(232 days)
EpiLight® and PhotoDerm® HR are used for the removal of unwanted hair. EpiLight® and PhotoDerm® HR are also intended to effect stable long-term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
EpiLight® and PhotoDerm® HR are electro-optical medical devices designed for effective photothermal treatment of unwanted hair and its removal.
The provided text is a 510(k) summary for the EpiLight® and PhotoDerm® HR devices, which are electro-optical medical devices for hair removal. The document focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for a new AI-powered device. Therefore, much of the requested information regarding AI device performance, sample sizes, ground truth establishment, and MRMC studies is not available in the provided text.
Based on the information given, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define acceptance criteria in terms of specific quantitative metrics (e.g., sensitivity, specificity, accuracy) for a new device's performance. Instead, it relies on demonstrating "substantial equivalence" to predicate devices through technical comparisons and clinical trials.
The primary performance claim for the EpiLight® and PhotoDerm® HR is:
- Permanent hair reduction: Defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
The document states that a technical comparison and clinical trials were performed to establish substantial equivalence. However, no specific performance metrics resulting from these studies are provided in this summary.
| Acceptance Criteria (Implicit from Intended Use) | Reported Device Performance |
|---|---|
| Removal of unwanted hair | Achieved (by substantial equivalence to predicates) |
| Stable long-term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles | Achieved (by substantial equivalence to predicates) |
| Permanent hair reduction: a long-term stable reduction in the number of hairs regrowing after a treatment regime. | Achieved (by substantial equivalence to predicates) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "clinical trials were performed by ESC Medical Systems," but it does not provide any details about:
- The sample size of the test set (number of participants or observations).
- The data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide any information regarding experts used to establish ground truth.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The devices described are medical devices for hair removal, not AI-assisted diagnostic tools requiring reader interpretation. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The devices are physical medical devices for hair removal, not AI algorithms.
7. The Type of Ground Truth Used
Given the nature of the device (hair removal), the "ground truth" for "permanent hair reduction" would most likely be based on clinical observation and measurement of hair regrowth over time following a treatment regime. However, the document does not explicitly state the method for establishing this ground truth (e.g., photographic assessment, hair count, patient self-reporting, etc.).
8. The Sample Size for the Training Set
This question is not applicable as the document describes a physical medical device, not an AI algorithm that undergoes training.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable.
§ 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.