(154 days)
The iPulse Hair Removal System is an over the counter device intended for the removal of unwanted hair.
The iPulse Hair Removal System is indicated for the removal of unwanted hair.
The iPulse is an intense pulsed light (IPL) system composed of a base unit housing the electrical and electronic sub-assembly and an umbilical cord which is connected to the applicator, located in which is the source of optical radiation, namely a Xenon flashlamp. The system is powered from AC power via an external power converter.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Hair reduction | 31.3% less hair at 6 months |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): 61 subjects.
- Data Provenance: The document does not explicitly state the country of origin. The study was prospective in nature, as subjects underwent 12 weekly treatments under clinical supervision and were followed for 6 months.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: An "independent assessor" was used. The exact number of individuals is not specified, but the phrasing suggests at least one, and potentially more who reached a consensus.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document states that "hair count before and after treatment was recorded from photographs and reviewed by independent assessor." It does not specify a formal adjudication method like "2+1" or "3+1." It implies a single or consensus review by an independent party.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This study is for a hair removal device, not an AI diagnostic/assessment tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a "standalone algorithm" performance was not done. The device is a physical intense pulsed light (IPL) system for hair removal, where the outcome is directly observed on the subjects, not by an algorithm processing data.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth was established by expert assessment of photographic evidence and subsequent calculation of hair density reduction. This falls under a form of expert consensus or independent assessment of objective data (hair counts from photographs).
8. The sample size for the training set
- The document does not mention a "training set" in the context of an algorithm. The study described is a clinical trial to demonstrate the efficacy of the physical device itself.
9. How the ground truth for the training set was established
- Not applicable, as there is no mention of a training set for an algorithm. The clinical study directly evaluated the device's performance through observable outcomes on subjects.
§ 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.