(198 days)
The PhotoGenica sV laser is indicated for the treatment of recurrent respiratory papillomatosis of the glottis.
The PhotoGenica sV is a pulse-dye laser, having the organic dye as the lasting medium. It is pulsed dye laser with a wavelength of 585nm. Laser activation is by footswitch. Overall weight of the laser is 285lbs. and the size is 44"x19"x24" (HxWxD). Electrical requirement is 110 VAC or 220 VAC, 20A, 50-60 Hz, single phase.
The provided 510(k) summary for the Cynosure PhotoGenica sV Laser indicates that it is a medical laser system intended for the treatment of recurrent respiratory papillomatosis of the glottis.
This document describes a medical device, which is different from an AI/ML powered device. Medical devices, especially those like lasers, go through a different approval process than AI/ML algorithms. The provided text does not contain any information about acceptance criteria or a study proving device performance as typically expected for an AI/ML powered device.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods because such information is not typically included in a 510(k) summary for a non-AI/ML medical device like a laser system.
The "Comparison" section states: "The PhotoGenica sV laser has an equivalent indication for uses, the same principle of operation, the same wavelength and pulse energy range as the predicate devices." This suggests that the device was approved based on its substantial equivalence to a legally marketed predicate device (PhotoGenica V), rather than a de novo clinical study establishing performance against specific acceptance criteria.
In summary, none of the requested information regarding acceptance criteria and study details for an AI/ML powered device is available in the provided text.
§ 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.