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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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The FortiBridge™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

The FortiBridge™ System consists of implants and instruments for implantation. It is an anterior cervical plate and screw system which includes fixed and variable screws having standard, self-drilling or self-tapping tips, and one- through four-level plates. The implants are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient. The devices are sold sterile.

This document does not contain information about acceptance criteria or a study proving a device meets acceptance criteria in the context of an AI/ML medical device.

The provided text is a 510(k) premarket notification for the FortiBridge® Anterior Cervical Plate System, which is a physical spinal implant. The document details the device's indications for use, materials, and substantial equivalence to previously cleared predicate devices.

Specifically, page 5 states: "Performance data was not provided in this submission." This indicates that the submission relies on substantial equivalence to predicate devices rather than new performance data to demonstrate safety and effectiveness.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

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The FortiBridge™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis or scoliosis), pseudarthrosis or failed previous fusion.

The FortiBridge™ System consists of implants and instruments for implantation. It is an anterior cervical plate and screw system which includes fixed and variable screws having standard, self-drilling or self-tapping tips, and one- through four-level plates. The implants are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.

The provided text describes the FortiBridge™ Anterior Cervical Plate System, a medical device, and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria related to an AI/ML algorithm or software.

The document is a 510(k) summary for a spinal implant system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through mechanical testing and comparison of design, materials, and intended use, rather than a clinical study evaluating an AI/ML system's performance.

Therefore, many of the requested items cannot be answered from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable for AI/ML device. The document discusses the "performance" in the context of technological characteristics of a spinal implant system, not an AI/ML algorithm. It states: "These include: performance (as described above), basic design (plate and screw system), implant grade materials (titanium alloy), and sizes (dimensions are within the range(s) offered by the predicates)." No specific numerical acceptance criteria or reported performance results in terms of sensitivity, specificity, AUC, etc., are provided.

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

• Not applicable for AI/ML device. This information is not relevant to a 510(k) submission for an orthopedic implant. The focus is on mechanical testing and material properties.

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

• Not applicable for AI/ML device. There is no mention of experts establishing a "ground truth" in the context of an AI/ML algorithm for this spinal implant.

4. Adjudication Method for the Test Set:

• Not applicable for AI/ML device. No adjudication method is described as this is not an AI/ML study.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was done:

• No. This type of study is not mentioned as it is irrelevant for a spinal implant device's 510(k) submission.

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

• Not applicable. The device is a physical spinal implant, not an algorithm.

7. The Type of Ground Truth Used:

• Not applicable for AI/ML device. The "ground truth" for this device would relate to engineering specifications, material standards (e.g., ASTM F136 for titanium alloy), and biomechanical testing results, not clinical outcomes for an AI/ML system.

8. The Sample Size for the Training Set:

• Not applicable for AI/ML device. There is no training set for a physical implant.

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

• Not applicable for AI/ML device.

Summary based on the provided text:

The provided document is a 510(k) summary for the FortiBridge™ Anterior Cervical Plate System. It describes the device, its intended use, materials, and predicate devices. The primary method for demonstrating that the device meets regulatory requirements (substantial equivalence) is by showing it has the "same intended use and technological characteristics as the predicate devices." This includes demonstrating similar performance characteristics through engineering principles, material science, and mechanical testing, which is typical for physical orthopedic implants. The document does not pertain to an AI/ML-driven device or study.

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