(335 days)
A-Link Z is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral body space.
A-Link Z is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
A-Link Z may be used as a stand alone device when all four (4) vertebral body bone screws are used. If the physician chooses to use fewer than the four (4) screws, then an additional supplemental spinal fixation system cleared for use in the lumbosacral spine must be used.
The A-Link Z is a spinal device that is implanted in the intervertebral body space to improve stability of the spine while supporting fusion. Components are offered in different shapes and sizes to meet the requirements of the individual patient anatomy.
The interbody components are manufactured using medical grade polyetheretherketone (PEEK) conforming to ASTM D2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications or titanium alloy, Ti-6Al-4V ELI conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The PEEK version of the interbody comes with two tantalum markers conforming to ASTM F560 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications to facilitate implant placement. The A-Link Z is available in one footprint (36 mm wide). It has an anatomic shape with serrations on the superior and inferior surfaces. The A-Link Z is available in two lordotic angle options (79 and 12°). The 7° lordotic option has heights ranging from 11 mm in 2 mm increments and the 12° lordotic option has heights ranging from 11 mm to 19 mm increments.
The interbody comes with a press fit plate manufactured from titanium alloy, Ti-6Al-4V ELI conforming to ASTM F136. The plate has four screw holes that allow the passage of bone screws.
The 5.0 mm and 5.5 mm diameter bone screws are available in three lengths (20 mm, 25 mm and 30 mm). The screws are manufactured from titanium alloy, Ti-6A1-4V ELI according to ASTM F136. The A-Link Z is fixed to the adjacent vertebral bodies through the use of four screws inserted through anterior screw holes of the implant.
The screws are prevented from backing out after insertion by the attachment of a cover plate and a cover plate screw to the anterior side of the plate. The cover plate and cover plate screw are manufactured from titanium alloy, Ti-6A1-4V ELI according to ASTM F136.
This document is a 510(k) premarket notification for the A-Link Z intervertebral body fusion device. It does not describe an AI/ML powered device, therefore the vast majority of the requested information regarding acceptance criteria, study design, ground truth, and reader studies is not applicable.
Here's the relevant information provided in the document:
Device Name: A-Link Z (Intervertebral body fusion device)
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes performance testing conducted but does not provide specific acceptance criteria values or detailed reported device performance in a numerical table format that would typically be expected for an AI/ML device. Instead, it states that "Performance testing to demonstrate substantial equivalence included methods described in the standards ASTM F2077 Test Methods for Intervertebral Body Fusion Devices and ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression."
The tests performed were:
- Static & Dynamic Compression testing per ASTM F2077
- Static & Dynamic Torsion testing per ASTM F2077
- Static & Dynamic Compression Shear testing per ASTM F2077
- Expulsion testing
- Subsidence testing per ASTM F2267
- Static tensile testing (to measure force required to separate face plate from interbody spacer)
The conclusion states that "Any differences in the technological characteristics between the subject and predicate devices do not raise different questions of safety or effectiveness," implying the device met the performance standards established by the predicate devices through these tests.
2. Sample size used for the test set and the data provenance: Not applicable. This is a mechanical device, not an AI/ML model requiring a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a mechanical device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a mechanical device, not an AI/ML powered device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a mechanical device. The "ground truth" for a mechanical device is its physical performance characteristics meeting established engineering standards and comparison to predicate devices.
8. The sample size for the training set: Not applicable. This is a mechanical device.
9. How the ground truth for the training set was established: Not applicable.
Summary of what the document does provide regarding device evaluation:
The document describes performance evaluation based on non-clinical data, specifically:
- Performance testing (listed above, following ASTM standards)
- Engineering analysis
- Dimensional analysis
The evaluation method for substantial equivalence was primarily comparison to legally marketed predicate devices based on:
- Intended use
- Technological characteristics (footprint, height, lordotic angle, screw dimensions, screw locking mechanism)
- Materials (medical grade PEEK, titanium alloy, tantalum markers)
- Packaging
- Sterilization methods (gamma sterilized)
The document explicitly states: "Clinical data were not submitted in this premarket notification."
In essence, the "acceptance criteria" were implied to be the performance demonstrated by the predicate devices and established by recognized ASTM standards for intervertebral body fusion devices. The "study" proving the device met these criteria consisted of the non-clinical performance testing, engineering analysis, and dimensional analysis, all demonstrating similarity to the predicate devices.
§ 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.