(153 days)
These devices are intended for use with any holmium laser (with a compatible connector) for its cleared applications.
The Multiuse Switchable Tip is a fiber optic energy delivery device consisting of a nearcontact fixed laser fiber contained in a stainless steel shaft; it attaches to the Omni'10 Multiuse Handpiece through a quick-connect mechanism.
This document is a 510(k) summary for a medical device (Trimedyne Multiuse Switchable Tips). It explicitly states that "No clinical tests were submitted in this Premarket Notification." This means there is no study described within this document that proves the device meets specific acceptance criteria based on clinical performance.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies cannot be provided from the given text.
The only "tests" mentioned are "Nonclinical Tests" which included sterilization, mechanical, biological, and performance studies. However, the document does not elaborate on specific acceptance criteria for these nonclinical tests, nor does it provide detailed results or methodologies for these tests beyond their general categories.
§ 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.