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Universal CMF System Intended use The Universal CMF System is intended for stabilization and rigid fixation of the craniomaxillofacial (CMF) skeleton. Indications for use Craniomaxillofacial Implants The Universal CMF System is 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. MP Lefort I Plates Intended Use The Stryker Leibinger Universal CMF and Universal 2.0 Mini Plating Systems are Craniomaxillofacial (CMF) plate and screw systems intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. Indications for Use The MP LeFort I Plates as part of the predicate subgroup Universal 2.0 Mini Plating System are implants indicated for osteotomy, stabilization, and rigid fixation of LeFort I fractures of the maxillofacial skeleton. Stryker Upper-Face AXS Screws And Mid-Face AXS Screws Indications for Use The Stryker Universal CMF System is a Cranio-maxillofacial (CMF) plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. Stryker MP, Mandible, HMMF And MMF AXS Screws -Universal CMF System: Intended Use The Universal CMF System is intended for stabilization and rigid fixation of the craniomaxillofacial (CMF) skeleton. Indications for Use Craniomaxillofacial Implants The Universal CMF System is 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. -Stryker Universal SMARTLock Hybrid MMF System: Intended Use The Stryker Universal SMARTLock Hybrid MMF System is intended to be used for temporary stabilization of mandibular and maxillary fractures in order to maintain proper occlusion during fracture healing. Indications for Use The Stryker Universal SMARTLock Hybrid MMF System is indicated for the treatment of mandibular and maxillary fractures in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted. -Stryker MMF Screw Intended use The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion. Indications for use The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion. Stryker Universal Orbital Floor System Intended Use The Stryker Universal Floor System is intended to be used in the reconstruction of the floor and/or medial wall of the orbit. Indications for Use The Stryker Universal Orbital Floor System is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in patients 15 years of age and older. Stryker Universal Smartlock Hybrid MMF System Intended use The Stryker Universal SMARTLock Hybrid MMF System is intended to be used for temporary stabilization of mandibular and maxillary fractures in order to maintain proper occlusion during fracture healing. Indications for use The Stryker Universal SMARTLock Hybrid MMF System is indicated for the treatment of mandibular and maxillary fractures in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted. Stryker MMF Screw Intended use The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion. Indications for use The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion.

This Bundled. Traditional 510(k) is for a single change the MR status that affects multiple devices and can be assessed during one review. There are no changes to the predicate devices themselves, just the addition to allow MR Conditional use of the implants in scope after MRI compatibility testing was completed. Associated labeling for each Predicate Device is also updated to reflect the MR conditional use of the implants.

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The Biomet Microfixation OmniMax MMF System is indicated for temporary stabilization of mandibular and maxillary fractures to maintain proper occlusion during surgery and for post-operative fracture healing in adults and adolescents (age 12 and older) in whom permanent teeth have erupted.

The Biomet Microfixation OmniMax MMF System is composed of metallic plates (arch bars) and locking screws that provide temporary stabilization of mandibular and maxillary bone during fracture healing and/or temporarily maintain a stable occlusion during surgery. Mandibular and Maxillary Fixation (MMF) is achieved through application of fixation plates and locking screws to bone; wire or elastics are then secured around hooks. The arch bar plate is manufactured from Commercially Pure Titanium; and the locking screws are manufactured from Titanium Alloy (Ti-6Al-4V).

This document describes the Biomet Microfixation OmniMax MMF System, a medical device for temporary stabilization of mandibular and maxillary fractures. It does not contain information about an AI/ML device or its performance criteria, nor does it detail a study involving AI. Therefore, I cannot fulfill the request for information regarding acceptance criteria and studies proving the device meets them based on AI/ML performance.

The document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data and device characteristics. It mentions "Non-Clinical Performance Data: All non-clinical performance testing passed according to the acceptance criteria" and lists the types of tests conducted:

• Screw: Insertion/Fracture Torque, Bending/Shear, Push-Through
• Plate and Screw Construct: Static and Fatigue Testing
• Simulated Use Cadaver Lab

However, it does not provide the specific numerical acceptance criteria for these tests or the reported performance values. It also explicitly states, "Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence."

Without information related to AI/ML, I cannot provide details on:

• Acceptance criteria and reported device performance for an AI/ML component.
• Sample sizes, data provenance, or ground truth for test sets for an AI/ML component.
• Number of experts or their qualifications for establishing ground truth related to AI/ML.
• Adjudication methods for AI/ML test sets.
• Multi-reader multi-case (MRMC) comparative effectiveness studies involving AI assistance.
• Standalone performance of an algorithm.
• Type of ground truth used for AI/ML.
• Sample size or ground truth establishment for a training set for an AI/ML component.

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