(41 days)
The Laser Peripherals Holmium Bare Fibers are indicated for a variety of surgical uses including open, laparoscopic or endoscopic ablation, coagulation, incision, excision, and vaporization. The delivery system may be used in each surgical specialty or procedure for which compatible Holmium and Nd: YAG lasers have received regulatory clearance.
Not Found
The provided document is a 510(k) clearance letter from the FDA for "Laser Peripherals Holmium Bare Fibers." This type of document establishes substantial equivalence to a predicate device but does not typically contain detailed acceptance criteria, study designs, or performance results in the same way a pre-market approval (PMA) application or a peer-reviewed study publication would.
Based solely on the provided text, I cannot answer the requested questions as the information is not present. The letter confirms market clearance but does not describe the specific studies or data used to demonstrate safety and effectiveness beyond stating substantial equivalence to a predicate device.
Therefore, I must state that the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) is not available in the provided document.
§ 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.