(241 days)
The iPulse SmoothSkin Gold Hair Removal System is indicated for the removal of unwanted hair. The iPulse Smoothskin Gold is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
The iPulse SmoothSkin Hair Removal System is an intense pulsed light (IPL) system consisting of:
Handset - contained within the handset is the Capacitor, Capacitor Charger, Control electronics, Optics (Lamp, Filter, Reflector, Light Pipe), Trigger mechanism and Skin Tone / proximity Sensors (STS);
External Power Supply - used to convert the electricity from the mains supply (either 110V or 230V, 50/60Hz) to a lower DC value, typically 24V. This power supply unit is an "off-the-shelf" component which meets all the relevant electrical safety standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (iPulse SmoothSkin Gold) |
|---|---|
| Hair Reduction at 6 months Post Treatment | 43.9% |
| Hair Reduction at 12 months Post Treatment | 36.0% |
| % of Subjects met success (>30% hair reduction) on all body areas at 12 months post-treatment | 66.7% |
2. Sample Size and Data Provenance for Test Set:
- Sample Size: 50 subjects for the 6-month post-treatment evaluation, and 33 subjects for the 12-month post-treatment evaluation.
- Data Provenance: Prospective, single-center clinical study. The country of origin of the data is not explicitly stated, but the company (iPulse Limited) is based in Swansea, Wales, United Kingdom.
3. Number of Experts and Qualifications for Ground Truth:
- The ground truth for hair count was established by 2 independent assessors.
- Their specific qualifications (e.g., radiologist with X years of experience) are not explicitly stated in the provided text.
4. Adjudication Method for the Test Set:
- The results from the 2 independent assessors were averaged. This implies a form of consensus or averaging method rather than a strict 2+1 or 3+1 adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses on device performance for hair reduction, not on human reader improvement with or without AI assistance.
6. Standalone Performance:
- Yes, a standalone performance study was done. The clinical testing assessed the iPulse SmoothSkin Gold Hair Removal System directly for its efficacy in hair reduction without human-in-the-loop performance in terms of interpretation or decision-making. The device is an over-the-counter hair removal system.
7. Type of Ground Truth Used:
- Expert consensus (averaged hair counts) based on direct physiological measurements (hair counts) and clinical photographs.
8. Sample Size for the Training Set:
- The provided text does not explicitly mention a separate "training set" or its sample size. The clinical study described appears to be the primary efficacy evaluation without a distinct training phase in the context of an AI/algorithm.
9. How Ground Truth for the Training Set Was Established:
- Not applicable, as a separate training set is not explicitly described for an AI/algorithm. The ground truth for the clinical efficacy evaluation (the device's performance) was established by the averaged hair counts from 2 independent assessors.
§ 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.