(25 days)
The BPS Wrist Fracture System is indicated for the fixation of simple and complex intra-articular and extra-articular fractures, and for osteotomies of the distal radius in adults. The device is indicated for fixation of Fractures AO types A2, A3, B1, B3, C1, C2, C3.
The BPS Wrist Fracture System includes bone plate and bone screw implants designed for fixation of certain fractures, fusions, or osteotomies in the distal radius. To meet various patient anatomical needs, the BPS Wrist Fractures several sizes of distal radius plates as well as various styles of locking, non-locking, and cortical bone screws. The plates are manufactured from Commercially Pure Titanium Grade 4 per ASTM F67. The screws are manufactured from Titanium Alloy Grade 5 (Ti-6Al-4V ELI) per ASTM F136.
I'm sorry, but based on the provided FDA 510(k) clearance letter for the "BPS Wrist Fracture System," this device is a physical medical implant (a metallic bone fixation appliance) and not an AI or software-based medical device.
Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/software performance metrics (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, etc.) is not present in this document.
The 510(k) summary explicitly states:
- "The BPS Wrist Fracture System includes bone plate and bone screw implants designed for fixation of certain fractures, fusions, or osteotomies in the distal radius."
- "The plates are manufactured from Commercially Pure Titanium Grade 4 per ASTM F67. The screws are manufactured from Titanium Alloy Grade 5 (Ti-6Al-4V ELI) per ASTM F136."
- The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section only mentions "cleaning, sterilization, biocompatibility, mechanical and performance characteristics," which are typical for physical implants, not AI/software.
None of the provided text suggests any AI or software component requiring the kind of study details you've asked for.
To answer your specific questions related to AI/software, I would need a 510(k) clearance letter or similar documentation for an AI/software medical device.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.