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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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