(146 days)
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 and moderate inflammatory acne which includes treatment of pustular inflammatory acne in patients with Fitzpatrick skin types I-IV.
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 inflammatory acne (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 text is a 510(k) summary for the Radiancy Acne System with ClearTouch™ Light Unit Assembly, intended for treating mild to moderate inflammatory acne. It makes a claim of substantial equivalence to a predicate device, the ClearLight Phototherapy System, Model CL 420. However, the document does not provide specific acceptance criteria for device performance or a detailed study description with the requested metrics.
The statement regarding a study is: "Clinical data demonstrates that the Radiancy Acne System treats mild and moderate inflammatory acne which include pustular inflammatory acne in patients with Fitzpatrick skin types I-IV." This is a very high-level statement without any of the requested numerical details or methodological information.
Therefore, I cannot populate the table or provide the requested study details for the Radiancy Acne System based on the information given.
Here's what can be extracted and why other requested information is absent:
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Table of acceptance criteria and reported device performance:
- Not Available. The document states "Clinical data demonstrates that the Radiancy Acne System treats mild and moderate inflammatory acne..." but does not specify quantitative acceptance criteria (e.g., a percentage reduction in lesion count) or report specific performance metrics (e.g., "75% reduction in inflammatory lesions").
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Sample size used for the test set and the data provenance:
- Not Available. The document mentions "Clinical data" but gives no sample size, country of origin, or whether the data was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Available. There is no mention of how ground truth was established or the involvement of experts.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Available. No information on adjudication is provided.
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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/Not Available. The device is a "Light Unit Assembly," not an AI-driven image analysis system. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this type of device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable/Not Available. As mentioned above, this is a phototherapeutic light device, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Available. The document does not specify how "treatment of mild and moderate inflammatory acne" was measured or validated as ground truth.
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The sample size for the training set:
- Not Applicable/Not Available. This device is a physical light therapy system, not a machine learning algorithm that requires a training set in that context.
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How the ground truth for the training set was established:
- Not Applicable/Not Available. As above, a training set for machine learning is not relevant to this device.
Conclusion:
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on intended use, principles of operation, and technological characteristics. It mentions "Clinical data demonstrates that the Radiancy Acne System treats mild and moderate inflammatory acne," but crucially lacks any of the detailed quantitative or methodological information typically found in reports of studies proving performance against specific acceptance criteria. This type of detail is often found in the full clinical trial reports, which are not part of this 510(k) summary document.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.