(302 days)
The TELIGEN System is indicated to provide minimally invasive access, visualization, magnification and discectomy of the surgical area of the spine.
The TELIGEN Procedure Kit is part of the TELIGEN System. It is a sterile, single use kit intended for use in surgical spinal procedures to allow for access, visualization, discectomy and graft delivery.
The TELIGEN Procedure Kit includes a camera, ports and port holder, TELIGEN Clear, a soft tissue retractor, a port cutter cartridge and bone graft delivery instruments.
The TELIGEN HD Camera Control System (CCS) is part of the TELIGEN System. It operates the TELIGEN Camera which is used for illumination and visualization of the surgical site. The image collected at the camera head, is transferred to the CCS and subsequently displayed on the monitor.
I am sorry, but the provided text does not contain any information about acceptance criteria or specific study results to prove device performance. The document is an FDA 510(k) premarket notification letter and a 510(k) Summary for the TELIGEN System. This type of document declares substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and performance data, but it does not typically include detailed clinical study results with specific acceptance criteria and outcome metrics in the way your request describes.
The "Performance Data" section (Section I) only lists the types of evaluations conducted (e.g., Design Verification and Validation Testing, Human Factor/Usability, Electrical Safety, Thermal Safety & EMC Testing, Software and Systems Testing), but it does not provide the results, acceptance criteria, or study details such as sample size, provenance, expert qualifications, or ground truth methodology.
Therefore, I cannot provide the requested table or information regarding the study that proves the device meets acceptance criteria based on the provided text.
§ 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.