(405 days)
The Minisilk FT pulsed light device is indicated for permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels and treatment of benign pigmented lesions.
The Minisilk_FT is a pulsed light system having a Xenon flashlamp located in the handpieces. It is a light source emitting in the wavelength range 500-1200 nm. Emission activation is by footswitch. Overall weight of the system is 16 kg, and the size is 22x37x45 cm (H x W x D). Electrical requirement is: 115 VAC, 10A, 50-60 Hz, single phase.
This 510(k) summary explicitly states: "Nonclinical Performance Data: None; Clinical Performance Data: None."
Therefore, based on the provided document, the following information regarding acceptance criteria and a study to prove the device meets them cannot be detailed:
- A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are provided.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable as no clinical study was conducted.
- 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 study was conducted.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical study was conducted.
- 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 document describes a pulsed light system, not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document describes a pulsed light system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no clinical study was conducted.
- The sample size for the training set: Not applicable as no clinical study was conducted, and the device is not an AI algorithm requiring a training set.
- 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.