(7 days)
The modified screw designs for use 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-weight bearing fixation, including cranial bone fixation, brow fixation and orbital fixation. Each device is intended for sinqle use only and only in conjunction with other titanium and titanium alloy implants.
Modified screw designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes titanium allov screws of varving diameters and lengths and are used for fixation of unalloved, commercially pure titanium and titanium alloy plates to the craniofacial bony tissue.
The provided document is a 510(k) premarket notification for a medical device (Modified screw designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery). It is a declaration of substantial equivalence to predicate devices, not a study describing acceptance criteria and a device performance study as typically seen for AI/ML-driven devices.
Therefore, the document does not contain the information requested to fill out the table and answer the questions related to acceptance criteria, device performance, sample sizes, ground truth, experts, adjudication, or MRMC studies.
This type of submission (510(k) for a traditional medical device like screws and plates) primarily focuses on demonstrating that the new device has the same technological characteristics and intended use as devices already legally marketed (predicate devices). The "study" here is essentially a comparison to predicate devices to prove substantial equivalence, rather than a clinical trial or performance study against predefined acceptance criteria for a novel technology.
Here's why the requested information is not available in the provided text:
- Acceptance Criteria & Reported Device Performance: These are not defined because the submission aims to demonstrate equivalence, not to meet specific performance metrics through a clinical study. The "performance" is implicitly deemed equivalent to the predicate devices.
- Sample Size (Test Set & Training Set), Data Provenance, Ground Truth, Experts, Adjudication, MRMC Study, Standalone Study: These concepts are relevant to the evaluation of AI/ML or complex diagnostic devices, where performance is measured against a ground truth. For a bone screw, the "study" is likely mechanical testing and a review of materials, not a clinical study involving human readers or expert consensus on images.
- How Ground Truth was Established: Not applicable in this context.
In summary, the provided document does not describe the kind of study and acceptance criteria typically associated with performance evaluation of AI/ML or diagnostic devices. It is a regulatory submission for a physical medical device (bone screws and plates) demonstrating substantial equivalence to already approved predicate devices.
§ 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.