(104 days)
Integrated Drive/Pump System functions as a powered The instrument system consisting of blades, burs, bur guards, associated handpieces, drive/pump console, footswitch, shaver adapter, and irrigation tubing sets to perform resection of soft tissue and bone. The fields of application include: Otolaryngology, Neurological Surgical, Orthopedic, and Spinal surgical procedures.
The Integrated Drive/Pump System is a combination of the Linvatec Universal Drive System and Hall® Irrigation System with the addition of three new handpieces used in Otolaryngology, Neurological Surgical, Orthopedic, and Spinal procedures.
The Integrated Drive/Pump System consists of an AC powered drive/pump console, a sterilizable handpiece cord, a high speed handpiece, high speed drill, cranial perforator, various blades, burs, bur guards, irrigation tubing sets, shaver adapter, and a footswitch.
The provided text describes the "Integrated Drive/Pump System" by Linvatec Corporation and its substantial equivalence to predicate devices. However, it does not contain information about specific acceptance criteria or a study detailing device performance against such criteria.
The document states:
- "Testing has been done to prove safety and effectiveness of the devices." (Page 3 of 5, Section G)
But it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test sets.
- Details about experts, ground truth establishment, or adjudication methods.
- Information about MRMC or standalone studies.
- Training set details.
Therefore, I cannot provide the requested table and detailed study information based on the input text. The document is a 510(k) Summary of Safety and Effectiveness, which typically focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance study results with acceptance criteria.
§ 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.