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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.
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MAY 1 6 1996
SLT FUMICH PROBE GUIDE 510K SUMMARY
Device Description:
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.
Equivalency:
The SLT Fumich Probe Guide is designed to be used with the distal end of the SSRH8 handpiece. This hand-piece is inserted through the proximal end of the Fumich Probe Guide; prior to use, a probe can be threaded onto that hand-piece and then withdrawn through the guide so that the guide can be first placed on tissue locating the tissue for contact with the probe. This accessory to the SLT Laser Multidimensional Fiber Delivery System is similar to the CO2 laser arm distal end that incorporates the tissue stabilizer or backstop such as that for the Sharplan 1100 CO2 surgical laser system. CO2 lasers have this guide to facilitate the tissue fiber location for assuring the location of the coagulation and vaporization of tissue.
Conclusion:
The SLT Fumich Probe Guide will be provided as a sterile single use only accessory to the SLT Multidimensional Fiber Delivery System.
§ 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.