(107 days)
The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064nm) into a single handpiece. It is intended for temporary hair reduction in Fast Hair Removal Mode(FHR).
The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064 nm) into a single handpiece, which intended for temporary hair reduction in Fast Hair Removal Mode(FHR). It consists of a main unit, a foot switch and a handle-piece. The foot switch and the handle switch are activated to start emitting light pulses. The hand-piece has a cooled light outlet. The laser parameters and other system functions are controlled by a control panel on the main unit.
I am sorry, but the provided text does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as per your detailed request.
The document is an FDA 510(k) clearance letter and a 510(k) summary for a laser hair removal system. It addresses general regulatory compliance, device characteristics, and substantial equivalence to predicate devices, but it does not include a detailed report of performance testing against specific acceptance criteria, nor does it describe a study involving human readers or expert consensus as would be typical for an AI/ML medical device.
Specifically, the text states:
- "No clinical study is included in this submission." (Page 5)
- The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section on Page 5 only lists compliance with various IEC and ISO standards related to electrical safety, EMC, laser safety, and biocompatibility. It does not provide performance metrics like sensitivity, specificity, or accuracy, which would typically be associated with acceptance criteria for a diagnostic or AI-powered device.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication methods.
- Information on MRMC studies or effect sizes.
- Standalone performance data.
- Type of ground truth used (other than references to standards compliance).
- Sample size for the training set.
- How ground truth for the training set was established.
This document pertains to a hardware device (laser system) and its safety and performance based on engineering and biocompatibility standards, not an AI/ML software device that typically involves the kind of performance metrics and study designs you are asking about.
§ 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.