(144 days)
The Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted hair from small areas such as, but not limited to, underarm and facial hair below the chin line and large areas such as legs, in patients with Fitzpatrick Skin Phototypes I-V.
The Home Use Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using IPL technology. And it consists of IPL main device and AC adapter, and a detachable lamp cap located in the IPL main device which is the source of optical radiation, namely a Xenon flashlamp.
The Home Use Hair Removal Device includes three models, T1, T2 and T3. All three models are exactly the same with the exception of the LCD display contents (mainly as the symbol of treatment level). T1 and T3 both adopt shape identification to display the treatment levels, which T1 adopts fan-shaped display and T3 adopts rectangle-shaped display. And T2 direct adopts digital symbol to display treatment levels.
The provided text is a 510(k) Summary for a medical device (Home Use Hair Removal Device). It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence for regulatory purposes.
However, it does not contain any information about a study proving the device meets specific acceptance criteria related to its performance in hair removal. Instead, it focuses on the engineering and safety performance of the device to demonstrate that it is as safe and effective as a previously approved device.
Therefore, many of the requested sections below cannot be populated with information from the provided text.
Here is the information that can be extracted or derived from the text, with an explanation of why other sections cannot be completed:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of hair reduction efficacy or clinical outcomes, as it primarily focuses on the technical and safety equivalence to predicate devices. It reports on various engineering and safety tests.
| Acceptance Criteria Category | Reported Device Performance (from text) |
|---|---|
| Biocompatibility | Passed ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization) |
| Electrical Safety | Passed IEC 60601-1-2, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57 |
| Eye Safety | Passed IEC 62471 (Photobiological safety) |
| Software Validation | All software requirement specifications met and hazards mitigated. |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical study or a "test set" in the context of hair removal efficacy. The "performance data" mentioned refers to engineering and safety testing. Therefore, there is no sample size for a test set or data provenance related to clinical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a clinical study with a test set requiring expert ground truth for hair removal efficacy.
4. Adjudication method for the test set
Not applicable. No clinical test set described.
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. The device is a physical hair removal device, not an AI-assisted diagnostic or imaging tool. There are no "human readers" or AI assistance involved in its direct function.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a physical hair removal device, not an algorithm.
7. The type of ground truth used
For the engineering and safety performance data, the "ground truth" is defined by the requirements of the international standards listed (e.g., ISO 10993, IEC 60601, IEC 62471). Deviations from these standards would indicate failure.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a "training set".
9. How the ground truth for the training set was established
Not applicable. This device 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.