(176 days)
Indications remain unchanged from pre-pandemic COVID-19 vaccines for use in individuals 6 months of age and older.
HPE 8570B 50 Ohm Programmable Step Attenuator, DC to 18 GHz
This FDA clearance letter for the Arthrex Spine Endoscope (K243602) does not contain information about the development and validation of an AI/ML device. Instead, it describes a traditional medical device submission for an endoscope.
The letter explicitly states on Page 6: "The Arthrex Spine Endoscope did not require animal testing or human clinical studies to support the determination of substantial equivalence." and "All verification activities were successfully completed to confirm the subject device meets product requirements and design specifications established for the device." This indicates that the clearance was based on non-clinical bench testing and comparison to a predicate device, typical for traditional medical devices, rather than a novel AI/ML algorithm requiring extensive clinical validation with ground truth, expert readers, and comparative effectiveness studies.
Therefore, I cannot extract the requested information about acceptance criteria and study proving an AI/ML device meets those criteria from this document. The document pertains to a physical endoscope, not an AI/ML system.
If you have a different document pertaining to an AI/ML medical device, please provide it, and I will do my best to extract the requested information.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. 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 § 888.9.