Search Results
Found 2 results
510(k) Data Aggregation
(69 days)
The Normandy VBR System is indicated for use in the cervical spine (C2-C7), and thoracolumbar spine (T1-L5) in skeletally mature patients for partial or total replacement of a diseased, collapsed, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The Normandy VBR System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The Normandy 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, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
The Normandy VBR System is intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, and anterior plate systems). When used at more than two levels, supplemental fixation should include posterior fixation.
The Normandy VBR System is an adjustable height vertebral body replacement device that is implanted into the vertebral body space to provide structural stability in skeletally mature patients following corpectomy or vertebrectomy. The system is comprised of spacers of various sizes and options to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. The device is mechanically locked at the required height by means of a locking screw. Each spacer has an axial hole to allow autograft or allograft to be packed inside each spacer. Protrusions on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Components are manufactured from titanium alloy (Ti-6AL-4V) per ASTM F-136.
The provided text describes a medical device, the Normandy VBR System, and its substantial equivalence determination by the FDA. However, it does not contain information regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning an AI/algorithm's performance.
The document is a 510(k) premarket notification approval letter and summary for a spinal implant. It focuses on demonstrating that the Normandy VBR System is substantially equivalent to existing predicate devices based on design, intended use, material composition, function, and mechanical performance.
Therefore, I cannot fulfill your request for information regarding AI device acceptance criteria and a study proving an AI device meets them. The provided text does not describe an AI medical device or its performance evaluation in the context you've outlined.
Here's what the document does provide the closest to your request, but is entirely in the context of a physical medical device (spinal implant) and its mechanical testing, not AI:
1. A table of acceptance criteria and the reported device performance:
| Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static and Dynamic Axial Compression | Passed (Substantially equivalent to predicate devices) | Demonstrated substantial equivalence to predicate devices. |
| Static and Dynamic Torsion | Passed per ASTM F2077 (Substantially equivalent to predicate devices) | Demonstrated substantial equivalence to predicate devices. |
| Subsidence | Passed per ASTM F2267 (Substantially equivalent to predicate devices) | Demonstrated substantial equivalence to predicate devices. |
| Expulsion | Passed (Substantially equivalent to predicate devices) | Demonstrated substantial equivalence to predicate devices. |
Important Note: The "acceptance criteria" here are implicitly that the device performs equivalently to the predicate devices through mechanical testing. The document doesn't provide specific quantitative thresholds for these tests but rather states that the "mechanical test results demonstrated that the Normandy VBR System is substantially equivalent to the predicate devices."
The following points cannot be addressed as the provided text pertains to a physical spinal implant, not an AI/algorithmic device:
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method
- If a multi reader multi case (MRMC) comparative effectiveness study was done
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
Ask a specific question about this device
(125 days)
The AIS Modulift VBR System is indicated 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 AIS Modulift VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The AIS Modulift VBR System may be used with bone graft.
The AIS Modulift VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the system is comprised of spacers and foot plates of various heights and sizes to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. Once it is adjusted to the desired height the column is mechanically locked in place by means of locking screws (grub screws). Each spacer has an axial hole to allow grafting material to be packed inside the device. Spikes on the end of the foot plates improve the anchoring of the implant to the vertebral body. The foot plates of the device are available in various lordotic and kyphotic angles. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136, and cobalt chrome (CoCr) per ASTM F1537.
The document describes the AIS Modulift VBR System, an adjustable vertebral body replacement device. This device is indicated 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). It is intended for use with supplemental spinal fixation systems and may be used with bone graft.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test) | Performance (Result) |
|---|---|
| Static and Dynamic Torsion (ASTM F2077) | Met or exceeded the performance of predicate devices |
| Static and Dynamic Compression (ASTM F2077) | Met or exceeded the performance of predicate devices |
| Subsidence (ASTM F2267) | Met or exceeded the performance of predicate devices |
| Wear Debris (ASTM F2077 & ASTM F1877) | Met or exceeded the performance of predicate devices |
| Expulsion (ASTM Draft Standard F-04.25.02.02) | Met or exceeded the performance of predicate devices |
2. Sample size used for the test set and the data provenance:
The document describes non-clinical performance testing of the device. It does not provide details on specific sample sizes for each test beyond stating that "non-clinical testing was performed." The data provenance is from laboratory testing performed on the device itself, not from human data or clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The "ground truth" for this device's performance is established by a set of ASTM and draft standards for orthopedic implants, which define the testing methodology and acceptance criteria. There is no mention of human experts establishing ground truth for the performance tests, as these are engineering and material science tests.
4. Adjudication method for the test set:
Not applicable. The tests are based on engineering standards, and the results are objective measurements against specified criteria, not subjective interpretations requiring adjudication.
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 is a physical medical device (vertebral body replacement system), not an AI/software device that requires human readers or clinical image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
The ground truth used for demonstrating device performance is based on established engineering standards and safety/performance benchmarks for spinal implants, specifically various ASTM standards (F2077, F2267, F1877) and a draft ASTM standard (F-04.25.02.02). The device's performance is compared against these standards and against predicate devices.
8. The sample size for the training set:
Not applicable. This refers to a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established:
Not applicable. This refers to a physical medical device, not a machine learning model.
Ask a specific question about this device
Page 1 of 1