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The Nano FortiFix® System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the non-cervical spine for the following indications: DDD (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudarthrosis and/or failed previous fusion.

Nano FortiFix® is a posterior pedicle screw system consisting of rods, polyaxial pedicle screws, connectors and fasteners in a variety of sizes to accommodate differing anatomic requirements. The Nano FortiFix® pedicle screw shaft is available with or without a nanosurface. The Nano FortiFix® nano pedicle screw has a micro- and nano-roughened surface that demonstrates the requirements for nanotechnology. The surface of the nano screw threads has been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties. These threads are electrochemically treated to possess a controlled nanotopography composed of nanotube arrays having a pore size diameter between 30-90 nanometers. Calcium and phosphate are incorporated into the nanotube surface.

This report focuses on the Nano FortiFix® System, a thoracolumbosacral pedicle screw system, and assesses its substantial equivalence to predicate devices, particularly concerning its use of nanotechnology.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria for device performance from a clinical trial in the typical sense of accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" are implied through comparative mechanical testing and in vitro evaluations demonstrating substantial equivalence to predicate devices and adherence to specific standards for the nanosurface.

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

The document does not specify a "test set" in the context of patient data or clinical imaging. The evaluations are primarily in vitro and mechanical.

• Mechanical Testing: "Worst case construct" and "worst case subconstruct" were tested. The exact number of samples for these tests is not provided, but it implies a representative selection.
• In Vitro Evaluations: Osteoblast (OB) and mesenchymal stem cell (MSC) cultures were used to quantify mineralization. The number of samples/replicates for these cultures is not specified.
• Bacterial Endotoxin Testing: Conducted in accordance with AAMI ST72:2011. The number of samples is not specified.

Data Provenance: All data appears to be from laboratory and bench testing, rather than human clinical data. Therefore, there is no mention of country of origin or whether the data is retrospective or prospective in a clinical sense.

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

This information is not applicable as the study described is not a clinical study involving the establishment of ground truth by human experts (e.g., radiologists interpreting images). The "ground truth" for the mechanical and in vitro tests is based on established engineering and biological standards and methodologies.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical PIVOTAL study with a test set requiring adjudication from a panel of experts. The evaluations were laboratory-based (mechanical, in vitro, endotoxin).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The Nano FortiFix® System is a medical implant (pedicle screw system), not an AI diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done

Not applicable. The Nano FortiFix® System is a medical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for the substantial equivalence determination for this device is based on:

• Mechanical Standards: Adherence to ASTM F1717 for static and dynamic mechanical properties.
• Biological Standards: In vitro demonstration of statistically significant enhanced mineralization in osteoblast and mesenchymal stem cell cultures (a functional biological outcome related to bone integration) and meeting bacterial endotoxin limits (safety).
• Material Science Standards: Use of materials compliant with ASTM F136 (titanium alloy) and ASTM F1537 (cobalt chrome).
• Regulatory Guidance: Adherence to FDA's "Points to Consider" for nanotechnology in medical devices.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set as this is not an AI/ML device.

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