(90 days)
The C3™ Anterior Cervical Plate System is intended as a temporary internal fixation device used for the correction and stabilization of the cervical spine. The system is also intended to enhance the development of a solid fusion.
The C3™ Anterior Cervical Plate System is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.) spondylolisthesis, and spinal stenosis.
The C3™ Anterior Cervical Plate System is also indicated for stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.
The C3™ Anterior Cervical Plate System is a titanium alloy anterior cervical plate fixation system. The system consists of a number of plates and screws of varying lengths and a variety of cover plates with locking set screws. Screws are available in different diameters, several lengths, and two different styles: fixed angle and variable angle. Fixed angle screws are used to build a rigid fixation construct. Variable angle screws are used to build a non-rigid construct. Hybrid constructs are possible by combining fixed and variable angle screws.
The provided text describes the "C3™ Anterior Cervical Plate System" and its 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices through performance data. However, the document does not contain specific acceptance criteria, detailed study designs, or results that could be used to fill out the requested table for proving the device meets acceptance criteria.
The information provided only mentions "Non-clinical: Static and fatigue testing was performed. Properties of stiffness, strength, and fatigue life were characterized." This is a general statement about the type of testing conducted, but it lacks specific acceptance thresholds, detailed test parameters, or quantitative results to demonstrate compliance with particular criteria.
Therefore, I cannot provide a detailed response to most of your questions as the necessary information is not present in the provided text.
Here's a breakdown of what can be inferred from the text and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document states that "Static and fatigue testing was performed. Properties of stiffness, strength, and fatigue life were characterized." However, it does not specify what the acceptance criteria were for these properties (e.g., minimum stiffness values, maximum fatigue cycles without failure, specific strength thresholds) or the reported performance in terms of numerical values to compare against those criteria.
2. Sample size used for the test set and the data provenance:
- Cannot be provided. The document does not mention any sample sizes used for the non-clinical testing. It also does not discuss any clinical studies, and thus, there is no information on data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This question pertains to studies involving subjective assessments, often in areas like image analysis or diagnostic performance. The provided text only discusses non-clinical mechanical testing of a medical device, which does not involve "ground truth" derived from expert consensus in the same way.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Similar to point 3, this is relevant for studies involving human assessment and disagreement resolution, not for mechanical device testing.
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:
- Cannot be provided. The device is an anterior cervical plate system, a physical implant. The document describes non-clinical mechanical testing, not a diagnostic or AI-assisted system that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided. The device is a physical implant, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable based on the provided text. For mechanical testing, the "ground truth" often refers to the actual mechanical properties measured against engineering specifications or established standards. The text implies standard mechanical testing methodologies for stiffness, strength, and fatigue life, but does not detail the specific "ground truth" definitions or how they were established beyond the characterization through testing.
8. The sample size for the training set:
- 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:
- Not applicable. The device is a physical implant, not an AI model.
In summary: The provided 510(k) summary focuses on general non-clinical performance testing (static and fatigue) to demonstrate substantial equivalence for a physical medical device. It does not contain the detailed study information, acceptance criteria, or performance metrics typically requested for AI/diagnostic devices or comprehensive clinical studies.
§ 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.