(214 days)
The Tenodesis Button is used for fixation of bone or soft tissue to bone, and is intended as fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications; anterior cruciate ligament, posterior cruciate ligament, pectoralis repair (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.
The Arthrex Tenodesis Button is made of titanium alloy. The proposed button is preloaded onto a driver/inserter, for single use. The holes in the button allow for the buttons to be threaded with Arthrex non-absorbable suture.
This document is an FDA 510(k) clearance letter for a medical device called the "Arthrex Tenodesis Button." This type of document does not describe an AI/ML powered device, nor does it contain information about an AI/ML study, acceptance criteria, or ground truth establishment in the way AI/ML product submissions do.
Therefore, I cannot provide the requested information, which pertains to the acceptance criteria and study proving an AI/ML device meets those criteria. The provided text describes a physical medical implant and its clearance based on substantial equivalence to a predicate device, supported by physical performance testing (tensile, cyclic loading, MR compatibility, bacterial endotoxin testing), not an AI/ML model's performance on a test set.
The categories you've asked for (such as experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are specific to the validation of AI/ML diagnostic or prognostic tools and are not applicable to the clearance of this type of traditional medical device.
§ 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.