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The Wiltrom Spinal Fixation System is intended to provide immobilization 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided non-sterile, and the implants are for single use only.

This document is a 510(k) premarket notification for a medical device called the Wiltrom Spinal Fixation System. It focuses on establishing substantial equivalence to a predicate device, the Fortex Pedicle Screw System (K090224). The information provided is primarily related to mechanical testing for safety and effectiveness, rather than a clinical study evaluating diagnostic or prognostic performance based on specific acceptance criteria for AI or algorithmic output. Therefore, many of the requested sections about AI/algorithm performance and ground truth establishment cannot be directly answered from this document.

Here's a breakdown of what can be extracted and what cannot:

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

The document discusses mechanical testing criteria for the physical device, not for an AI or algorithm.

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

This information is for mechanical testing of the physical device, not an AI test set. The sample size would refer to the number of implants/constructs tested. The document states "mechanical testing including static torsion testing, static and dynamic axial compression bending testing were conducted," but does not specify the number of samples for each test or the provenance of the data in the context of clinical or image 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. Ground truth, in this context, would relate to the physical integrity and performance of the device under stress, measured through engineering standards, not expert evaluation of clinical data.

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

Not applicable. Adjudication methods are typically for clinical or imaging studies where expert consensus is needed. The testing here is mechanical.

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. This is not a study involving human readers or AI assistance.

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

Not applicable. This document does not describe an AI algorithm.

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

For mechanical testing, the "ground truth" would be established by the engineering standards themselves (e.g., ASTM F1717-15) and the objective measurements of force, deformation, and failure points taken during the tests.

8. The sample size for the training set

Not applicable. This document does not pertain to the development of an AI algorithm with a training set.

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

Not applicable. This document does not pertain to the development of an AI algorithm with a training set.

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