(87 days)
The Cardo Medical Cervical Plate System components are intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with:
- Degenerative disk disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- Trauma (including fractures) .
- Tumor ●
- Deformity (defined as kyphosis, lordosis or scollosis) .
- Pseudoarthrosis .
- Failed previous fusions. ●
The Cardo Medical Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7.
The Cardo Medical Cervical Plate System consists of titanium cervical plates and both self-tapping and self-drilling screw components. The surgeon uses the components to make a construct that is placed anteriorly for spinal fixation. The construct is used for temporary fixation which allows for fusion of the cervical spine. The modified system includes the addition of a fixed angle cervical screw as an option for the surgeon.
The Cardo Medical Cervical Plate System is a medical device designed for anterior interbody fixation of the cervical spine. The provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study on acceptance criteria with specific performance metrics.
Based on the provided text, here’s an analysis of the acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in a quantitative manner (e.g., "the device must withstand X force for Y cycles"). Instead, it references a standard and states equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ASTM F1717 (Static and Fatigue Testing) | The proposed device was equivalent to the predicate device for all testing performed. |
| Equivalence to Predicate Device (Vertebron Cervical Plate Systems) in terms of materials and safety/effectiveness impacts | The Cardo Medical Cervical Plate System consists of plates and screws manufactured from the same titanium alloy as the Vertebron, Inc. Cervical Plate Systems. Cardo Medical has determined that any differences in the proposed device will not impact the safety or effectiveness of the cervical plate system for its intended use. |
| Meeting requirements of "Spinal System 510(k)s" guidance document | Testing has shown that the proposed device meets the requirements of the current FDA Guidance document entitled "Spinal System 510(k)s" dated May 3, 2004. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the sample size (number of devices or tests performed) for the mechanical testing conducted according to ASTM F1717.
- Data Provenance: The study is a prospective engineering test conducted on the Cardo Medical Cervical Plate System components. The location of the testing is not specified, but it would presumably be in a laboratory setting. There is no mention of clinical data or patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- This question is not applicable to this type of submission. The "ground truth" for mechanical testing is established by the specified standards (ASTM F1717) and engineering principles, not through expert consensus on medical images or clinical outcomes. The focus is on physical and mechanical properties.
4. Adjudication Method for the Test Set:
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical or imaging studies, typically involving multiple expert readers reviewing cases. For mechanical testing, the results are objectively measured against defined criteria within the standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- This question is not applicable. An MRMC study is relevant for evaluating diagnostic or screening devices where human readers interpret medical images or data, often with and without AI assistance. This submission is for a physical implant (cervical plate system), and its evaluation relies on mechanical testing.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- This question is not applicable. This device is a physical implant, not an algorithm or AI-driven system. Therefore, "standalone algorithm performance" is not relevant.
7. Type of Ground Truth Used:
- The "ground truth" for this device's evaluation is primarily established by engineering standards and specifications, specifically ASTM F1717. This standard dictates the test methods for evaluating static and fatigue performance of spinal implant constructs. The results are compared against the performance of a predicate device that is already deemed safe and effective.
8. Sample Size for the Training Set:
- This question is not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established:
- This question is not applicable for the same reasons as point 8.
§ 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.