(89 days)
The ConMed Linvatec 24k Irrigation System is a dual-head pump system intended to provide fluid distention, irrigation, and suction during diagnostic and operative knee, shoulder, hip, and small bone arthroscopic procedures and fluid irrigation during laparoscopic procedures.
The ConMed Linvatec 24k Irrigation System is a peristaltic pump system designed to automatically provide and control distention and irrigation of the operative site during arthroscopic procedures and fluid irrigation of the operative site during laparoscopic procedures using sterile fluids. The pump is used in conjunction with specific tubing sets designed for either arthroscopic or laparoscopic procedures.
The provided document, K063326 for the ConMed Linvatec 24k Irrigation System, is a 510(k) summary and associated FDA clearance letter. It focuses on demonstrating substantial equivalence to predicate devices based on intended use, design, and technological characteristics.
As such, this document does not contain the specific information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
Medical device 510(k) submissions typically demonstrate substantial equivalence through comparisons with legally marketed predicate devices, often relying on performance testing (e.g., electrical safety, EMC, biocompatibility) to ensure the new device does not raise new questions of safety and effectiveness, rather than conducting extensive clinical studies with specified acceptance criteria and human expert evaluations like a diagnostic algorithm.
The document states:
- "Testing conducted prior to product release will assure the new device does not raise any new issues of safety and efficacy." (Page 3)
This general statement indicates that some form of internal testing was performed to verify the device's basic functionality and safety, but the details of these tests (e.g., specific acceptance criteria, test methodology, results) are not included in this summary.
Therefore, I cannot provide the requested table and detailed information 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.