(86 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 Craniofacial Plates are titanium plates in a variety of shapes and sizes designed for various cranio-facial procedures.
This looks like a 510(k) premarket notification for a medical device. This type of document focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing acceptance criteria and proving performance through a standalone study as would be seen for a novel device or a PMA application.
Therefore, many of the requested elements for a study proving acceptance criteria will not be present in this document. The document explicitly states:
"Documentation was provided which demonstrated the Synthes Craniofacial Plates to be substantially equivalent to other legally marketed devices."
And the FDA's letter confirms:
"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
Given this, I cannot extract information about acceptance criteria, detailed study designs, sample sizes, expert qualifications, or multi-reader multi-case studies as these are not part of a substantial equivalence claim for a device like this.
Here's how I can address what is available:
Acceptance Criteria and Device Performance
Since this is a substantial equivalence submission, there are no specific performance-based acceptance criteria or a dedicated study described to prove performance against such criteria in the provided text. The "acceptance criteria" here implicitly relate to demonstrating equivalence to predicate devices in terms of material, design, and intended use. The "reported device performance" is not quantified in the way you might expect for a novel diagnostic algorithm; rather, it's inferred to be similar to the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Material is Titanium | Device is made of Titanium, same as predicate. |
| Design is plates for craniofacial procedures | Device consists of titanium plates in various shapes and sizes, described as similar to predicate. |
| Intended Use for craniofacial fixation | 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, which aligns with predicate devices. |
| Compliance with general controls | Device is expected to comply with general controls provisions of the Act. |
Study Information (Based on Substantial Equivalence, Not Performance Study)
- Sample size used for the test set and the data provenance: Not applicable. No test set for performance evaluation is described. The "test" for a 510(k) is often a comparison of technical characteristics and intended use to a predicate device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is described.
- Adjudication method 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. This device is a physical bone plate, not an AI or diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a 510(k) is the established performance and safety of legally marketed predicate devices.
- The sample size for the training set: Not applicable. No training set for a performance model is described.
- How the ground truth for the training set was established: Not applicable.
In essence, for a 510(k) of a device like the Synthes Craniofacial Plates, the "study" is the comparison against predicate devices, and the "acceptance criteria" revolve around demonstrating that the new device is as safe and effective as those already on the market, rather than meeting specific quantifiable performance metrics from a new dataset.
§ 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.