(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.
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EMERALD MEDICAL, INC. Mill Lane Rd. Brimfield, MA 01010
JAN 28 1997
Premarket Notification EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System Confidential
964919
510 (k) Summary EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System
This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510 (k), Premarket Notification, was in accordance with 21 CFR 807.87.
The EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System is an assortment of surgical instruments utilized in minimally invasive percutaneous lumbar discectorny surgical procedures.
The conclusion that the EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System is substantially equivalent to legally marketed predicate systems was reached through consideration of the requirements of substantial equivalence determinations. These requirements are set forth in the document, published on June 30, 1986 by the Center for Devices and Radiological Health (CDRH), entitled "Guidance on the Center for Devices and Radiological Health's Premarket Notification Review Program."
The new disc removal tools contain substantially equivalent technology and materials as the predicate disc removal tools utilized in the Acufex Microsurgical Interceptre Arthroscopic Discectorny System, 510 (k) K941709. and the Smith & Nephew Arthroscopic MicroDiscectorny System, AMD™. The proposed introduction kit contains the same components as the current instrument introduction systems developed by Acufex Microsurgical, Surgical Dynamics, Sofamor Danek, and Smith & Nephew Spine.
Based on the reasons provided, the EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System is substantially equivalent to legally marketed predicate minimally invasive percutaneous lumbar discectomy surgical instruments.
§ 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.