(175 days)
The SunLase 800P is indicated for incising, excising and coagulating intraoral soft tissue, including the marginal and interdental gingiya. This includes incising, excising and coagulating the epithelium lining, the free or marginal gingiva, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).
Not Found
I apologize, but this document contains a letter from the FDA regarding a 510(k) clearance for the Sunlase 800P Laser System. It does not contain any information about acceptance criteria or a study proving device performance in the way you've outlined in your request (e.g., test sets, ground truth, expert qualifications, MRMC studies).
The document is a notification of substantial equivalence for a medical device, which means the device was found to be as safe and effective as a legally marketed predicate device. The 510(k) process typically doesn't involve the detailed performance study data you're asking for in this format, especially for devices cleared in 1999.
Therefore, I cannot fulfill your request with the provided input.
§ 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.