(77 days)
The MTP Arthropump Disposable Tubing Set is intended for use by qualified surgeons for the infusion of sterile irrigant solution into joints during arthroscopic surgical procedures.
The MTP Arthropump Disposable Tubing Set is intended to be utilized with the Karl Storz Arthropump Irrigation System for the infusion of sterile irrigant solution into joints during arthroscopic surgical procedures.
The MTP Arthropump Disposable Tubing Set is intended for use by qualified surgeons for the infusion of sterile irrigant solution into joints during arthroscopic surgical procedures. The body contact materials are PVC, silicone, polyolefin, and Makrolon.
I apologize, but this document does not contain the information requested regarding acceptance criteria and studies proving device performance. The provided text is a 510(k) summary for a medical device (MTP Arthropump Disposable Tubing Set), which focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.
The document primarily covers:
- Applicant and contact information
- Device identification and indication for use
- Device description
- Claim of substantial equivalence to a predicate device
- FDA's letter acknowledging the 510(k) submission and substantial equivalence determination.
Therefore, I cannot provide a table of acceptance criteria and device performance, nor details about sample sizes, ground truth establishment, or multi-reader studies from this document.
§ 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.