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510(k) Data Aggregation
(118 days)
MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM
When used as a cervical intervertebral body fusion device, the Maxim Surgical X-Treme Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Maxim Surgical X-Treme Interbody Fusion System is a cervical interbody fusion system comprised of neutral and lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach.
The Maxim Surgical X-Treme Interbody Fusion System implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.
The Maxim Surgical X-Treme Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
The Maxim Surgical X-Treme Interbody Fusion System is a cervical interbody fusion device. The acceptance criteria and the study that proves the device meets the acceptance criteria are outlined below:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test Standard) | Reported Device Performance (Compliance) |
|---|---|
| Static and dynamic compression testing (ASTM F2077-11) | Conforms to standard |
| Static and dynamic torsion testing (ASTM F2077-11) | Conforms to standard |
| Subsidence testing (ASTM F2267-04) | Conforms to standard |
| Expulsion testing (ASTM Draft Standard F-04.25.02.02) | Conforms to standard |
2. Sample Size and Data Provenance for Test Set:
- Sample Size: Not explicitly stated for each test. The document indicates that "non-clinical testing" was conducted on the device.
- Data Provenance: The data is generated from non-clinical laboratory testing of the device itself. This is prospective data generation for testing the device's mechanical properties. The country of origin for the data is not specified but is implicitly associated with the manufacturer (Maxim Surgical, Richardson, Texas, USA).
3. Number of Experts and Qualifications for Ground Truth of Test Set:
Not applicable. The ground truth for this device's performance is based on quantifiable engineering standards and mechanical test results, not expert interpretation of clinical data or images.
4. Adjudication Method for Test Set:
Not applicable. As the performance is based on standardized mechanical tests, there is no need for expert adjudication. The results are objective measurements against predefined criteria in the ASTM standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is a medical device (interbody fusion system), not an AI diagnostic or interpretive system. The study focuses on the physical and mechanical properties of the implant.
6. Standalone Performance Study:
Yes, a standalone study of the device's mechanical performance was conducted. This refers to the non-clinical testing performed on the Maxim Surgical X-Treme Interbody Fusion System itself, independent of human interaction during testing, to ensure it meets established safety and performance standards. The "Discussion of Non-Clinical Testing" section explicitly lists these tests.
7. Type of Ground Truth Used:
The ground truth used for the acceptance criteria and performance evaluation is based on established engineering and material science standards (ASTM standards) for intervertebral body fusion devices. These standards define the acceptable mechanical properties and performance characteristics (e.g., strength, resistance to subsidence, resistance to expulsion) of such implants.
8. Sample Size for Training Set:
Not applicable. This device is a physical implant, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI or data-driven models.
9. How Ground Truth for Training Set Was Established:
Not applicable, as there is no training set for this device.
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