(120 days)
The PL-1064 laser, collimated handpiece will be indicated for ablation, vaporizing, excision, incision, and coagulation of soft tissue encountered in dermatology, plastic surgery, and podiatry including but not limited to plantar warts, periungual and subungual warts and telangiectasia.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding a laser surgical instrument (Sheaumann PL-1064). This type of document primarily confirms that the FDA has reviewed the device and determined it to be "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed.
Crucially, this document DOES NOT contain the details of the performance study or acceptance criteria. The FDA's 510(k) clearance process relies on the manufacturer demonstrating substantial equivalence, which often involves testing but the specific results and methodology of those tests are typically not included in the public-facing clearance letter. They are part of the detailed submission made by the manufacturer to the FDA.
Therefore, I cannot provide the requested information from the given text. The information requested (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are all specifics of a performance study that are not present in this regulatory correspondence.
§ 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.