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510(k) Data Aggregation
(218 days)
The Irix-A Lumbar Integrated Fusion System is a stand-alone intervertebral body fusion device intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1 inclusive). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) months of non-operative treatment. In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Irix-A System is intended to be used with autogenous bone graft material, and is to be used with three titanium alloy bone screws included as part of the system.
The Irix-A Lumbar Integrated Fusion System is a stand-alone intervertebral fusion device to restore biomechanical height and act as an aid in fusion of the lumbar spine in anterior discectomy procedures. The device is generally box-shaped with teeth on the superior and inferior faces of the drix-A implant is manufactured from both titanium alloy (Ti6Al4V) in accordance with ASTM F136 and Invibio PEEK-Optima LT1 in accordance with ASTM F2026, or from Ti6AMV titanium alloy alone. The device will be supplied with the option of having the superior and inferior surfaces of the device plasma coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580. The device is secured in location through the use of bone screws, also manufactured from titanium alloy (Ti6Al4V) per ASTM F136. The devices are provided in various sizes and screws are offered in multiple lengths to adjust for variations in patient anatomy.
The CP-Ti coated devices will be sterile packed with the balance of system components being provided clean and non-sterile. The non-sterile components are to be sterilized by a healthcare professional using a steam autoclave in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the manufacturer of the autoclave.
The information provided describes the Irix-A™ Lumbar Integrated Fusion System, which is an intervertebral body fusion device, not a device that relies on AI algorithms or machine learning. Therefore, many of the requested categories related to acceptance criteria for AI/ML performance, such as sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, and MRMC studies, are not applicable.
The acceptance criteria and supporting study for this device are based on mechanical performance testing to demonstrate substantial equivalence to existing predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | ASTM F2077 | Must meet the requirements for intervertebral body fusion devices, including static and dynamic compression, and static and dynamic compression-shear. | "Substantially equivalent to predicate device performance and is capable of performing in accordance with its intended use." (Specific quantitative values not provided in summary). |
| ASTM F2267 | Must meet the standard for measuring load-induced subsidence of an intervertebral body fusion device under static axial compression. | "Substantially equivalent to predicate device performance and is capable of performing in accordance with its intended use." (Specific quantitative values not provided in summary). | |
| Expulsion Testing | There is no cited standard, but the device must demonstrate acceptable resistance to expulsion. | Performed as part of the submission, and results contributed to the overall finding of substantial equivalence. (Specific quantitative values not provided in summary). | |
| Material Qualification | FDA Guidance & ASTM F1580 | For plasma coating (CP-Ti), full material performance qualification and characterization. | Performed, and results contributed to the overall finding of substantial equivalence. (Specific details not provided in summary). |
| Wear Debris Analysis | For plasma coating, wear debris particulate analysis from dynamic compression-shear testing. | Performed, and results contributed to the overall finding of substantial equivalence. (Specific details not provided in summary). |
2. Sample size used for the test set and the data provenance
This is a medical device (spinal implant) and not an AI/ML device relying on a test set of data in the common sense. The "test set" refers to the physical devices and materials tested. The summary does not specify the exact number of units or samples tested for each mechanical test, but implies sufficient testing was conducted to meet the ASTM standards and satisfy FDA requirements for substantial equivalence.
Data provenance: The testing was conducted by X-spine Systems, Inc. in Miamisburg, OH, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this type of device is established by meeting engineering and mechanical standards, not by expert consensus on data interpretation. Performance is objectively measured against specified limits in the ASTM standards.
4. Adjudication method for the test set
Not applicable. Mechanical testing results are objective measurements against pre-defined engineering standards, not subjective interpretations requiring adjudication.
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 not an AI/ML device, and thus no MRMC study involving human readers and AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical spinal implant, not an algorithm.
7. The type of ground truth used
The "ground truth" in this context is based on established engineering principles, materials science, and biomechanical performance standards (e.g., ASTM F2077, ASTM F2267). The device's performance is objectively measured against the requirements of these standards and compared to the performance of predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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