(22 days)
The modified plate 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-load bearing fixation, including cranial bone fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.
Modified plate designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes a variety of plate configurations for different anatomical applications. Titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxillofacial bony tissue. The bone plates will be manufactured of commercially pure titanium.
This is a 510(k) premarket notification for a medical device (Modified plate designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery) and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness through clinical trials with defined acceptance criteria and statistical performance metrics. Therefore, explicit "acceptance criteria" for device performance in the context of an AI study, and a "study that proves the device meets the acceptance criteria" as typically described for AI/algorithm performance, are not present in the provided text.
The document primarily relies on comparison with predicate devices to establish substantial equivalence regarding technological characteristics and intended use.
However, I can extract information related to the device and its intended purpose, which could hypothetically form the basis of acceptance criteria if this were an AI device.
Here's a breakdown of the requested information based on the provided document, noting that many items are not applicable (N/A) because this is not an AI device or an AI study:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Hypothetical for a similar AI device) | Reported Device Performance (N/A - This submission is for a physical medical device) |
|---|---|
| Mechanical Strength/Stiffness: | The document states "All of the technical characteristics of the modified plate designs...are substantially equivalent to the corresponding characteristics of the predicate devices..." |
| * Tensile strength Y cycles under Z load* | |
| Biocompatibility: | The bone plates will be manufactured of commercially pure titanium, which is a well-established biocompatible material in predicate devices. |
| * No cytotoxicity (ISO 10993-5)* | (Presumed to be met by using commercially pure titanium.) |
| * No irritation (ISO 10993-10)* | |
| Dimensional Accuracy: | The device is a "modified plate design," implying specific dimensions and configurations. |
| * Plate thickness within +/- 0.XX mm* | (Implicitly, the dimensions are consistent with predicate devices for the intended applications. Specific tolerances are not detailed.) |
| * Screw hole diameter within +/- 0.XX mm* | |
| Fixation Security: | N/A - This would be a clinical outcome for a physical device, not an AI performance metric. |
| * Successful fracture stabilization in 95% of cases* | |
| * No plate failure during expected use* |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This is a 510(k) submission for a physical medical device, not an AI device or an AI study. There is no "test set" in the context of an algorithm's performance. The submission relies on a comparison of technical characteristics to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. Since this is not an AI device or an AI study, there is no ground truth, test set, or experts establishing ground truth in this context. The FDA's review process itself involves experts within the agency, but this is for regulatory clearance based on substantial equivalence, not for evaluating an algorithm's performance against a ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. As there is no test set for an algorithm, there is no adjudication method described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. No MRMC study was done, as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. There is no ground truth described as this is not an AI study. The "truth" in this submission relies on the established safety and effectiveness of the predicate devices and the physical properties of the materials and design.
8. The sample size for the training set
- N/A. This is a physical medical device, not an AI algorithm, so there is no training set.
9. How the ground truth for the training set was established
- N/A. As there is no training set, there is no ground truth for it.
In summary, the provided document is a 510(k) summary for a physical medical device (bone plates and screws). The regulatory pathway for such devices primarily involves demonstrating substantial equivalence to pre-existing, legally marketed predicate devices, rather than conducting new clinical trials or performance studies with specific statistical acceptance criteria as would be the case for a novel AI/software as a medical device (SaMD).
§ 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.