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PYRENEES and BLUE RIDGE Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondy lolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

The Pyrenees Cervical Plate System consists of plates (1-5 levels) and screws (self-tapping and self-starting) made of titanium in accordance with ASTM F1472 and F136 and CP titanium per ASTM F67. The Pyrenees Cervical Plates are offered in both constrained and translational designs. The subject 510(k) adds additional Mono screws to the system. The Pyrenees system components are provided non-sterile.

Function: The system functions as a spinal fixation device to provide support and stabilization of the cervical vertebrae.

The provided text is a 510(k) summary for a medical device, the Pyrenees Cervical Plate System. It describes the device, its intended use, and its substantial equivalence to predicate devices based on technological comparison and non-clinical performance evaluation.

However, the document does not contain information related to a study that proves the device meets specific acceptance criteria based on clinical performance, human-in-the-loop studies (such as MRMC), or AI/algorithm performance. The assessment is based on non-clinical performance (mechanical testing) and demonstrates substantial equivalence to predicate devices, not on the kind of clinical or AI-driven performance metrics requested in the prompt.

Therefore, I cannot provide the detailed information requested in your prompt (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study results, standalone performance, ground truth details for AI/algorithm validation, etc.) because this information is not present in the provided text.

The document focuses on:

• Device Description: Plates and screws for cervical spine fixation.
• Materials: Titanium alloys.
• Intended Use: Anterior screw fixation to the cervical spine (C2-T1) for conditions like DDD, spondylolisthesis, trauma, stenosis, tumors, failed fusions, and deformity.
• Non-clinical Performance Evaluation: Static compression, static torsion, and dynamic compression testing in accordance with ASTM F1717 for the predicate plates, with engineering rationales for subject screws.
• Conclusion: Substantial equivalence to other marketed devices in design, function, material, and intended use.

This is typical for a 510(k) submission for a spinal implant, which primarily relies on mechanical testing and comparison to legally marketed predicate devices, rather than clinical efficacy studies or performance metrics derived from AI/algorithm evaluations.

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