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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.

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FLARETM single-use surgical laser fiber is intended to be used to deliver the laser radiation to the target tissue when used with compatible surgical lasers with operational wavelength between 532 nm-2140 mm and equipped with SMA 905 compatible connector.

FLARETM single-use surgical laser fiber is indicated for use in general surgical applications for open, laparoscopic, and endoscopic ablation, vaporization, excision, incision, coagulation of soft tissue and for lithotripsy.

FLARE™ single-use surgical laser fiber is designed, manufactured by Realton (Suzhou) Medical Technology Co., Ltd.. The optical fiber material is fused quartz. One end of the fiber is connected to the medical laser equipment through a connector, and the other end directly outputs laser energy for laser operation. The product is sterilized by EO. It is a disposable medical device.

The provided text is a 510(k) Premarket Notification from the FDA regarding a medical device, the FLARE™ single-use surgical laser fiber. It details the device's characteristics, intended use, and comparison to a predicate device.

However, the document does not contain information about a study that assesses a device's performance against specific acceptance criteria in the context of an AI/human-in-the-loop study, or a standalone algorithm performance study.

The "Performance testing" section on page 6 states: "Performance testing was conducted on FLARE™ single-use surgical laser fiber. Technical parameters about dimension, optical performance and mechanical strength were evaluated in the performance testing. In addition, the shelf life was evaluated. All of the tested parameters met the predefined acceptance criteria."

This statement refers to engineering and material performance tests (e.g., optical properties, mechanical strength, dimensions, shelf life) of the laser fiber itself, not a clinical study involving human readers or AI for diagnostic or interpretative tasks. Therefore, the detailed information requested in the prompt (acceptance criteria for a clinical study, sample sizes for test/training sets, expert qualifications, MRMC studies, ground truth establishment for AI/diagnostic performance) is not present in this document.

In summary, the provided document does not contain the information needed to answer the prompt's specific questions regarding acceptance criteria and a study proving device performance related to diagnostic accuracy, human-in-the-loop performance, or AI algorithms. The "performance testing" described is for the physical and functional aspects of the laser fiber for its intended surgical application, not for a diagnostic or AI-assisted interpretation task.

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