(95 days)
The Zyston Straight Spacer System is indicated for vertebral body replacement and intervertebral body fusion. When used for vertebral body replacement, the Zyston Straight Spacer System is indicated for use in the thoracolumbar spine (i.e., TI- L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Zyston Straight Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The Zyston Straight Spacer 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 of time. When used for vertebral body replacement, the Zyston Straight Spacer System is designed for use with bone graft and is intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.
As an intervertebral body fusion device, the Zyston Straight Spacer System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. When used as an intervertebral body fusion device, the Zyston Straight Spacer System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
The Zyston Straight Spacer System may also be implanted using the AccuVision System to provide the surgeon with a minimally invasive approach for posterior or posterolateral spinal surgery.
The purpose of this submission is the introduction of a new device for intervertebral body fusion and vertebral body replacement. The Zyston Straight Spacer System is constructed of medical grade Polyetheretherketone (PEEK-OPTIMA LT1, a registered trademark of Invibio Limited) and tantalum radiographic markers for spinal applications.
The provided text describes a medical device submission (K112014) for the "Zyston Straight Spacer System," a non-cervical spinal spacer and vertebral body replacement device. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results or acceptance criteria in the way a clinical trial for an AI/software device would.
Therefore, the information requested in the prompt related to the acceptance criteria and study for an AI/software device, such as sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance, cannot be found in this document.
This document describes a mechanical device, and the "study" it refers to is primarily mechanical testing to demonstrate the device's physical performance characteristics and substantial equivalence to existing devices, not clinical studies in the typical sense used for AI/software.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied by Special Controls Guidance) | Reported Device Performance |
|---|---|
| Static Axial Compression (ASTM F-2077) | Sufficient mechanical strength for intended use |
| Dynamic Axial Compression (ASTM F-2077) | Sufficient mechanical strength for intended use |
| Static Compression-Shear (ASTM F-2077) | Sufficient mechanical strength for intended use |
| Dynamic Compression-Shear (ASTM F-2077) | Sufficient mechanical strength for intended use |
| Subsidence (ASTM F-2267 and ASTM F-2077) | Sufficient mechanical strength for intended use |
| Static Torsion (ASTM F-2077) | Sufficient mechanical strength for intended use |
| Dynamic Torsion (ASTM F-2077) | Sufficient mechanical strength for intended use |
| Expulsion (ASTM Draft F-04.25.02.02) | Sufficient mechanical strength for intended use |
Study Description:
The study conducted was a series of mechanical tests on the Zyston Straight Spacer System. These tests were performed in accordance with "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" and "Guidance for Industry and FDA Staff: Spinal System 510(k)s." The specific ASTM standards followed were:
- ASTM F-2077 for Static Axial Compression, Dynamic Axial Compression, Static Compression-Shear, Dynamic Compression-Shear, Static Torsion, and Dynamic Torsion.
- ASTM F-2267 and ASTM F-2077 for Subsidence.
- ASTM Draft F-04.25.02.02 for Expulsion.
The overall reported performance is that the "Mechanical testing shows that the mechanical strength of the subject device is sufficient for the intended use."
Information NOT available in the provided text (as it pertains to AI/software device studies):
- Sample size used for the test set and the data provenance: Not applicable to this mechanical device testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For mechanical devices, the "ground truth" is typically defined by engineering specifications and direct physical measurement against established standards (e.g., strength, durability).
- The sample size for the training set: Not applicable (this is not an AI/ML device).
- How the ground truth for the training set was established: Not applicable.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.