(212 days)
The ALIF System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to -S1.
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 six months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).
The ALIF System 10° - 20° lordotic cages may be used as a standalone system. The ALIF System 25° - 40° lordotic cages must be used with supplemental internal spinal fixation systems pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.
The ALIF System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.
For use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
The Axis Spine Technologies ALIF is an interfixated interbody system consisting of a modular interbody spacer manufactured from Ti6Al4V. The system is designed to be assembled in vivo. The spacer comprises of two endplates and a central core. Each component is available in a variety of shapes and sizes to allow the assembled device to suit the individual pathology and anatomical conditions of the patient.
The Axis Spine Technologies ALIF System intervertebral fusion device is designed to address lumbar pathologies utilizing placement through an anterior approach. The device's hollow core or graft aperture allows for packing of autogenous and/or allogeneic bone graft to help promote a solid fusion. A rough surface on the device endplates serves to grip the adjacent vertebrae to resist migration and expulsion of the device, alternately models with protrusions on the device endplates grip the adjacent vertebrae to resist migration and aid in expulsion resistance. The ALIF System 10° - 20° lordotic cages may be used as a standalone system. The ALIF System 25° - 40° lordotic cages must be used with supplemental internal spinal fixation systems (i.e., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.
The ALIF System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel deqenerative scoliosis; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.
The Axis Spine Technologies ALIF implant is composed of:
- one (1) inferior endplate manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3.
- . one (1) inferior endplate manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3.
- . one (1) core manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3.
- . three (3) bone screws manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3.
- . one (1) cover plate manufactured from PEEK-Optima HA Enhanced.
This FDA 510(k) summary provides information on a medical device, the Axis Spine Technologies ALIF, an intervertebral body fusion device. Crucially, it does not describe acceptance criteria, a study that proves the device meets those criteria, or clinical performance data. Instead, it focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical (mechanical) testing.
Therefore, many of the requested categories cannot be populated from the provided text.
Here's a breakdown of what can be extracted and what information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Meet or exceed the performance of the predicate device (implied from non-clinical testing) | "The results of these studies show that the Axis Spine Technologies ALIF meets or exceeds the performance of the predicate device" |
| Not introduce any new risks (implied from non-clinical testing) | "and does not introduce any new risks" |
| Perform within its design specifications (implied conclusion) | "and performs within its design specifications" |
| Be "as safe and effective as the currently marketed predicate devices" (overall conclusion) | "The Axis Spine Technologies ALIF is as safe and effective as the currently marketed predicate devices." |
Specific non-clinical tests performed and their implied acceptance criteria (meeting or exceeding predicate performance):
| Test | Implied Acceptance Criteria | Reported Performance |
|---|---|---|
| Static and dynamic compression testing per ASTM F2077 | Performance comparable or superior to predicate | Met/exceeded predicate performance |
| Static and dynamic compression shear testing per ASTM F2077 | Performance comparable or superior to predicate | Met/exceeded predicate performance |
| Subsidence testing per ASTM F2267 | Performance comparable or superior to predicate | Met/exceeded predicate performance |
| Expulsion and Axial Pushout of Retention Device testing | Performance comparable or superior to predicate | Met/exceeded predicate performance |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document refers to "studies" and "results" of "nonclinical testing" but does not provide sample sizes for these tests.
- Data Provenance: Not specified. These are non-clinical mechanical tests, so concepts like "country of origin" or "retrospective/prospective" don't directly apply in the same way they would for patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth is not established in the context of mechanical testing. The tests are performed against standardized ASTM methods.
4. Adjudication method for the test set
- Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical studies, not mechanical testing.
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
- No. This is a medical device (intervertebral fusion device), not an AI/imaging device. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical implant, not an algorithm or software.
7. The type of ground truth used
- Not applicable. For these non-clinical tests, the "ground truth" is adherence to and performance within the parameters defined by the ASTM standards (e.g., F2077, F2267) and comparability to the predicate devices.
8. The sample size for the training set
- Not applicable. As this is not an AI/machine learning device, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As this is not an AI/machine learning device, there is no "training set" or ground truth for it.
In summary:
This document is a 510(k) summary for a physical medical device. It demonstrates substantial equivalence primarily through non-clinical (mechanical) testing results, showing the device performs comparably to or better than predicate devices according to established ASTM standards. It does not involve AI, clinical studies, or expert review of data in the way a diagnostic software device submission would.
§ 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.