(91 days)
The Scandius Absorbable ACL Reconstruction System is intended for use in fixation of ligament and tendon grafts in cruciate ligament reconstructions.
The Absorbable ACL Reconstruction System consists of a two piece implant. The femoral implant is designed to maintain the graft block in the femoral tunnel. A screw placed transversely to the femoral tunnel secures the graft block in place. The System includes instrumentation to create the bone tunnel and place the device as well as a sterilization tray.
The provided document is a 510(k) summary for the Scandius Absorbable ACL Reconstruction System, submitted to the FDA in 2004. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, primarily through performance data like bench testing. It is not a clinical study report for an AI/ML powered device, and therefore does not contain the information requested in the prompt regarding acceptance criteria, expert ground truth, sample sizes for training/test sets, or MRMC studies.
The document explicitly states:
- "Bench testing demonstrates that any minor technological differences do not... [raise] new questions of safety and effectiveness." (page 2 of 2)
- "The following performance data was provided in support of the substantial equivalence determination: Mechanical ultimate failure strength. In-Vitro Analysis." (page 2 of 2)
Therefore, I cannot provide the requested information for an AI/ML powered device study. The document only details mechanical and in-vitro performance data for a medical implant.
§ 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.