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The Tempus™ Cervical Plate System is intended for anterior cervical fixation (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), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Tempus™ Cervical Plate System consists of screws and plates. Screws are available in a variety of diameter-length combinations. Plates are available in a variety of lengths to accommodate fusion procedures from one to five levels of the cervical spine. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Tempus™ Plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate.

The provided text describes the 510(k) summary for the Tempus™ Cervical Plate System. This is a medical device, and the evaluation is for substantial equivalence to predicate devices, not for an AI/ML diagnostic or prognostic system. Therefore, many of the requested categories in the prompt are not applicable to this type of medical device submission.

Here's an attempt to address the prompt based only on the provided text, noting where information is not relevant or available:

1. Table of Acceptance Criteria and Reported Device Performance

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

This is not applicable as the study described is a non-clinical, mechanical bench testing study (physical testing of the device), not a study involving patient data or a "test set" in the context of an AI/ML model.

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

This is not applicable. Ground truth for mechanical testing is established by physical measurements against engineering standards and specifications, not by expert human interpretation.

4. Adjudication Method for the Test Set

This is not applicable, as the evaluation is based on mechanical performance data against a standard, not on subjective interpretations requiring adjudication.

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

This is not applicable. The device is a physical spinal implant, not an AI/ML system that would assist human readers in image interpretation or diagnosis.

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

This is not applicable. The device is a physical product, not an algorithm. The "standalone" performance here refers to the device's mechanical integrity under various loads, which was indeed tested (as described under "PERFORMANCE DATA").

7. The Type of Ground Truth Used

The ground truth for this medical device study is based on:

• Engineering Standards: Adherence to ASTM F1717–11 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.
• Mechanical Properties: The device's ability to withstand specified forces and its static and dynamic mechanical performance as measured by standardized tests.
• Predicate Device Performance: Comparison to the known, accepted mechanical performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of mechanical bench testing for a spinal implant. The "training" in this context would refer to the design and refinement process, which isn't detailed here but doesn't involve a data training set.

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

This is not applicable. There is no "training set ground truth" for this type of device. The design specifications and mechanical properties are engineering-driven.

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