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The Axis Anterior Cervical Plate System is in skeletally mature patients for anterior screw fixation to the cervical spine (C2-T1) as an adjunct to fusion for the following indications: (a) degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); (b) trauma (including fractures); (c) tumours; (d) deformity (defined as kyphosis); (e) spondylolisthesis; (f) spinal stenosis; (g) pseudarthrosis and (h) revision of previous surgery.

The Axis Anterior Cervical Plate System (also called the Axis2 Anterior Cervical Fusion Plate in markets outside the US) is intended for anterior screw fixation to the cervical spine. The Axis Anterior Cervical Plate System consists of a variety of sizes of bone plates and screws to accommodate anatomical needs. The components are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The implants are provided in sterile and non-sterile packaging.

The provided text is a 510(k) summary for the Axis Anterior Cervical Plate System. It describes the device, its indications for use, and its technological characteristics. However, the document does not contain information about software, AI, or diagnostic performance studies that would involve acceptance criteria, test sets, expert ground truth, or MRMC studies for a device with those functionalities.

The performance data mentioned in the document is exclusively for non-clinical mechanical testing of the implant's structural integrity. Therefore, I cannot provide the requested information related to the acceptance criteria and study that proves a device meets diagnostic performance criteria because such data is not present in the provided text.

The closest information related to "acceptance criteria" is that the device was tested per ASTM F1717 for mechanical properties and the results showed "sufficient" strength and substantial equivalence to predicate devices.

Here's an overview of what is in the document regarding performance, and why it doesn't match your request:

Performance Data Section from Document:
"The Axis Anterior Cervical Plate System has been tested in the following test modes:

• Static & Dynamic Compression Bending per ASTM F1717
• Static Torsion per ASTM F1717
  The results of this non-clinical testing show that the strength of the Axis Anterior Cervical Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

This information pertains to material science and mechanical engineering, not diagnostic accuracy or AI performance.

Therefore, I cannot populate the table or answer the questions related to diagnostic performance or AI effectiveness.

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