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The APOLLO™ Anterior Cervical Plate (ACP) System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
· Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),

• · Spondylolisthesis,
• · Trauma (including fractures or dislocations),
• · Tumors,
• · Deformity (defined as kyphosis, lordosis, or scoliosis),
• · Pseudarthrosis,
• · Failed previous fusion,
• · Spinal stenosis

The APOLLO™ Anterior Cervical Plate (ACP) System is comprised of cervical plates and bone screws constructed of titanium alloy as described by ASTM F136. Plates are available in multiple levels and lengths, and screws are available in multiple diameters, lengths, and tip configurations to accommodate variations in patient anatomy. The Integrated screw locking mechanism is used to block the screw heads after the device construct has been attached to the anterior cervical spine.

The provided text is a 510(k) summary for the APOLLO™ Anterior Cervical Plate (ACP) System. This document describes a medical device (an implanted plate and screws for spinal fusion), not an AI/ML-driven device or diagnostic system.

Therefore, the requested information (acceptance criteria for AI/ML performance, study details for AI/ML device validation, such as sample size, ground truth establishment, MRMC studies, etc.) is not applicable to this submission. The "Performance Data" section explicitly states:

• "Non-clinical mechanical testing was performed consisting of the following test modes: Static and dynamic compression bending per ASTM F1717 . Static torsion per ASTM F1717"
• "The results of this non-clinical testing show that the strength of APOLLO™ device is sufficient for its intended use."
• "Clinical data and conclusions were not needed for this device."

This indicates that the clearance was based on mechanical bench testing demonstrating the structural integrity and equivalence to a predicate device, rather than a study evaluating diagnostic or predictive performance using patient data, which would be the case for an AI/ML device.

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