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510(k) Data Aggregation
(30 days)
Vy Spine VyLam Laminoplasty System
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.
The provided document is a 510(k) summary for the Vy Spine™ VyLam™ Laminoplasty System. It focuses on demonstrating substantial equivalence to a predicate device, primarily through mechanical testing and a comparison of technological characteristics. It does not describe a study involving human subjects, AI/algorithm performance, or the establishment of ground truth by expert consensus for diagnostic purposes.
Therefore, most of the requested information about acceptance criteria, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and ground truth types cannot be found in this document.
However, I can extract information related to the performance data and the "acceptance criteria" (in this context, demonstrating equivalent mechanical strength).
Here's what can be extracted based on the provided text:
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a Finite Element Analysis (FEA) for the additional implant plates.
1. A table of acceptance criteria and the reported device performance:
The document states: "FEA analyses for the additional plates' four-point bending (based on ASTM F2193) were performed to compare the strength of the additional plates to the standard plate in the predicate Vy Spine™ VyLam™ Laminoplasty System (K232471). The performance data verifies that the subject is substantially equivalent to the predicate Vy Spine™ Laminoplasty System (K232471)."
While a specific table is not provided, the "acceptance criteria" implicitly relates to the additional plates demonstrating equivalent or superior mechanical strength to the standard plate of the predicate device, as verified by FEA. The "reported device performance" is the conclusion that the performance data verifies substantial equivalence in strength.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical strength of new plates is comparable to predicate plates as per ASTM F2193 in four-point bending. | Performance data (FEA analyses) verifies subject is substantially equivalent to predicate in terms of strength. |
2. Sample size used for the test set and the data provenance:
- Sample Size: This was a computational study (FEA) rather than a study with a "test set" in the sense of patient data or a large number of physical parts tested. The "sample" would be the computational models of the specific new plates: VyLam™ Double Hook Plate, VyLam™ Inline Double Hook Plate, and VyLam™ Support Plate. The number of models is not explicitly stated beyond "additional plates."
- Data Provenance: Not applicable as this is a computational analysis, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a mechanical engineering analysis (FEA), not a medical image interpretation study. "Ground truth" in this context would be derived from accepted engineering principles and standards (ASTM F2193).
4. Adjudication method for the test set:
- Not applicable. This is a computational analysis.
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:
- No. This is not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI device.
7. The type of ground truth used:
- For the mechanical performance, the "ground truth" is based on established engineering standards (ASTM F2193) and the mechanical properties of the predicate device, against which the new designs were compared via FEA.
8. The sample size for the training set:
- Not applicable. This is not an AI device trained on data.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI device.
In summary, the document describes a mechanical performance study using Finite Element Analysis (FEA) to demonstrate substantial equivalence of new implant plates to an existing predicate device based on their mechanical strength. It does not involve patient data, expert interpretations, or AI algorithm performance.
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(55 days)
Vy Spine VyLam Laminoplasty System
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.
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