(26 days)
The Bioplate® Riqid 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 single use only and only in conjunction with other titanium and titanium alloy implants.
The supplementary label/labeling material will be used for training and promotional purposes and does not affect the intended use of the devices.
The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes titanium alloy screws of varying diameters and lengths and are used for fixation of unalloyed, commercially pure titanium and titanium allov plates to the craniofacial bony tissue.
The provided text is a 510(k) premarket notification for a medical device – The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery. This document primarily focuses on establishing "substantial equivalence" to predicate devices, rather than detailing a specific clinical study with acceptance criteria and performance metrics in the way a robust clinical trial with AI would.
Therefore, many of the requested sections (e.g., AI performance, MRMC study, ground truth for training data) are not applicable to this type of submission. The document relies on a comparison of characteristics and intended use to predicate devices that were already legally marketed.
Here's an analysis based on the provided text, addressing the applicable points and explaining why others are not present:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present quantitative acceptance criteria or device performance measurements in the typical sense of a clinical study. Instead, the "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to existing legally marketed predicate devices. The "reported device performance" is implicitly that the device performs equivalently to the predicates.
| Acceptance Criteria (for 510(k) Substantial Equivalence) | Reported Device Performance (as stated in submission) |
|---|---|
| Same Indications for Use as predicate devices | "The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surqery has the same indications for use as the Bioplate, Inc., Walter Lorenz, Synthes USA, Osteomed Corp., and KLS-Martin predicate devices." |
| Similar Technological Characteristics to predicate devices | "All of the technical characteristics of the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are substantially equivalent to the corresponding characteristics of the predicate devices." |
| No New Issues of Safety and Efficacy | "...any minor differences raise no new issues of safety and efficacy." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This 510(k) submission does not describe a clinical "test set" in the context of evaluating a new performance claim or an AI algorithm’s accuracy. Substantial equivalence is typically demonstrated through bench testing (mechanical properties, material composition, etc.) and comparison to predicate devices, rather than a prospective clinical study with a patient test set for performance comparison. The document does not provide details on specific bench tests conducted or the data generated from them beyond general statements.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As there is no "test set" for performance evaluation against a ground truth in the context of an AI device, this information is not provided. The 'ground truth' here is essentially established by the historical performance and regulatory approval of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. No "test set" and corresponding adjudication method are described for this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a physical medical implant (bone plating system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" in the context of this 510(k) submission is the established safety and efficacy of the predicate devices already on the market. The Bioplate® system is deemed safe and effective because it is substantially equivalent to these already accepted devices. This is a regulatory "ground truth" rather than a clinical ground truth like pathology or outcomes data for a novel performance claim.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device, so there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no AI algorithm or training set for this device.
In summary, this 510(k) submission for The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery demonstrates substantial equivalence to existing predicate devices by showing it has the same intended use and similar technological characteristics, raising no new safety or efficacy concerns. The requested information regarding acceptance criteria, study details, and AI performance metrics are primarily relevant for AI/ML-based medical devices or devices demonstrating novel clinical performance, which this implantable device is not.
§ 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.