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The Altus Spine HA 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 HA 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); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The Altus Spine HA 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/lumbar system the Altus Spine HA Pedicle Screw System may also be used for the same indications listed above as an adjunct to fusion.

The Altus Spine HA 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 HA Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spine 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, cobalt chrome meeting the requirements of ASTM F1537 and Hydroxyapatite meeting the requirements of ASTM F1185. Other components included in this submission are (e.g., cross connectors, lateral connectors, inline connectors, dominos, etc.). Only the HA coated screws are supplied sterile packaged. All other components are supplied non-sterile.

This document is a 510(k) Premarket Notification from the FDA regarding the Altus Spine HA Pedicle Screw System. It declares the device substantially equivalent to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/software performance.

Instead, the document explicitly states:

"No testing is required. (e.g., engineering rational demonstrated that no new worst-case was introduced with the addition of the HA screws and all other components were previously cleared in (K200322). Altus Spine HA Pedicle Screw System are manufactured the same as the primary predicate Altus Spine Pedicle Screw System (K200322). Hydroxyapatite coating and sterile packing are processed the same as the primary predicate Whistler Modular Pedicle Screw System (K182478)."

This indicates that the submission relies on engineering rationale and substantial equivalence to previously cleared predicate devices, rather than new performance studies with specific statistical acceptance criteria for a new AI/software component. The device is a physical medical implant (pedicle screw system), not an AI/software device.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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