(72 days)
The Tyber Medical Mini-Frag System is indicated for fixation of fractures, osteotomies, malunions, replantations, and fusions of short bones and small fragments of bone including the hand, wrist, foot, and ankle. The minifrag system is also intended for reduction and stabilization of non-load bearing long bone fragments.
The Tyber Medical Mini-frag System is not for Spinal Use.
The Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System consists of titanium plates (straight and T-plate) and locking /non-lockingscrews (1.3mm) and are offered in a range of configurations to accommodate patient anatomy. The plates and screws are non-sterile.
This document describes the FDA's decision regarding Tyber Medical, LLC.'s Tyber Medical Anatomical Plating System and does not contain information about the acceptance criteria or study details for a software device. The information provided is for a traditional metallic bone fixation appliance and accessories, which typically involve mechanical testing rather than AI/software performance studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and study that proves a device meets the acceptance criteria based on the provided text, as the text describes a physical medical device and not a software device with associated AI/ML performance metrics.
The provided text only mentions:
- Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
- "The mechanical testing for the subject devices were performed in conformance with the FDA currently-recognized version of ASTM F382 for metallic bone plates and ASTM F543 for bone screws."
- "No clinical testing was performed."
This indicates that the evaluation was based on mechanical engineering standards for physical components, not on a study with AI performance metrics, ground truth, expert readers, or sample sizes related to an AI model's output.
§ 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.