(62 days)
The AngioDynamics, Inc. ELVS Procedure Kit is indicated for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and is also indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein.
The AngioDynamics, Inc. ELVS Procedure Kit is indicated for use with 810 mm and 980 nm Diode Lasers with SMA 905 connectors.
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The provided text is a 510(k) clearance letter from the FDA for a medical device (AngioDynamics, Inc. ELVS Procedure Kit). It primarily addresses the regulatory approval process and includes the device's indications for use.
Crucially, this document focuses on confirming substantial equivalence to a predicate device and does NOT contain the detailed information necessary to answer your specific questions about acceptance criteria, study design, performance data, sample sizes, ground truth establishment, or expert qualifications.
The 510(k) clearance process typically involves demonstrating that a new device is as safe and effective as a legally marketed predicate device. While this involves some form of testing and data, the details requested in your prompt (e.g., specific acceptance criteria, sample sizes for test/training sets, expert ground truth establishment) are generally contained within the full 510(k) submission, which is not provided here.
Therefore, I cannot provide the requested information based solely on this document. To answer your questions, I would need access to the actual 510(k) submission or a summary of the clinical/performance data presented in it.
§ 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.