(375 days)
The Smisson Stabilization System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine (C2-T1) during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.
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The provided text is a 510(k) premarket notification letter from the FDA to Smisson-Cartledge Biomedical, LLC, for the "Smisson Stabilization System." This document primarily indicates the FDA's "substantial equivalence" determination for the device, which is a regulatory classification, not a study evaluating its direct performance against acceptance criteria in the way medical software or AI devices are often assessed.
Therefore, the information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in the provided document. The letter focuses on the regulatory approval process based on comparison to a legally marketed predicate device, rather than detailed performance metrics from a specific study.
What is present and can be inferred:
- Device Name: Smisson Stabilization System
- Intended Use: Anterior interbody screw fixation of the cervical spine (C2-T1) for temporary stabilization during cervical spine fusions in patients with several conditions (degenerative disc disease, trauma, tumors, deformity, pseudarthrosis, failed previous fusions).
- Regulatory Classification: Class II, product code KWQ.
- Predicate Device: The approval is based on substantial equivalence to legally marketed predicate devices, implying that its design and intended use are similar to devices already on the market prior to May 28, 1976, or reclassified devices. The specific predicate device(s) are not named.
Regarding the requested information, here's why it cannot be extracted from this document:
- Acceptance Criteria and Reported Device Performance: This document does not contain a table of performance metrics or specific acceptance criteria (e.g., accuracy, sensitivity, specificity, mechanical strength tolerances) that would be a result of a direct device performance study. The "acceptance" here relates to regulatory clearance of substantial equivalence, not a direct performance benchmark.
- Sample Sizes and Data Provenance for Test Set: No information about a test set, sample size, or data provenance is provided.
- Number and Qualifications of Experts for Ground Truth: The concept of "ground truth" established by experts in an evaluation study is not discussed, as this document is a regulatory clearance letter.
- Adjudication Method: Not applicable or discussed.
- MRMC Comparative Effectiveness Study: There is no mention of a Multi-Reader Multi-Case (MRMC) study, nor is there any discussion of AI assistance or human reader improvement. This device is a physical spinal fixation system, not an AI software device.
- Standalone Performance Study: While the device would have undergone various mechanical and biocompatibility tests (not detailed here but implied by regulatory requirements), a "standalone" performance in the context of an algorithm's output is not relevant for this type of physical implant.
- Type of Ground Truth: The concept of "ground truth" (expert consensus, pathology, outcomes data) typical for diagnostic or AI-driven devices isn't explicitly used here. The basis for approval is substantial equivalence to a predicate, meaning its design principles and intended use are considered safe and effective because similar devices are already approved.
- Sample Size for Training Set: Not applicable or discussed.
- How Ground Truth for Training Set was Established: Not applicable or discussed.
In summary, the provided document is a 510(k) clearance letter for a physical medical device (spinal stabilization system), not a study report for a diagnostic or AI-powered device. Therefore, the specific details requested about performance studies, acceptance criteria, and ground truth establishment are not present in this regulatory correspondence.
§ 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.