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The ORTRAUTEK TRAUMA SYSTEM is a cranio-maxillofacial titanium plate and screw system intended for osteotomy, stabilization and rigid fixation of cranio-maxillofacial fracture and reconstruction.

The ORTRAUTEK TRAUMA SYSTEM is composed of bone plates and bone screws of various shapes and sizes, and associated accessories for use in oral and maxillofacial surgery. The accessories include the instruments used to implant bone plates and screws. These accessories include screwdrivers, forceps, and drills. The bone plates meet ASTM F67 standards of unalloved titanium surgical implants. The bone screws meet ASTM F136 standards. The system contains various shapes and sizes of plates. The thickness of these plates is either 1.0 mm or 0.6 mm. The system contains bone screws that are 2.0 mm, 2.4 mm, or 1.5 mm.

The provided document is a 510(k) summary for the ORTRAUTEK TRAUMA SYSTEM. This type of regulatory submission establishes substantial equivalence to predicate devices and does not typically include detailed performance studies with acceptance criteria, sample sizes, or ground truth establishment in the way that an AI/ML medical device submission would.

Therefore, the document does not contain the information required to populate the acceptance criteria and study details for an AI-based device.

The document discusses:

• Device Trade Name: ORTRAUTEK TRAUMA SYSTEM
• Common/Usual Name: Bone Plate System
• Classification Name: Bone Plate
• Predicate Devices: Several bone plate systems (K854886, K022185, K002619, K974555, K944561, K953385).
• Device Description: Composed of bone plates and bone screws made of unalloyed titanium (meeting ASTM F67 and F136 standards, respectively), and associated accessories.
• Intended Use: Cranio-maxillofacial titanium plate and screw system intended for osteotomy, stabilization, and rigid fixation of cranio-maxillofacial fracture and reconstruction.
• Basis of Substantial Equivalence: Identical in material, design, composition, function, and intended use to predicate devices.

There is no mention of acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes, ground truth, expert adjudication, or AI/ML-related studies within this document. This is a hardware device (bone plates and screws), not a software or AI-driven diagnostic/therapeutic device that would rely on such performance metrics.

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The ORTRAUTEK ORTHOGNATHIC SYSTEM is intended for oral, maxillofacial surgery: selective trauma, reconstructive surgery, and selective orthognathic surgeries on maxilla and mandible.

The ORTRAUTEK ORTHOGNATHIC SYSTEM is composed of bone plates and bone screws of various shapes and sizes, and associated accessories for use in oral and maxillofacial surgery. The accessories include the instruments used to implant bone plates and screws. These accessories include screwdrivers, forceps, and drills. The bone plates meet ASTM F67 standards of unalloyed titanium surgical implants. The bone screws meet ASTM F136 standards. The system contains various shapes and sizes of plates. The thickness of these plates is either 1.0 mm, 0.6 mm, or 0.8 mm. The system contains bone screws that are 2.0 mm, 2.4 mm, or 1.5MM.

I am sorry, but based on the limited information provided in the given text, I cannot describe the acceptance criteria and the study that proves the device meets them. The text primarily focuses on the 510(k) summary for the "ORTRAUTEK ORTHOGNATHIC SYSTEM," detailing its description, predicate devices, and intended use as part of its substantial equivalence claim to previously marketed devices.

There is no mention of:

• Acceptance criteria: Specific performance metrics or thresholds the device needs to meet.
• A study proving acceptance criteria: Details about any clinical or performance studies, their design, results, or statistical analyses.
• Sample sizes: For test sets or training sets.
• Data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document is a premarket notification (510(k)) that argues for substantial equivalence primarily based on material, design, composition, function, and intended use being identical or similar to predicate devices. It does not contain the kind of detailed performance study information typically found when a device is evaluated against specific acceptance criteria.

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