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The SLT Fumich Probe Guide geometry consists of PVC tubing with an adjustable sleeve being a 2-pronged fork on the distal end and a silicone connector on the proximal end of this tubing. Total length of this is approximately 4 inches. The distal end configuration is designed to slide onto tissue and stabilize this tissue. Laser fiber is threaded through the lumen of this guide with a probe at the end of the fiber for direct contact with tissue. Therefore, this configuration allows the user to know where the tissue and the probe are making contact and facilitates contact of the probe to tissue.
The provided text describes a medical device called the "SLT Fumich Probe Guide" and its intended use, but it does not contain any information about acceptance criteria, performance studies, or clinical (or even non-clinical) data proving its effectiveness or meeting specific criteria.
Therefore, I cannot fulfill your request for a table of acceptance criteria, reported performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This information is completely absent from the provided 510(k) summary.
The document is a 510(k) summary, which typically focuses on describing the device and establishing substantial equivalence to a predicate device, rather than presenting detailed performance study results like those you've requested. For information regarding acceptance criteria and performance data, one would typically need access to the full 510(k) submission, clinical study reports, or design verification and validation documents, none of which are included here.
§ 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.