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K Number
K221855
Device Name
Universal CMF System
Manufacturer
Stryker Leibinger GmbH & Co. KG
Date Cleared
2022-11-09

(135 days)

Product Code
JEY
Regulation Number
872.4760
Type
Traditional
Panel
DE
Reference & Predicate Devices
K022185,K014263
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

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).

AI/ML Overview

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.

§ 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.