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510(k) Data Aggregation
(70 days)
The NuVasive X-CORE® Expandable 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 X CORE® Expandable 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 material may be used at the surgeon's discretion.
The NuVasive X-CORE® Mini Cervical Expandable VBR System is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following Corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The NuVasive X-CORE® Mini Cervical Expandable VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.
These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The NuVasive X-CORE® Mini Cervical Expandable VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
X-Core Expandable VBR and X-Core Mini Cervical Expandable VBR devices are vertebral body replacement devices manufactured from Titanium alloy Ti6Al-4V ELI conforming to ASTM F136 and ISO 5832-3. Devices are offered in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
The purpose of this 510(k) application is to add the sterile implants option to the previously cleared system.
I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study that proves a device meets such criteria. The document is an FDA clearance letter for a medical device (NuVasive X-Core® Expandable VBR System), outlining its indications for use, technological characteristics, and stating its substantial equivalence to predicate devices. It mentions performance data related to sterilization and packaging but does not include details on acceptance criteria or clinical/comparative studies involving device performance metrics as requested in your prompt.
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(155 days)
C-VBR is a vertebral body replacement device indicated for use in the cervical spine (spanning C2-T1 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The C- VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.
These implants are intended for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The C-VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
C-VBR is a vertebral body replacement device manufactured from titanium alloy (Ti-6AI-4V), and is available in a variety of sizes to suit the individual anatomic and clinical circumstances of each patient. C-VBR is a single-piece device manufactured using electrical discharge machining. having a trapezoidal cross section with a hollow interior to accommodate the placement of autograft or allograft bone. Intended for placement via an anterior approach. C-VBR is to be used in combination with supplemental fixation indicated for use in the cervical spine. C-VBR is provided with superior and inferior endplates that are either parallel (no lordosis) or angled to provide intrinsic lordosis (9.6° or 11.5°), and with various heights from 16 mm to 72 mm.
This document describes the regulatory approval of the C-VBR vertebral body replacement device. The approval is based on a demonstration of substantial equivalence to previously marketed predicate devices, rather than a separate clinical study with predefined acceptance criteria for the C-VBR device itself. Therefore, many of the requested details about acceptance criteria, specific study design for the C-VBR, and AI-related aspects are not directly applicable or available in this document.
However, I can extract the relevant information regarding the performance testing and clinical data review that were used to support the substantial equivalence.
Here's a breakdown of the available information:
1. Table of acceptance criteria and the reported device performance:
Since this is a substantial equivalence submission relying on predicate devices and specific performance tests, there aren't explicit acceptance criteria for the C-VBR in the format of "minimum sensitivity X, specificity Y." Instead, the acceptance is based on demonstrating mechanical performance equivalent to or better than the predicate devices and a review of clinical outcomes from actual device use.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance and Basis for Approval |
|---|---|---|
| Mechanical Performance | Meet or exceed standards for intervertebral body fusion devices (ASTM F2077, ASTM F2267) | "Mechanical performance testing provided previously in K1211176 and K142030 are applicable to the subject device." |
| "The mechanical testing data demonstrated that the compressive strength, torsional strength, and expulsion resistance of the subject device are adequate to meet the clinical requirements of the intended use." | ||
| Static Compression | Pass ASTM F2077 | Covered by the above statement and previous predicate device clearances. |
| Dynamic Compression | Pass ASTM F2077 | Covered by the above statement and previous predicate device clearances. |
| Static Torsion | Pass ASTM F2077 | Covered by the above statement and previous predicate device clearances. |
| Dynamic Torsion | Pass ASTM F2077 | Covered by the above statement and previous predicate device clearances. |
| Subsidence | Pass ASTM F2267 | Covered by the above statement and previous predicate device clearances. |
| Static Expulsion | Adequate resistance | "Static expulsion testing also was performed." |
| "expulsion resistance of the subject device are adequate to meet the clinical requirements of the intended use." | ||
| Clinical Performance (Safety) | No device-related complications or revision surgeries | "There were no device-related complications and no device-related revision surgeries." |
| Clinical Performance (Effectiveness) | Improvement in Nurick Classification scores, maintenance/improvement in Cobb angle, no significant subsidence, radiographic evidence of fusion | "Effectiveness... demonstrated by the improvement in the Nurick Classification scores (mobility restriction caused by cervical myelopathy), maintenance or improvement in cervical sagittal alignment demonstrated by Cobb angle measurements, no significant subsidence of the implants, and radiographic evidence of fusion." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size (Clinical Data Review): 97 patients treated with a total of 103 C-VBR devices.
- Data Provenance: The document does not specify the country of origin. It is a "review of the results of a series of 97 patients." This implies retrospective data collection, reviewing existing patient records or a previous study. It does not appear to be a newly conducted prospective clinical trial for this specific 510(k) submission.
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)
Not applicable. The clinical data presented is a review of outcomes from actual patient treatments, likely relying on the assessments of the treating physicians and radiologists involved in those cases, rather than a separate "ground truth" expert panel specifically for this 510(k) submission. No information is provided about the number or qualifications of experts involved in the original patient care or the subsequent review mentioned in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This was a review of existing clinical outcomes, not a study involving independent readers or adjudication for a diagnostic accuracy assessment.
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
Not applicable. This device is a surgical implant (vertebral body replacement) and the submission does not involve Artificial Intelligence (AI) or an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical implant and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The clinical performance was assessed based on outcomes data including:
- Nurick Classification scores (mobility restriction assessment)
- Cobb angle measurements (cervical sagittal alignment)
- Radiographic evidence (absence of significant subsidence, evidence of fusion)
- Absence of device-related complications or revision surgeries.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device. The design and validation relied on engineering principles and comparison to predicate devices, not a training set in the context of AI.
9. How the ground truth for the training set was established
Not applicable.
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