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The M Series Phototherapy Devices are indicated for use to treat diagnosed skin disorders such, as but not limited to, psoriasis, vitiligo, and atopic dermatiis (eczema) under the direction of a physician will determine the light spectrum (ultraviolet to visible), the energy or duration of the treatment, as well as the treatment environment. The population may range from pediatric, when accompanied by a responsible adult to operate it, to geriatric.

The M Series Phototherapy Devices are intended to be used as a partial body therapeutic device. They are designed to be used under the direction of a physician for individuals who require phototherapy. Treatments are controlled through the ClearLink Software interface or the Smart Touch Software interface. Access to the interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Authorized operators program treatments in joules or millijoules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency.

This document is a 510(k) Premarket Notification from the FDA regarding the "M Series Phototherapy Equipment." It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria for a new, innovative device.

Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating the performance of a novel diagnostic or AI-driven device, is not present in this document.

The document indicates that the M Series Phototherapy Equipment's performance data is "the same as or very similar to that of the claimed predicate device." It also states that the lamps and construction are the same, and the primary difference is an updated indication for use and intended use. This implies that the device is not being evaluated for new performance outcomes requiring extensive clinical studies with specific acceptance criteria that would typically be detailed in a submission for a novel technology. Instead, it relies on the established safety and effectiveness of its predicate devices.

Based on the provided text, the following information can be extracted/inferred:

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

   • This document does not specify quantitative acceptance criteria or detailed performance metrics for the M Series Phototherapy Equipment itself. The basis for clearance is substantial equivalence to predicate devices.
   • Implied "Performance": The document states: "The M Series phototherapy equipment performance data is the same as or very similar to that of the claimed predicate device. The lamps and construction used in the production of the predicate devices and the M Series phototherapy equipment are the same." This implies that its performance is accepted as equivalent to the predicates (ClearLink Controlled Phototherapy Equipment K182215 & 1 Series Phototherapy Unit K100378).

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

   • No specific "test set" or associated sample size is mentioned, as this is not a study validating a new performance claim. The submission relies on a comparison to predicate devices, not on new clinical data demonstrating specific performance numerically.

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

   • Not applicable, as no new test set requiring expert ground truth establishment for a novel performance claim is described.

4. Adjudication method for the test set:

   • Not applicable.

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 phototherapy equipment, not an AI or diagnostic tool.

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

   • Not applicable. This is not an algorithm.

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

   • Not applicable, as new performance claims requiring ground truth establishment are not the basis of this submission. The "ground truth" for its safety and effectiveness is implicitly derived from the previously cleared predicate devices.

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device requiring a training set.

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

   • Not applicable.

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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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