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The NOVEL™ VBR Spinal System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Novel™ VBR System is intended for use with supplemental spinal fixation systems. Specifically, the Novel™ VBR System is to be used with the Alphatec Zodiac™ Polyaxial Pedicle Screw System or the Alphatec Mirage™ Top Tightening Spinal System. Furthermore, the Novel™ VBR 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 various shapes and sizes to meet individual patient anatomy. System components are manufactured from titanium alloy (ASTM F-136) or polyetheretherkeytone (PEEK) material (ASTM F 2026 and ISO 10993). A radiographic marker fabricated from titanium alloy (ASTM F-136) or tantalum (ASTM F-560) allows for easy radiographic identification.

This document, K050553 for the NOVEL™ VBR Spinal System, is a 510(k) premarket notification. It describes a medical device and its intended use, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

The document states:

• "Performance data were submitted to characterize the NOVEL™ VBR Spinal System manufactured from PEEK material." (Section VIII)
• It refers to "substantial equivalence" to a previously cleared device.
• It is a regulatory clearance document, not a performance study report.

Therefore,Based on the provided document, the following information about acceptance criteria and a study proving the device meets those criteria cannot be found or inferred:

1. A table of acceptance criteria and the reported device performance: This document does not specify any quantitative acceptance criteria for the device's performance, nor does it present device performance data in a table or any other format that would allow for comparison to such criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No information regarding sample sizes for any test sets, data provenance, or study design (retrospective/prospective) is provided. The document mentions "Performance data were submitted to characterize," but does not detail the specifics of this data or the studies generating it.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Since no clinical performance study is described, there is no mention of experts, ground truth establishment, or their qualifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: No adjudication method is mentioned as no test set or clinical assessment is detailed.
5. 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: This is a spinal surgical implant, not an AI-powered diagnostic device. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As this is a physical medical implant and not an algorithm, the concept of standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth is discussed as no clinical performance study is detailed.
8. The sample size for the training set: There is no mention of a training set, as this is a physical device and not a machine learning model.
9. How the ground truth for the training set was established: Not applicable, as there is no training set for an algorithm.

In summary, this document is a 510(k) clearance letter confirming that the FDA found the NOVEL™ VBR Spinal System substantially equivalent to a predicate device. It does not contain the detailed performance study information with acceptance criteria that you are requesting.

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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.

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