(24 days)
The DePuy AcroMed VBR System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spine.
The DePuy AcroMed VBR System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
The DePuy AcroMed VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the VBR System include DePuy AcroMed titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch, and Profile).
The additional size cages are identical to the previously cleared stackable cages with regards to indications for use, function and material. The design of the cage is slightly different; the footprint of the device has been slightly modified.
The provided text describes specific details about a medical device known as the DePuy AcroMed VBR System, focusing on its acceptance criteria and the study used to demonstrate its performance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Modification | Risk Associated with Change | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Addition of Sizes | New sizes will not have the same mechanical characteristics as the predicate sizes. | The proposed device will perform the same as or better than the device previously cleared in K990148 and K001340. | By design, these parts are thicker in cross section than the existing devices and are therefore not worst case for the system. The worst case testing for the system has been provided in Test Report ACRO-0400-01. (This implies that the new sizes meet or exceed the performance of the predicate devices). |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions that "worst case testing for the system has been provided in Test Report ACRO-0400-01" and that a "Design Risk Analysis was used to assess risk for the additional sizes... performed in accordance with DePuy AcroMed Design Control and Quality procedures using static testing."
- Sample Size for Test Set: Not explicitly stated in terms of number of devices or scenarios. The phrase "worst case testing" suggests a selection of samples representing the most challenging conditions.
- Data Provenance: The testing was "performed in accordance with DePuy AcroMed Design Control and Quality procedures," indicating an internal, manufacturer-driven study. The provided text doesn't specify the country of origin of the data or if it was retrospective or prospective, though internal product testing is typically prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This study refers to mechanical testing of a spinal implant, not a diagnostic or algorithmic device that requires expert ground truth establishment for a test set.
4. Adjudication Method for the Test Set:
Not applicable. This is a physical device testing, not a study involving human interpretation or subjective assessment that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This is a submission for a physical medical device (spinal implant), not an AI/software device that would typically involve an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This is a physical device submission.
7. The Type of Ground Truth Used:
The ground truth used for demonstrating compliance with acceptance criteria was mechanical performance metrics obtained through static testing. The performance of the new sizes was compared against the "previously cleared" predicate devices K990148 and K001340.
8. The Sample Size for the Training Set:
Not applicable. This is a physical device and does not involve machine learning algorithms with a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, this is a physical device.
§ 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.