(88 days)
The Silk'n Infinity is an over the counter device intended for the removal of unwanted hair. The Infinity device is also intended for 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 Silk'n Infinity electric output is indicated for facial stimulation for over-the-counter aesthetic use.
The Silk'n Infinity device is designed as a hand held, home use device, which utilizes Intense Pulsed Light (IPL) for hair removal and galvanic microcurrents for skin stimulation. The device comprises a power adaptor and device applicator. The applicator consists of a single lamp producing the light energy that is emitted via the flash window, and a chrome-coting stripe (touch electrode) located around the flash window, through which the micro-current pulses are discharged. The applicator spot size is 2.7cm2 The user interface located on the applicator contains ON/OFF button, pulsed trigger button and six green LED indicators which provide information on the energy level, system status & errors. The Silk'n Infinity device contains a skin sensor, providing the user with an additional safety measure to detect appropriate skin tones and a proximity sensor that identifies full contact with the skin before pulse activation. The light output power range is from 3 to 5 J/cm 2, the optical filter cut off wavelength is 475-1200nm.
This document is a 510(k) summary for the Silk'n Infinity device, which is an over-the-counter device intended for hair removal and facial stimulation. The focus of this document is to demonstrate "substantial equivalence" to predicate devices, rather than to prove performance against specific acceptance criteria for a novel device through a formal study.
Therefore, many of the typical elements of an AI/ML device study described in the prompt (e.g., test set sample size, number of experts, MRMC studies, standalone performance, ground truth establishment) are not applicable or not present in this document.
The document primarily focuses on:
- Bench testing: Verifying output parameters and safety in simulated home-use settings.
- Compliance with recognized standards: Showing the device meets established electrical, mechanical, and safety standards for medical electrical equipment.
- Substantial Equivalence Argument: Comparing the Silk'n Infinity to legally marketed predicate devices (Silk'n Glide for IPL hair removal and Facial Spa for microcurrent facial stimulation) based on similar technology, intended use, and safety features.
Here's an attempt to answer the questions based only on the provided text, acknowledging that many questions relate to performance studies that were not conducted or detailed in this 510(k) summary:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria for a device's performance against clinical endpoints like hair reduction efficacy or skin stimulation effectiveness, nor does it provide reported device performance data in that format. Instead, the acceptance is based on:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| IPL Output Performance: Match predicate device (Silk'n Glide) specifications. | "The Silk'n Infinity device, IPL optical output performance specifications are based on the same performance specifications as those of the main predicate, the Silk'n Glide which were already evaluated and well established in K131870 & K141242." Specific values are given for predicate: Light Output Power 3-5 J/cm², Pulse duration 500-800 µsec, Wavelength 475-1200nm. |
| Microcurrent Output Performance: Comply with design requirements and align with reference predicate (Facial Spa). | "The test results demonstrated that the output parameters complied with the device design requirements and were in line with the reference predicate output specifications." Specific values for the device are: Maximal output current 420 μA, Maximal output voltage 210 mv & 840 mv. |
| Safety in Simulated Home Use: Safe for intended use. | "The test results showed that the device was safe for use as intended." |
| Software Validation: Met system requirements. | "The Silk'n Infinity device underwent software validation testing as well as was tested and found to comply with..." "These performance tests demonstrated that the device specifications met the system requirements..." |
| Compliance with Electrical & Mechanical Safety Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 60601-1-11, IEC 60601-2-10 | "The Silk'n Infinity device has been tested and complies with the following voluntary recognized standards:" (lists all mentioned standards). "The results of the tests demonstrated that all of the device specifications met the system requirements and do not raise new safety or effectiveness concerns." |
| Biocompatibility: Comply with ISO 10993-1. | "All patient contacting materials were tested for biocompatibility and found to comply with the ISO 10993-1 standard." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: For the "simulated home use settings" safety test, the sample size was eight human volunteers.
- Data Provenance: The document does not explicitly state the country of origin for the volunteers. The study was a "bench test" described as evaluating device safety in a simulated home use setting, implying a prospective test conducted for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The "simulated home use settings" test was a safety test, not a performance study requiring human "ground truth" for disease detection or similar tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/provided. The described tests are bench and safety performance tests, not clinical efficacy studies requiring adjudication of outcomes or diagnoses.
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 MRMC comparative effectiveness study was done or reported in this document. This device is not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/provided. This device is a direct-use medical device (IPL hair removal and microcurrent stimulation), not an algorithm. Bench tests were performed on the device itself to verify output and safety parameters.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the safety test on human volunteers, the "ground truth" would be the direct observation of adverse events or lack thereof, relative to device parameters. For the technical specifications, the ground truth is established by engineering measurements against predetermined design requirements and compliance with recognized standards.
8. The sample size for the training set:
Not applicable. This document describes a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, this is not an AI/ML algorithm.
§ 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.