(29 days)
The Bone Mulch Screw System is indicated for use in anterior cruciate ligament (ACL) reconstruction using semigracilis/semitendinosus or fasc ... !ata (namstring tendons) graft. It is intended for use in fixing the graft within the femoral graft tunnel.
The predicate Bone Mulch Screw System consists of three different Bone Mulch Screws made of Titanium alloy Ti-6A1-4V per ASTM F-136 which are available in different lengths as well as cannulated and noncannulated configurations. The Cannulated Bone Mulch Screw is comprised of two components, the cannulated screw and either a titanium screw plug or an UHMWPE plug. The cannulated screw portion has a blunt nose, available in a standard or +5mm length, which resides across the femoral bone tunnel. The tendon graft is wrapped over this portion of the cannulated screw and never comes in contact with the threads of the cannulated screw. The larger threaded, portion of the cannulated screw resides in the femoral bone adjacent to the tunnel and acts as a passageway for bone graft. The opening in the cannulated screw just prior to the blunt nose allows for passage of bone graft to lie adjacent to the tendon graft to aid in graft incorporation. The bone graft material is pushed into the bone tunnel by a graft insertion rod. The bone graft material is secured at the reconstruction site by inserting either the titanium screw plug or the UHMWPE plug into the hollow end of the screw. The UHMWPE plug is designed to allow the surgeon to insert it with the graft insertion rod. The non-cannulated Bone Mulch Screw is identical to the cannulated Bone Mulch Screw in design and function but is solid and does not require bone graft to be packed inside it.
The modified design continues the cannulation into the nose allowing the screw to be passed over a wire . The added length to the tip will cause the screw to go deeper into the medial wall of the graft tunnel thereby preventing the most likely failure mode of the screw - the tip being p ' ''ed downward into the tunnel in a cantilever manner.
The provided text is a 510(k) premarket notification for a medical device (Bone Mulch Screw System), which focuses on demonstrating substantial equivalence to a predicate device. It is not a study report that describes the acceptance criteria and performance of a device or algorithm as would typically be found for AI/ML-based medical devices.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from the provided text.
The text describes a physical device used in ACL reconstruction and its modification. Clinical studies with detailed methodology for evaluating such devices typically involve mechanical testing, animal studies, or human clinical trials, which are not outlined in this regulatory submission.
In summary, the provided document (K993025) is a regulatory filing for a medical device (Bone Mulch Screw System) and does not contain the information required to answer the prompt regarding acceptance criteria and a study proving device performance in the context of AI/ML or diagnostic test evaluation.
§ 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.