(84 days)
The plate and screw designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-load bearing fixation, including, but not limited to cranial bone fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.
The plate and screw designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery.
The provided text is a 510(k) premarket notification letter from the FDA to Biomedics, Incorporated, regarding their "Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery." This document does not contain the acceptance criteria, reported device performance, or details of any studies demonstrating the device meets such criteria.
The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means the device does not need to submit clinical trial data to demonstrate safety and effectiveness for this review pathway. Instead, substantial equivalence relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or different technological characteristics but no new questions of safety and effectiveness and is as safe and effective as the predicate device.
Therefore, I cannot provide the requested information based on the given text.
To be clear:
- Acceptance criteria and reported device performance: Not present.
- Sample size and data provenance for test set: Not applicable, as no study results are provided.
- Number and qualifications of experts for ground truth: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone algorithm performance: Not applicable (this is a medical device, not an algorithm).
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
§ 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.