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The MedCAD® AccuPlate® Patient-Specific Plate is intended for prescription use in oral and maxillofacial surgery, trauma and reconstructive surgery.

Specific Indications for Use:

• Primary mandibular reconstruction with bone graft
• Temporary bridging until delayed secondary reconstruction
• Secondary mandibular reconstruction
• Comminuted mandibular fractures
• Fractures of edentulous and/or atrophic mandibles
• Unstable mandibular fractures
• Maxillary reconstruction with or without bone graft
• Maxillary trauma

MedCAD® AccuPlate® Patient-Specific Plates are metal bone plates used in conjunction with commercially available metal bone screws for the fixation to bone, specifically in the areas of the mandible and maxilla. The design and dimensions of each plate within the envelope specification is based upon the patient's anatomical data (CT scan, CBCT scan, or MRI), and the intended anatomy to be fixated as determined from input provided by the surgeon. The plates are designed by MedCAD in consultation with the surgeon and manufactured by MedCAD only. MedCAD® AccuPlate® Patient-Specific Plates are not intended to be bent or modified in surgery. The MedCAD® AccuPlate® Patient-Specific Plates are manufactured from commercially pure titanium, are provided non-sterilized prior to use, and are intended for single use only. Plates are fastened to bone using commercially available bone screws with diameters ranging from 2.0 mm to 2.7 mm and lengths ranging from 4.0 mm to 23.0 mm.

This document is a 510(k) Premarket Notification from the FDA regarding the MedCAD® AccuPlate® Patient-Specific Plate. It is a medical device clearance document, not a study report for an AI/software device. Therefore, it does not contain the information typically presented for acceptance criteria and study results of an AI or software as a medical device (SaMD).

The document concerns a patient-specific bone plate used in oral and maxillofacial surgery. The "performance data" section refers to non-clinical functional and material testing (e.g., static and dynamic bending, screw pushout testing, sterilization, and biocompatibility validation) to demonstrate substantial equivalence to predicate devices, not performance metrics of an AI or software.

Therefore, I cannot provide the requested information regarding acceptance criteria and study results for an AI/software medical device because this document does not describe such a device or study.

Specifically:

1. A table of acceptance criteria and the reported device performance: The document mentions "All test method acceptance criteria were met" for sterilization validation and that mechanical tests showed the device "meets the performance of the predicate / reference devices." However, it does not provide specific acceptance values or performance metrics for these non-clinical tests in a table format that would be relevant to an AI/software device.
2. Sample sizes used for the test set and the data provenance: Not applicable to this type of device. The "test set" would refer to physical prototypes in mechanical testing, not a dataset for software.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device performance is established through engineering specifications and standardized testing protocols.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance for clinical tasks, which is not the scope of this bone plate device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: For physical performance testing, the ground truth is defined by engineering standards (e.g., ASTM F382 for bending, ISO 10993-1 for biocompatibility).
8. The sample size for the training set: Not applicable. This is a manufactured physical device, not an AI model.
9. How the ground truth for the training set was established: Not applicable.

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The Stryker Facial iD Plating System is intented for osteotomy, stabilization of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher).

Specific Indications for Use:

-Orthognathic surgery

-Reconstructive maxillofacial surgery

-Mandible and maxillofacial trauma surgery.

The Stryker Facial iD Plating System (Subject Device) is intended for osteotomy, stabilization and rigid fixation of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher), with the specific Indications for Use in orthognathic surgery, reconstructive maxillofacial surgery, and mandible and maxillofacial trauma surgery.

The Subject Device plate(s) are additively manufactured patient-specific plates, and the patientspecific design of the plates allows certain features to be configured to meet the individual needs of each patient. The Subject Device plate(s) are provided with a printed version of the surgeonapproved Design Proposal, an electronic Instruction for Use (IFU) and an optional Anatomical Model. Additionally, the Subject Device is compatible with a separately provided Marking / Cutting Guide accessory.

The provided document describes the Stryker Facial iD Plating System, a custom-designed maxillofacial plating system. The following information is extracted regarding its acceptance criteria and the studies performed:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:
   The document focuses on bench testing and validation studies, not clinical studies involving patient data. Therefore, the concepts of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) as typically applied to AI/diagnostic device studies using patient data are not directly applicable here. The "test sets" refer to physical samples (e.g., plates, accessory models) used in engineering and biocompatibility tests. The number of samples for each specific test is not detailed, but it is implied that sufficient samples were tested to meet the respective standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable as the studies described are bench tests and validation studies for a medical device (bone plate system), not a diagnostic AI device requiring expert-established ground truth from patient data. The "ground truth" for these tests are the established standards and specifications (e.g., ISO, ASTM).

4. Adjudication method for the test set:
   Not applicable, as no human expert adjudication of patient cases or images is described. The results of the tests were evaluated against predefined standards and criteria.

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, an MRMC comparative effectiveness study was not performed. This document describes the clearance of a physical medical device (bone plating system), not an AI/diagnostic software.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   While "Software output validation" was conducted for the design and manufacturing workflow, this is not a standalone performance evaluation of a diagnostic or assistive AI algorithm in the typical sense. It validates the output of the design software, ensuring it accurately translates digital models to manufacturing data. There's no performance metric comparing the algorithm's output to a ground truth established by humans for diagnostic purposes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For bench testing and validation, the ground truth is based on:

   • Established engineering standards: e.g., ASTM F382 for metallic bone plates, ASTM STP 731 for fatigue limits, ASTM D642 for compressive resistance, ASTM F1886M for seal integrity, ASTM E2314 for cleaning effectiveness.
   • Biocompatibility standards: e.g., ISO 10993 series and FDA guidance.
   • Sterilization standards: e.g., ISO 17665-1, ISO 14937.
   • Internal design specifications and user requirements: For software output validation and compatibility testing.

8. The sample size for the training set:
   Not applicable. This device is a physical bone plating system, not an AI model that requires a training set of data. The "patient-specific design" does involve software to design the plates for individual patients, but this is a design workflow, not a machine learning model that learns from a training set in the conventional sense.

9. How the ground truth for the training set was established:
   Not applicable, as there is no mention of a "training set" for an AI model in this 510(k) submission.

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