(50 days)
The Dyonics® InteliJET™ Inflow/Outflow Cannula is indicated for use with the InteliJET Fluid Management System during arthroscopic surgical procedures of the knee, shoulder and small joints to regulate flow of irrigation fluids through the joint to maintain intra-articular pressure for uniform distention and clear visualization of the surgical site.
The Dyonics InteliJET Inflow/Outflow Cannula is used to establish a portal to the surgical site during arthroscopic surgical procedures. The Dyonics InteliJET Inflow/Outflow Cannula is designed to work in conjunction with the InteliJET Fluid Management System to maintain intraarticular pressure for uniform distention and clear visualization of the surgical site.
This 510(k) summary describes a device, the Dyonics® InteliJET™ Inflow/Outflow Cannula, which is a hardware component. The provided text does not include any information about an AI/ML powered device, a study designed to prove the device meets acceptance criteria, or acceptance criteria itself. The document focuses on establishing substantial equivalence to predicate devices based on design, materials, principle of operation, and intended use for regulatory clearance. It does not contain the type of performance evaluation details requested for AI/ML devices. Therefore, I cannot generate the requested table and answer the study-related questions.
§ 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.