(89 days)
The Axle PEEK Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Axle PEEK Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.
The Axle PEEK Interspinous Fusion System consists of plates and inserts of various sizes that are used to provide supplemental stabilization of the spinous processes to support fusion. The system components can be assembled in a variety of configurations so that adaptations can be made to take into account pathology and individual patient anatomy. The implant components are provided clean and non-sterile.
The plate components of the device are made from titanium alloy per ASTM F136 and the insert components are made from polyetheretherketone (Invibio PEEK-Optima LT1).
The provided 510(k) summary (K112592) concerns the Axle PEEK Interspinous Fusion System, a medical device. This document does not describe an AI/ML-based device and therefore does not contain information on acceptance criteria for an algorithm's performance, sample sizes for test or training sets, expert review, or MRMC studies.
Instead, the document focuses on demonstrating the device's substantial equivalence to a predicate device through biomechanical performance data. The "acceptance criteria" and "study" are interpreted in the context of a traditional medical device's engineering and performance standards rather than AI model metrics.
Here's a breakdown of the information as it relates to the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For this physical medical device, "acceptance criteria" are not reported as numerical thresholds, but rather as meeting the standards set by the predicate device through specific biomechanical tests. The reported performance is that it met those standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM F1717 – Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model | |
| Static Compression Bending | Substantially equivalent to predicate device performance. |
| Static Torsion | Substantially equivalent to predicate device performance. |
| Fatigue Compression Bending | Substantially equivalent to predicate device performance. |
The conclusion states that "biomechanical testing results indicate that the Axle PEEK Interspinous Fusion System is substantially equivalent to predicate device performance and is capable of safely and effectively performing in accordance with its intended use."
2. Sample Size Used for the Test Set and Data Provenance
This document describes biomechanical testing of a physical implant, not a software algorithm. Therefore, "test set" and "data provenance" as typically understood for AI/ML validation are not applicable. The testing was conducted on samples of the device components (plates and inserts) in a lab setting according to specified ASTM standards. The provenance is internal to the manufacturer's testing process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study assessing interpretations by experts, but rather a mechanical performance test. The "ground truth" is defined by the objective physical properties and performance characteristics as measured against established engineering standards.
4. Adjudication Method for the Test Set
Not applicable. There was no need for adjudication as the data consists of physical measurements of the device's performance.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. This is a biomechanical study, not a clinical or reader-based study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by validated engineering and biomechanical standards (ASTM F1717). The device's performance is compared against the performance of a legally marketed predicate device as measured by these same standards.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no "training set" for physical device manufacturing and testing in this context.
§ 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.