(110 days)
The Affix II Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions:
- Degenerative disc disease (DDD) 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)
- Tumor
The Affix II Spinous Process Plate System is not intended for stand-alone use.
The Affix II Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion, and is not intended for stand-alone use. When the Affix II Plate is used as supplemental fixation in interbody fusion procedures, its use is limited to the treatment of degenerative disc disease (DDD) of the lumbosacral spine (L2-S1).
Here's an analysis of the provided text regarding the Affix® II Spinous Process Plate System.
Please Note: The provided document is a 510(k) summary for a medical device (an orthopedic implant), not an AI algorithm or diagnostic tool. Therefore, many of the requested points, especially those related to AI-specific studies (e.g., MRMC studies, training sets, ground truth establishment for AI), are not applicable to this type of submission. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Acceptance Criteria and Device Performance (Non-Clinical Testing)
The "acceptance criteria" for this device are implicitly demonstrating substantial equivalence to predicate devices through non-clinical biomechanical performance testing. The reported device performance indicates that these tests were successfully passed, showing equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Static axial compression performance equivalent to predicate. | Results demonstrate substantial equivalence to predicate. |
| Dynamic axial compression performance equivalent to predicate. | Results demonstrate substantial equivalence to predicate. |
| Static torsion performance equivalent to predicate. | Results demonstrate substantial equivalence to predicate. |
| Static post distraction performance equivalent to predicate. | Results demonstrate substantial equivalence to predicate. |
| Material composition equivalent to predicate. | Was shown to have equivalent technological characteristics to predicate. |
| Design equivalent to predicate. | Was shown to have equivalent technological characteristics to predicate. |
| Labeling/intended use equivalent to predicate. | Was shown to have equivalent technological characteristics to predicate. |
| Function equivalent to predicate. | Was shown to have equivalent technological characteristics to predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for the non-clinical tests. These are typically bench tests conducted on a sufficient number of devices to ensure statistical validity, but the exact N is not disclosed in this summary.
- Data Provenance: Not applicable in the context of clinical data. This refers to non-clinical, benchtop mechanical testing performed in a lab setting.
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 clinical studies or AI algorithm evaluation is not relevant here. The "truth" for these non-clinical tests is based on objective measurements against established engineering standards and comparison to a predicate device's known performance.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical data labeling. This document details non-clinical, objective biomechanical 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
Not applicable. This is a medical device (implant), not an AI system or diagnostic tool, so an MRMC study is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a medical device (implant), not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance data is the performance characteristics of the predicate device (NuVasive Spinous Process Plate System K073278 and NuVasive Affix Spinous Process Plate System K131238) and general engineering standards for spinal fixation devices. The goal was to prove "substantial equivalence" to these established devices.
8. The Sample Size for the Training Set
Not applicable. There is no training set as this is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for a physical medical 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.