(22 days)
The Smart CO2 surgical lasers are indicated for incision, and coagulation of body soft tissue. It's typical applications include dermatology, plastic surgery, urology, gastroenterology, neurosurgery, gynecology and general surgery.
Smart CO₂ is a CO₂ laser, having a sealed CO₂ gas tube as the lasing medium. It is a laser with a wavelength of 10.6 μm. Laser activation is by foot switch. Overall weight of the laser is 25 Kg, and the size is 180x62x42 cm (HxWxD). Electrical requirement is 110 VAC, 15A, 50-60 Hz, single phase.
The provided text is a 510(k) summary for the Smart CO2 laser. It explicitly states:
- "Nonclinical Performance Data: none"
- "Clinical Performance Data: none"
Therefore, based on the provided document, no studies were conducted to prove the device meets acceptance criteria, as there are no reported nonclinical or clinical performance data. The device's substantial equivalence determination was based on comparison to a predicate device (PhotoAppeal laser) with the same principle of operation, wavelength, and essentially the same power range and indications for use.
Consequently, none of the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) can be extracted from this document, as no such performance data or studies are mentioned.
§ 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.