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The 7 Series Phototherapy Devices are indicated for use to treat diagnosed skin disorders such, as but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. The population may range from pediatric to geriatric.

The 7 Series Phototherapy Equipment is a partial-body, ultraviolet light source emitting phototherapy panel. The physician will determine the light spectrum (ultraviolet to visible), the energy or duration of the treatment, as well as the treatment environment. Its nominal size ranges from a 4 lamp no door; 74.5 In X 20 In X 24 In, 75 lbs (189.2 cm X 50.8 cm X 61 cm, 34 kg) to a 12 lamp with doors open; 74.5 In X 39.5 In X 24 In, 129 Lbs. (189.2 cm X 100.3 cm X 61 cm, 58.5 Kg) that is controlled by either an integrated digital timer with an LCD segmented display and four membrane buttons as the interface (the Flex Controller) or a microprocessor controller with an LCD touch screen display (the ClearLink Controller). When the operator sets the treatment time or the desired dose using the operator interface located on the control panel, the treatment begins by illuminating the lamps which emit the prescribed light. The treatment area consists of 4, 6, 8, 10, or 12 100-watt lamps and reflective surfaces configured in a panel. The patient stands in front of the panel during treatment.

This document describes the 7 Series Phototherapy Device, which is a medical device and not an AI or software device. Therefore, the questions related to AI/software performance criteria (such as sample size, ground truth, experts, MRMC studies, or standalone performance) are not applicable.

The performance of the 7 Series Phototherapy Device is established through comparison to a legally marketed predicate device, the ClearLink Phototherapy Equipment (K182215). The submission states that the new device's performance data is "the same as or very similar" to the predicate.

Here's the information available regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and data provenance:
This information is not applicable as the device's performance is demonstrated through substantial equivalence to a predicate device, rather than a clinical trial with a distinct test set. The submission states that the 7 Series Phototherapy Equipment is constructed with "identical energy sources and materials of identical or similar composition" and that the "lamps and construction used in the production of the predicate devices and the 7 Series phototherapy equipment are the same."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment by experts is described for this type of device submission, as it relies on substantial equivalence to an existing device.

4. Adjudication method for the test set:
Not applicable. No test set requiring adjudication is described.

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 device.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm.

7. The type of ground truth used:
Not applicable. Performance is established by demonstrating substantial equivalence to a predicate device, not by comparing to a "ground truth" in the context of diagnostic accuracy.

8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI/machine learning device.

Study Summarized:

The study that proves the device meets the acceptance criteria is a substantial equivalence comparison study to a predicate device (ClearLink Phototherapy Equipment, K182215). The core of the evidence is that the 7 Series Phototherapy Equipment shares fundamental technological characteristics and performance features with the legally marketed predicate.

The 510(k) summary explicitly states that the 7 Series phototherapy equipment is constructed "in the same design configuration as the predicate device, utilizing identical energy sources and materials of identical or similar composition." It further asserts that the "spectral output, mode of operation, labeling, treatment area, treatment modality, patient safety, and general operating principals of the 7 Series phototherapy equipment is the same or similar to those of the predicate device."

This type of study does not involve prospective clinical trials with specific acceptance criteria in the typical sense of measuring efficacy against a clinical outcome. Instead, it demonstrates that the new device performs as safely and effectively as a device already on the market through direct comparison of its technical specifications and principles of operation.

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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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