(55 days)
The IPL Hair Removal Device (Model: AI01) is intended for the removal of unwanted body hair.
IPL Hair Removal Device, model: Al01 is a device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon Arc Flashlamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. Device includes a main unit, an adaptor, and accessories, accessories include goggle.
The provided text is a 510(k) summary for the IPL Hair Removal Device, model: AI01. It describes acceptance criteria for safety and effectiveness based on non-clinical testing and comparison to a predicate device, as well as the study that demonstrates the device meets these criteria. No clinical study was performed.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission and not a clinical study report, the acceptance criteria are primarily related to meeting recognized consensus standards for safety and biocompatibility, and demonstrating substantial equivalence to a predicate device. The "reported device performance" refers to the successful completion of these tests and alignment with the predicate.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Safety - Electrical | ANSI AAMI ES60601-1 | Complied |
| Safety - Electromagnetic Compatibility | IEC 60601-1-2 | Complied |
| Safety - Home Healthcare Environment | IEC 60601-1-11 | Complied |
| Safety - Performance of Non-Laser Light Source | ISO 60601-2-57: 2011 | Complied |
| Safety - Photobiological | IEC 62471: 2006 | Complied |
| Biocompatibility - Cytotoxicity | ISO 10993-5:2009 | Meets requirement ("positive results" for validation implies successful testing if "positive" refers to the test for meeting the standard) |
| Biocompatibility - Irritation & Sensitization | ISO 10993-10:2010 | Meets requirement ("positive results" for validation implies successful testing if "positive" refers to the test for meeting the standard) |
| Software Verification & Validation | IEC 62304:2006+A1:2015 and FDA Guidance for Software | Performed in accordance with guidance |
| Substantial Equivalence - Indications for Use | Same as predicate (unwanted body hair removal) | Same (with a note on OTC vs. Prescription, deemed not to raise new safety questions) |
| Substantial Equivalence - Technology | Intense Pulse Light (IPL) | Same |
| Substantial Equivalence - Technical Specifications | Wavelength, Spot Size, Max. Fluence, Pulse Duration, Output energy, Pulsing Control | Same as predicate |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "There was no clinical testing performed." Therefore, there is no sample size for a clinical test set, nor is there data provenance from human subjects. The testing was non-clinical (device bench testing, biocompatibility, and software validation). The country of origin for the device manufacturer is China.
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)
Not applicable, as no clinical testing was performed for hair removal effectiveness. The "ground truth" for the non-clinical tests is based on adherence to recognized international standards and comparison to the predicate device's established safety and performance characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical testing with human subjects or expert adjudication of results was performed.
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
Not applicable. This device is an IPL hair removal device, not an AI-assisted diagnostic or imaging device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a physical IPL hair removal device, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) submission is primarily:
- Adherence to Recognized Standards: The device's components and overall system passed various safety, biocompatibility, and software validation tests according to established international standards (e.g., IEC 60601 series, ISO 10993 series, IEC 62304).
- Substantial Equivalence to Predicate Device: The device's technical characteristics, operating principle, and indications for use are demonstrated to be substantially equivalent to a legally marketed predicate device (K183217). The "ground truth" here is the established safety and effectiveness profile of the predicate.
8. The sample size for the training set
Not applicable. No machine learning or AI algorithm requiring a training set for clinical performance was described in the context of hair removal effectiveness. The software referred to in the document is for device control and functionality, not for performing a diagnostic or predictive task.
9. How the ground truth for the training set was established
Not applicable, as there was no training set mentioned in the context of clinical performance.
§ 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.