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510(k) Data Aggregation
(33 days)
DSSTM Stabilization System - Rigid
The DSSTM Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid is intended to be used with autograft and/or allograft.
DSSTM Stabilization System - Slotted
The DSSTM Stabilization System - Slotted is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudarthrosis).
In addition, the DSS™ Stabilization System - Slotted is indicated for use in patients:
- Who are receiving fusions with autogenous graft only; .
- Who are having the device fixed or attached to the lumbar or sacral spine; .
- . Who are having the device removed after the development of a solid fusion mass.
Note: The Rigid Coupler and Slotted Coupler are not intended to be used together.
The DSS™ Stabilization System is comprised of a variety of pedicle screws sizes, and couplers that act as longitudinal spacers that are uniquely fitted for each individual case. The pedicle screws and couplers are manufactured from medical grade titanium alloy (Ti6Al4V).
The purpose of this Special 510(k) is to add a straight rod, straight rod with pan, and polyaxial screw to the DSS Stabilization System - Rigid. The modifications are intended to allow the operating surgeon to better accommodate patient anatomies with more construct options. The modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Testing per ASTM F1717) | Reported Device Performance (DSS™ Stabilization System - Rigid) |
|---|---|
| Static Compression Bending (comparable to predicate devices) | Equivalent performance to predicate devices (K022949, K024096, K042962, K072022, K080241, K090099, K090408, K090408, and K101083) |
| Static Torsion (comparable to predicate devices) | Equivalent performance to predicate devices |
| Dynamic Compression Bending (comparable to predicate devices) | Equivalent performance to predicate devices |
2. Sample Size and Data Provenance for Test Set
The provided document does not specify a separate "test set" in the context of clinical data or patient samples. The performance testing relies on mechanical testing per ASTM F1717. Therefore, the concept of sample size and data provenance from patient data is not applicable here. The "sample size" would refer to the number of devices tested under each mechanical test condition, which is not provided.
3. Number of Experts and Qualifications for Ground Truth
Again, this section is not applicable to the type of study presented. Ground truth in this context is established by standardized mechanical testing protocols (ASTM F1717) and comparison to the performance of previously cleared predicate devices, not by expert consensus on clinical findings.
4. Adjudication Method for Test Set
Not applicable. There is no clinical test set requiring adjudication in this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on mechanical substantial equivalence to predicate devices, not on the impact of the device on human reader performance.
6. Standalone (Algorithm Only) Performance Study
No, a standalone performance study (algorithm only without human-in-the-loop performance) was not done. This device is a physical medical implant, not an AI algorithm.
7. Type of Ground Truth Used
The ground truth used is based on established engineering standards and performance data of previously cleared predicate devices. Specifically, the "ground truth" for substantial equivalence is the demonstration that the DSS™ Stabilization System - Rigid performs equivalently to predicate devices under the mechanical stress tests outlined in ASTM F1717.
8. Sample Size for Training Set
Not applicable. This submission does not involve an AI algorithm or a "training set" in the context of machine learning. The "training" for this device's acceptance is based on its mechanical properties meeting established standards compared to existing devices.
9. How Ground Truth for Training Set Was Established
Not applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it does not apply. The "ground truth" for the device's acceptance relates to its physical performance characteristics as determined by standardized testing methods.
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