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The Altus Spine Monaco Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The Altus Spine Monaco Pedicle Screw System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); turnor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the Altus Spine Monaco Pedicle Screw System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); turnor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The Altus Spine Monaco Pedicle Screw System consists of a system of implantable screws to be used with implantable rods for the purpose of aiding in spinal fusion. The Altus Spine Monaco Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct with the intent to stabilize the spinal operative site during the fusion process of bone graft in the disc space. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136 and cobalt chrome meeting the requirements of ASTM F1537. The device is supplied non-sterile and is intended for sterilization by hospital personnel.

The provided text is a 510(k) premarket notification for a medical device, the Altus Spine Monaco Pedicle Screw System. It describes the device's purpose, indications for use, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to predicate devices.

However, the document does not contain information about:

• Acceptance criteria for an AI/ML-based device performance study.
• Any study involving a test set, expert readers, ground truth establishment, or human-in-the-loop performance with AI assistance.
• Sample sizes for training sets or provenance of data for AI models.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.

The provided text focuses on the mechanical and material properties of the pedicle screw system, demonstrating its substantial equivalence to previously cleared devices through bench testing (in accordance with ASTM F1717-21 for Dynamic Compression Bend, Static Compression Bend, and Static Torsion tests). This is typical for orthopedic implant submissions concerning physical integrity and function.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies demonstrating a device meets those criteria for an AI/ML-based medical device from this document. The information requested (points 1-9) pertains to the evaluation of AI/ML software as a medical device (SaMD) or as part of a medical device, which is not what this document describes.

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