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The nvª, nvª, and nv are intended for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device systems must be used with supplemental fixation and autograft to facilitate fusion and are implanted via an anterior, posterior, or transforaminal approach. Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation or anterior buttress plate with posterior supplemental fixation.

The nv4, nvP, and nvb are intervertebral body fusion devices used in the lumbar spine following discectomy. All devices are manufactured from PEEK Optima LT1 per ASTM F2026 or PEEK Optima HA Enhanced and include tantalum markers per ASTM F560 for radiographic visualization.

The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow center to accommodate bone graft. The devices are implanted via a variety of approaches including anterior, posterior, or transforaminal. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability, and prevent back out and migration.

The provided text describes a medical device, the nvª, nvP, and nvb intervertebral body fusion devices, and their 510(k) premarket notification to the FDA. However, it does not contain information about acceptance criteria, device performance from a clinical study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to AI/ML device testing.

This document pertains to the regulatory clearance of a physical medical implant (intervertebral body fusion device) based on its substantial equivalence to previously cleared predicate devices, primarily through non-clinical engineering analysis of mechanical performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details as they would apply to an AI/ML device, because this document is about a physical medical device and its mechanical performance, not an AI/ML algorithm.

The document explicitly states:

• "No FDA performance standards have been established for the nv4, nv7, and nv1." (Page 4)
• "The following was performed to demonstrate safety per methods of the previous submission: Engineering analysis comparison of mechanical performance in compression/ compression shear, subsidence, and expulsion (reference ASTM F2077 and F2267). The results of the engineering analysis indicate that the nv3, nvP and nv system is substantially equivalent to the predicate devices." (Page 4)

This indicates that the safety and effectiveness were demonstrated through engineering analysis and comparison to predicate devices, not through a clinical study involving human or AI evaluation with performance metrics like sensitivity, specificity, etc.

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The ny', nv", and nv are intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis at involved levels. The device systems must be used with supplemental fixation and autograft to facilitate fusion and are implanted via an anterior, or transforaminal approach.

The nv3, nvP, and nv1 are an intervertebral body fusion device used in the lumbar spine following discectomy. All devices are manufactured from PEEK Optima® LT1 per ASTM F2026 and include tantalum markers per ASTM F560 for radiographic visualization. The purpose of this submission is to make changes to the number and design of the tantalum markers.

The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow center to accommodate bone graft. The devices are implanted via a variety of approaches including anterior, posterior, or transforaminal. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability, and prevent back out and migration.

Here's an analysis of the provided text regarding the acceptance criteria and study for the nv³, nvº, and nv¹ intervertebral body fusion devices:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states, "No FDA performance standards have been established for the nvª, nvº, and nv*. A summary of the following tests that were performed was provided in order to demonstrate safety based on current industry standards." Therefore, the acceptance criteria are implicitly meeting the current industry standards as defined by ASTM F2077 and ASTM F2267 for static/dynamic compression and subsidence, respectively, and passing an "expulsion" test. The device's reported performance is that it met these criteria and was found to be "substantially equivalent to the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: This information is not provided in the document. The document only lists the types of non-clinical tests performed (static/dynamic compression, subsidence, expulsion) but does not specify the number of devices or test conditions used for each.
• Data Provenance: The data is "non-clinical testing" conducted by the manufacturer, Nvision Biomedical Technologies, LLC. The provenance (e.g., country of origin, retrospective/prospective) of the data itself isn't explicitly stated beyond being lab-based mechanical testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

• This information is not applicable/provided. The study described is non-clinical bench testing of a physical device's mechanical properties, not a clinical study involving human patients or expert review of medical images/data. Therefore, there's no concept of "ground truth" established by medical experts in this context.

4. Adjudication Method for the Test Set

• This information is not applicable/provided. As above, this was non-clinical bench testing, so there was no adjudication process involving experts comparing results. The "adjudication" would be a comparison of measured mechanical properties against pre-defined engineering acceptance limits for the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• This information is not applicable/provided. The document describes the marketing clearance for an intervertebral body fusion device (an implantable medical device), not an Artificial Intelligence (AI) or software as a medical device (SaMD) that assists human readers. Therefore, an MRMC study and AI assistance effect size are not relevant here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This information is not applicable/provided. As explained in point 5, this is not an AI/SaMD product.

7. The Type of Ground Truth Used

• The "ground truth" for this non-clinical testing is the pre-defined mechanical performance specifications set by relevant ASTM standards (ASTM F2077 for static/dynamic compression and ASTM F2267 for subsidence), and an unspecified internal expulsion test criteria. The device's performance was compared against these established engineering and material standards.

8. The Sample Size for the Training Set

• This information is not applicable/provided. This is a physical, implantable medical device, not a machine learning model. Therefore, there is no "training set" in the context of an algorithm.

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable/provided. As explained in point 8, there is no concept of a "training set" for this type of device.

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