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The Pyrenees and K2M Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD), spondylolisthesis, 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 is a spinal fixation system which consists of cervical screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy. Materials: The devices are manufactured from Commercially Pure titanium alloy per ASTM and ISO standards. Function: The system functions as an adjunct to fusion to provide immobilization of cervical segments of the spine.

The Pyrenees Cervical Plate System, Translational Plate, is a spinal fixation system consisting of cervical screws and plates made from Commercially Pure titanium alloy. It's intended for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document describes mechanical testing and comparison to predicate devices rather than a clinical study with a test set of human subjects or data. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable in the context of this submission. The "test set" here refers to the physical devices subjected to mechanical loads.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the "ground truth" for mechanical testing is established by the specifications of ASTM F1717 and the performance of predicate devices, not expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable as the assessment is based on objective mechanical measurements against a standard (ASTM F1717) and direct comparison to predicate device performance. No human adjudication is mentioned or implied for this type of test.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC comparative effectiveness study, AI assistance, or human readers in the provided document. This submission focuses on the mechanical and functional equivalence of a spinal fixation device, not a diagnostic or interpretative AI-based system.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical spinal implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

• Established mechanical testing standards: Specifically, ASTM F1717.
• Performance of legally marketed predicate devices: The Pyrenees system's performance was compared directly to that of predicate devices in static torsion, dynamic compression, and static tension.
• Material and design specifications: Adherence to ASTM and ISO standards for materials, and equivalence in design features and sizing to predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. The device is an orthopedic implant, not a machine learning model that undergoes training on a dataset.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the reasons stated in point 8.

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