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The Inertia™ Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T1 to S2): severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Inertia™ Pedicle Screw System consists of rods, polyaxial screws and set screws. Rods are available in either straight or pre-contoured (curved) forms and in a variety of lengths. Polyaxial screws are available in a variety of diameter-length combinations. Set screws are used to fasten the rod and polyaxial screw.

The provided text describes a 510(k) summary for the "Inertia™ Pedicle Screw System" and details the device's characteristics and performance testing. However, it does not include information about AI algorithms, ground truth establishment for AI, expert consensus, or multi-reader multi-case studies. This submission is for a traditional medical device (pedicle screw system), not an AI/ML-driven device.

Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation cannot be filled from the provided document.

Here's a breakdown of the available information based on the request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance
The document describes mechanical performance testing on the device itself, not a test set of data like an image dataset. The "sample size" here refers to the number of constructs tested. The text does not specify the exact number of constructs tested, but typical mechanical testing involves multiple samples to ensure statistical validity.

• Sample size for test set: Not explicitly stated (refers to "worst case Inertia™ Pedicle Screw System construct" without specifying the number of samples).
• Data Provenance: Not applicable in the context of device mechanical testing (no country of origin or retrospective/prospective data collection as for clinical data).

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

• Not applicable as this is a mechanical device performance study, not an AI/ML-driven medical image analysis or diagnostic study requiring expert ground truth.

4. Adjudication Method for the Test Set

• Not applicable as this is a mechanical device performance study.

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

• No. This is a traditional medical device (pedicle screw system), not an AI/ML device.

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

• No. This is a traditional medical device (pedicle screw system), not an AI/ML device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this device is its physical and mechanical performance against established engineering standards (ASTM F1717) and comparison to predicate devices, rather than a clinical ground truth like pathology or expert consensus. The "ground truth" is adherence to these mechanical standards.

8. The Sample Size for the Training Set

• Not applicable. This is a traditional medical device, not an AI/ML device that requires a training set.

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

• Not applicable. This is a traditional medical device, not an AI/ML device.

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