(55 days)
The Novel™ VBR Spinal System is intended for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Novel™ VBR Spinal System is intended for use with supplemental spinal fixation systems. Specifically, the Novel™ VBR Spinal System is to be used with the Alphatec Zodiac™ Polyaxial Pedicle Screw System or the Alphatec Mirage™ Top Tightening Spinal System. Additionally, the Novel™ VBR Spinal System is intended for use with bone graft.
The NOVEL™ VBR Spinal System is a vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. System components are offered in three footprints of varying lengths, widths and heights to meet individual patient anatomy. System components are manufactured from titanium alloy (ASTM F136).
The provided text is a 510(k) summary for the NOVEL™ VBR Spinal System, which is a vertebral body replacement device. This document describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the specific information required to answer your questions regarding acceptance criteria and a study proving device performance using AI/ML methodologies.
Here's a breakdown of why the information is missing and what it does provide:
- No AI/ML Component: The NOVEL™ VBR Spinal System is a physical medical device (an implant). The 510(k) summary describes standard mechanical testing (Static and dynamic testing) for comparing its physical properties to predicate devices, not AI/ML performance.
- Approval Date: The 510(k) was cleared in 2004, well before the widespread application of AI/ML in medical device performance evaluation as you've described in your questions.
- Focus of the Document: A 510(k) summary primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, not necessarily extensive novel performance studies in the way you've outlined for AI/ML systems.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone performance for an AI/ML device because this document does not pertain to such a device or study.
What the document does provide regarding performance:
VIII. Performance Data:
Static and dynamic testing of the NOVEL™ VBR Spinal System was performed. The test results demonstrated that the NOVEL™ VBR Spinal System is at least comparable to, if not better than those of the predicate devices.
Based on the available document, I cannot complete your request. It describes a physical medical device (a spinal implant) and its mechanical testing, not an AI/ML diagnostic or assistive device that would have acceptance criteria for algorithms, ground truth creation by experts, or MRMC studies.
§ 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.