(191 days)
The Z-Clamp ISP System is a posterior, non-pedicle supplemental fixation device, intended for use as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous process for the purpose of achieving stabilization as an adjunction in patients with degenerative disc disease – defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation) and/or tumor. The Z-Clamp ISP System is not intended for standalone use.
The Zavation Z-CLAMP ISP System is a spinous process plate which is a temporary, titanium alloy (Ti-6AL-4V ELI per ASTM F136), multiple component system comprised of a variety of nonsterile, single use implantable components. The system consist of plates and lock screw. The components are available in a variety of lengths and sizes in order to accommodate patient anatomy.
This document is a 510(k) premarket notification for a medical device called the Z-Clamp ISP System. It is focused on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria for diagnostic accuracy or efficacy through clinical studies. Therefore, much of the requested information regarding diagnostic device performance, expert review, and MRMC studies is not available in these documents.
Here's a breakdown of the available information and how it relates to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this device are largely defined by its mechanical performance compared to the predicate device, as it's a spinal fixation orthosis. The document states that the device performs "as well as or better than the predicate devices" in several mechanical tests. Since the predicate device is already marketed, this implies that its established mechanical performance serves as the de facto acceptance criteria.
| Acceptance Criteria (Implied from Predicate) | Reported Device Performance (Z-Clamp ISP System) |
|---|---|
| Mechanical performance of a legally marketed predicate device (K141508 Spineart, Romeo 2Pad) across various tests (Static torsion, Static compression bending, Dynamic compression bending, Static foam pull-off, Static plate dissociation). | Performs as well as or better than the predicate devices in Static torsion test, Static compression bending test, Dynamic compression bending test, Static foam pull-off test and Static plate dissociation test. |
2. Sample Size for the Test Set and Data Provenance
This is not applicable to this type of submission. The performance assessment is based on mechanical testing of the device itself, not on a test set of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable. Ground truth, in the context of device performance, would relate to its physical and mechanical properties, not diagnostic accuracy requiring expert interpretation.
4. Adjudication Method for the Test Set
This is not applicable. The device's performance is determined through reproducible mechanical tests, not based on expert adjudication of a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance to assess diagnostic performance. The Z-Clamp ISP System is a physical spinal implant.
6. Standalone Performance Study (Algorithm Only)
No standalone performance study of an algorithm was done. This device is not an algorithm; it's a physical medical device. The "performance" refers to its mechanical integrity and function.
7. Type of Ground Truth Used
The "ground truth" for this device is established through standardized mechanical testing. The tests performed were:
- Static torsion test
- Static compression bending test
- Dynamic compression bending test
- Static foam pull-off test
- Static plate dissociation test
These tests are specifically designed to assess the physical properties and structural integrity of the spinal fixation system under various forces, using methods "according to a modified ASTM F1717." The results are quantitative measurements against established engineering and material science standards for similar devices.
8. Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of a physical medical device like this spinal clamp. This term is relevant for machine learning algorithms.
9. How Ground Truth for the Training Set Was Established
This is not applicable as there is no training set.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.