(233 days)
The Reliance Interspinous Plate System is a supplemental fixation device intended as an adjunct to fusion of the thoracolumbar (T1- S1) spine by fixation to the spinous processes in skeletally mature patients, and is indicated for the following:
- degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- spondylolisthesis
- trauma (i.e., fracture or dislocation)
- tumors
This device is not intended for stand-alone use.
The Reliance Interspinous Plate System consists of an interspinous process spacer-plate and process lock plate assembly for posterior fixation of the spine in order to achieve fusion. The interspinous process spacer-plate and process lock plate are available in multiple sizes to accommodate various patient anatomies. The insert features a lateral plate with teeth to interface with the bone of the spinous processes. The process lock plate also features teeth which contact the bone of the spinous processes. The process lock plate is passed through the insert such that, in their final position, interspinous process spacer-plate and process lock plate surround the spinous processes on both sides, and fixation is achieved via compression of the two components onto the spinous processes.
The provided submission is for the Reliance Interspinous Plate System, a medical device, not an AI/ML device. Therefore, the questions related to AI/ML device evaluation criteria such as sample size for test/training sets, data provenance, ground truth establishment, MRMC studies, and standalone performance are not applicable.
However, based on the provided text, I can infer the acceptance criteria and how the device claims to meet those criteria for a traditional medical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Test | Reported Device Performance |
|---|---|---|
| Mechanical Performance (Strength & Durability) | Static axial compression (per ASTM F1717-13) | Sufficient for intended use, substantially equivalent to predicate devices |
| Static torsion (per ASTM F1717-13) | Sufficient for intended use, substantially equivalent to predicate devices | |
| Static axial pull-out (per ASTM F1717-13) | Sufficient for intended use, substantially equivalent to predicate devices | |
| Dynamic axial compression (per ASTM F1717-13) | Sufficient for intended use, substantially equivalent to predicate devices | |
| Static plate dissociation | Sufficient for intended use, substantially equivalent to predicate devices | |
| Material Biocompatibility | Manufactured from medical grade Titanium (Ti 6Al-4V) per ASTM F136 | Meets material standard, assumed biocompatible with predicate devices |
| Sterilization | Provided non-sterile with instructions for sterilization | Standard practice, similar to predicate devices |
| Indications for Use | Adjunct to fusion of thoracolumbar (T1-S1) spine in skeletally mature patients for degenerative disc disease, spondylolisthesis, trauma, tumors (not stand-alone use) | Similar to predicate devices' indications |
| Technological Characteristics | Material, structural support mechanism, sterilization, size options, design for compression fixation | Nearly identical to predicate devices; minor differences do not raise new safety/effectiveness issues |
Regarding the AI/ML-specific questions (2-9), these are not applicable to this submission as it is for a physical medical device.
- 2. Sample size used for the test set and the data provenance: Not applicable (not an AI/ML device).
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable (not an AI/ML device).
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable (not an AI/ML device).
- 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 (not an AI/ML device).
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (not an AI/ML device).
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable (not an AI/ML device). Ground truth for a physical device is typically based on engineering standards and mechanical testing results.
- 8. The sample size for the training set: Not applicable (not an AI/ML device).
- 9. How the ground truth for the training set was established: Not applicable (not an AI/ML device).
Summary of Acceptance Criteria and Study:
The acceptance criteria for the Reliance Interspinous Plate System are primarily based on mechanical performance testing against industry standards (ASTM F1717-13) and comparison of technological characteristics and indications for use to legally marketed predicate devices.
The study that proves the device meets the acceptance criteria is a series of non-clinical performance tests:
- Static axial compression
- Static torsion
- Static axial pull-out
- Dynamic axial compression
- Static plate dissociation
The results of these tests demonstrated that the device's strength is sufficient for its intended use and is substantially equivalent to the predicate devices. The materials and design are also compared to predicate devices to establish substantial equivalence.
§ 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.