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510(k) Data Aggregation
(72 days)
ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
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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(206 days)
ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
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, lordosis, or scoliosis), 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 titanium alloy plates and screws that act to stabilize the spine during the intervertebral fusion process. The ANODYNE® Anterior Cervical Plate System is manufactured from anodized Ti-6AI-4V ELI in accordance with ASTM F136. The two-screw per level plates are available in lengths of 13-30mm (1-level), 26-46mm (2-level), 46-70mm (3-level), and 60-100mm (4-level).
The provided text describes the 510(k) summary for the ANODYNE® Anterior Cervical Plate System, focusing on its substantial equivalence to predicate devices rather than a standalone clinical study proving the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity.
Therefore, many of the requested sections regarding acceptance criteria, performance metrics, ground truth, sample sizes, and expert adjudication are not applicable or cannot be extracted from the provided document, as it pertains to a mechanical device and a substantial equivalence review, not an AI/diagnostic software study.
Here's a breakdown based on the provided text, indicating what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from performance standards) | Reported Device Performance |
|---|---|
| Adherence to ASTM F1717 performance standards | All applicable requirements were met, indicating substantial equivalence to predicate devices. |
| Static compression bending | Testing performed. |
| Static torsion | Testing performed. |
| Dynamic compression bending | Testing performed. |
| Finite Element Analysis (FEA) | Performed. |
Explanation: The "acceptance criteria" here are defined by adherence to ASTM F1717 performance standards, which cover mechanical testing for spinal implant assemblies. The reported performance is that the device met these standards, demonstrating substantial equivalence to its predicate devices in terms of mechanical behavior. Specific quantitative values for these tests are not provided in this summary.
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: Not applicable in the context of this device's mechanical testing for 510(k) clearance. The "test set" refers to the physical devices undergoing mechanical tests, not patient data.
- Data Provenance: Not applicable. The "data" comes from engineering and mechanical testing, not clinical patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. Ground truth for mechanical performance is established through standardized testing protocols (ASTM F1717) and engineering analysis, not expert consensus on clinical data.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Mechanical testing results are objectively measured and analyzed against predetermined standards, not adjudicated by human readers.
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 (spinal plate system), not AI software or an imaging diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for this device's performance is established by validated mechanical testing methodologies and engineering principles as defined by the ASTM F1717 standard. The "truth" is that the device withstands specified loads and forces according to these standards, demonstrating mechanical equivalence to previously cleared devices.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of mechanical device testing for substantial equivalence.
9. How the ground truth for the training set was established
- Not applicable.
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