(132 days)
The Biomet Microfixation OmniMax MMF System is indicated for temporary stabilization of mandibular and maxillary fractures to maintain proper occlusion during surgery and for post-operative fracture healing in adults and adolescents (age 12 and older) in whom permanent teeth have erupted.
The Biomet Microfixation OmniMax MMF System is composed of metallic plates (arch bars) and locking screws that provide temporary stabilization of mandibular and maxillary bone during fracture healing and/or temporarily maintain a stable occlusion during surgery. Mandibular and Maxillary Fixation (MMF) is achieved through application of fixation plates and locking screws to bone; wire or elastics are then secured around hooks. The arch bar plate is manufactured from Commercially Pure Titanium; and the locking screws are manufactured from Titanium Alloy (Ti-6Al-4V).
This document describes the Biomet Microfixation OmniMax MMF System, a medical device for temporary stabilization of mandibular and maxillary fractures. It does not contain information about an AI/ML device or its performance criteria, nor does it detail a study involving AI. Therefore, I cannot fulfill the request for information regarding acceptance criteria and studies proving the device meets them based on AI/ML performance.
The document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data and device characteristics. It mentions "Non-Clinical Performance Data: All non-clinical performance testing passed according to the acceptance criteria" and lists the types of tests conducted:
- Screw: Insertion/Fracture Torque, Bending/Shear, Push-Through
- Plate and Screw Construct: Static and Fatigue Testing
- Simulated Use Cadaver Lab
However, it does not provide the specific numerical acceptance criteria for these tests or the reported performance values. It also explicitly states, "Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence."
Without information related to AI/ML, I cannot provide details on:
- Acceptance criteria and reported device performance for an AI/ML component.
- Sample sizes, data provenance, or ground truth for test sets for an AI/ML component.
- Number of experts or their qualifications for establishing ground truth related to AI/ML.
- Adjudication methods for AI/ML test sets.
- Multi-reader multi-case (MRMC) comparative effectiveness studies involving AI assistance.
- Standalone performance of an algorithm.
- Type of ground truth used for AI/ML.
- Sample size or ground truth establishment for a training set for an AI/ML component.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.