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The Radiancy Acne System with ClearTouch Light Unit Assembly ("Radiancy Acne System") is intended to provide phototherapeutic light to the body. The Radiancy Acne System is generally indicated to treat dermatological conditions. The Radiancy Acne System is specifically indicated to treat mild to moderate inflammatory acne vulgaris which includes pustular inflammatory acne, in patients with Fitzpatrick skin types I-VI.

The ClearTouch LUA is mounted on the hand piece of Radiancy's SpaTouch Photoepilation System (the "SpaTouch"), or on the hair removal / acne hand piece of Radiancy's SkinStation (the "SkinStation"), in order to treat acne vulgaris (the "Radiancy Acne System"). The Radiancy Acne System consists of two green-coated flash lamps. The Radiancy Acne System produces a wavelength spectrum of 430 – 1100 nm with a pulse duration of 35 msec and has a spot size of 22 x 55 mm.

The provided document is a 510(k) summary for the Radiancy Acne System with ClearTouch™ Light Unit Assembly, dated April 27, 2005. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain the detailed study information required to fully answer the questions about acceptance criteria, sample size, ground truth, or MRMC comparative effectiveness. It merely states that "Clinical data demonstrates that the Radiancy Acne System treats mild to moderate inflammatory acne vulgaris in all skin types with only minor side effects" without providing the specifics of that clinical data.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's what can be extracted based on the document's content:

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

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It generally claims the device "treats mild to moderate inflammatory acne vulgaris in all skin types with only minor side effects."

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

The document does not provide details on the sample size used for any test set or the provenance of clinical data. It only broadly mentions "Clinical data."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document.

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

This information is not provided in the document.

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

The document does not mention an MRMC study or the involvement of human readers with AI assistance. The device is a light therapy system, not an AI diagnostic tool.

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

This question is not applicable as the device is a light therapy system, not an algorithm.

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

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

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