(91 days)
AcneLift " is generally indicated for treatment of dermatological conditions and specifically indicated for the treatment of moderate inflammatory acne vulgaris.
AcneLift uses panels of LED's which emit visible light of 407 ± 5 nm and is not associated with the risks or harmful side effects of ultraviolet radiation. Thermal Management is achieved by a fan mounted in close proximity to an aluminum heat sink. The lights are mounted to a mechanical arm and are controlled by an analog timing device. The treatment area is approximately 960 cm4 The total light emitted is 42 Watts giving a fluence of about 45 mW/cm2. Thus, AcneLift provides 50 Joules/cm of energy, in approximately 18-20 minutes.
The provided text describes the FDA 510(k) summary for the AcneLift device, which is an LED light therapy device for treating moderate inflammatory acne vulgaris. However, the document explicitly states that no performance data or studies were conducted for the AcneLift device itself to establish acceptance criteria or demonstrate its performance.
Instead, the submission relies on the substantial equivalence to a predicate device, the Omnilux Blue (K030883).
Here's a breakdown of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. The submission for AcneLift did not establish specific acceptance criteria based on its own clinical performance. | Not applicable. No specific performance data (e.g., efficacy rates, reduction in lesions) for AcneLift are reported, as the submission relies on substantial equivalence to a predicate device. |
Explanation: The document states: "Based on analysis of performance characteristics of Omnilux Blue and AcneLift, Inneract LLC does not believe that any significant differences exist. Therefore, the AcneLift device does not impose any new safety or effectiveness concerns." This indicates that the acceptance criteria for AcneLift were indirectly met by demonstrating its substantial equivalence to a legally marketed predicate device (Omnilux Blue), implying that if the predicate device was safe and effective, then AcneLift, being substantially equivalent, would also be considered safe and effective for the stated indications.
2. Sample Size for the Test Set and Data Provenance
No sample size for a test set is reported for the AcneLift device, as no direct performance study was conducted. The data provenance is not applicable, as there is no specific test data for AcneLift.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
Not applicable, as no test set requiring expert ground truth establishment was conducted for the AcneLift device.
4. Adjudication Method (Test Set)
Not applicable, as no test set requiring adjudication was conducted for the AcneLift device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted for AcneLift.
6. Standalone Performance Study
No standalone performance study (algorithm only without human-in-the-loop performance) was done for AcneLift. The device itself is a light therapy device, not a software algorithm.
7. Type of Ground Truth Used (Test Set)
Not applicable, as no test set was used to establish direct performance for AcneLift.
8. Sample Size for the Training Set
Not applicable, as AcneLift is not a software algorithm that requires a training set. The device's "software" section explicitly states: "AcneLift™ does not use any software programs. The treatment time, is controlled by a digital timer which turns off the LED's after the selected time interval."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as AcneLift does not use a training set.
§ 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.