(240 days)
The Superior Hair Remover is an over the-counter device intended for removal of unwanted body and/or facial hair.
The Superior Hair Remover, an over-the-counter device, is a home-use device for the removal of unwanted hair from body parts. The device provides hair reduction using Intense Pulse Light(IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device can 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 can flash for 300,000 times. The device is composed of a hand-held handle, a main unit, an external power cord, and eye protector, two attachable flash heads. It is used AC Powered (100-240V AC, 50/60Hz). The Superior Hair Remover includes T31 and T61 two models. Their indications for use, working principle, mode of action, operating mode, over-temperature protection function, structure design, button function, skin contact detection function, treatment area, spot size and operation are basically identical, with the minor differences contains product appearance, control buttons on touch panel, light intensity levels.
The provided text describes a 510(k) premarket notification for a hair removal device, focusing on its substantial equivalence to a predicate device. However, it does not contain information about the acceptance criteria or a study proving the device meets those criteria in terms of clinical efficacy. The document primarily addresses electrical safety, biocompatibility, software verification, and usability studies. It explicitly states, "No clinical testing was performed."
Therefore, I cannot provide the requested information regarding acceptance criteria for device performance and a study proving it, as that information is not present in the provided text.
Here is what can be extracted or inferred based on the text regarding testing:
1. A table of acceptance criteria and the reported device performance:
This information is not present. The document focuses on regulatory compliance and substantial equivalence to a predicate device, not clinical performance metrics.
2. Sample size used for the test set and the data provenance:
- Usability Study: 60 subjects. Data provenance is not explicitly stated beyond "Usability testing was completed in 60 subjects." It is not specified if this was retrospective or prospective, or the country of origin of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical efficacy study or expert-adjudicated ground truth for device performance is mentioned. The usability study involved participants, not experts establishing ground truth for efficacy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical efficacy study or ground truth adjudication for device performance is mentioned.
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 a hair removal device, not an AI-assisted diagnostic or imaging tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable as this is a physical device for hair removal, not an algorithm.
7. The type of ground truth used:
- Usability Study: The "ground truth" for the usability study would be the successful and correct operation of the device by the participants according to instructions, and their ability to comprehend the labeling. This is established by observing their performance and understanding.
8. The sample size for the training set:
- Not applicable. The document does not mention any machine learning or AI components that would require a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.