(94 days)
The NuVasive Adjustable VBR System is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The NuVasive Adjustable VBR System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.
The NuVasive Adjustable VBR System includes different sized adjustable height core and endplates to suit the individual pathology and anatomical conditions of the patient. The cores can extend in height to properly match the anatomy and the endplates come in three major types: symmetric, asymmetric, and round.
This document is a 510(k) premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria.
Here's a breakdown based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not provide explicit quantitative acceptance criteria or a study demonstrating the device's "performance" in the way one might expect for an AI/diagnostic device. Instead, the "acceptance criteria" are implied by the regulatory requirements for showing substantial equivalence to an existing predicate device.
The essential claim for acceptance is that:
- The device has indications for use identical to its predicate.
- The device employs the same principles of operation as its predicate.
Table of "Acceptance Criteria" (Implied) and Reported "Performance"
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device "Performance" (as per 510(k) Summary) |
|---|---|
| Identical Indications for Use (NuVasive Adjustable VBR System vs. NuVasive Mesh System) | The subject device has indications for use identical to those of its predicate. |
| Same Principles of Operation (NuVasive Adjustable VBR System vs. NuVasive Mesh System) | The subject device employs the same principles of operation. |
| Mechanical Performance (Appropriate for a vertebral body replacement system, typically verified via non-clinical tests) | Mechanical testing was presented (Summary of Non-Clinical Tests G). Specific results are not detailed in this summary. |
| Safety and Effectiveness (Demonstrated through substantial equivalence, without raising new questions of safety/effectiveness) | Found substantially equivalent by FDA, implying no new safety or effectiveness concerns were raised. |
Study Details (as inferable from the document):
It's crucial to note that this 510(k) summary is for a physical medical device (Vertebral Body Replacement System), not an AI/diagnostic algorithm. Therefore, many of the typical questions for AI studies regarding training/test sets, ground truth, and reader studies are not applicable.
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Sample size used for the test set and the data provenance:
- N/A. This is a physical device, and the "test set" would refer to mechanical testing samples, not a data set. The document states "Mechanical testing was presented" but does not detail the sample sizes or specific tests conducted.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth in the context of diagnostic/AI performance is not relevant for this physical device. Mechanical properties would be assessed by engineering standards and experts.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Not relevant for mechanical testing of a physical implant.
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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, N/A. This is a physical medical implant, not a diagnostic or AI-powered system that human readers would interact with.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. Not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. For this device, "ground truth" relates to mechanical properties meeting specifications, material compatibility, and structural integrity. This is typically established through engineering standards, material testing, and biomechanical studies, not clinical pathology or outcomes data in the sense of a diagnostic.
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The sample size for the training set:
- N/A. Not an AI algorithm.
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How the ground truth for the training set was established:
- N/A. Not an AI algorithm.
Summary of what was done according to the document:
- Non-Clinical Tests: "Mechanical testing was presented." This is the primary "study" mentioned, aimed at demonstrating the physical device's performance characteristics (e.g., strength, durability, fatigue resistance) according to established standards for spinal implants. Details of these tests (sample size, specific methodologies, results) are not included in this summary.
- Clinical Tests: "Not Applicable." This indicates that no human clinical trials were required for the 510(k) clearance, as substantial equivalence could be demonstrated based on non-clinical data and comparison to the predicate device.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.