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Synthes Patient Specific Plates are a metallic bone plates used in conjunction with metallic bone screws for the internal fixation of maxillofacial bone, specifically in the areas of the mandible and maxilla. The design and dimensions (number and placement of holes, hole angulation, plate length, etc.) of each plate are based on of the patient's anatomic (CT scan) data, the surgical plan, and input from the surgeon. Synthes Patient Specific Plates are not intended to be further bent or contoured during surgery. Synthes Patient Specific Plates are manufactured from commercially pure titanium, are provided non-sterile, must be sterilized prior to use, and are intended for single use only.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Synthes Patient Specific Plates (K122647):

This submission is a 510(k) for a Class II medical device, which typically relies on demonstrating substantial equivalence to a predicate device rather than full clinical trials. Therefore, the "study" described is primarily focused on non-clinical (bench) testing to support this equivalence.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance
Bending Resistance	Proposed device should have equivalent or better in-plane resistance to bending compared to predicate devices.	"The bending resistance of the proposed plates was determined to be equivalent or better to the predicate devices."
Cantilever Bend Fatigue Life	Proposed device should have equivalent or better cantilever bend fatigue life compared to predicate devices.	"The fatigue life of the proposed plates was determined to be equivalent or better to the predicate devices."
Safety & Effectiveness	Differences in technological characteristics should not raise any new questions of safety and effectiveness compared to predicate devices.	"Therefore, it is concluded that the proposed plates do not raise any new questions of safety or efficacy in terms of bending resistance." and "Therefore, it is concluded that the proposed plates do not raise any new questions of safety or efficacy in terms of cantilever bend fatigue life." The overall conclusion states: "The information submitted supports substantial equivalence."

Study Information

Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The tests were "cross-sectional analysis" and "mechanical testing," suggesting multiple samples were tested for each device type (proposed and predicate). The exact number of plates or test specimens is not provided.
- Data Provenance: Not explicitly stated, but as this is bench testing for a device manufactured by Synthes (USA), it's implied that the testing was performed in a controlled laboratory environment, likely within the US or a facility affiliated with the manufacturer. It is retrospective in the sense that the device design already existed and was being tested against established predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was non-clinical bench testing, not a study involving human interpretation or clinical data where expert ground truth would be established. The "ground truth" here is the physical performance of the devices as measured by standardized mechanical tests.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As above, this was non-clinical bench testing. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints.
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. An MRMC study was not conducted. This device is a custom-fit bone plate, not an AI-assisted diagnostic or therapeutic tool. The comparison was between the physical performance of the proposed plate and existing predicate plates.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical medical implant, not a software algorithm. Its performance is inherent to its material and design, not an algorithm's output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this non-clinical study was based on objective mechanical measurements of physical properties (bending resistance, fatigue life) compared against established performance characteristics of legally marketed predicate devices. There is no expert consensus, pathology, or outcomes data used to establish "ground truth" in this context.
The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its design is based on patient-specific CT data and surgical plans, which is a different concept from a machine learning training set.
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI/ML algorithm involved, there is no ground truth for a training set to establish. The design of the individual patient-specific plate uses the patient's anatomical CT scan data and the surgeon's input as its 'blueprint'.

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