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The X-spine Systems, Inc. Zygafix Spinal Facet Screw System is intended for posterior fixation to the lumbar spine (L1 to S1 inclusive). The system is intended for bilateral, transfacet fixation of the facet joint in order to provide stability for fusion. The system is intended for use with only autogenous bone graft material. The system is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels:

• . Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies),
• . Degenerative disease of the facets with pain and/or instability on plain flexion and extension lateral radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm,
• Trauma (i.e., fractures and/or dislocations), .
• Spondylolisthesis, .
• Spondylolysis, ●
• Pseudoarthrosis and/or failed previous fusions. .

The X-spine Zygafix Spinal Facet Screw System is designed to provide bilateral, transfacet fixation of the spinal facet joint in the lumbar spine. The system consists of titanium alloy, cannulated bone screws that are available in various lengths and thread configurations to account for variations in patient anatomy. Each screw option contains axial fenestrations to allow the optional packing of bone graft. The screws are manufactured of medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F136.

This system is not to be used with bone cement. The safety and efficacy of using bone cement with this system has not been established.

The implant components are provided clean and non-sterile. These devices are sterilized by a healthcare professional using a Steam Autoclave in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the manufacturer of the Autoclave.

The Zygafix™ Spinal Facet Screw System is a medical device for posterior fixation to the lumbar spine. Its acceptance criteria and performance are based on biomechanical testing and comparison to predicate devices, rather than a clinical study involving human readers or AI.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Zygafix™ Spinal Facet Screw System are based on its performance in biomechanical tests, demonstrating substantial equivalence to its predicate devices. The system was tested against various aspects of ASTM F543 and ASTM F2193 standards, designed for metallic bone screws and spinal skeletal system components, respectively. While specific numerical acceptance thresholds are not explicitly stated in the provided text, the overall acceptance criterion is that the device's performance must be "substantially equivalent to predicate device performance and is capable of safely and effectively performing in accordance with its intended use."

2. Sample Size for the Test Set and Data Provenance

The provided document describes biomechanical testing of the device components, not a clinical study involving a "test set" of patients or data in the typical sense of a diagnostic or AI device. Therefore, the concept of sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) as it applies to medical imaging or diagnostics is not applicable here. The "sample" in this context refers to the number of physical devices or components subjected to the mechanical tests. The document does not specify the number of devices or components used for each biomechanical test.

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

This information is not applicable as the study is a biomechanical engineering study focusing on mechanical properties of an implant, not a study requiring expert interpretation or ground truth establishment in a clinical or diagnostic context.

4. Adjudication Method for the Test Set

This information is not applicable as the described study is a biomechanical engineering study and does not involve clinical data adjudication.

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

This information is not applicable. The provided document describes a premarket notification for a spinal implant, which relies on biomechanical testing for substantial equivalence, not a comparative effectiveness study involving human readers or AI assistance.

6. Standalone Performance Study

This information is not applicable. The device is an implantable medical device, not a software algorithm or diagnostic tool. Its "performance" is assessed through biomechanical testing of its physical properties.

7. Type of Ground Truth Used

The ground truth for this device is based on accepted engineering standards and physical mechanical properties. The "ground truth" for the performance of the Zygafix™ Spinal Facet Screw System is its ability to meet the performance characteristics specified in the ASTM F543 and ASTM F2193 standards, demonstrated through direct physical testing. The goal is to show it performs comparably to legally marketed predicate devices under these rigorous engineering standards.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical implant, not a machine learning model, and therefore does not involve a "training set" in the computational sense.

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

This information is not applicable for the same reasons as above; there is no "training set" for a physical medical implant.

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