(30 days)
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
| Acceptance Criteria (from industry standards) | Reported Device Performance (Summary of Test Results) |
|---|---|
| Static and dynamic compression (per ASTM F2077) | Meets criteria, indicating substantial equivalence to predicate devices. |
| Subsidence (per ASTM F2267) | Meets criteria, indicating substantial equivalence to predicate devices. |
| Expulsion | Meets criteria, indicating substantial equivalence to predicate devices. |
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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.