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The LOCK-IN Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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; pseudarthrosis; and/or failed previous fusion.
The LOCK-IN Spinal Fixation System is intended to be used with autograft and/or allograft.

The LOCK-IN Spinal Fixation System is a spinal pedicle fixation system consisting of polyaxial pedicle screws (expandable and non-expandable; cannulated and non-cannulated), rods (straight and curved), rod lockers, and crosslinks. All components are manufactured from Ti-6Al-4V ELI titanium alloy. All screws are available with either standard or spondylolisthesis head configurations. Fixation is provided via a posterior approach.

The LOCK-IN Spinal Fixation System expandable pedicle screws increase screw pullout strength when compared to similarly sized conventional screws. These screws are recommended for cases when increased fixation strength is desired.

The LOCK-IN Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion in the non-cervical spine, including the thoracic, lumbar and/or sacral spine (T1- S5). The LOCK-IN Spinal Fixation System consists of a variety of shapes and sizes of rods, screws, cross connectors that provide internal fixation and stabilization during bone graft healing and /or fusion mass development.

This document pertains to the clearance of a mechanical spinal fixation system, not an AI/software-based medical device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, is not applicable or present in this context.

Specifically, the document describes the LOCK-IN Spinal Fixation System, which is a physical device composed of pedicle screws, rods, rod lockers, and crosslinks made from titanium alloy. The performance testing detailed focuses on the mechanical properties of these components (e.g., pull-out strength, bending, torsion), not on a software algorithm's diagnostic or predictive capabilities.

Therefore, I cannot provide details such as:

1. Table of acceptance criteria and reported device performance (for an AI/software device): The Acceptance Criteria section applies to the mechanical properties of the device, not the AI/software performance.
2. Sample size for test set and data provenance: No software "test set" in the AI/ML sense is mentioned.
3. Number of experts and qualifications: Experts are not mentioned in the context of establishing ground truth for an AI algorithm.
4. Adjudication method for test set: Not applicable to a mechanical device.
5. MRMC comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable to an AI algorithm. The "ground truth" for this device would relate to its mechanical integrity and biological compatibility, demonstrated through physical testing and material science, not clinical consensus from images.
8. Sample size for training set: Not applicable for a mechanical device.
9. How ground truth for training set was established: Not applicable.

The document states:

• "Non-clinical testing was performed to demonstrate the LOCK-IN Spinal Fixation System is substantially equivalent to the listed predicate devices in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", issued May 3, 2004." This indicates the evaluation was based on engineering and biomechanical testing demonstrating equivalence to already cleared devices, rather than a clinical study involving human readers or AI performance metrics.
• The tests performed are primarily ASTM (American Society for Testing and Materials) standards like F543 (Pedicle Screw Pull-Out, Driving Torque, Torsional Testing), F1717 (Static/Compressive Bending and Torsional Testing), F2193 (Static and Dynamic Cantilever Bending Testing), and F1798 (Tulip Disassociation Testing). These are all mechanical and material property tests for physical implants.
• "Expandable Screw Cadaver Pullout Comparative Performance Study" is mentioned, which is a biomechanical study, not a study of AI performance.

In summary, the provided text describes the clearance of a Class II mechanical spinal implant, not an AI/ML-driven device. As such, the requested information about AI acceptance criteria and study methodologies is not present in the document.

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