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The Altus Spine 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 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 Pedicle Screw System may be used for noncervical pedicle fixation via in posterior percutaneous approach with MIS instrumentation for the indications listed above. When used as an anterolateral thoracic/umbar system the Altus Spine Pedicle Screw System may also be used for the same indications listed above as an adjunct to fusion.

The Altus Spine 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 Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spine. Which 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 Rod-to-Rod Connectors, Lateral Connectors, Dominos and Cross Connectors. All 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.

I am sorry, but based on the provided text, I cannot provide the requested information. The document is an FDA 510(k) clearance letter for a medical device called the "Altus Spine Pedicle Screw System." This type of document establishes substantial equivalence to a predicate device based on material properties, design, and intended use, often supported by mechanical testing.

The document does not contain any information about an AI-powered device, a clinical study involving human readers, ground truth establishment for a test set, expert adjudication, or metrics like sensitivity, specificity, or AUC which are typically associated with AI/ML medical device performance studies.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance (in the context of AI metrics).
• Sample sizes and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study results.
• Standalone AI performance.
• Type of ground truth used.
• Training set sample size and ground truth establishment.

The document specifically mentions "SUMMARY OF NON-CLINICAL TESTS SUBMITTED:" and lists "Static Compression Bending, Static Torsion, and Dynamic Compression Bending per ASTM F1717-15." These are mechanical engineering tests for the structural integrity of the pedicle screw system, not clinical performance data for an AI algorithm.

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