(284 days)
The Silkn Blue is indicated as an over the counter phototherapy device for the treatment of mild to moderate acne.
Silkn Blue is a hand held device battery operated that uses low power light spectrum, LED, at wavelength of 415 ±15 nm, combine with tip temperature stabilizer at 41ºC. The emitting optical power is in a uniform distribution with no hot spots.
The provided text describes a clinical study to demonstrate the performance and safety of the Silkn Blue device for treating mild to moderate acne. However, it does not specify pre-defined acceptance criteria (e.g., a minimum percentage improvement or reduction in lesion count that the device needed to achieve to be considered successful).
The study aims to determine the ability of the device to treat mild to moderate inflammatory acne and to assess if users can operate it correctly.
Here's the information parsed from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance |
|---|---|
| Implicit: Demonstrate efficacy in treating mild to moderate acne | Average improvement after one month: 56.7% |
| Average improvement after three months: 57.7% ± 9.4% | |
| Implicit: Demonstrate user usability | Users successfully operated the device according to labeling and filled out a questionnaire. |
| Implicit: Demonstrate safety | No immediate reactions or adverse effects associated with the treatment were observed. |
2. Sample Size and Data Provenance:
- Sample Size for Test Set: 50 subjects
- Data Provenance: Not explicitly stated, but the company is based in Israel, so it's likely the study was conducted there or a similar region. The study is prospective as it involves subjects using the device over a specified period with follow-up visits.
3. Number of Experts and Qualifications for Ground Truth:
- The document does not specify the number of experts used or their qualifications to establish the ground truth for the test set. It mentions "2 follow-up visits to evaluate the results," suggesting clinical evaluation, but doesn't detail who performed these evaluations.
4. Adjudication Method:
- The document does not specify an adjudication method (e.g., 2+1, 3+1).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The study is a single-arm clinical trial evaluating the device's performance, not comparing human readers' performance with and without AI assistance. The Silkn Blue is a phototherapy device, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only) Performance Study:
- No, a standalone study was not done. The Silkn Blue is a physical phototherapy device with human-in-the-loop (the user operating it). It does not involve an algorithm working independently.
7. Type of Ground Truth Used:
- The ground truth used was based on clinical evaluation ("reduction in lesion count") performed during follow-up visits by unmentioned evaluators and self-reported usability via a questionnaire.
8. Sample Size for Training Set:
- The concept of a "training set" is not applicable here as the Silkn Blue is a physical medical device, not an AI or machine learning algorithm that requires training data.
9. How Ground Truth for Training Set Was Established:
- As above, the concept of a "training set" and establishing ground truth for it is not applicable for this device.
§ 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.