(236 days)
The TITAN 3-D™ Wedge System implants are intended to be used for internal bone fixation for bone fractures, fusions or osteotomies in the foot and ankle. The TITAN 3-D™ Wedge System implants are use with ancillary fixation. The TITAN3-DTM Wedge System implants are not intended for use in the spine.
The TITAN 3-D™ Wedge System contains a series of titanium alloy implants used for the correction of small bones in the foot. It is offered in varying shapes and sizes to accommodate a variety of small bone applications. The implants are sold sterile.
This document is a 510(k) premarket notification for the TITAN 3-D™ Wedge System, a bone fixation device. It describes the device, its intended use, and its equivalence to predicate devices, but it does not contain acceptance criteria for the performance of an AI/ML powered device, nor does it describe a study proving the device meets such criteria.
The information provided relates to a medical device's regulatory submission, not a study validating an AI/ML algorithm's performance against specific acceptance criteria. Therefore, I cannot extract the requested information from the provided text.
Here's why and what can be extracted:
- Device Type: The TITAN 3-D™ Wedge System is a physical implant (titanium alloy wedges) for internal bone fixation. It is not an AI/ML software or algorithm.
- Performance Data: The document mentions "Performance Data: Static and dynamic compression, and static compression-shear testing was performed following ASTM F2077. Expulsion testing was performed. Abrasion testing per ASTM F1978 was performed. LAL testing for bacterial endotoxins was performed." These are engineering and biocompatibility tests for a physical implant, not a study evaluating an AI algorithm's diagnostic or predictive performance.
- Acceptance Criteria & Reported Performance: Since this is not an AI/ML device, the concept of AI-specific acceptance criteria (like sensitivity, specificity, AUC) and reported AI performance (like 90% sensitivity, 85% specificity) is not applicable here.
- Study Design for AI/ML: All points related to sample size for test sets/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance are irrelevant to this document because it's not about an AI/ML device.
In summary, the provided document does not contain the information requested about acceptance criteria and a study proving an AI/ML device meets them. It's a regulatory filing for a physical medical implant.
§ 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.