(79 days)
Synthes Mandible External Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
Synthes Mandible External Fixator consists of the following components: An Adjustable Clamp - MR Safe; 4.0/2.5 Schanz Screws; 2.5 mm K-wires; 4.0 mm Pre-bent Titanium Rods; and 4.0 mm Carbon Fiber Rods. The components of this system are designed for use in the MR environment. The rods and Schanz Screws are available in various lengths.
The input document is a 510(k) Summary for the Synthes Mandible External Fixator. This document indicates the device's classification and its substantial equivalence to a predicate device based on mechanical test results. Product 510(k) summaries for surgical tools and implants typically include mechanical testing and comparison to predicate literature. These do not typically include clinical studies or data from AI models. Therefore, the requested information (performance criteria in a clinical study for an AI model) cannot be extracted from the provided text.
Based on the provided text, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The device is considered substantially equivalent to the predicate device.
- Reported Device Performance: "The new device is considered to be substantially equivalent to the predicate device based on mechanical test results."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- This information is not available in the provided text. The evaluation was based on mechanical test results, not a test set of human data.
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)
- Not applicable. The evaluation was based on mechanical test results, not expert review of a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. The evaluation was based on mechanical test results, not expert review of a test set.
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
- No, a multi-reader multi-case comparative effectiveness study was not done. This device is a physical medical device (external fixator), not an AI-based diagnostic tool.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device (external fixator), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for demonstrating substantial equivalence was the performance of the predicate device, as established through mechanical test results.
8. The sample size for the training set
- Not applicable. There is no mention of a training set for an AI model.
9. How the ground truth for the training set was established
- Not applicable. There is no mention of a training set for an AI model.
§ 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.