(59 days)
Properly used, this system is intended for anterior interbody screw fixation from C2 to T1. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.
NOTA BENE: This device system is intended for anterior cervical intervertebral body fusions only. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The ATLANTIS® Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (set screws and washers are pre-assembled to the plates), screws, and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.
The ATLANTIS® Anterior Cervical Plate System implant components are made from titanium alloy, with certain plates having subcomponents manufactured from shape memory alloys (Nitinol-NiTi). Stainless steel and titanium implant components must not be used together in a construct. Do not use any of the ATLANTIS® Anterior Cervical Plate System components with the components from any other system or manufacturer.
The subject devices are manufactured from ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications.
The subject plates and bone screws are implants that are single use only. The subject implants are provided sterile by gamma irradiation.
This document describes the ATLANTIS® Anterior Cervical Plate System, a spinal intervertebral body fixation orthosis, and its substantial equivalence determination by the FDA based on non-clinical testing. This is a medical device submission, and therefore the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the regulatory requirements for medical devices and the testing performed to demonstrate substantial equivalence to legally marketed predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Non-clinical) | Reported Device Performance (ATLANTIS® Anterior Cervical Plate System) |
|---|---|
| Sterilization: Validation of sterilization parameters for gamma irradiation. | Sterilization assessments completed, and reports provided adequate evidence for validated sterilization parameters. Device is provided sterile by gamma irradiation. |
| Shelf Life: Package integrity for a specified shelf life. | Shelf life rationale indicates an eight-year shelf life for sterile subject device package integrity. |
| Mechanical Testing (ASTM F1717): |
- Compression fatigue
- Static compression
- Static torsion | Mechanical testing was completed in accordance with ASTM F1717 for compression fatigue, static compression, and static torsion. Test results determined the subject devices to be substantially equivalent to the predicate devices. |
| Biocompatibility: (Implied, as medical device materials need to be biocompatible) | The subject devices are manufactured from ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy, a commonly accepted biocompatible material for surgical implants. Some plates have subcomponents from shape memory alloy (Nitinol-NiTi). |
| Substantial Equivalence: To legally marketed predicate devices in terms of intended use, overall dimensions, and fundamental scientific technology. | The subject devices were determined to be substantially equivalent to the predicate devices (K021461, K063100, K130640 ATLANTIS® Anterior Cervical Plate System and K141632 ZEVO® Anterior Cervical Plate System) based on non-clinical test results and additional supporting documentation. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the "sample size" for the mechanical testing in terms of number of devices or components tested. It only mentions that "Mechanical testing, in accordance with ASTM F1717, was also completed." ASTM F1717 outlines standard test methods for spinal implant constructs in a corpectomy model, which would include specific sample sizes based on the test type (e.g., typically at least 6 samples per group for static and fatigue testing).
The data provenance is non-clinical (laboratory testing), not patient data. Therefore, there is no country of origin of the data in the context of human subjects, nor is it retrospective or prospective in that sense. The testing was conducted by or for Medtronic Sofamor Danek USA, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of submission. The "ground truth" for non-clinical mechanical testing is established by adherence to recognized industry standards (ASTM F1717) and engineering principles, not by expert consensus on clinical findings.
4. Adjudication method for the test set
This is not applicable as the study involves non-clinical mechanical testing, not clinical data requiring adjudication.
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
This is not applicable. The device is a physical spinal implant, not an AI software/diagnostic tool that would involve interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical spinal implant, not an algorithm.
7. The type of ground truth used
The "ground truth" for the non-clinical testing is compliance with established engineering standards (ASTM F1717) and equivalence to the mechanical properties of predicate devices.
8. The sample size for the training set
This is not applicable. There is no concept of a "training set" for physical device mechanical testing.
9. How the ground truth for the training set was established
This is not applicable.
§ 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.