(189 days)
The me is an over-the-counter device intended for the removal of unwanted hair. Me is also intended for permanent reduction in hair growth following an initial treatment regimen with or without maintenance when measured at 6, 9, and 12 months.
The me device is a small over-the-counter, compact system comprised of a base unit assembly with power supply, and connected, via cable, to a handheld applicator with an air-cooling system. The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for Syneron Beauty Ltd.'s mē Hair Removal System (K131649)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for "permanent reduction in hair growth" are explicitly stated as "at least 30% hair reduction measured at 12 months post-treatment compared to baseline." The study also reports on the percentage of subjects and body sites achieving this success.
| Acceptance Criteria | Reported Device Performance (No Maintenance Group) | Reported Device Performance (Maintenance Group) |
|---|---|---|
| Permanent reduction in hair growth defined as: |
- At least 30% hair reduction at 12 months post-treatment (Subject Success) | All Subjects (Table 1): 45% success observed in 44 subjects (those with long-term follow-up at 12 months)
Subgroup of 21 Subjects (Table 3): 52% success observed in 21 subjects (those continuously followed for 6, 9, and 12 months) | All Subjects (Table 2): 59% success observed in 44 subjects (those with long-term follow-up at 12 months)
Subgroup of 21 Subjects (Table 4): 62% success observed in 21 subjects (those continuously followed for 6, 9, and 12 months) |
| Permanent reduction in hair growth defined as: - At least 30% hair reduction at 12 months post-treatment (Body Site Success) | All Subjects (Table 1): 54% success observed in 72 sites (those with long-term follow-up at 12 months)
Subgroup of 21 Subjects (Table 3): 68% success observed in 37 sites (those continuously followed for 6, 9, and 12 months) | All Subjects (Table 2): 72% success observed in 75 sites (those with long-term follow-up at 12 months)
Subgroup of 21 Subjects (Table 4): 80% success observed in 40 sites (those continuously followed for 6, 9, and 12 months) |
| No serious adverse events | No serious adverse events observed | No serious adverse events observed |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Initial Study (3-Month Group): 87 healthy participants.
- Sample Size for Long-Term Follow-up (Test Set):
- 6-Month Group: 40 participants
- 9-Month Group: 26 participants
- 12-Month Group: 44 participants
- Total Evaluated Long-Term: 58 participants were evaluated in at least one follow-up time point (6, 9, or 12 months). A subgroup of 21 participants completed continuous follow-up at 6, 9, and 12 months.
- Data Provenance: The study was a "medically supervised clinical study" conducted in "Israel" (based on the submitter's address). It appears to be a prospective study, as participants were enrolled and followed over time with specific treatment regimens and evaluation points.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Two independent evaluators.
- Qualifications: The document does not explicitly state the qualifications of these evaluators (e.g., dermatologists, trained technicians, etc.) beyond being "independent."
4. Adjudication Method for the Test Set
- The ground truth (hair reduction) was measured "by two independent evaluators through hair count on images taken from the treatment area that were subsequently averaged." This indicates a type of consensus by averaging rather than a formal adjudication method like "2+1" (where a third expert breaks ties) or "3+1."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the device's efficacy with and without maintenance treatments; it does not compare human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone (algorithm only) performance study was not done. The device is for user operation, and the study focuses on the clinical effectiveness of the device when used by participants. There is no mention of an AI algorithm operating independently to perform hair reduction.
7. Type of Ground Truth Used
- The ground truth used was expert consensus (through averaging) of hair count from images. These images were taken at baseline and subsequent follow-up visits, and the hair count reduction was calculated from these images.
8. Sample Size for the Training Set
- This information is not provided in the document. The document describes a "clinical study" which is typically considered the evaluation or test set for regulatory clearance. It does not elaborate on any prior "training" studies or datasets. Given the nature of this device (IPL technology), it is unlikely there was a "training set" in the context of machine learning, but rather prior clinical data for device development and predicate device clearances.
9. How the Ground Truth for the Training Set Was Established
- As a training set is not explicitly mentioned or implied in the context of device development or machine learning, this information is not applicable/not provided. If the question refers to the development process for the device's underlying technology (IPL), then the ground truth for that would be established through a series of lab tests, animal studies, and initial human clinical trials to determine effective parameters for hair follicle targeting and destruction without excessive skin damage. However, these are not described as a "training set" for the present regulatory 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.