(44 days)
The Smith & Nephew InteliJET™ Fluid Management System is indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids in the knee, shoulder, hip and small joints to maintain intra-articular pressure for uniform distension and clear visualization of the surgical site.
The Smith & Nephew InteliJET™ Fluid Management System-HERMES Ready is indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids in the knee, shoulder, hip and small joints to maintain intra-articular pressure for uniform distension and clear visualization of the surgical site.
The Smith & Nephew InteliJETTM Fluid Management Systems are microprocessor-controlled delivery of irrigation fluid during intra-articular surgery. This controlled delivery is accomplished via an electronic pressure control loop between the control unit and the tube cassette.
The provided text is a 510(k) summary for the Smith & Nephew InteliJET™ Fluid Management Systems. It describes the device, its intended use, and its comparison to predicate devices, but it does not contain any information about acceptance criteria, device performance, or details of a study that proves the device meets specific criteria.
The document states: "All verification and validation data demonstrate that the devices are safe and effective and performs as intended." However, it does not provide any specifics on what these data are, what the acceptance criteria were, or the results of any such studies.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as none of this information is present in 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.