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The Signature Orthopaedic C-Zero Pedicle Screw System and Freedom Pedicle Screw System are 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 and deformities of the thoracic, lumbar, and sacral spine: 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; and failed previous fusion (pseudarthrosis). In addition, the C-Zero Pedicle Screw and Freedom Pedicle Systems are intended for skeletally mature patients in the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra and degenerative spondylolisthesis with objective evidence of neurologic impairment.

All of the Signature Orthopaedics' C-Zero and Freedom Pedicle Screw Systems' components (except for CoCr longitudinal rods) are manufactured from Ti6Al4V alloy per ISO 5832-3 and ASTM-F136. The subject systems' CoCr longitudinal rods are manufactured from wrought Cobal-Chromium as per ASTM-F1537.

The Signature Orthopaedics' C-Zero and Freedom Pedicle Screw Systems are used to provide immobilization and stabilization of spinal segments in the treatment of acute and chronic instabilities or deformities of the lumbar, thoracic and sacral spine. These pedicel rod and screw systems surgically implanted from a posterior approach. The device subject to this file include polyaxial pedicle screws, rods, connectors and hooks.

The provided text describes a 510(k) premarket notification for a medical device, the Signature Orthopaedics C-Zero Pedicle Screw System and Freedom Pedicle Screw System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and detailed study results for a novel AI/software device.

Therefore, much of the requested information (acceptance criteria, device performance tables, sample sizes for AI training/test sets, expert adjudication details, MRMC studies, standalone performance for AI, and ground truth for AI) is not applicable to this type of submission. This document describes the mechanical testing of a physical implantable device, not the performance of an AI or software algorithm.

However, I can extract the relevant information regarding the performance testing that was conducted to support the substantial equivalence claim.

Device Description and Purpose:
The Signature Orthopaedic C-Zero Pedicle Screw System and Freedom Pedicle Screw System are pedicle rod and screw systems intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. They are used for various acute and chronic instabilities and deformities of the thoracic, lumbar, and sacral spine, including degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, and failed previous fusion. They are also intended for severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra and degenerative spondylolisthesis with objective evidence of neurologic impairment.

Performance Testing to Establish Substantial Equivalence (Not Acceptance Criteria for an AI Device):

The submission states that "Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Signature Orthopaedic C-Zero Pedicle Screw System and Freedom Pedicle Screw System are adequate for anticipated in-vivo use." This testing specifically targeted the "worst case sizes" of the pedicle screws.

Here's the closest information available to your requested format, reinterpreted for a mechanical device submission seeking substantial equivalence:

Table of Performance Testing and Reported Device Performance

Testing Standard Compliance:
The testing was carried out according to the following standards:

• ASTM-F1717 Standard Test Methods for Spinal Implant Construct in a Vertebrectomy Model
• ASTM-F1798-13 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
• ASTM-F543 Standard Specification and Test Method for Metallic Medical Bone Screw

Information Not Applicable or Not Provided for This Type of Submission:

1. Sample size used for the test set and the data provenance: Not applicable. This refers to physical components, not a data-driven AI test set. The testing was conducted on "worst case sizes" of the pedicle screws.
2. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for an AI algorithm is not relevant here. The "ground truth" for a mechanical device is its physical performance characteristics against established engineering standards and predicate device performance.
3. Adjudication method: Not applicable.
4. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This is for AI-assisted diagnostic or interpretation tasks.
5. Standalone (i.e. algorithm only without human-in-the loop performance): Not applicable. This is a physical device, not an algorithm.
6. The type of ground truth used: For a mechanical device, the ground truth is established mechanical properties and performance deemed adequate by engineering standards and comparison to legally marketed predicate devices.
7. The sample size for the training set: Not applicable. This is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable.

Conclusion stated in the document:
"Based upon the predicate comparison, the intended use, similar technological characteristics and the results of the various mechanical testing, the proposed devices are substantially equivalent to the predicate devices."

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