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The Threshold™ Pedicular Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients 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); turnor; pseudoarthrosis; and/ or failed previous fusion.

Spineology's Threshold Pedicular Fixation System consists of cannulated and solid titanium alloy screws and rods to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Threshold cannulated and solid screws are available with or without a hydroxyapatite coating. The system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The cannulated and solid screws can be placed in the pedicles in a variety of trajectories ranging from standard anatomic transpedicular path projected medially toward the ventral vertebral body, to a caudocephalad path sagittally and a laterally directed path in the transverse plane.

This document describes acceptance criteria and studies for the Threshold™ Pedicular Fixation System, specifically for the addition of uncoated and hydroxyapatite (HA) coated Threshold solid pedicle screws.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated as traditional "test sets" for a performance study were not used for this submission. The submission relies on non-clinical testing (mechanical testing, finite element analysis) and comparison to predicate devices, rather than a clinical study with human subjects.
• Data Provenance: The mechanical testing was performed in accordance with ASTM standards, implying laboratory-based testing. The finite element analysis (FEA) is a computational method. This is retrospective in the sense that it relies on existing data and models or newly generated data in a lab setting, rather than prospective human clinical trials for this particular submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable. The submission does not involve a clinical study with human patients and an associated ground truth established by experts for diagnostic or treatment outcomes. The evaluation is based on engineering and material science principles.

4. Adjudication Method for the Test Set:

• Not applicable, as a clinical test set requiring expert adjudication was not part of this submission. The evaluation was based on meeting engineering standards and comparison to predicate devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission pertains to a pedicle fixation system, a physical implant, and not an AI-powered diagnostic or treatment assistance device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• No, a standalone performance study in the context of an algorithm's performance was not done. This is a physical medical device.

7. Type of Ground Truth Used:

• The "ground truth" for this device's evaluation is primarily established by engineering standards and material specifications. For mechanical testing, this means the defined limits and methodologies of the ASTM standards (F1798-97, F543-13, F1717-13) and for biocompatibility, the limits of ANSI/AAMI/ST72. Substantial equivalence to predicate devices serves as a comparative benchmark.

8. Sample Size for the Training Set:

• Not applicable. This submission does not involve a machine learning algorithm requiring a "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. There is no training set for this device.

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