(114 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 for a medical device called the "Axis Spine Technologies ALIF," an intervertebral body fusion device.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail threshold format that would typically be found in a performance study for, for example, diagnostic accuracy. Instead, it states that non-clinical testing was performed to demonstrate substantial equivalence to predicate devices. The reported device performance is that it "meets or exceeds the performance of the predicate device and does not introduce any new risks."
Therefore, the "acceptance criteria" can be inferred as meeting the established standards for intervertebral body fusion devices, and the reported performance is that the device successfully met these standards.
| Acceptance Criteria (Inferred from testing standards) | Reported Device Performance |
|---|---|
| Demonstrate performance per ASTM F2077 for static and dynamic compression. | Met or exceeded the performance of the predicate device. |
| Demonstrate performance per ASTM F2077 for static and dynamic compression shear. | Met or exceeded the performance of the predicate device. |
| Demonstrate performance per ASTM F2267 for subsidence. | Met or exceeded the performance of the predicate device. |
| Demonstrate performance for expulsion and axial pushout of retention device. | Met or exceeded the performance of the predicate device. |
| Not introduce any new risks compared to predicate devices. | Does not introduce any new risks. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not provide specific sample sizes for the non-clinical tests. It refers to "nonclinical testing" without detailing the number of specimens tested for each type of evaluation (e.g., number of interbody spacers for compression testing).
The studies performed are non-clinical (mechanical/physical tests), not involving human or animal subjects, so terms like "country of origin of the data," "retrospective," or "prospective" are not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable. The studies conducted are non-clinical mechanical tests, not clinical studies requiring expert interpretation or ground truth establishment in a medical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable, as the tests are non-clinical mechanical validations.
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 MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical studies were conducted as part of submission to prove substantial equivalence." This device is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable. For non-clinical mechanical tests, "ground truth" would refer to the physical properties and performance metrics established by the ASTM standards, not clinical or pathological diagnoses. The "ground truth" for these tests are the specified parameters and methodologies defined by the ASTM standards (F2077, F2267).
8. The sample size for the training set:
This information is not applicable. There is no "training set" for physical device testing as there would be for an AI algorithm.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no training set for this type of submission.
§ 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.