(39 days)
The Spinal Concepts, Inc. (SCI) Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following:
- Degenerative disc disease (DDD) as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies;
- Trauma (including fractures);
- Tumor;
- Spondylolisthesis;
- Spinal stenosis;
- Deformity (i.e., scoliosis, kyphosis, lordosis);
- Pseudarthrosis; and
- Failed previous fusions.
The Spinal Concepts, Inc. (SCI) Anterior Cervical Plate System components are temporary implants that are used to stabilize the cervical spine during the development of a solid spinal fusion. The SCI Anterior Cervical Plate System consists of single and multi-segmented titanium bone plates of various sizes and lengths, titanium bone screws in two diameters of various lengths, and associated instrumentation. Fixation is provided by the insertion of bone screws through the two openings at each end of a plate segment into the vertebral bodies of the cervical spine. Additional screws may be inserted into the variable-distance holes at the center of each plate segment, if needed, i.e., for multi-level interbody fusions or long strut graft reconstructions.
The provided text describes the Spinal Concepts, Inc. (SCI) Anterior Cervical Plate System. This is a medical device submission, and the content focuses on establishing substantial equivalence to previously approved devices rather than detailing acceptance criteria and performance studies in the way you'd typically find for an AI/software device.
Therefore, many of the requested categories for AI device studies (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truth types) are not applicable or cannot be extracted from this document, as it falls outside of the scope of an AI device submission.
However, I can extract the relevant information regarding the performance and the study that supports it, tailored to the context of this device.
Acceptance Criteria and Device Performance for SCI Anterior Cervical Plate System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Integrity | Must be able to withstand clinical loading and maintain mechanical integrity for its intended use. | Static and fatigue testing demonstrated that the SCI Anterior Cervical Plate System is able to withstand clinical loading and maintain mechanical integrity. |
| Material Equivalence | Materials must be substantially equivalent to predicate devices. | Stated to be substantially equivalent in material to SOFAMOR DANEK ORION™ Anterior Cervical Plate System and SYNTHES Cervical Locking Plate System. |
| Design Equivalence | Design must be substantially equivalent to predicate devices. | Stated to be substantially equivalent in design to SOFAMOR DANEK ORION™ Anterior Cervical Plate System and SYNTHES Cervical Locking Plate System. |
| Function Equivalence | Function must be substantially equivalent to predicate devices. | Stated to be substantially equivalent in function to SOFAMOR DANEK ORION™ Anterior Cervical Plate System and SYNTHES Cervical Locking Plate System. |
| Intended Use Equivalence | Intended Use must be substantially equivalent to predicate devices. | Stated to be substantially equivalent in intended use to SOFAMOR DANEK ORION™ Anterior Cervical Plate System and SYNTHES Cervical Locking Plate System. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided in this document. The submission pertains to a physical medical implant (Anterior Cervical Plate System) and its mechanical performance, not a software or AI device that would typically involve test sets of patient data. The "study" here refers to mechanical 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)
This information is not applicable and not provided. Ground truth in the context of AI/software devices typically refers to expert annotations of data. For a mechanical device, performance is assessed through engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are relevant for human-based evaluations of AI/software output, not for mechanical 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
This information is not applicable and not provided. MRMC studies are specific to evaluating the clinical impact of AI systems on human readers, which is not relevant for a spinal implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This concept applies to standalone AI algorithms, not physical medical devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" would be the physical properties and behavior of the device under defined loads, measured by established engineering standards and instruments (e.g., load cells, displacement sensors, cycle counters). This is not expert consensus or pathology in the clinical sense. The document states: "Static and fatigue testing was performed on the SCI Anterior Cervical Plate System."
8. The sample size for the training set
This information is not applicable and not provided. This device is a physical implant, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As there is no training set for a physical device, this question is not relevant.
Summary of the Study:
The "study" used to prove the device meets its acceptance criteria was Mechanical Testing, specifically "Static and fatigue testing." This testing was performed on the SCI Anterior Cervical Plate System itself. The results demonstrated that the device "is able to withstand clinical loading and maintain mechanical integrity and is, therefore, suited for its intended use." This conclusion supports the substantial equivalence claim by demonstrating that the device performs mechanically at least as well as its predicate devices, which are already deemed safe and effective. The FDA's 510(k) clearance process relies heavily on demonstrating substantial equivalence to already marketed devices.
§ 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.