(355 days)
The MaxAn® Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the development of cervical fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis), pseudarthroses, and/or failed previous fusions. The intended levels for treatment range from C2-T1.
The MaxAn® Anterior Cervical Plate System Cervical Plate System consists of titanium alloy plates and screws intended for use in anterior cervical discectomy and fusion (ACDF) procedures. Cervical plates are intended for use at 1-5 levels, and are available in lengths from 8mm-130mm. Screws are available in both fixed and variable versions in sizes 4.0mm and 4.5mm in various lengths. All components are available in both sterile and non-sterile configurations.
The purpose of this submission is to add MR Conditional labeling for the components of the MaxAn system.
Here's a breakdown of the acceptance criteria and the study details for the MaxAn® Anterior Cervical Plate System, based on the provided text:
Important Note: The provided document is a 510(k) summary for adding MR Conditional labeling to an already cleared device (MaxAn® Anterior Cervical Plate System). Therefore, the "study" described herein specifically pertains to MR compatibility, not the primary clinical effectiveness or safety of the spinal fixation itself, which would have been established in the original K080646 submission. The information below reflects what's available in this specific document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (ASTM Standard) | Reported Device Performance (MaxAn® Anterior Cervical Plate System) |
|---|---|
| ASTM F2052-06 (Magnetically Induced Displacement Force on Medical Devices) | Test results indicate that the device meets the ASTM recommendations for MR Conditional labeling in terms of magnetically induced displacement. |
| ASTM F2119-07 (Evaluation and Labeling of MR Image Artifacts) | Test results indicate that the device meets the ASTM recommendations for MR Conditional labeling in terms of MRI artifacts. |
| ASTM F2182-11a (Heating of Medical Devices During MRI) | Test results indicate that the device meets the ASTM recommendations for MR Conditional labeling in terms of device heating. |
| ASTM F1717-04 (Static & Dynamic Testing of Spinal Constructs) | Qualitative torque testing was presented. (The document states these tests were conducted, implying performance met standards, but specific quantified acceptance criteria and performance values are not detailed in this summary for these mechanical tests). |
| Static compression bending | (Implied to meet ASTM F1717-04 recommendations, but specific criteria/results not detailed.) |
| Static torsion | (Implied to meet ASTM F1717-04 recommendations, but specific criteria/results not detailed.) |
| Dynamic compression | (Implied to meet ASTM F1717-04 recommendations, but specific criteria/results not detailed.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in this 510(k) summary. The document refers to "testing conducted" according to ASTM standards, which would imply a number of device samples were used for each test. Specific quantities are not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing described is bench testing (mechanical and MR compatibility), not human or animal studies, so "retrospective or prospective" is not applicable in the typical clinical sense. The tests were performed to evaluate the physical properties of the device components.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not applicable as the "ground truth" for these tests is the direct measurement of physical properties against established ASTM standards, not expert interpretation of clinical data or images. The "experts" involved would be engineers and technicians executing the tests and interpreting the raw data, but their number and specific qualifications are not detailed in this regulatory summary.
4. Adjudication Method for the Test Set
- This is not applicable. As these are bench tests measuring physical properties, there is no "adjudication method" in the sense of reconciling differing expert opinions. The outcome is determined by whether the measured physical property (e.g., heating, displacement) falls within the acceptable limits defined by the ASTM standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed as described in this document. This submission pertains to MR Conditional labeling for a device, which involves bench testing, not clinical performance comparison with human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- This is not applicable. The device is a physical spinal implant, not an algorithm or AI system. The testing performed is to assess the physical device's compatibility with an MRI environment.
7. Type of Ground Truth Used
- The "ground truth" used for these tests is the objective measurements of physical forces, temperatures, and image artifacts as defined and evaluated against the specified ASTM (American Society for Testing and Materials) standards. These standards provide the accepted methodology and limits for determining MR compatibility and mechanical performance.
8. Sample Size for the Training Set
- This is not applicable. The device is a physical implant, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable for the same reason as point 8.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.