(30 days)
Arthroscopic blades and burs are indicated for resection of tissue within joint spaces under arthroscopic control.
Reprocessed Used Disposable Arthroscopic Blades and Burs are single use surgical devices used for resection of tissue within joint spaces under arthroscopic control. MDS Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades Burs are composed of the same materials as currently marketed hand-manipulated Stryker and Dyonics Disposable Arthroscopic Blades/Burs sold new.
The provided text is a 510(k) summary for the reprocessing of used, disposable arthroscopic blades and burs. It focuses on establishing substantial equivalence to a predicate device and does not contain information about specific acceptance criteria, performance studies, or data related to AI or ground truth establishment.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, or information about MRMC, standalone, or AI studies based on the provided document. The document is about a reprocessed medical device, not an AI/ML-driven device, and does not describe any such studies.
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(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 § 878.9.