(90 days)
The Trigon™ Ti Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot, such as:
- Cotton (opening wedge) osteotomies of the medial cuneiform
- Evans lengthening osteotomies
The Trigon Ti wedges are intended for use with ancillary fixation.
The Trigon Ti Stand-Alone Wedge Fixation System is not intended for use in the spine.
The Trigon Ti Stand-Alone Wedge Fixation System is a family of additively manufactured titanium wedges used for angular correction of small bones of the foot. The wedges incorporate an organized lattice structure and two screw-receiving holes. The system rectangular and kidney shaped wedges may or may not include a window for containing grafting material. The wedges are designed in rectangular and kidney shaped footprints in a range of sizes (16x16mm to 20x22mm) and in multiple thicknesses (5 to 12mm). The associated 2.5mm diameter screws are designed in lengths of 10 to 20mm.
When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating. When used without the provided screws Trigon wedges are intended for use with ancillary fixation. Windowless wedge designs that do not allow for graft placement should only be used with ancillary plating.
The provided text describes a medical device, the Trigon™ Ti Stand-Alone Wedge Fixation System, and its 510(k) premarket notification. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm or software.
The document primarily focuses on:
- Regulatory review: The FDA's substantial equivalence determination for the device.
- Device description: Physical characteristics, materials, and intended use of the bone wedge system.
- Predicate devices: Identification of similar devices already on the market.
- Non-clinical testing: Mechanical testing (compression, compression shear, expulsion, screw strength/pullout) to demonstrate substantial equivalence to predicates.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets those criteria, as it relates to AI/ML performance, because that information is not present in the provided text.
Specifically, the document does not mention or provide data for any of the following:
- AI/ML algorithm performance.
- Test sets, training sets, or data provenance.
- Experts establishing ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) studies.
- Standalone algorithm performance.
- Types of ground truth (beyond mechanical test results for a physical 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.