(88 days)
The King Cobra™ Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
The King Cobra™ Cervical Plate System consists of self-tapping screws and plates. Screws are available in a variety of diameter- length combinations. Plates are available in a variety of lengths.
The provided text describes the "King Cobra™ Cervical Plate System" and its substantial equivalence to a predicate device, rather than an AI/ML device. Therefore, the questions related to AI/ML specific aspects like acceptance criteria for algorithmic performance, expert adjudication, MRMC studies, standalone algorithm performance, and training/test set details are not applicable here.
However, I can extract the information related to the device's technical characteristics and the study performed to support its substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices, "acceptance criteria" often refer to performance standards met through specific tests. In this case, the device is a spinal plate system, and its performance is evaluated against mechanical testing standards. The acceptance criterion is that the device performs "as well as or better than the predicate device."
| Test/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Design | Same basic design as predicate (plate-based fixation with self-tapping screws) | Possesses the same basic design as predicate. |
| Material | Same material as predicate (titanium alloy (Ti-6Al-4V) per ASTM F136) | Manufactured from titanium alloy (Ti-6Al-4V) as predicate. |
| Sizes | Plate and screw sizes encompassed by predicate systems | Sizes are encompassed by those offered by predicate systems. |
| Intended Use | Same intended use as predicate | Same intended use as predicate. |
| Mechanical Testing | Performs as well as or better than the predicate device according to ASTM F1717 | Performed as well as or better than the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in the context of human data or test sets. The performance data is based on mechanical testing of the "worst case King Cobra™ construct." The specific number of constructs tested is not detailed.
- Data Provenance: Not applicable as this is mechanical testing of a medical device, not a study involving human data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable as this is mechanical testing of a medical device, not a study establishing ground truth with expert review.
4. Adjudication Method
- Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done as this is a mechanical medical device, not an AI/ML system or diagnostic tool typically evaluated with such studies.
6. Standalone Performance Study (Algorithm Only)
- Not applicable as this is a mechanical medical device.
7. Type of Ground Truth Used
- The "ground truth" for the mechanical performance was established by ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model), which is an industry standard for mechanical testing of spinal implants. The comparison was against the performance of a predicate device.
8. Sample Size for the Training Set
- Not applicable as this is a mechanical medical device, not an AI/ML model that requires training data.
9. How Ground Truth for the Training Set Was Established
- Not applicable.
§ 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.