(90 days)
The SLT Venous Fiber is intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
SLT Venous FDS products include the Venous Diffusing Fiber, the Venous Conical Fiber, and the Venous Flat Fiber.
SLT Venous Diffuser Fibers are flexible fibers with an active diffusing portion that diffuses the laser energy in a uniform pattern about its active diffusing length, resulting in a cylindrical or elongated spheroidal zone of coagulation.
SLT Venous Conical Fibers splay the laser energy radially at their distally conical portion, providing a much smaller and more focused coagulation zone than the Venous Diffuser Fiber.
SLT Venous Flat Fibers direct the laser energy forward from their distally flat end, providing the highest energy density of the three SLT Venous Fibers.
SLT Venous Fibers are available with SLT proprietary connectors (to fit SLT Contact Laser Systems) and SMA-905 connectors (to fit lasers with standard SMA-905 launch interfaces).
SLT Venous Diffuser Fibers are compatible for use only with lasers having wavelengths between 980nm and 1064nm.
SLT Venous Conical and Flat Fibers are compatible for use with lasers having wavelengths between 810nm and 1064nm.
SLT Venous Fibers are flexible and therefore, when used for endovascular applications, a catheter, cannula, or similar device should be used to insert the fiber into the vein.
SLT Venous Fiber products are sold sterile, and are intended for single use only.
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving a device meets them. The document is a 510(k) summary for "SLT Venous Fiber Delivery Systems," which focuses on establishing substantial equivalence to previously marketed devices rather than detailing specific performance acceptance criteria and a study to meet them.
Here's what the document does provide:
- Device Description and Intended Use: The SLT Venous Fiber Delivery Systems are intended for endovascular coagulation of the greater saphenous vein in patients with superficial vein reflux.
- Predicate Devices: The document lists several predicate devices (e.g., Diomed 810nm Surgical Lasers and EVLT Procedure Kit, VNUS® Closure™ System, Ceralas D Diode Laser Systems) for comparison.
- Basis for Substantial Equivalence: The submission states that the intended use, method of tissue interaction, specifications, clinical technique, and animal study results are "the same or very similar" to the predicate devices.
- Safety and Effectiveness: Animal studies were performed to demonstrate "substantially equivalent safe and effective performance" to the predicate devices. Biocompatibility testing (USP Class VI and ISO 10993-1, including hemocompatibility per ISO 10993-4) was also successfully performed.
Missing Information:
The document does not include:
- A table of specific acceptance criteria (e.g., specific quantitative metrics for coagulation effectiveness, safety endpoints).
- Reported device performance against such criteria.
- Details on the sample size used for any test set in the animal studies.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts used or their qualifications.
- Adjudication method.
- Information on multi-reader multi-case (MRMC) comparative effectiveness studies or human reader improvement with/without AI assistance.
- Results from standalone (algorithm only) performance studies.
- The specific type of ground truth used in the animal studies (beyond "animal studies").
- Sample size for any training set.
- How ground truth for a training set was established.
The document primarily focuses on asserting substantial equivalence based on general performance observations in animal studies and biocompatibility, rather than providing a detailed breakdown of acceptance criteria and a quantitative study proving adherence to them as would be expected for an AI/CADe device.
§ 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.