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FortiCore® is intended for spinal fusion procedures in skeletally mature patients with disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). Additionally, FortiCore® can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. FortiCore® devices are to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation indicated for lumbar spinal fusion procedures.

FortiCore® consists of implants and instruments for implantation. The upper and lower aspects of the implant incorporate a three-dimensional titanium scaffold electrochemically treated to possess a controlled nanotopography composed of nanotube arrays with an average pore size between 60-80 nanometers, which assists in securing the implant in the intervertebral space and provides radiographic confirmation of the implant location. Calcium and phosphate are incorporated into the nanotube surface. Nanovis has not submitted data to show that phenomena, including chemical properties or biological effects are attributable to these features. The devices are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.

The provided text is a 510(k) summary for the FortiCore® intervertebral body fusion device. It does not contain information about acceptance criteria for a device's performance in terms of diagnostic accuracy or a study proving that the device meets such criteria for an AI/ML device.

Instead, the "Performance Data" section of the 510(k) summary (page 3) discusses mechanical testing related to the physical device itself:

• Acceptance Criteria and Reported Device Performance: This document describes mechanical performance testing, not clinical or diagnostic performance.
  • Acceptance Criteria (Implicit): That the device's mechanical performance (dynamic compression, static and dynamic compression shear) is "substantially equivalent to the predicate devices" according to ASTM F2077.
  • Reported Device Performance: Mechanical testing was performed on "worst case FortiCore® devices" according to ASTM F2077. The results "demonstrate that the FortiCore device performance is substantially equivalent to the predicate devices."

The following points refer to information typically found in studies for AI/ML devices, which are not present in this document as it's for a physical intervertebral fusion device, not a diagnostic AI/ML algorithm.

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical FortiCore® devices subjected to mechanical testing, not a dataset of patient images or clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement, not expert opinion.
4. Adjudication method: Not applicable.
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. This is for a physical implant, not an AI assistance tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For this device, the "ground truth" for performance is compliance with mechanical testing standards (ASTM F2077) and comparison to predicate devices, demonstrating substantial equivalence in physical performance.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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When used as a cervical intervertebral body fusion device, FortiCore™ is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. FortiCore™ devices are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures.
When used as a lumbar intervertebral body fusion device, FortiCore™ is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). FortiCore™ devices are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.

FortiCore™ consists of implants and instruments for implantation.
The upper and lower aspects of the implant are open and have an integrated titanium scaffold which assists in securing the implant in the intervertebral space. The devices are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.

The provided document is a 510(k) premarket notification for a medical device called FortiCore™. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specified acceptance criteria and performance metrics. Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, study design, expert involvement, or sample sizes related to clinical performance.

The "Performance Data" section (page 4) refers to mechanical testing of the device, not a study of its clinical performance in patients.

Here's a breakdown of what can be extracted from the document and why other information is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated for clinical performance. The document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing.
• Reported Device Performance: The document states: "The mechanical test results demonstrate that the FortiCore device performance is substantially equivalent to the predicate devices."
  • Mechanical Tests Performed:
    • Static and dynamic compression (according to ASTM F2077)
    • Static and dynamic torsion (according to ASTM F2077)
    • Subsidence testing (according to ASTM F2267)
    • Shear and tension testing (according to ASTM F1044 and F1147, respectively) to evaluate the metal-polymer interface.

This document does not contain information about:

2. Sample size used for the test set or its data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Standalone (algorithm-only) performance. This is a medical implant, not an AI/software device.
7. Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

Reason for Missing Information:

The document is a 510(k) submission to the FDA. The primary purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" in terms of its intended use and technological characteristics to a legally marketed "predicate" device. This typically involves:

• Comparing indications for use.
• Comparing technological characteristics (materials, design, performance specifications).
• Conducting non-clinical performance testing (like the mechanical tests mentioned here) to show the new device performs at least as well as the predicate for relevant characteristics.

A 510(k) does not typically require extensive clinical trials with human subjects, setting acceptance criteria for clinical performance metrics (like sensitivity/specificity for diagnostic devices or specific clinical outcomes for therapeutic devices), or rigorous ground truth establishment as would be seen in studies designed to prove de novo safety and effectiveness or for AI/ML device evaluations. The mechanical testing described here is to ensure the device's physical properties are safe and comparable to established devices.

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