(252 days)
Synthes RIA System is intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis.
The RIA System consists of two types of components; a series of disposable reamer assemblies and reusable drive shafts. The RIA is a device designed for expedited reaming of a medullary canal in preparation of internal fixation. The device includes a free rotating reamer head connected to the distal end of the manifold/tube assembly. The manifold allows both irrigation and aspiration during the reaming process. Irrigation is passed through the cannulation of the reamer and aspiration is drawn from the rear of the flutes in the reamer. The RIA coupled with the Drive Shaft serves as a flexible reaming device and is available in reaming diameters ranging from 9 mm to 24 mm and range in 200 mm to 550 mm in effective reaming lengths.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or how ground truth was established.
The document is a 510(k) summary for the "Synthes Reamer/Irrigator/Aspirator (RIA) System," which primarily focuses on regulatory approval, substantial equivalence to predicate devices, and intended use. It does not contain details about performance testing or clinical studies in the context of acceptance criteria.
§ 888.4540 Orthopedic manual surgical instrument.
(a)
Identification. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.