(226 days)
The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.
The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is a thulium laser, producing a pulsed beam of coherent near-infrared light (1940 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated touch screen gives the user control over the necessary laser system LED parameters. The URSUS Laser System is equipped with a 550 nm aiming beam.
The SOLTIVE Laser System is produced in two models, the SOLTIVE™ Premium SuperPulsed Laser and SOLTIVE™ Pro SuperPulsed Laser. The Premium has a maximum power output of 60 Watts and a maximum Frequency output of 2400 Hz. A secondary, foldable screen is provided. The Pro can operate at a maximum power of 35 Watts and Frequency limited to 100Hz. Both systems are operated with a wireless footswitch or wired footswitch, and both systems can utilize an auxiliary video monitor to display operating parameters. The Premium and Pro Laser must be used with a SOLTIVE Laser Fiber, offered in diameters from 150 - 940 microns.
The system includes:
- Laser console
- Laser fibers - sterile single use and reusable
- Foot pedal, wireless or wired
- Accessories power cord, HDMI cable, safety goggles/glasses, fiber cutter, fiber cleaver, fiber gripper, sterilization tray, cart
The devices do not incorporate medicinal substances, tissues, or blood products. The laser fibers are single-use and reusable, and both single-use and reusable are initially sterilized by Ethylene Oxide. Fibers are compatible with the Olympus endoscope models as listed on the IFU.
The provided document is a 510(k) premarket notification letter and summary for the Olympus SOLTIVE™ Laser System. It focuses on demonstrating substantial equivalence to predicate devices for its intended surgical applications. While it outlines various non-clinical tests (electrical safety, biocompatibility, sterilization, software verification, ex-vivo and in-vivo studies), it does not contain information about specific acceptance criteria, performance metrics, or study details (like sample sizes for test sets, number of experts for ground truth, adjudication methods, or MRMC studies) typically associated with the rigorous evaluation of AI/ML-based medical devices or diagnostic tools.
The document discusses fundamental laser device performance, safety, and effectiveness, not the performance of an AI algorithm against a ground truth clinical diagnosis. Therefore, I cannot extract the requested information about acceptance criteria and a study proving device performance in the context of an AI/ML system.
The "study" mentioned for the SOLTIVE™ Laser System refers to:
- Bench testing: Comparing optical and energy outputs to predicate devices.
- Animal testing/tissue analyses: Demonstrating comparable tissue response and device performance.
- Usability studies: Showing effective and safe operation.
- Verification testing: Showing "statistical equivalence" to the predicate, likely in terms of laser output parameters rather than diagnostic accuracy.
Based on the provided text, none of the specific acceptance criteria or study details relevant to AI/ML device performance (as requested in your prompt) can be found. The document is for a laser surgical system, not an AI-powered diagnostic or treatment planning system that would rely on specific clinical output metrics like sensitivity, specificity, or reader improvement.
§ 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.