(163 days)
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.
§ 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.