(85 days)
The ATLANTIS ® Anterior Cervical plate system is intended for anterior interbody screw fixation from C2 to T1 in the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients 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) pseudoathrosis. 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 is intended for the anterior screw fixation from C2 to T1 in the cervical spine. The device is manufactured from titanium alloy. Stainless steel and titanium implant components must not be used together in a construct.
The ATLANTIS® Anterior Cervical Plate System consists of plates of various lengths and screws. 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 is to be used with cleared cervical supplemental instrumentation.
This document describes a 510(k) submission for the MEDTRONIC Sofamor Danek ATLANTIS® Anterior Cervical Plate System. It is a medical device for spinal fixation. As such, the submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical performance studies or algorithm-based evaluations. Therefore, many of the requested categories related to acceptance criteria, specific study designs (like MRMC or standalone performance studies for algorithms), ground truth establishment for AI/ML, and sample sizes for training/test sets are not applicable or cannot be extracted from this type of regulatory document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated for Performance, but for Equivalence) | Reported Device Performance / Assessment |
|---|---|
| Material Composition | Manufactured from titanium alloy. |
| Device Configuration | Consists of plates of various lengths and screws, intended for anterior screw fixation from C2 to T1. |
| Intended Use / Indications | Temporary stabilization of the anterior spine during development of cervical spinal fusions in patients with: 1) degenerative disc disease, 2) trauma, 3) tumors, 4) deformity, 5) pseudoarthrosis, and/or 6) failed previous fusions. Intended for anterior cervical intervertebral body fusions only. |
| Sterilization | Acceptance Criteria (Implied): Device must be demonstrably sterile and maintain sterility for its shelf life. |
| Reported Performance: Sterilization assessments were completed for sterile subject plates and screws. Reports provide adequate evidence for validated sterilization parameters. | |
| Packaging | Acceptance Criteria (Implied): Packaging must maintain device sterility and integrity for its shelf life. |
| Reported Performance: Shelf life rationales show sterile subject device package integrity with an eight-year shelf life. | |
| Substantial Equivalence to Predicate Device | Acceptance Criteria: Device must demonstrate substantial equivalence to legally marketed predicate devices in terms of design features, materials, and indications for use. |
| Reported Performance: The device is deemed substantially equivalent to the predicate ATLANTIS® Anterior Cervical Plate System (K021461 and K081038) based on sterilization and packaging rationales and other supporting documentation. FDA concurrence signifies this equivalence. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission is for a physical medical device (spinal plate system), not an AI/ML-based diagnostic or imaging device requiring a test set of data samples. The "study" mentioned refers to non-clinical testing for equivalence, primarily focused on sterilization and packaging.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No ground truth establishment by experts for a test set is described, as this is not an AI/ML or diagnostic performance study.
4. Adjudication method for the test set
- Not Applicable. No test set or related adjudication is described.
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
- No. This is a physical implantable device, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical implantable device; it does not involve an algorithm for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Given that this is a 510(k) for a physical medical device, the concept of "ground truth" in the context of diagnostic accuracy or AI/ML performance is not relevant. The "truth" here is related to the physical and functional characteristics of the device (sterility, mechanical integrity, material composition) and its equivalence to a predicate device.
8. The sample size for the training set
- Not Applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set or related ground truth to establish.
§ 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.