(245 days)
The Anchorage Bone Plating System is indication and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones in the hands, feet, wrists, and toes. The system may be used in adults and pediatric patients.
The Anchorage Bone Plating System includes single use bone fixation appliances intended to be permanently implanted. They are designed with different shape plates made from titanium alloy. The Anchorage Bone Plating System uses either a 3 mm or 3.5mm screws. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary in curvature, length, thickness, number of holes, and plate shape. The Anchorage Bone Plating System is intended for fracture fixation.
The provided text is a 510(k) summary for the Stryker Anchorage Bone Plating System. This document describes a medical device, its indications for use, and how it was determined to be substantially equivalent to a previously marketed device.
Crucially, this document specifies:
"Clinical testing was not required for this submission."
Therefore, based solely on the provided text, there is no information available regarding a study that proves the device meets acceptance criteria related to clinical performance or AI/software algorithm performance. The substantial equivalence determination was based on non-clinical mechanical testing.
As such, I cannot provide the requested information about acceptance criteria and a study proving the device meets them in the context of an AI/software algorithm.
If this was a misunderstanding and you were expecting information about the mechanical acceptance criteria and how the non-clinical testing proved the device meets them, I can extract that to a limited extent:
Information based on Non-Clinical Testing Section:
- Acceptance Criteria (Implied): Mechanical performance equivalent to the predicate device, the Memometal Anchorage Bone Plating System (K083477).
- Reported Device Performance: "Mechanical testing was performed and demonstrated that Stryker Anchorage Bone Plating System is equivalent in mechanical performance to the predicate device, the Memometal Anchorage Bone Plating System (K083477)."
- Tests Performed:
- Cantilever bending
- Torque to failure
- Push-Out
- Shear-off
However, the document does not provide any specific quantitative acceptance criteria values, sample sizes for these tests, or detailed results. It only states that equivalence was demonstrated.
Therefore, I cannot fulfill your request for the comprehensive table and detailed study information as it pertains to AI/software performance or detailed quantitative mechanical performance data, because the provided text explicitly states "Clinical testing was not required for this submission" and does not describe such a study.
§ 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.