(55 days)
The CYGNUS™ Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis which is intended to provide temporary immobilization and stabilization of the development of cervical spinal fusions (C2 to C7) in patients with: (1) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); (2) Spondylolisthesis; (3) Trauma (including fractures or dislocations); (4) Spinal cord stenosis; (5) Deformity or curvatures (i.e. kyphosis, lordosis); (6) Tumors; (7) Pseudarthrosis; (8) Failed previous fusions.
The CYGNUS™ Anterior Cervical Plate System consist of implants manufactured from Commercially Pure Titanium per ASTM F67, Titanium-15 Molybdenum per ASTM F2066, and Titanium-6 Aluminum-4 Vanadium ELI per ASTM F136. and instrumentation manufactured from stainless steel per ASTM F899. The Anterior Cervical Plate Devices are offered in four configurations of various sizes to accommodate different patient anatomy. The implants will be provided non-sterile and are intended for single use only.
This is a 510(k) premarket notification for the CYGNUS™ Anterior Cervical Plate System, a spinal intervertebral body fixation orthosis. As such, the information provided focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing, rather than clinical studies involving human patients or complex AI algorithm performance.
Therefore, many of the requested categories related to AI models, human reader performance, and detailed clinical study design will not be present in this document.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
The document refers to "preclinical testing" based on a standard, and concludes substantial equivalence. It does not provide a table with specific acceptance criteria values and reported performance values for each criterion. It broadly states:
| Acceptance Criteria (implied) | Reported Device Performance | |
|---|---|---|
| Mechanical Performance | Met the requirements of ASTM F1717-15 for static and dynamic compression bending and static torsion. The device should perform equivalently or better than predicate devices to ensure safety and effectiveness for its intended use. | "The preclinical testing listed above that was performed on the CYGNUS™ Anterior Cervical Plate System indicate that it is substantially equivalent to the predicate devices in mechanical performance." Specific numerical results are not provided in this summary. |
| Material Composition | Implants manufactured from Commercially Pure Titanium per ASTM F67, Titanium-15 Molybdenum per ASTM F2066, and Titanium-6 Aluminum-4 Vanadium ELI per ASTM F136; instrumentation from stainless steel per ASTM F899. | Conforms to specified ASTM standards for materials. |
| Indications for Use | Must be substantially equivalent to predicate devices. | The Indications for Use for the CYGNUS™ system are listed and are deemed substantially equivalent to predicate devices. |
| Technological Characteristics | Must be substantially equivalent to predicate devices. | Deemed substantially equivalent. |
| Labeling | Must be substantially equivalent to predicate devices. | Deemed substantially equivalent. |
| Safety and Efficacy | Should not raise any new questions of safety or efficacy. | "The CYGNUS™ Anterior Cervical Plate System does not raise any new questions of safety or efficacy when compared to the predicate device(s)." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This device is not an AI/software device that typically uses test sets of data (like images or patient records). The "test set" here refers to the physical devices tested.
- Test Set Description: The device itself (CYGNUS™ Anterior Cervical Plate System) was tested.
- Sample Size: Not explicitly stated as a number of individual units tested, but multiple configurations and sizes were likely tested to cover various design parameters. The text mentions the system "are offered in four configurations of various sizes."
- Data Provenance: The testing was preclinical mechanical testing performed according to ASTM standards. It's not human patient data, so "country of origin" and "retrospective/prospective" are not applicable in the clinical trial sense.
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. As this is a mechanical device, ground truth for its performance is established through standardized engineering testing (ASTM F1717-15), not expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Mechanical testing does not involve adjudication by experts in the context of clinical data interpretation. The results are typically objective measurements from testing machines.
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. This is not an AI-powered device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is derived from mechanical testing standards (ASTM F1717-15), which define acceptable mechanical properties and performance under various loading conditions (static and dynamic compression bending, static torsion). The "truth" is whether the device meets these engineering specifications and performs equivalently to legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 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.