(87 days)
The BiLok® ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures. The BiLok® ST Screw is used to provide suspensary fixation during femoral fixation in ACL reconstruction using a double looped (semitendinosus/gracilis) or quadruple (semitendinosus) graft.
The cannulated BiLok® ST Screws are 6 – 9mm diameters and 30 – 40mm lengths. The Bil.ok® ST Screw is moulded from a Poly L lactide/Beta Tri-Calcium Phosphate composite.
The provided text describes a 510(k) premarket notification for the BiLok® ST Screw, a device used in ACL reconstruction. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on:
- Identical material of construction and manufacturing methods to the previously cleared BiLok Screw (K002070).
- Same function and indications for use as Arthrex Bio Transfix Cross Pin (K011172) and Biosteon Cross Pin (K021351).
- Claimed equivalent functional mechanical performance characteristics to the predicate devices.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, nor can I provide details on sample sizes, ground truth establishment, or AI-related study specifics, as this information is not present in the provided text.
The document is a regulatory submission for a medical device and thus does not include the type of detailed performance study data you are asking for.
§ 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.