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The Stryker Spine TRIO TRAUMA Spinal System is intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications:

• Degenerative disc disease (DDD) (defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies);
• Spondylolisthesis;
• Trauma (i.e., fracture or dislocation); ●
• Spinal Stenosis; ●
• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis); .
• Tumor; .
• Pseudoarthrosis; and .
• Failed previous fusion.

The Trio Trauma Spinal system consists of cannulated pedicle screws in a variety of diameters and lengths, 6.0 mm diameter rods that are offered straight and pre-bent (rad rods) in a variety of lengths and an offset connector. The offset connector is supplied in one size, which accommodates the 6.0 mm diameter rods. The system components are manufactured from Titanium alloy (Ti6Al4V)

The Stryker Spine Trio Trauma Spinal System is a medical device and, as such, its acceptance criteria and the study proving it meets these criteria are based on engineering and mechanical performance tests rather than clinical, AI, or human-reader studies typical for diagnostic devices. Therefore, many of the requested categories (2-9) are not applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study involved a series of mechanical performance tests conducted according to ASTM standards.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated in the provided text. For mechanical testing of medical devices, sample sizes are typically determined by regulatory guidance (e.g., ASTM standards) to ensure statistical significance for material and design performance.
• Data Provenance: The tests (Static Compression Bending, Dynamic Compression Bending, Static Torsion, and Static Axial Gripping Capacity) were performed on the Trio Trauma System components. The location or specific laboratory where these tests were conducted is not mentioned, but the study was part of a regulatory submission to the FDA in the United States. They are considered prospective tests performed on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable. The "ground truth" for a mechanical device like a spinal system is defined by its physical properties and mechanical performance under standardized testing conditions, not by expert interpretation. The "experts" involved would be engineers and technicians conducting the tests and interpreting the results against established ASTM standards and predicate device performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This is not applicable. Mechanical tests do not involve adjudication in the clinical sense. The results are quantitative measurements interpreted against established standards and predicate device performance.

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. This device is a surgical implant, not an AI-powered diagnostic tool.

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

This is not applicable. This device does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" in this context is the mechanical performance and material properties of the device components as determined by standardized laboratory testing (ASTM F1717 and ASTM F1798). The comparison is made against the established performance of legally marketed predicate devices.

8. The sample size for the training set:

This is not applicable. There is no "training set" as this is not an AI or machine learning study.

9. How the ground truth for the training set was established:

This is not applicable. There is no training set for this type of device submission.

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