(89 days)
The Synthes Craniofacial Plates are intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
The Synthes Orbital Plates come in a variety of shapes and sizes to meet the anatomical need of the patient. The plates are sterile / non-sterile and for single use only.
The provided document is a 510(k) premarket notification for Synthes Orbital Plates. It details the device's classification, predicate devices, description, intended use, and material. However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it contain information about AI or software performance.
The 510(k) submission process for devices like general bone plates primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new performance studies against specific acceptance criteria for software or AI. The assessment of substantial equivalence typically involves comparing device design, materials, intended use, and sometimes mechanical or bench testing data to ensure it is as safe and effective as the predicate.
Therefore, I cannot fulfill the request to provide information based on the given document regarding:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on demonstrating substantial equivalence, not on a performance study against specific acceptance criteria.
- Sample size used for the test set and the data provenance: Not applicable, as no performance study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. The device is a physical orbital plate, not an AI software.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical orbital plate, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document states: "Documentation is provided which demonstrates that the Synthes Orbital Plates are substantially equivalent to other legally marketed Synthes devices." This indicates that the regulatory pathway relied on demonstrating equivalence, not on conducting new clinical or performance studies with acceptance criteria as one would for novel software or AI.
§ 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.