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FortiCore® cervical devices are intended for anterior cervical spinal fusion procedures in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at multiple contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. FortiCore® cervical devices are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures. Nano FortiCore® cervical devices are intended for anterior cervical spinal fusion procedures in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at multiple contiguous levels from C2-T1. These patients should have had at least six weeks of non-operative treatment. Nano FortiCore® cervical devices are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures. Nano FortiCore® lumbar devices are 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). Additionally, Nano FortiCore® lumbar devices can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. Nano FortiCore® lumbar 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® and Nano FortiCore® consist of implants and instruments for implantation. The upper and lower surfaces of the implant incorporate a three-dimensional titanium scaffold with interconnected pores averaging 523 µm, and pore interconnections averaging 229 um in diameter. This product demonstrates the requirements for nanotechnology. The surface has been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties. The scaffold of the Nano FortiCore® devices is electrochemically treated to possess a controlled nanotopography composed of nanotube arrays having an average pore size between 60-80 nanometers. Calcium and phosphate are incorporated into the nanotube surface. The scaffold with nanotubes assists in securing the implant in the intervertebral space and provides radiographic confirmation of the implant location. The FortiCore® and Nano FortiCore® devices are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.

The provided text describes a 510(k) premarket notification for two intervertebral body fusion devices, FortiCore® and Nano FortiCore®, and asserts their substantial equivalence to predicate devices. However, this document does not include information about acceptance criteria or a study proving that the device meets such criteria in terms of AI/algorithm performance.

The "Performance Data" section solely discusses mechanical testing of the devices according to ASTM F2077 and F2267, as well as in vitro evaluations related to nanotechnology and bacterial endotoxin testing. It concludes that "The mechanical test results demonstrate the FortiCore® and Nano FortiCore® device performance is substantially equivalent to the predicate devices."

Therefore, based only on the provided text, I cannot answer the questions regarding acceptance criteria and an AI/algorithm-related study. The document pertains to a physical medical device (intervertebral body fusion device) and its mechanical/material properties, not an AI or software as a medical device (SaMD).

To explicitly answer your request based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document discusses mechanical testing results in comparison to predicate devices, but doesn't present specific acceptance criteria in a table or quantitative performance metrics for an AI/algorithm.
2. Sample sizes used for the test set and the data provenance: Not applicable. The "test set" refers to physical devices undergoing mechanical tests, not a data set for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This concept is for AI/algorithm validation, not mechanical testing of a medical implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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 AI-assisted diagnostic or interpretative devices.
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 (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here would be the physical properties and performance of the implant under mechanical stress, compared to established standards (ASTM).
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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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, the Nanovis Intervertebral Body Fusion is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as neck pain 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. Nanovis Intervertebral Body Fusion System 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 is intended for spinal fusion procedures in skeletally mature patients with degenerative disc 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 I spondylolisthesis or retrolisthesis at the involved spinal level(s). Nanovis Intervertebral Body Fusion System implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.

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.

The Nanovis Intervertebral Body Fusion and FortiCore® Systems include PLIF 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 PLIF devices from both systems are available in a variety of shapes and sizes to accommodate the individual patient anatomy. The Nanovis Intervertebral Body Fusion System and FortiCore® PLIF implants are offered as sterile.

The provided text describes a 510(k) premarket notification for the Nanovis Intervertebral Body Fusion System and FortiCore®. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting performance as would be expected for a novel AI/medical device.

Therefore, many of the requested categories related to AI/algorithm performance and clinical study details are not applicable to this submission. This is a common characteristic of 510(k) submissions for devices that are evolutionary rather than revolutionary, where the primary goal is to show similarity to existing, legally marketed products.

Here's the information extracted and, where applicable, noted as "N/A" for "Not Applicable" given the context of the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): Not specified in terms of number of actual device units tested, but references "dimensional analyses of the modified Nanovis Intervertebral Body Fusion and FortiCore® devices".
• Data Provenance: N/A for clinical data, as this is a mechanical and material performance study, not a clinical trial. The study was conducted by the manufacturer to demonstrate substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• N/A. Ground truth in this context refers to mechanical and material standards (ASTM and ANSI/AAMI), not expert clinical consensus.

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

• N/A. This is a technical performance study against specified standards, not a clinical study requiring human reader adjudication.

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

• N/A. This document pertains to an intervertebral body fusion device, not an AI-assisted diagnostic or therapeutic tool.

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

• N/A. This document pertains to an intervertebral body fusion device, not an AI/algorithm-based device.

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

• The ground truth relies on established engineering standards (ASTM F2077 for mechanical testing, ANSI/AAMI ST-72:2011 for bacterial endotoxin testing) and comparison to the characteristics of legally marketed predicate devices.

8. The sample size for the training set

• N/A. No training set is relevant for this type of mechanical and material characteristics study.

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

• N/A. No training set is relevant for this type of mechanical and material characteristics study.

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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.

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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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