(114 days)
The Interspinous Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1) of skeletally mature patients. It is intended for single level plate fixation/attachment to spinous process 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), trauma (i.e. fracture or dislocation), spondylolisthesis, and/or tumor. It is not intended for stand-alone use.
The Precision Spine Interspinous Plate System consists of an ISP female plate and an ISP male plate for posterior fixation of the spine in order to achieve fusion. The ISP female plate and an ISP male plate are available in multiple sizes to accommodate various patient anatomies. The ISP female plate and an ISP male plate feature teeth to interface with the bone of the spinous processes. The ISP male plate is passed through the insert such that, in their final position, the ISP female plate and an ISP male plate surround the spinous processes on both sides, and fixation is achieved via compression of the two components onto the spinous processes.
This document describes a 510(k) premarket notification for the "Interspinous Plate System," a medical device. The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than a study with a test set, ground truth, or expert review typical for AI/software devices. Therefore, many of the requested categories are not applicable.
Here's an analysis of the provided text based on your prompt:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test Mode) | Reported Device Performance (Conclusion) |
|---|---|
| Static axial compression | Sufficient for intended use, substantially equivalent to predicate devices. |
| Static torsion | Sufficient for intended use, substantially equivalent to predicate devices. |
| Dynamic axial compression | Sufficient for intended use, substantially equivalent to predicate devices. |
| Static axial pull-out | Sufficient for intended use, substantially equivalent to predicate devices. |
| Static plate dissociation | Sufficient for intended use, substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. The tests are for mechanical properties of the device, implying a small number of physical samples rather than patient data.
- Data Provenance: Not applicable in the context of patient data. The testing appears to be laboratory-based mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is a mechanical implant, and its performance is evaluated through physical tests, not by human expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This device is a mechanical implant; human adjudication is not part of its performance evaluation.
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 or software device that involves human reader interpretation.
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 (expert consensus, pathology, outcomes data, etc)
- Ground Truth: The "ground truth" for the performance of this mechanical device is based on the established mechanical testing standards (e.g., ASTM F1717-13) and the comparative performance against legally marketed predicate devices. The "truth" is whether the device meets the mechanical strength and stability requirements for its intended use, as demonstrated through these physical tests.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI/software device that requires 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.