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WASTON Metallic Bone Plate and Screw Systems are intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, nonunions and malunions, and osteotomies of the femuri

The proposed products, WASTON Metallic Bone Plate and Screw Systems, contain (1) Distal lateral femoral (condylar) LOC plate, (2) Bone screws and (3) various specific instruments.

The raw material of the plate, titanium, conforms to ASTM F67-13, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50400, UNSR50550, UNS R50700). The bone screws are made of titanium alloy (TI-6AL-4V ELI), which complies with ASTM F136-13, Standard Specification for Wrought Titanium-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

The devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10-6 by hospital prior to use.

The provided document does not describe the acceptance criteria and study for a software-based AI/ML device. Instead, it details a 510(k) premarket notification for "WASTON Metallic Bone Plate and Screw Systems," which are physical orthopedic implants.

Therefore, I cannot provide the requested information regarding AI/ML device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the content of this document.

The document focuses on demonstrating the substantial equivalence of the metallic bone plates and screw systems to predicate devices through non-clinical mechanical testing and material standards conformance.

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