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The Alpine 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudoarthrosis).

In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1) with removal of the implants after the attainment of a solid fusion.

The Alpine Pedicle Screw System is a spinal system that consists of screws, rods, and associated instruments. Fixation is provided by bone (pedicular) screws inserted into the vertebral body of the spine using a posterior approach.

The provided text describes a medical device, the Alpine Pedicle Screw System, and its mechanical testing. However, it does not contain information about acceptance criteria and the study that proves the device meets those criteria in the format requested, which implies clinical or diagnostic performance metrics.

The document is a 510(k) summary for a spinal implant, focusing on its substantial equivalence to predicate devices based on design, materials, and mechanical performance. The "acceptance criteria" mentioned relate to mechanical testing standards for spinal implants (ASTM F1717 and F1798), not clinical performance or diagnostic accuracy.

Therefore, I cannot populate the table or provide the detailed information requested regarding clinical study design, sample sizes, expert qualifications, or ground truth for diagnostic AI.

Here's a summary of what is available in the provided text regarding device performance:

1. A table of acceptance criteria and the reported device performance

Important Note: The provided document is a 510(k) summary for a mechanical implant. The "acceptance criteria" and "device performance" here refer to mechanical properties and biocompatibility, not diagnostic accuracy or clinical outcomes that would typically involve AI models, expert readers, or ground truth derived from pathology or outcomes data.

Regarding the other requested information (which is not present in the provided text):

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. This document details mechanical testing, not a clinical or diagnostic study with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not provided.

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

• Not applicable / Not provided.

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

• Not applicable / Not provided. This is a mechanical implant, not an AI-assisted diagnostic tool.

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

• Not applicable / Not provided.

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

• Not applicable / Not provided. For mechanical testing, the "ground truth" is adherence to established ASTM standards.

8. The sample size for the training set

• Not applicable / Not provided.

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

• Not applicable / Not provided.

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