(55 days)
The Vy Spine™ VyLam™ Laminoplasty System is indicated for use in laminoplasty of the lower cervical and upper thoracic spine (C3 to T3) in skeletally mature patients. The system devices are designed for use with allogenic bone graft in order to prevent the allograft from expulsion or impinging on the spinal cord. One device may be used per vertebra.
The Vy Spine™ VyLam™ Laminoplasty System is comprised of implant and instrument components. The implant components, plates and screws, will hold the decompression after a laminoplasty procedure. The implant components are manufactured from Ti-6Al-4V ELI per ASTM F136 and are available in multiple anatomical sizes to accommodate various vertebral bodies. The instruments are manufactured from stainless steel per ASTM F899, high grade plastic, and silicone rubber.
This document is a 510(k) premarket notification for a medical device (Vy Spine™ VyLam™ Laminoplasty System). The information provided focuses on the regulatory aspects and substantial equivalence to predicate devices, rather than a study proving the device meets specific performance acceptance criteria in the way a clinical or diagnostic AI study would.
Therefore, many of the requested categories related to AI/diagnostic study design (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this type of submission.
However, I can extract information related to the mechanical performance data that was conducted to demonstrate substantial equivalence.
Here's the breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test Standard) | Reported Device Performance |
|---|---|
| Static Four-Point Bend Testing per ASTM F2193 | Met all mechanical test requirements |
| Dynamic Four-Point Bend Testing per ASTM F2193 | Met all mechanical test requirements |
| Axial Pullout Testing per ASTM F543 | Met all mechanical test requirements |
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 for Test Set: This information is not provided in the document. Mechanical testing typically involves a certain number of specimens per test, but the specific quantity is not reported here.
- Data Provenance: Not applicable for mechanical testing. This is lab-based testing of device components.
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 is mechanical testing to established standards, not a diagnostic study requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is mechanical 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 mechanical testing, not an AI or diagnostic imaging study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is mechanical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for mechanical performance in this context is the established ASTM standards (ASTM F2193 and ASTM F543). The device's performance must meet the requirements defined within these standards.
8. The sample size for the training set
Not applicable. This is mechanical testing, not a machine learning study with a training set.
9. How the ground truth for the training set was established
Not applicable.
Study Proving Device Meets Acceptance Criteria:
The study referenced is the mechanical testing detailed in the "Performance Data and Substantial Equivalence" section.
- Tests Conducted: Static four-point bend testing per ASTM F2193, dynamic four-point bend testing per ASTM F2193, and axial pullout testing per ASTM F543.
- Conclusion: "The performance data indicates that the subject device is substantially equivalent to predicate devices and has met all mechanical test requirements based on worst-case construct testing and the engineering rationale."
This statement confirms that the results of these mechanical tests demonstrated that the Vy Spine™ VyLam™ Laminoplasty System met the acceptance criteria defined by the relevant ASTM standards, thereby supporting its substantial equivalence to predicate devices for regulatory clearance.
§ 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.