(253 days)
The surgical green laser system is intended for surgical treatment of benign prostatic hyperplasia (BPH) through photoselective vaporization of the prostate (PVP).
The surgical green laser system is designed, manufactured by Realton (Suzhou) Medical Technology Co., Ltd.. The device is a semiconductor pumped, Q-switched and double-frequency solid-state Nd:YAG green laser. The device has the following models according to different output laser powers: PVP-120, PVP-140, PVP-160 and PVP-180. It shall be used with the laser fibers cleared under K202601.
The pulse rate of the device is 10kH-18kH, and pulse width of the device is 100ns-180ns.
The surgical green laser system consists of a semiconductor-pumped controller, Laser internal circulating cooling system, electronic control system and footswitch.
The provided document is a 510(k) premarket notification for a medical device (Surgical Green Laser System) and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML powered medical device.
The document describes a traditional medical device and its comparison to a predicate device for substantial equivalence. The "Performance testing" section (page 10) refers to tests conducted on the laser system according to IEC 60825-1:2014, optical pulse and RF Wireless performance tests, electrical safety, laser safety and electromagnetic compatibility (EMC) tests (ANSI AAMI ES60601-1, IEC 60601-2-22, IEC 60601-1-2), and software verification and validation testing. These are standard engineering and safety tests for hardware and software, not clinical performance studies for an AI/ML algorithm.
Specifically, the document explicitly states: "Based on the similarities of the device specifications, intended use, indications for use between the surgical green laser system and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification." This confirms that there are no studies related to the clinical performance of an AI-powered device, nor acceptance criteria for such a device.
Therefore, I cannot provide the requested information for an AI/ML powered medical device from this document.
§ 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.