(55 days)
The SuperBall-RC™ System is intended for use as a suture retention device to facilitate percutaneous and endoscopic soft tissue procedures.
The SuperBall-RC™ System is indicated for use in rotator cuff repair procedures.
The SuperBall-RC™ System is an all-inside, all-suture repair device. Each device includes two non-absorbable, soft suture bundles that are attached to each other (USP 1 UHMWPE) and preloaded within a needle delivery system along with the SuperBall securing element made of a braided, coreless sack. The adjustable depth delivery system insertion needle angles), enables the positioning and subsequent deployment of the two bundles under/within the soft tissue. Once placed, manipulation of the delivery system's the pulling suture (USP 3-0 Polyester Cottony II Green), thereby approximating the positioned bundles. The tightened implant is secured by the SuperBall is passed to nestle beside the deployed bundles. By pulling the SuperBall Actuating suture (USP 2-0 Polyester Tevdek II Green), a ball is formed, securing the implant in position.
This document is an FDA 510(k) clearance letter and 510(k) summary for the SuperBall-RC™ device. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way that an AI/ML medical device would.
The document discusses the mechanical strength (shear pullout testing) and usability of the device, but these are general engineering and user experience validations, not a study against specific, quantified acceptance criteria for performance metrics (like accuracy, sensitivity, specificity, etc.) typically seen for AI/ML devices.
Therefore, it's not possible to extract the requested information (like a table of acceptance criteria, sample size for test/training sets, number of experts for ground truth, MRMC study results, etc.) from this document. This device is a physical surgical implant, not an AI/ML diagnostic or therapeutic software.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.