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The Preference Elite Pedicle Screw System is intended to help provide immobilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine as follows:

The Preference Elite System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

In addition, when used as a pedicle screw fixation system, the Preference Elite Pedicle Screw System is indicated for skeletally matures patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (15-S1) vertebral joint, (b) who are receiving fusions using autogenous bone graft only, (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below), and (d) who are having the device removed after the development of a solid fusion mass.

The Preference Elite Pedicle Screw System is a spinal fixation system consisting of a variety of components including screws, various types and sizes of rods, cross-connectors and accessories, as well as implant components from the Preference Pedicle Screw System. The components are designed to be rigidly locked into a variety of configurations with each construct being appropriate for the individual patient.

Implant components from the Preference Pedicle Screw System including the curved and straight rods, set-screws, and cross-connectors are compatible with the Preference Elite Pedicle Screw System.

The Preference Elite Pedicle Screw System implants and components are made from titanium alloy (Ti-6A1-4V) per ASTM F136 and Cobalt-28 Chromium-6 Molybdenum Alloy (Co-28Cr-6Mo) per ASTM F1537.

The provided document is a 510(k) Pre-market Notification from the FDA regarding the "Preference Elite Pedicle Screw System." This document is not a study that proves a device meets acceptance criteria in the context of an AI/ML medical device, but rather a regulatory submission for a traditional medical device (a pedicle screw system).

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, and AI-specific performance metrics (MRMC, standalone algorithm performance) is not applicable to this document. This document primarily focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and comparison of design, materials, and intended use.

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 does not present acceptance criteria or reported performance in the context of an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, it states that "Testing and analyses were completed in accordance with the applicable standards" and "The testing results demonstrate that the new system, Preference Elite Pedicle Screw System, is substantially equivalent to the predicates."

The applicable standards mentioned are:

• ASTM F1717 Static Axial Compression Bending
• ASTM F1717 Static Torsion
• ASTM F1717 Dynamic Axial Compression Bending
• ASTM F1798 Static Pull-off

The "acceptance criteria" here would be meeting the established performance requirements set by these ASTM standards for spinal implant systems, which are intended to ensure mechanical integrity and safety. The reported "performance" is that the device did meet these standards and was found substantially equivalent.

2. Sample sized used for the test set and the data provenance

• Sample size for the test set: Not stated in terms of patient data. The testing mentioned (ASTM standards) refers to mechanical testing of the device components, not human subject data. The "sample size" would relate to the number of devices or components tested, which is not specified in this summary.
• Data provenance: Not applicable in the context of clinical data. The "data" pertains to mechanical test results of the device itself.

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

Not applicable. This is not a study involving human interpretation or ground truth establishment by experts for clinical data.

4. Adjudication method for the test set

Not applicable. There is no expert adjudication for mechanical testing of a medical device like a pedicle screw system.

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 an AI/ML device, and no MRMC study was performed or described.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

Not applicable in the context of clinical data. For mechanical testing, the "ground truth" is typically defined by the objective physical measurements and established parameters of the ASTM standards themselves.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. This is not an AI/ML device, so there is no training set or ground truth in that context.

Summary relevant to the document provided:

The document describes a regulatory submission for a pedicle screw system, not an AI/ML device. The "acceptance criteria" and "study" refer to mechanical testing performed according to ASTM standards to demonstrate the device's mechanical integrity and its substantial equivalence to previously cleared predicate devices. The study concludes that the Preference Elite Pedicle Screw System is substantially equivalent based on these tests and comparison of its characteristics.

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