(69 days)
SBI WristFIT™ (Fracture In Tension) Distal Radius System implants are indicated in the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotomies geared towards a functionally stable osteosynthesis in small and long bones. This includes:
- . distal radius fractures
- t distal ulna fractures
- . radial osteotomies
- . radial fusions
- . tarsal fractures
The system features non-sterile stainless steel plates with cortical locking, non-locking, and Cannulated screws in two diameters (2.4mm and 2.7mm), high angle screws with low profile heads when inserted into specially designed screw holes at angles as high as 60° to 70° off perpendicular, or 30° to 70° from the plate or bone axis, and the instruments with which to implant them.
This K051747 510(k) summary describes a medical device (SBI WristFIT™ Internal Fixation System), not an AI/ML powered device. As such, the concepts of "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of AI/ML performance metrics are not applicable here.
The 510(k) summary focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is a regulatory pathway for non-AI medical devices. This typically involves showing that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate device. The information provided in the document confirms this:
- Substantial Equivalence: The document explicitly states: "Documentation is provided which demonstrated the SBI WristFIT™ to be substantially equivalent to other legally marketed devices."
- Predicate Devices: The FDA letter confirms the substantial equivalence determination.
Therefore, the requested AI/ML specific information (acceptance criteria table, sample sizes, ground truth, MRMC studies, etc.) cannot be extracted from this document, as it pertains to a different type of device and regulatory assessment.
In summary, none of the requested information regarding acceptance criteria or studies proving device performance, in the context of AI/ML, can be provided as this document describes a traditional medical device (internal fixation system) undergoing a 510(k) substantial equivalence review.
§ 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.