(30 days)
The Hedrocel® Vertebral Body Replacement System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Hedrocel® Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Hedrocel® Vertebral Body Replacement may be used with bone graft.
The Hedrocel® Vertebral Body Replacement System is designed to be used as a replacement for a single diseased or damaged vertebral body and the adjacent disc when spinal surgery through an anterior approach is indicated. The Hedrocel® Vertebral Body Replacement (VBR) System is comprised wholly of Hedrocel® Porous Tantalum (tantalum deposited on a vitreous carbon skeleton). The VBR is available to accommodate replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to properly tension the spine. The superior and inferior surfaces of the device have a pattern of ripples to provide increased stability. The Hedrocel® Vertebral Body Replacement implants have an included angle to maintain the natural contour of the lumbar spine. The use of titanium or titanium alloy instrumentation is recommended.
The provided text describes a 510(k) premarket notification for the "Hedrocel Vertebral Body Replacement System." This is a medical device, and the acceptance criteria mentioned are related to its mechanical performance and biocompatibility, demonstrating substantial equivalence to predicate devices. The document does not describe a study involving human subjects or AI; therefore, many of the requested fields are not applicable.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Data provided to support the material's use. |
| Mechanical Behavior (equivalent to predicates): |
- Static compression
- Dynamic compression
- Static torsion
- Dynamic torsion
- Abrasion | Test data provided regarding these aspects, demonstrating the device will perform as intended and is equivalent to cited predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for mechanical testing. The data provenance is not explicitly stated beyond "Performance Data: The Hedrocel Vertebral Body Replacement System was tested per applicable standards (reference K010378)." This suggests laboratory-based mechanical testing, not clinical data from patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth for this device's performance is established through engineering standards and mechanical testing, not expert interpretation of clinical data in the context of AI.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of clinical outcomes or image interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This submission is for a medical implant device, not an AI or diagnostic tool that would typically undergo an MRMC study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The device is a physical implant, not an algorithm. The performance data refers to the mechanical integrity and biocompatibility of the implant itself.
7. Type of Ground Truth Used
The ground truth used for validating the device's performance primarily relied on engineering standards and direct physical measurements obtained through mechanical testing (static and dynamic compression, torsion, abrasion) and biocompatibility assessments. It is compared to the established performance of predicate devices.
8. Sample Size for the Training Set
Not applicable. This is not a study involving machine learning where a "training set" would be used.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.