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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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The Nanovis Spinal System is intended for posterior, non-cervical (i.e., T1-S1) pedicle and non-pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.

The Nanovis Spinal System consists of rods, hooks, monoaxial and polyaxial screws with set screws, and crosslinks with fastening set screws. Rods are available either straight or pre-contoured in a variety of lengths. Hooks are offered in a variety shapes and sizes. Solid and cannulated monoaxial and polyaxial screws are available in standard and reduction versions in a variety of diameter-length combinations to accommodate differing patient anatomy.

The Nanovis Spinal System is a medical device and its approval is based on a demonstration of substantial equivalence to predicate devices rather than the typical performance study structure found in AI/ML device submissions. Therefore, many of the requested categories related to human-AI performance, sample sizes for training/test sets, and ground truth establishment are not applicable.

Here's the information extracted from the provided text regarding the Nanovis Spinal System:

Acceptance Criteria and Device Performance

The acceptance criteria for the Nanovis Spinal System are based on demonstrating mechanical performance that is "as well as or better than the predicate device" through ASTM F1717 testing.

Study Proving Device Meets Acceptance Criteria

The study conducted was a mechanical testing study performed according to ASTM F1717.

1. Sample size used for the test set and data provenance:

   • Sample Size: Not explicitly stated as a number of samples in the classic sense (e.g., cases, images). The testing refers to "the worst case Nanovis construct." This implies that specific configurations of the device were chosen for testing, likely representative samples of the manufactured components.
   • Data Provenance: Not applicable in the context of clinical data. This refers to mechanical testing performed on physical prototypes/products.

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

   • Not applicable. Mechanical testing uses engineering standards (ASTM F1717) and physical measurements as the 'ground truth,' not expert clinical opinion.

3. Adjudication method for the test set:

   • Not applicable. Adjudication is relevant for subjective assessments, typically in clinical studies or image review. Mechanical tests yield objective, quantifiable results.

4. 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:

   • No. This is a mechanical device, not an AI/ML diagnostic or assistive tool.

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

   • Not applicable. This refers to a physical medical device (spinal implant system).

6. The type of ground truth used:

   • The "ground truth" for this device's performance evaluation was established by the specified mechanical testing protocols and acceptance criteria of ASTM F1717. This standard defines the methods for assessing the static and fatigue properties of metallic spinal implant constructs.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of AI/ML or statistical modeling.

8. How the ground truth for the training set was established:

   • Not applicable. As above, there is no "training set" in this context.

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When used as a cervical intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System 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. 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 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). 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.

The Nanovis Intervertebral Body Fusion System consists of implants (cages) and related instruments intended to be used for intervertebral body fusion procedures involving the cervical (C2 - T1) and lumbar (L2 - S1) spine. The cages are available in a variety of shapes and sizes to accommodate the individual anatomic and clinical circumstances of each patient, and are available in two materials: polyetheretherketone (PEEK) and titanium alloy (Ti-6AI-4V ELI).

The provided text is a 510(k) Summary for the Nanovis Intervertebral Body Fusion System. This document is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study report detailing clinical performance and acceptance criteria for a novel device against predetermined benchmarks.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance defined in terms of clinical accuracy metrics (e.g., sensitivity, specificity for a diagnostic device).
• Details about a "test set" for performance evaluation against ground truth (e.g., sample size, data provenance).
• Information on "experts" establishing ground truth or adjudication methods.
• A "multi-reader multi-case (MRMC) comparative effectiveness study" or its effect size.
• A "standalone (algorithm only without human-in-the-loop performance)" study.
• The "type of ground truth used" in the context of device performance metrics.
• Training set sample size or how ground truth was established for a training set.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Intended Use: The Nanovis system has the same intended use as the predicate devices for spinal fusion.
• Technological Characteristics: The device is made of the same materials (PEEK and titanium alloy), has similar overall shapes, and encompasses the same range of physical dimensions as the predicate devices.
• Performance Testing: While performance testing was done, it was focused on mechanical testing against engineering standards to confirm that the device's physical properties are comparable to the predicates, not on clinical performance metrics. The standards mentioned are:
  • ASTM F2077 (static and dynamic axial compression, and static and dynamic torsion)
  • ASTM F2267 (subsidence)
  • Draft standard ASTM F04.25.02.02 (expulsion)

The document explicitly states: "Any differences in technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy." This is the core argument for 510(k) clearance, not the achievement of specific clinical performance acceptance criteria.

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