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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

Specific non-clinical tests performed and their implied acceptance criteria (meeting or exceeding 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.

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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 sketally mature and have had six months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

The ALIF System 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.

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 inter-fixated 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. The subject device is indicated for use with supplemental internal spinal fixation (i.e., posterior pedicle screw and rodsystem).

The Axis Spine Technologies ALIF implant is composed of:

• one (1) inferior endplate manufactured from titanium alloy (Ti-6AI-4V ELI) conforming to ASTM F136 and ISO 5832-3.
• one (1) inferior endplate manufactured from titanium alloy (Ti-6AI-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 document is a 510(k) summary for the Axis Spine Technologies ALIF system, an intervertebral body fusion device. It details the device's characteristics, intended use, and comparative testing against predicate devices to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided PDF:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for performance metrics like sensitivity, specificity, accuracy, etc., and "reported device performance" are typical for diagnostic or AI-driven devices where a quantitative measure of performance against a ground truth is established.

However, this document describes a spinal implant (intervertebral body fusion device). For such devices, acceptance criteria primarily revolve around mechanical performance, biocompatibility, and substantial equivalence to existing devices, rather than diagnostic accuracy. The "study" proving acceptance criteria is primarily non-clinical (bench) testing and comparison to predicate devices.

Therefore, the table format for typical medical device AI/diagnostic performance metrics (sensitivity, specificity, etc.) is not directly applicable here. Instead, the acceptance criteria are based on biocompatibility and mechanical performance tests to ensure the device is safe and effective and performs comparably to or better than predicate devices.

Table of Acceptance Criteria (for a spinal implant) and Reported Device Performance:

The study that proves the device meets the acceptance criteria:

The study proving the device meets the acceptance criteria is primarily a non-clinical (bench-top) performance testing program and a comparison against legally marketed predicate devices.

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • Test Set (Non-Clinical): For mechanical testing, the "sample size" refers to the number of physical devices or components tested. While not explicitly stated with a specific number (e.g., n=X devices), the tests were conducted per relevant ASTM standards (ASTM F2077, ASTM F2267). These standards specify the number of samples required for each test (e.g., 6 samples for static compression, 3 for dynamic, etc.).
   • Data Provenance: The device is manufactured by Axis Spine Technologies Ltd, located in the United Kingdom. The testing would have been conducted in a laboratory setting, typically in the country of manufacture or a qualified testing facility. The data is retrospective in the sense that it's generated from manufactured devices for the purpose of regulatory submission, not from a patient population study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • For an implantable medical device undergoing non-clinical mechanical testing, "ground truth" is established by engineering standards and specifications (e.g., ASTM standards) and the objective physical measurements of the devices' performance.
   • There isn't a concept of a "human expert" establishing ground truth in the way a radiologist establishes ground truth for an AI diagnostic algorithm. The "experts" involved would be engineers and technicians conducting the tests in accordance with validated protocols and interpreting the results against the specified standards and predicate device performance. Their qualifications would be in biomedical engineering, mechanical engineering, or materials science.

3. Adjudication method for the test set:

   • Not applicable in the context of non-clinical mechanical testing. Adjudication is relevant for subjective assessments (like image interpretation) where multiple readers' opinions need to be reconciled. Here, the results are quantitative physical measurements.

4. 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. An MRMC study is a clinical study typically used to evaluate the performance of diagnostic devices or AI algorithms when used by human readers. This submission is for an implantable spinal fusion device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This is not an AI/algorithm-driven device. It is a physical implant.

6. The type of ground truth used:

   • For this device, the "ground truth" is defined by established engineering performance standards (ASTM) and the demonstrated performance characteristics of the legally marketed predicate devices. The goal is to show comparable or superior mechanical performance and material properties.

7. The sample size for the training set:

   • Not applicable. This device is a physical implant, not an AI algorithm that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. See point 7.

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