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510(k) Data Aggregation
(72 days)
The CoreLink ANODYNE™ Anterior Cervical Plate System is intended for anterior fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the evolution of cervical fusions in patients with degenerative disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, or scollosis), pseudarthrosis, and/or failed previous fusions. The intended levels for treatment range from C2 - T1.
The Anodyne™ Anterior Cervical Plate System is comprised of an assortment of cervical plates and screws that act to stabilize the spine during the intervertebral fusion process. The cervical plate has a rotatable anti-backout "lock" for each screw position to prevent back-out of the screw.
The plate is available in single and double plate configurations with multiple lengths ranging from 13 mm – 22 mm (1 level) and 26 mm – 40 mm (2 level) for the single plates. The double plates include 1 level (13 mm - 30 mm), 2 level (26 mm - 46 mm), 3 level (46 mm - 70 mm), and 4 level (60 mm -100 mm). The screws are available in various lengths from 12 mm - 20 mm, with major thread diameter options of 4.6 mm or 5.2 mm.
The Anodyne™ Anterior Cervical Plate System is a medical device intended for anterior fixation of the cervical spine. The device's acceptance criteria and the study proving it meets these criteria are outlined in the 510(k) summary.
1. Acceptance Criteria and Reported Device Performance:
The acceptance criteria for the Anodyne™ Anterior Cervical Plate System are based on the mechanical performance of the device, specifically its ability to withstand static and dynamic loads and torsion, as compared to predicate devices. The study demonstrates that the device performs equivalently to previously cleared devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance (Static and Dynamic Compression per ASTM 1717): Ensure the device can withstand static and dynamic compression forces without failure, matching or exceeding predicate devices. | The Anodyne™ Anterior Cervical Plate System's mechanical performance in static and dynamic compression was found to be equivalent to predicate devices. |
| Mechanical Performance (Static Torsion per ASTM F1717): Ensure the device can withstand static torsional forces without failure, matching or exceeding predicate devices. | The Anodyne™ Anterior Cervical Plate System's mechanical performance in static torsion was found to be equivalent to predicate devices. |
| Materials: Use of Ti-6Al-4V alloy per ASTM F136. | The device uses Ti-6Al-4V alloy per ASTM F136, matching the material specification. |
| Substantial Equivalence: Demonstrate substantial equivalence to predicate devices in terms of intended use, design, materials, mechanical safety, and performance. | The device was determined to be substantially equivalent to predicate devices in all specified aspects. |
2. Sample Size and Data Provenance for the Test Set:
- Sample Size: Not explicitly stated as a number of devices tested. Instead, the testing refers to "the ANODYNE™ Anterior Cervical Plate System" as the subject of the tests, implying a representative sample of its components (plates and screws across various sizes and configurations).
- Data Provenance: The tests are described as "Non-Clinical Test Summary" and were likely conducted in a controlled laboratory environment. There is no information regarding the country of origin of the data or whether it was retrospective or prospective, as these are non-clinical (mechanical) tests rather than clinical studies on human subjects.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set):
Not applicable. This device underwent non-clinical mechanical testing, not clinical studies involving human patients or expert interpretation of medical images. Therefore, no medical experts were involved in establishing ground truth for a test set.
4. Adjudication Method for the Test Set:
Not applicable. As described above, there was no clinical test set requiring adjudication. The assessment was based on objective mechanical testing results against industry standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.
6. Standalone Performance Study:
No. Since no clinical studies were performed, there was no standalone algorithm performance study (the device is a physical medical implant, not an AI or digital diagnostic tool). The "standalone performance" in this context refers to the device's mechanical integrity as tested in a lab setting, independent of human interaction during real-world use, which was indeed evaluated through the non-clinical tests.
7. Type of Ground Truth Used:
The ground truth for the non-clinical tests was established by recognized industry standards (ASTM F1717) for mechanical testing of spinal implants. The performance of the Anodyne™ system was compared against the established mechanical properties and performance of legally marketed predicate devices.
8. Sample Size for the Training Set:
Not applicable. The device is a physical medical implant, not an AI algorithm. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a physical medical implant.
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