Search Results

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.

Ask a specific question about this device

When used as a cervical intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System and FortiCore® are intended for spinal fusion procedures in skeletally mature patients with 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. The Nanovis Intervertebral Body Fusion System and FortiCore® implants 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, the Nanovis Intervertebral Body Fusion System and FortiCore® are intended for spinal fusion procedures in skeletally mature patients with 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 at the involved spinal level(s). The Nanovis Intervertebral Body Fusion System and FortiCore® implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.

The Nanovis Intervertebral Body Fusion System and FortiCore® consist of implants and related instruments for implantation. The upper and lower aspects of the implants from both systems are open and have a central column to be packed with autogenous bone graft. The FortiCore® implants have an integrated titanium scaffold which assists in securing the implant in the intervertebral space. The devices from both systems are available in a variety of shapes and sizes to accommodate the individual patient anatomy.

This document is a 510(k) summary for the Nanovis Intervertebral Body Fusion System and FortiCore®. It describes the device, its intended use, and the data submitted to demonstrate substantial equivalence to predicate devices. However, it does not contain a typical study design with acceptance criteria and performance metrics for an AI/ML device.

Instead, the performance data section describes engineering analyses for a physical medical device. Therefore, I cannot provide the information requested in your prompt as it pertains to an AI/ML device study.

Here's a breakdown of what the document does provide regarding performance and criteria for this non-AI/ML device:

1. A table of acceptance criteria and the reported device performance

The document describes performance data for the physical device, not an AI/ML algorithm.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. The performance data section refers to "finite element and dimensional analyses" and a "Bacterial Endotoxins Test (BET)," which are engineering and laboratory tests, not clinical studies with human patient data or test sets in the context of AI/ML.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This is not an AI/ML study involving expert interpretation of data to establish ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/ML study involving adjudication of human or algorithmic outputs.

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 not an AI/ML device, and therefore no MRMC study comparing human readers with and without AI assistance was performed.

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

Not applicable. This is a physical intervertebral body fusion system, not a software algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.)

For the engineering analyses, the "ground truth" would be established by validated engineering principles and test standards. For the Bacterial Endotoxins Test, the "ground truth" is meeting the specified endotoxin limits as defined by ANSI/AAMI ST72.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no training set in this context.

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

Not applicable. This is not an AI/ML device; there is no training set ground truth to establish.

In summary: The provided document is for a physical medical device (intervertebral body fusion system) and the performance data presented relates to engineering analyses and laboratory testing, not the evaluation of an AI/ML algorithm. Therefore, many of the questions are not applicable to the content of this specific document.

Ask a specific question about this device