(34 days)
The ClearTouch Lite is intended to provide phototherapeutic light to the body. The ClearTouch Lite is generally indicated to treat dermatological conditions. The ClearTouch Lite is specifically indicated to treat mild and moderate inflammatory acne, which includes pustular inflammatory acne in patients with Fitzpatrick skin types I-VI.
The ClearTouch Lite™ is a pulsed-light, manually controlled system designed to deliver light in a sequence of pulses to treat mild and moderate inflammatory acne.
The provided text is a 510(k) summary for the Radiancy ClearTouch Lite™ Acne Clearance System (K060411). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance data for the new device. As such, much of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment is not available in this document.
Here's a breakdown of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
Not available. The document states that the new device has "similar technical characteristics" and "the same intended use and the same indications for use" as the predicate. It also mentions a "minor difference" in energy delivery (lower intensity pulses in sequence vs. a single pulse) which does not raise new safety and effectiveness issues. However, specific quantitative acceptance criteria for acne treatment effectiveness (e.g., percentage reduction in lesions, success rates) and how the ClearTouch Lite performed against these criteria are not provided.
| Acceptance Criteria (Not explicitly stated for the new device) | Reported Device Performance (Not explicitly stated for the new device) |
|---|---|
| Likely related to reduction in mild to moderate inflammatory acne, similar to predicate device performance, but no quantitative figures are given. | Implied to be equivalent to the predicate device's performance for treating mild to moderate inflammatory acne, pustular inflammatory acne, in Fitzpatrick skin types I-VI. |
2. Sample Size Used for the Test Set and Data Provenance
Not available. This 510(k) summary does not describe a new clinical trial for the ClearTouch Lite. It relies on the substantial equivalence to a previously cleared device (K032205, K051268). Therefore, there is no mention of a test set, its sample size, or data provenance for the ClearTouch Lite itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not available. As no new test set is described, there's no information on experts or ground truth establishment for it.
4. Adjudication Method for the Test Set
Not available. No test set is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document does not describe an MRMC study. It's a 510(k) for a physical medical device (pulsed light system), not typically an AI/software device that would undergo MRMC comparative effectiveness studies in the context of human reader improvement with AI assistance.
6. If a Standalone Performance Study Was Done
No, not explicitly for the ClearTouch Lite. The submission hinges on substantial equivalence to a predicate device (Radiancy Acne System with ClearTouch™ Light Unit Assembly) which had already demonstrated its safety and effectiveness. The focus is on the minor technical difference (sequence of lower intensity pulses vs. single pulse) not raising new issues. There's no description of a separate, standalone clinical performance study specifically for the ClearTouch Lite in this document.
7. The Type of Ground Truth Used
Not available/Applicable. Since no new clinical performance study for the ClearTouch Lite itself is presented, there's no discussion of ground truth establishment. For the predicate device, it would presumably involve clinical assessment of acne lesions and potentially photographic evidence, but this is not detailed for the ClearTouch Lite's submission.
8. The Sample Size for the Training Set
Not applicable. This device is a pulsed light system, not an AI/machine learning algorithm that requires a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, the concept of a training set and its ground truth in this context is not relevant for this type of medical device submission.
§ 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.