(50 days)
The EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System is an assortment of surgical instruments utilized in minimally invasive percutaneous lumbar discectorny surgical procedures.
The EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System is an assortment of surgical instruments utilized in minimally invasive percutaneous lumbar discectorny surgical procedures.
I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) summary for the EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System, which focuses on establishing substantial equivalence to previously marketed predicate devices. It discusses the device's purpose and its similarity to existing systems but does not include:
- Acceptance criteria or reported device performance metrics.
- Details of any specific study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance).
- Information about training sets.
Therefore, I cannot provide a response filling in the requested table and study details based on the given input.
§ 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.