(52 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 a medical device, the Hedrocel Vertebral Body Replacement System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo clinical study to prove efficacy and safety with specific acceptance criteria related to a new device performance.
Therefore, much of the information requested in your prompt (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, standalone performance) is not applicable to this type of regulatory submission and is not present in the provided document.
Here's a breakdown of what can be extracted from the text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission like this, "acceptance criteria" and "reported device performance" are primarily focused on demonstrating mechanical equivalence to predicate devices. The acceptance criteria are implicit in the "applicable standards" referenced, and the "reported device performance" refers to the device meeting the mechanical safety and performance benchmarks set by those standards and the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance Statement |
|---|---|
| Compliance with applicable standards for vertebral body replacement devices, demonstrating equivalent mechanical behavior to predicate devices. | "The Hedrocel Vertebral Body Replacement System was tested per applicable standards. Biocompatibility data was provided to support the material's use. Performance testing was provided to support equivalent mechanical behavior to the predicates. The results demonstrated that the device will perform as intended and is equivalent to the cited predicate devices. Test data was provided regarding: Static compression, Dynamic compression, Static torsion, Dynamic torsion, and Abrasion." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states "test data was provided regarding" various mechanical tests, but doesn't detail the number of units tested.
- Data Provenance: Not specified. These are likely in vitro mechanical tests conducted in a laboratory setting, not clinical data from patients in a specific country.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For mechanical performance testing, "ground truth" is established through engineering and biomechanical testing against defined standards, not expert clinical consensus on images or outcomes.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This concept is relevant for clinical studies involving expert review, not for mechanical bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC study was not done. This type of study is for evaluating the impact of AI on human reader performance, typically in diagnostic imaging, and is not relevant to the mechanical performance of a vertebral implant.
- Effect Size of Human Readers Improve with AI vs. without AI Assistance: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. This device is a physical implant, not a software algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this device's performance is based on biomechanical and material science standards and benchmarks established by the predicate devices. These standards define acceptable levels of static compression, dynamic compression, static torsion, dynamic torsion, and abrasion.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This refers to training an AI model, which is not relevant to this device submission.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable.
Summary of Inapplicability:
The requested information (points 2-6, 8-9) largely pertains to the validation of AI/software devices or clinical efficacy studies. The K021025 submission for the Hedrocel Vertebral Body Replacement System is a 510(k) for a physical implant, demonstrating substantial equivalence through mechanical and biocompatibility testing against predicate devices and applicable standards. This process does not involve clinical "test sets" or "training sets" in the traditional sense of AI/diagnostic imaging validation.
§ 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.