(225 days)
The SureFix 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 SureFix Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.
The JG Spine SureFix Interspinous Fusion System device is a family of posterior, non-pedicle, supplemental fixation devices that are manufactured from Titanium alloy (per ASTM F136). More specifically, these devices are interspinous process implants that are offered in a variety of diameters and lengths and are clamped to two consecutive non-cervical spinous processes. The system is to be implanted from the posterior approach.
The SureFix Interspinous Fusion System is a medical device for spinal interlaminal fixation. The provided text outlines its characteristics, indications for use, and a summary of performance testing to establish substantial equivalence to predicate devices, but it does not describe an AI medical device or a study involving AI. Therefore, I am unable to provide information on acceptance criteria for an AI device, sample sizes for test/training sets, expert qualifications, or MRMC studies as these are not relevant to the provided content.
The provided text focuses on the mechanical and material properties of a physical spinal implant device, not a software algorithm or AI.
Summary of the Device's Performance and Basis for Substantial Equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define "acceptance criteria" in terms of pass/fail thresholds for specific quantitative metrics that are then reported. Instead, it states that testing was done "according to ASTM F1717-11" and "ASTM F543-07," which are general standards for spinal implant testing. The reported performance is a qualitative statement of "substantial equivalence" to predicate devices rather than numerical results against a pre-defined acceptance criterion.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance according to ASTM F1717-11 (construct static compression bending, static torsion, dynamic compression bending) | Testing was performed for these parameters. The device was found "substantially equivalent" to the predicate devices (Lanx Spinal System K100935 and Axle Interspinous Fusion System K101471). |
| Performance according to ASTM F543-07 (component level testing) | Testing was performed for this parameter. The device was found "substantially equivalent" to the predicate devices. |
| Demonstrates safety and effectiveness | The device is reported as both a "safe and effective device" based on testing and comparison with predicate devices. |
| Similarities in Indications for Use, technological characteristics, and materials to predicate devices | The device has the "same 'Indications for Use'," "share similar technological characteristics," and "Materials of manufacture are also similar" to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The study involves mechanical testing of physical medical devices, not a test set of data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This is not an AI study, and "ground truth" as typically understood in AI/medical imaging is not relevant here. The evaluation is based on engineering standards and comparison to previously cleared devices.
4. Adjudication Method for the Test Set
Not applicable. This is not an AI study requiring adjudication of expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The provided text describes mechanical testing of a physical implant, not a study evaluating human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI device.
7. The Type of Ground Truth Used
The "ground truth" in this context is the performance of the predicate devices and the compliance with established ASTM standards for mechanical properties. The substantial equivalence is established by demonstrating that the new device performs similarly or equivalently to these benchmarks.
8. The Sample Size for the Training Set
Not applicable. This is not an AI study involving a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI study.
§ 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.