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510(k) Data Aggregation
(48 days)
CervAlign**®** Anterior Cervical Plate System
The CervAlign Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion.
The CervAlign Anterior Cervical Plate System is designed to promote cervical fusion by providing temporary resistance to flexion, extension, lateral bending, and axial rotation with strength and stiffness in the cervical spine (C2-C7). The system includes implants of various sizes of screws and plates to accommodate varying patient anatomies. The plates have integrated cover-style locking mechanisms that actuate to cover each screw. Implants are manufactured from titanium alloy, Ti-6Al-4V ELI (ASTM F136). The implants are supplied with instrumentation necessary to facilitate the insertion and removal. The implants and instruments are provided non-sterile and must be sterilized before use. Sterilization cases and trays are provided to facilitate proper sterilization and storage.
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Mechanical Testing: | |
| Locking Mechanism Retention | Performance testing showed that the mechanical strength of the subject system is equivalent to or better than predicate devices and is therefore sufficient for the intended use. |
| ASTM F1717-18 static and dynamic compression bending | No specific numerical performance provided in this summary, but the document states: "Performance testing showed that the mechanical strength of the subject system is equivalent to or better than predicate devices and is therefore sufficient for the intended use." (This test was included in the previously cleared K183060). |
| ASTM F1717-18 static torsion | No specific numerical performance provided in this summary, but the document states: "Performance testing showed that the mechanical strength of the subject system is equivalent to or better than predicate devices and is therefore sufficient for the intended use." (This test was included in the previously cleared K183060). |
| MR Safety Evaluation: | |
| Magnetically Induced Displacement Force (ASTM F2052-15) | The devices are determined to be MR Conditional. |
| Magnetically Induced Torque (ASTM F2213-17) | The devices are determined to be MR Conditional. |
| Radio Frequency Induced Heating (ASTM F2182-19e2) | The devices are determined to be MR Conditional. |
| MR Image Artifacts (ASTM F2119-07 (Reapproved 2013)) | The devices are determined to be MR Conditional. |
| Marking for Safety in the MR Environment (ASTM F2503-20) | The devices are determined to be MR Conditional. |
| Other Testing: | |
| Packaging and Sterilization | Testing and evaluations were performed. |
| Biological Safety (ISO 10993-1) | Evaluations were performed. |
Note: The summary specifically states for the mechanical tests (ASTM F1717-18 series) and MR safety evaluations that there was "no impact to the following non-clinical performance data that was included in cleared submission K183060. This testing is not included in the subject submission." This indicates that these tests were previously conducted for the predicate device and were considered still valid for the current submission due to the device's similarity. The "Locking Mechanism Retention" test is explicitly mentioned as being part of the current submission.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not mention a "test set" in the context of clinical studies for this device. The submission is based entirely on non-clinical performance data and demonstration of substantial equivalence to a predicate device. Therefore:
- Sample Size for Test Set: Not applicable, as no human clinical test set was used.
- Data Provenance: Not applicable for clinical data. For non-clinical data, the provenance would be from laboratory testing. The country of origin for such testing is not specified. The testing described is likely prospective in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable, as no human clinical test set or ground truth established by experts for such a set was used for this submission. The device equivalence is based on engineering and materials testing, not diagnostic performance.
4. Adjudication Method for the Test Set
Not applicable, as no human clinical test set necessitating adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not done, as this is a physical implant device and not a diagnostic AI/CAD system. The submission relies on non-clinical performance testing and substantial equivalence to a predicate.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable, as this is a physical medical device (spinal implant) and not an algorithm or AI system.
7. Type of Ground Truth Used
The concept of "ground truth" (e.g., pathology, outcomes data) as typically understood for diagnostic or AI devices is not directly applicable here. For this device, the "truth" is established by:
- Engineering Standards: Adherence to established ASTM (American Society for Testing and Materials) standards for mechanical properties and MR compatibility.
- Biological Safety Standards: Compliance with ISO 10993-1 for biocompatibility.
- Predicate Device Performance: The primary "ground truth" for substantial equivalence is the known safe and effective performance of the predicate device (CervAlign Anterior Cervical Plate System K183060). The new submission aims to demonstrate that its characteristics and performance are equivalent or better than this established device.
8. Sample Size for the Training Set
Not applicable, as this is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/ML device requiring a training set.
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