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Intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.

The Mandibular Fracture / Reconstructive Devices (TraumaOne) are comprised of a variety of titanium fracture and reconstruction plates and screws with shapes and sizes designed for internal fixation of mandibular fractures and reconstruction procedures. The screws have locking head features. The plates have threaded through holes (which allows them to work with either the locking screws) and will include straight, angle, double angle, and crescent options with various lengths and thickness.

The provided text is a 510(k) summary for the Biomet Microfixation Mandibular Fracture / Reconstruction Devices (TraumaOne). This document is for a medical device (bone plates and screws for mandibular fractures) and focuses on demonstrating substantial equivalence to previously cleared devices, rather than detailing a clinical study with acceptance criteria and performance metrics for an AI/algorithm-based device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not present in the provided document.

This 510(k) summary describes:

• Device Name: Mandibular Fracture / Reconstructive Devices (TraumaOne)
• Intended Use: Stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.
• Contraindications: Active infection, foreign body sensitivity, limited blood supply/insufficient bone/latent infection, uncooperative patients, and unsupported use in mandibular resection cases without a graft.
• Description: Variety of titanium fracture and reconstruction plates and screws with locking head features.
• Sterility Information: Non-sterile, single-use devices.
• Possible Risks: Poor bone formation, nonunion, migration/bending/fracture of implant, metal sensitivity, decrease in bone density (stress shielding), pain/discomfort, increased fibrous tissue response, necrosis of bone, inadequate healing, and device failure if used to bridge resections without a graft.
• Substantial Equivalence to: Lorenz Titanium Fracture / Reconstructive Devices (K001238) and Lorenz Reconstruction System (K980512).

Conclusion: The provided document is a regulatory submission for a physical medical device (implants) seeking 510(k) clearance based on substantial equivalence. It does not involve an AI or algorithm-based device, and thus, the specific questions related to AI device evaluation (acceptance criteria, study design for performance, ground truth establishment, reader studies, etc.) are not applicable or answerable from this text.

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