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510(k) Data Aggregation
(100 days)
NuVasive**®** Modulus-C Interbody System
The NuVasive Modulus-C Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Modulus-C Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical and/or corticocancellous bone graft to facilitate fusion.
The subject NuVasive Modulus-C Interbody System are interbody implants manufactured from titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001. The solid and porous structures are simultaneously built using a powder bed fusion method. The hollow core, or graft aperture, allows for packing of graft to aid in the promotion of a solid fusion. Similarly, the macroporous internal lattice structure provides additional space for graft packing. The microporous, textured surface on the superior and inferior ends of the device serves to grip the adjacent vertebrae to resist migration and expulsion of the device. The device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the cervicothoracic spine. The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient.
The provided document is a 510(k) premarket notification for a medical device (NuVasive® Modulus-C Interbody System). It does not contain information about an AI/ML powered device, therefore the requested information regarding acceptance criteria and study details for such a device is not present.
Instead, the document focuses on demonstrating substantial equivalence of the Modulus-C Interbody System to existing predicate devices based on non-clinical performance data (mechanical testing and material analysis).
Summary of available information (as pertaining to a non-AI/ML device):
The device is an intervertebral body fusion device made of titanium alloy, designed for anterior cervical interbody fusion.
1. Table of acceptance criteria and reported device performance:
The document states that the NuVasive Modulus-C Interbody System meets the same criteria as the predicate devices, which implies that the acceptance criteria are aligned with the performance of the predicate devices in the tests listed below. However, the specific numerical acceptance criteria (e.g., minimum load for static compression) and the exact reported performance values for each test are not explicitly stated in this summary.
| Test Performed (per ASTM Standard) | Implied Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Static Compression (ASTM F2077) | Performance comparable to predicate devices | "The results demonstrate that the subject NuVasive Modulus-C Interbody System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate." |
| Dynamic Compression (ASTM F2077) | Performance comparable to predicate devices | "The results demonstrate that the subject NuVasive Modulus-C Interbody System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate." |
| Static Compression Shear (ASTM F2077) | Performance comparable to predicate devices | "The results demonstrate that the subject NuVasive Modulus-C Interbody System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate." |
| Dynamic Compression Shear (ASTM F2077) | Performance comparable to predicate devices | "The results demonstrate that the subject NuVasive Modulus-C Interbody System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate." |
| Gravimetric and Particulate analysis (ASTM F1714 and F1877) | Performance comparable to predicate devices and within safety limits | "The results demonstrate that the subject NuVasive Modulus-C Interbody System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate." |
| Push-out (ASTM F04-25-02-02 Draft) | Performance comparable to predicate devices (stability, resistance to expulsion) | "The results demonstrate that the subject NuVasive Modulus-C Interbody System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate." |
| Subsidence (ASTM F2267) | Performance comparable to predicate devices (resistance to subsidence into vertebrae) | "The results demonstrate that the subject NuVasive Modulus-C Interbody System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate." |
| Bacterial endotoxin testing (BET) (ANSI/AAMI ST72:2011/(R)2016) | Meets sterility requirements/limits | "The results demonstrate that the subject NuVasive Modulus-C Interbody System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate." |
2. Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for each mechanical test.
- Data provenance: Non-clinical (laboratory) testing. No information on country of origin. The study is a non-clinical, in-vitro/bench testing study, not a human data study, so "retrospective or prospective" is not applicable in the context of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the study involves non-clinical mechanical and material testing, not expert interpretation of human data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for non-clinical 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 a medical device for spinal fusion, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm.
7. The type of ground truth used:
- For mechanical testing: Engineering standards (ASTM) define the "ground truth" for performance.
- For material and endotoxin testing: Industry standards and regulatory limits define the "ground truth."
8. The sample size for the training set:
- Not applicable. This device does not use machine learning, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set.
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