(118 days)
The Zyston Curve Interbody 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.
The Zyston Curve Interbody 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 Curve Interbody 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 intervertebral body fusion device. The Zyston Curve Interbody Spacer System is a spacer constructed of medical grade Polyetheretherketone (PEEK) with a titanium alloy threaded insert, and tantalum radiographic markers for spinal applications.
Here's an analysis of the provided text regarding the Zyston Curve Interbody Spacer System, focusing on acceptance criteria and performance studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Mechanical Testing Standards) | Reported Device Performance |
|---|---|
| Static Axial Compression (ASTM F-2077) | Met or exceeded predicate |
| Dynamic Axial Compression (ASTM F-2077) | Met or exceeded predicate |
| Static Compression-Shear (ASTM F-2077) | Met or exceeded predicate |
| Dynamic Compression-Shear (ASTM F-2077) | Met or exceeded predicate |
| Subsidence (ASTM F-2267 and ASTM F-2077) | Met or exceeded predicate |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes mechanical performance testing for a medical device (Zyston Curve Interbody Spacer System). These tests are typically conducted on device samples, not on patient data.
- Sample Size for Test Set: The document does not specify the exact number of devices tested for each mechanical test. This information is often found in detailed test reports, not summarized in regulatory submissions like this 510(k).
- Data Provenance: Not applicable in the context of mechanical testing. The data is generated in a laboratory setting. If it were a clinical study, provenance might refer to the country of origin of patients or the type of clinical trial (retrospective/prospective); however, there is no clinical study described.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of study. Mechanical testing involves objective measurements based on standardized protocols (ASTM standards) and engineering principles, not expert consensus or interpretation of clinical data.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies where expert disagreement on ground truth is possible. Mechanical tests rely on direct measurements and adherence to testing standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly describes mechanical testing in a lab setting, not a clinical study involving human readers or patient cases.
- Effect size of human readers with AI vs. without AI assistance: Not applicable, as this was not an AI-assisted diagnostic study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This document concerns a physical medical implant device and its mechanical properties, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the mechanical performance tests is established by the ASTM standards themselves (F-2077, F-2267) which define the methods, parameters, and acceptable ranges or comparison criteria for evaluating the mechanical properties of intervertebral body fusion devices. The performance of the Zyston Curve was then measured against these standards and compared to legally marketed predicate devices.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not a machine learning or AI algorithm. The device's design is based on engineering principles and existing predicate devices, not trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set involved in the mechanical testing of this device.
§ 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.