blue lamps the ClearLink Controlled Phototherapy Equipment is intended for use for the treatment of mild to moderate acne vulgaris.

The ClearLink Controlled Phototherapy Equipment are medical ultraviolet devices, which are intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet radiation for diagnosed skin disorders. The ClearLink Phototherapy Equipment delivers treatment, with Narrow Band UVB, Broad Band UVB and/or UVA ultraviolet light. Treatments are controlled through the ClearLink Software interface. Access to this interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Authorized operators program treatments in joules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency.

The provided document is a 510(k) premarket notification for the "ClearLink Controlled Phototherapy Equipment." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific technical performance acceptance criteria through the kind of rigorous, independent study typically associated with AI/software as a medical device (SaMD).

Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving a device meets them in the context of an AI/SaMD. This device is a phototherapy unit, and its substantial equivalence is based on its construction, intended use, energy sources, and control system updates, rather than diagnostic performance metrics.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance (in the sense of AI performance metrics like sensitivity, specificity, AUC).
• Any details about a test set sample size, data provenance, or ground truth establishment by experts for diagnostic purposes.
• Information on Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance.

The "Performance Standards" section (page 6) explicitly states: "The ClearLink controlled phototherapy equipment performance data is the same as or very similar to that of the claimed predicate device. The ultraviolet light tubes and cabinet construction used in the production of the predicate device and the ClearLink controlled phototherapy equipment are the same. The only difference between the predicate flex devices and the link devices is the substitution of the link controller for the flex controller for actual entry of doses. The rest of the devices (materials, construction, treatment modality, patient safety, etc., remains exactly the same."

This statement highlights that the performance here refers to the physical and functional constancy with the predicate device, not the diagnostic accuracy or efficacy evaluation of an AI component.

In summary, none of the requested information regarding acceptance criteria, study design parameters (sample size, experts, ground truth, MRMC), or training set details for an AI/SaMD are present in this document because it is not an AI/SaMD submission.

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The 3 Series NeoLux, full body phototherapy device, is a medical ultraviolet cabinet, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (1 - VI).

The 3 Series NeoLux Phototherapy Unit is a full body medical ultraviolet device, which is intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet radiation for diagnosed skin disorders. The 3 Series NeoLux Phototherapy Unit delivers a 360 degree full body treatment, with spectral output at peak wavelengths of 311 nm (Narrow Band UVB) and/or 350 nm (UVA), through an array of 24-48 fluorescent lamps. Treatments are controlled through the Soft Touch Software interface. Access to this interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Authorized operators program treatments in joules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency.

The provided document describes the Daavlin 3 Series NeoLux Phototherapy Unit, a medical device for dermatologic disorders. However, it is a 510(k) summary for substantial equivalence to a predicate device, not a study demonstrating the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. Instead, it focuses on demonstrating that the new device is as safe and effective as a previously cleared device. Therefore, a direct answer to the request to populate a table of acceptance criteria and reported device performance related to a diagnostic or clinical outcome study, and details about sample sizes, ground truth establishment, or multi-reader studies, cannot be fully provided from this document.

The document does however, provide information regarding performance standards and non-clinical testing for compliance with electrical and EMC standards.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a phototherapy unit based on substantial equivalence, the "acceptance criteria" are primarily related to safety, electrical performance, and functional equivalence to the predicate device. It is not a diagnostic device with performance metrics like sensitivity, specificity, or AUC.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not applicable. This document describes a medical device, not a diagnostic algorithm or AI system that uses medical image data for a test set. The substantial equivalence relies on design, function, and safety testing, not on a clinical test set of patient data with ground truth.

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

• Not applicable. As stated above, there is no test set of patient data requiring expert ground truth in this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. No test set of patient data.

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 is not an AI-assisted diagnostic device.

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

• Not applicable. This is a phototherapy unit, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable. No ground truth for clinical outcomes data is discussed in this 510(k) summary, as it is based on substantial equivalence to a predicate device for its intended use, rather than proving new clinical efficacy through trials. The "ground truth" for the device's performance is adherence to electrical and safety standards, and functional equivalence to the predicate.

8. The sample size for the training set

• Not applicable. This is not an AI/ML-driven device that requires a training set.

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

• Not applicable. No training set exists for this device.

Summary based on the provided document:

The Daavlin 3 Series NeoLux Phototherapy Unit is a medical ultraviolet device intended for the treatment of psoriasis, vitiligo, and atopic dermatitis. Its acceptance criteria for FDA clearance (via 510(k)) were primarily based on demonstrating substantial equivalence to a previously cleared predicate device (the 3 Series SP/PC Phototherapy Unit, K063621).

The study that proves the device meets the "acceptance criteria" (i.e., substantial equivalence) is the comparison of the new device's design, materials, manufacturing, indications for use, and performance characteristics (e.g., spectral output, electrical requirements) to that of the predicate device, along with non-clinical performance testing for adherence to recognized electrical and safety standards (IEC 60601-1-2:2007, IEC 60601-1:2012, and IEC 60601-2-57:2011). The document explicitly states that the new device is "identical in nearly every aspect" to the predicate, with the only differences being changes in exterior cosmetics and lamp covering. This implies that the performance in these non-clinical tests was successful and confirmed the device's safety and functional equivalence to the predicate.

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