(8 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 Gold 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.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define acceptance criteria in terms of numerical performance metrics (e.g., specific hair reduction percentages at certain time points) against which the device's clinical performance is measured and reported.
Instead, the clinical performance is reported through the adverse event rate which is implicitly part of safety acceptance. The primary "performance" stated focuses on the safety profile of the device.
| Acceptance Criteria (Implicitly Safety) | Reported Device Performance |
|---|---|
| Low adverse event rate | 1.52% (5 "Device Related Events" out of 330 treatments) |
| Adverse events are minor and resolved | All adverse events were minor and resolved completely within 1-2 weeks. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Trial): 31 subjects
- Data Provenance: The document does not explicitly state the country of origin but implies the clinical trial was conducted for a UK-based company (CyDen Limited, located in Swansea, Wales, UK). The study is prospective as it describes a clinical trial where subjects were enrolled, treated over time, and adverse events recorded.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The clinical study primarily focuses on assessing adverse events where "ground truth" would be the direct observation and recording of these events, not an expert panel reviewing outcomes against a gold standard.
4. Adjudication Method for the Test Set
This information is not provided in the document. As noted above, the study focuses on adverse event reporting, which typically doesn't involve a complex adjudication process like in some diagnostic studies.
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
This is not applicable. The device is a "Hair Removal Device" (an Intense Pulsed Light system), not an AI diagnostic tool. Therefore, MRMC studies and AI assistance metrics are irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is an IPL hair removal system, not an algorithm. Performance is directly tied to the physical device and its use.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the safety aspect of the clinical study, the "ground truth" was direct observation and recording of adverse events by the clinical staff or investigators during and after the treatment period. For the effectiveness claim (permanent reduction in hair regrowth), while the document states this as an indication, the provided clinical performance section focuses solely on safety data. The effectiveness details (how it was measured at 6, 9, and 12 months) are not described in the given "Performance Testing - Clinical" section, although it is implied that previous submissions (K143003) likely included this.
8. The Sample Size for the Training Set
This is not applicable. The device is not an AI/ML algorithm that requires a training set. Non-clinical testing included biocompatibility, electrical safety, electromagnetic compatibility, and photobiological safety, along with software validation, but these do not involve "training sets" in the context of data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this type of medical 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.