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The Medina ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Medina ACP System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with the following indications:

• Degenerative disk disease (DDD) (defined by neck pain of discogenic origin with o degeneration of the disc confirmed by patient history and radiographic studies)
• Trauma (including fractures)
• o Tumors
• Deformities or curvatures (including kyphosis, lordosis, or scoliosis) ●
• Pseudoarthrosis ●
• Failed previous fusions ●
• Spondylolisthesis ●
• Spinal Stenosis ●

The Medina Anterior Cervical Plate System (ACP) System is intended for anterior screw fixation to the cervical spine. The Medina ACP system consists of a variety of shapes and sizes of bone plates and screws. The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136 and commercially pure titanium per ASTM F67. Components of the Medina ACP System should not be used with components from any other system or manufacturer, with exception of the Cage Pins which are to be used only with Alliance Spine's Alamo C or Alamo C-Ti systems. The Medina ACP System components are provided non-sterile. The products need to be steam sterilized by the hospital prior to use.

The provided text describes a medical device, the Medina Anterior Cervical Plate System, and its substantial equivalence determination by the FDA. However, the text does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria in relation to an AI algorithm.

The information provided focuses on:

• Regulatory Clearance (K201521): The FDA's substantial equivalence determination for the Medina Anterior Cervical Plate System.
• Device Description: What the device is, its materials, and intended use.
• Indications for Use: The medical conditions for which the device is intended.
• Technological Characteristics: Comparison to predicate devices.
• Performance Data (Non-Clinical): Mechanical testing (static compression bending, static torsion, dynamic compression bending) against ASTM F1717, concluding substantial equivalence to predicate devices in terms of strength.

Therefore, I cannot provide the requested table and study details as they pertain to AI algorithm performance and acceptance criteria, as this information is not present in the provided document.

The document describes a physical medical device (an anterior cervical plate system) and its mechanical performance testing, not an AI or software-as-a-medical-device (SaMD) product.

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