(141 days)
FairFix Adjustable Button is intended to be used during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery when a Ø4.5mm tunnel is realized.
FairFix Extender is intended to be used in association with FairFix Adjustable Button during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery with a Ø 6 - 11 mm tunnel.
The FairFix Adjustable Button System includes implantable devices indicated for knee ligament (i.e. ACL, PCL) reconstructive surgery for the fixation of tendons and ligaments by means of a suspensory fixation with an adjustable suture loop.
The FairFix Adjustable Button consists of a metal button with a pre-assembled, non-absorbable adjustable suture loop to be coupled with the graft, a pulling suture (blue) to pull the construct through the bone tunnel and a flipping suture (white) to flip the button once the extracortical side has been reached.
The device is provided pre-assembled on a dedicated graft preparation card, aiming to facilitate implant-graft connection.
The FairFix Adjustable Button Extender is intended to be used in association with the FairFix Adjustable Button in case of large tunnel conditions (e.g. cortical blowout, revision cases, full tunnel). It consists of an elongated metal plate with a recess to house the FairFix Adjustable Button and a lateral slot to allow suture passage.
The provided text is a 510(k) Premarket Notification for a medical device called the "FairFix Adjustable Button System." This document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices for a mechanical bone fixation fastener. The performance data presented are for non-clinical studies (e.g., design validation, characterization testing like lengthening under cyclic loading and load to failure, biocompatibility, pyrogenicity), not for a study involving AI/ML performance.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies for an AI/ML device based on the provided text. The document explicitly states: "No clinical studies were conducted." and there is no mention of an algorithm or AI component.
To answer your request, the input text would need to describe an AI/ML medical device and a study evaluating its performance against acceptance criteria.
§ 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.