(87 days)
The Small VBR is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a 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 Small VBR 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 Small VBR is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Small VBR is optional.
Small VBR™ is a system of corpectomy devices used to provide mechanical support to the cervical and thoracolumbar spine. Small VBR™ is a cylindrical implant with the capability for device expansion. The ends of the device incorporate a ring of teeth to engage the endplates of adjacent vertebrae. The device is offered non-sterile in various combinations of expansion range, angulation and footprint to accommodate patient anatomy.
The provided text is a 510(k) premarket notification for a medical device called "Small VBR™" (Vertebral Body Replacement). This document describes the device, its intended use, and its equivalence to legally marketed predicate devices, primarily through mechanical testing.
**Crucially, this document does not describe a study involving:
- Acceptance criteria based on AI or diagnostic performance metrics (e.g., sensitivity, specificity, AUC).
- Human readers, radiologists, or expert consensus for ground truth establishment.
- Training or test sets for an algorithm.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.**
Instead, the performance data section states: "Mechanical testing of the worst case Small VBR™ devices included static and dynamic compression and static and dynamic torsion following ASTM F2077. The mechanical test results demonstrate that Small VBR™ device performance is substantially equivalent to itself as a predicate device."
Therefore, based solely on the provided text, I cannot fulfill the request to describe acceptance criteria and a study that proves the device meets those criteria in the context of diagnostic performance or AI. The study described is a mechanical testing study for a spinal implant, comparing its physical performance to a predicate device.
Here's what I can extract based on the provided text about the mechanical testing:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (based on ASTM F2077) | Reported Device Performance |
|---|---|
| Demonstrated static compression performance per ASTM F2077 | Mechanical test results demonstrate substantial equivalence to predicate device. |
| Demonstrated dynamic compression performance per ASTM F2077 | Mechanical test results demonstrate substantial equivalence to predicate device. |
| Demonstrated static torsion performance per ASTM F2077 | Mechanical test results demonstrate substantial equivalence to predicate device. |
| Demonstrated dynamic torsion performance per ASTM F2077 | Mechanical test results demonstrate substantial equivalence to predicate device. |
Note: The specific numerical values for acceptance criteria or device performance are not provided in this document, only that they followed ASTM F2077 and demonstrated substantial equivalence.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated but implied to be "worst case Small VBR™ devices" for mechanical testing. For mechanical testing, this typically refers to a representative number of devices to ensure statistical validity, but the exact count isn't given.
- Data Provenance: Not applicable in the context of patient data. The "data" refers to mechanical test results from the manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for mechanical testing is established by engineering standards (ASTM F2077) and the physical properties of the device, not by expert human interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is a mechanical engineering test, not a diagnostic study requiring human 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:
- No, an MRMC study was not done. This device is a physical spinal implant, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used:
- The ground truth is established by the ASTM F2077 standard for mechanical testing of spinal implants.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning study.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning study.
In summary, the provided document details the regulatory clearance of a physical medical device (spinal implant) based on mechanical testing demonstrating substantial equivalence, not a study evaluating diagnostic performance or AI.
§ 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.