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Craniomaxillofacial Implants: The Universal CMF System is a Craniomaxillofacial (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction.

Mandible Implants: The Universal CMF System (mandible modules) is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction.

The subject device (combination of Universal CMF System (K022185) and NewGen/Universal Mandibular System (K014263)) consists of multiple modules including fracture and reconstruction modules. The modules consist of straight, angled, hemi/full mandible bridging, curved, and pre-bent plates. The screws in the modules include 1.2-2.7mm self-tapping, self-drilling, and locking screws that vary from 3mm-42mm in length. The plates and screws are made of commercially pure titanium (ASTM F 67-95) and titanium alloy (ASTM F136-98).

It appears there's a misunderstanding of the provided FDA document. The document, K221855 for the "Universal CMF System," is a 510(k) premarket notification for a bone plate and screw system, which is a physical medical device used for fixing craniomaxillofacial fractures.

It is NOT an AI/ML-driven medical device. Therefore, the document does not contain information about:

• Acceptance criteria for an AI/ML algorithm's performance (e.g., sensitivity, specificity, AUC).
• A "study" proving device performance in the context of an AI/ML algorithm (e.g., clinical trials for AI diagnostic accuracy).
• Test set sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

The "performance data" section (VIII) refers to:

• Sterilization validation: Ensuring the device can be properly sterilized by the end-user.
• Performance bench testing: Mechanical tests to ensure the physical plates and screws meet engineering standards (e.g., biocompatibility, insertion/removal torque, failure strength). These are standard tests for physical implants, not AI algorithm performance metrics.
• Animal and Clinical Testing: Explicitly states "not required as a basis for substantial equivalence" for this physical device.

In summary, there is no AI/ML component described in this document, and therefore, it's impossible to extract the requested information about AI/ML acceptance criteria and performance studies from it.

The request asks for specific details relevant to the validation of an AI/ML device. Since this document pertains to a physical implantable device, those details simply do not exist within this filing.

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