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Syntec OS Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of the following:

• Degenerative disc disease .
• Spondylolisthesis .
• Trauma (i.e., fracture or dislocation) .
• Spinal stenosis .
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) ●
• . Tumor
• . Pseudoarthrosis
• . Failed previous fusion

The Syntec OS Spinal Fixation System is manufactured from titanium alloy (as per ASTM F136) and is designed with various sizes to provide stabilization as an adjunct to spinal fusion surgery. Surgeons can use our top loading technique through the screws and rods to fix the components into a U-shaped opening

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the "sample size used for the test set" in terms of a number of physical devices. Instead, it refers to "the modified and predicate systems" being tested. There is no information regarding the data provenance (e.g., country of origin, retrospective or prospective) for these tests.

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

This information is not provided in the document. The study involved engineering analysis and performance testing of the device itself against established ASTM standards, not the interpretation of human physiological data. Therefore, the concept of "ground truth" established by experts in a clinical context (like radiologists) does not apply here.

4. Adjudication Method for the Test Set

This information is not provided in the document. As mentioned above, the testing involved physical device performance against standards, not expert adjudication of clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The reported performance data relates to engineering tests of the device itself (mechanical properties) and not to human reader interpretation or clinical outcomes.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the testing described appears to be a standalone performance evaluation of the device itself, without human-in-the-loop interaction.

7. The Type of Ground Truth Used

The "ground truth" in this context is the performance standards defined by ASTM F1717 for static and dynamic axial compression and static torsion tests. The device's performance was compared against these established engineering standards and against the performance of a predicate device.

8. The Sample Size for the Training Set

This information is not applicable and is not provided. The study is a performance evaluation of a physical medical device, not a machine learning algorithm that requires a training set.

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

This information is not applicable and is not provided, as there is no training set for a machine learning algorithm.

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