(111 days)
The Z-Link Cervical is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Z-Link Cervical should be packed with autogenous bone graft and implanted with an anterior approach.
The Zavation Z-Link Cervical includes a PEEK spacer, titanium interbody plate and screws. The spacer component is assembled to an interbody plate and implanted anteriorly. The endplate contacting surfaces of the spacer component include serrations, and the plate component includes two holes for inserting one bone screw in each vertebral body. The plate component also includes a screw lock at each hole. The bone screws are available in a variety of diameters and lengths. The interbody plate components are available in a variety of heights. The spacer components are available in a variety of depths, widths, and heights.
The provided document describes the Zavation Z-Link Cervical, an intervertebral body fusion device, and its acceptance criteria as demonstrated by mechanical testing. However, it does not include information about a study involving an AI algorithm or human readers. The acceptance criteria and the study proving it relate directly to the physical properties and performance of the medical device itself.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: | Demonstrated to be substantially equivalent to predicate devices. |
| - Static Axial Compression | Passed (implied by "substantially equivalent" and testing per ASTM F2077) |
| - Dynamic Axial Compression | Passed (implied by "substantially equivalent" and testing per ASTM F2077) |
| - Static Torsion | Passed (implied by "substantially equivalent" and testing per ASTM F2077) |
| - Dynamic Torsion | Passed (implied by "substantially equivalent" and testing per ASTM F2077) |
| - Load Induced Subsidence | Passed (implied by "substantially equivalent" and testing per ASTM F2267) |
| - Static Pushout | Passed (implied by "substantially equivalent" and testing per ASTM Draft F04.25.02.02) |
| Biocompatibility: | Materials (PEEK Zeniva ZA-500, Tantalum alloy, Titanium alloy) meet ASTM standards (Implied by stating use of medical grade materials adhering to specific ASTM standards, thus presumed biocompatible). |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document refers to "mechanical test results" but does not specify the number of devices or components tested. Data provenance is not applicable as this describes mechanical testing of a physical device, not analysis of human patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the type of study described. The "ground truth" for this device's mechanical performance is established by standardized engineering tests (ASTM standards) rather than expert human interpretation.
4. Adjudication Method for the Test Set
This information is not applicable. Mechanical testing according to established ASTM standards does not involve adjudication by experts in the same way clinical or imaging studies might. The results are objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This document describes mechanical testing of a physical medical device, not a study involving human readers or AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm study was not done. This document is about a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" used for this device's acceptance is based on the results of standardized mechanical engineering tests (ASTM F2077, ASTM F2267, ASTM Draft F04.25.02.02). The device's performance must meet the requirements of these standards to be considered "substantially equivalent" to predicate devices.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this document describes mechanical testing of a physical medical device, not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no "training set" or corresponding ground truth establishment described for an AI algorithm.
§ 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.