(106 days)
The Arthroscopes of appropriate size and length are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the hip, shoulder, knee, elbow, wist, and ankle, and also to provide illumination and visualization during open and closed arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the joint.
Hip Diagnostic procedures may include: Staging of avascular necrosis Chondral injuries Joint sepsis Synovial chondomatosis Unresolved hip pain Labral tears
Not Found
The provided text is a US FDA 510(k) clearance letter for an Arthroscope (K091398). This document primarily describes the regulatory clearance of a medical device and its intended use, but it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot fulfill your request for the specific details outlined, as this information is not present in the provided text. The document is about regulatory approval based on "substantial equivalence" to a predicate device, which often means demonstrating that the new device has the same intended use and technological characteristics as a legally marketed device, or that any differences do not raise new questions of safety or effectiveness. This type of submission generally does not require the comprehensive performance study data you're asking for.
§ 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.