(126 days)
Properly used, this system is intended for anterior interbody screw/plate 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 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) 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 components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion. The ATLANTIS® Anterior Cervical Plate System consists of a variety of shapes and sizes of bone 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 a superelastic allov (Nitinol-NiT). Stainless steel and titanium implant components must not be used together in a construct.
This document is a 510(k) premarket notification for the ATLANTIS® Anterior Cervical Plate System. It seeks to establish substantial equivalence to previously cleared devices rather than providing a study demonstrating the device meets specific acceptance criteria with quantifiable performance metrics. Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted directly from this submission.
However, based on the provided text, here's what can be stated:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria with quantifiable performance metrics (e.g., sensitivity, specificity, accuracy, mechanical failure rates, etc.) and corresponding reported device performance are presented in this 510(k) summary. The document relies on substantial equivalence to predicate devices rather than demonstrating performance against specific, pre-defined acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission, not a clinical study report. The submission references "prior mechanical testing" but does not provide details on sample size, data provenance, or the nature of this testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. The concept of "ground truth" established by experts for a test set is typically relevant for studies validating diagnostic or predictive algorithms, which is not the nature of this submission. This submission concerns a physical medical device (an anterior cervical plate system).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for studies involving human interpretation or assessment, which is not the focus of this 510(k) submission.
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. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic tools. This submission is for a physical orthopedic implant and does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant and does not have an "algorithm only" or "human-in-the-loop" performance component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The typical "ground truth" as described (e.g., expert consensus, pathology) is not directly applicable to the substantial equivalence of a spinal implant. The basis for substantial equivalence is primarily mechanical testing and comparison to predicate devices, demonstrating similar design, materials, and intended use.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable. As above, this device does not involve a training set that requires ground truth establishment.
Summary based on the provided text:
The ATLANTIS® Anterior Cervical Plate System's acceptance into the market is based on a 510(k) premarket notification which asserts substantial equivalence to existing legally marketed predicate devices. The document explicitly states:
- "Documentation, including a risk analysis and prior mechanical testing, was provided which demonstrated the subject plates to be substantially equivalent to predicate ATLANTIS® Anterior Cervical Plate System plates previously cleared in K970806, K021461 and K063100 and the C-Tek® MaxAn™ Anterior Cervical Plate System cleared in K080646."
This means that the "study" demonstrating the device meets acceptance criteria (in this regulatory context, substantial equivalence to predicate devices) primarily involved:
- Comparison of design and materials: The new ATLANTIS® system components (titanium alloy, Nidtinol) are compared to those of the predicate devices.
- Comparison of indications for use: The indications for the new device are consistent with or encompass those of the predicate devices.
- Mechanical Testing: Although details are not provided, the submission states "prior mechanical testing" was performed to support substantial equivalence. This testing would likely have compared the biomechanical performance (e.g., strength, fatigue resistance) of the new components to the predicate devices, showing performance within acceptable, comparable limits as established for the predicate devices.
The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This is the "acceptance" based on the provided information.
§ 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.