(263 days)
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.
The Aileron Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes in skeletally mature patients for the purpose of achieving, in conjunction with autogenous bone graft, single level supplemental fusion in the following conditions: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), (2) trauma (i.e., fracture or dislocation), (3) spinal tumor, (4) spondylolisthesis. The Aileron Interspinous Fixation System is not intended for stand-alone use.
The Aileron Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). Implants are manufactured from titanium alloy per ASTM F136 and are available in a range of sizes to suit the individual pathology and anatomical conditions of the patient. The purpose of this submission is to clear device modifications to the Aileron Interspinous Fixation System.
This document is a 510(k) premarket notification for the "Aileron Interspinous Fixation System," a medical device. It is primarily concerned with establishing substantial equivalence to previously cleared devices rather than presenting a detailed study of the device's performance against specific acceptance criteria for a new medical AI or diagnostic device.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria for a diagnostic or AI device is largely not applicable to this document. This document focuses on the mechanical and material properties of an implantable spinal fixation device.
However, I can extract the relevant "performance data" that the FDA considered in its substantial equivalence determination, and infer some "acceptance criteria" related to mechanical strength.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
- Note: The document does not explicitly state numerical acceptance criteria in the format typically seen for diagnostic performance measures (e.g., sensitivity, specificity). Instead, it refers to performance testing done "in accordance with a modified ASTM F1717 setup" and other specific mechanical tests. The "acceptance" is implicitly that the device performs equivalently to the predicate devices when subjected to these tests.
| Acceptance Criteria (Inferred from Test Types) | Reported Device Performance |
|---|---|
| Mechanical Strength (Static Compression): Demonstrate adequate strength under static compressive loads. | Testing performed in accordance with a modified ASTM F1717 setup (implying comparable or better performance to predicate). |
| Mechanical Strength (Dynamic Compression): Demonstrate adequate strength under dynamic/cyclic compressive loads. | Testing performed in accordance with a modified ASTM F1717 setup (implying comparable or better performance to predicate). |
| Mechanical Strength (Torsion): Demonstrate adequate strength under torsional loads. | Testing performed in accordance with a modified ASTM F1717 setup (implying comparable or better performance to predicate). |
| Spike Pull-off Strength: Demonstrate resistance to pull-out once implanted. | Testing performed (implying comparable or better performance to predicate). |
| Static Axial Grip Strength: Demonstrate resistance to axial displacement. | Testing performed (implying comparable or better performance to predicate). |
| Material Composition: Conformance to medical-grade material standards. | Manufactured from 6AL-4V-ELI titanium according to ASTM F136. |
| Intended Use: Compatibility with specified spinal conditions and level, and as supplemental fixation (not stand-alone). | Stated as a posterior, non-pedicle supplemental fixation device for T1-S1, for single-level supplemental fusion in specific conditions (degenerative disc disease, trauma, spinal tumor, spondylolisthesis), not for stand-alone use. |
The study that "proves" the device meets these criteria is referred to as "Performance Data" in the 510(k) summary. The conclusion explicitly states: "The information presented demonstrates the substantial equivalency of the Aileron Interspinous Fixation System." This means the device's mechanical performance was demonstrated to be equivalent to its predicate devices through the listed tests.
Regarding the specific questions about "diagnostic/AI device" studies:
2. Sample size used for the test set and the data provenance: Not applicable. This is not a study using a test set of data (e.g., medical images or patient records) for diagnostic assessment. The "test set" here refers to physical specimens of the device used for mechanical testing in a lab setting. No patient data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of diagnostic devices, would typically refer to clinical diagnosis or pathology. For mechanical implant testing, the "ground truth" is established by relevant engineering standards (e.g., ASTM F1717) and the results of the physical tests themselves. No medical experts are mentioned as establishing ground truth for these mechanical tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This relates to consensus readings for diagnostic images or data, which is not relevant here.
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 device is a mechanical implant, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" in this context is the engineering standard (ASTM F136 for material, modified ASTM F1717 for mechanical testing) and the physical properties/performance of the device itself as measured under laboratory conditions.
8. The sample size for the training set: Not applicable. This device does not involve machine learning algorithms that require a training set.
9. How the ground truth for the training set was established: Not applicable. There is no training set for this type of device.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.