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The DSS™ 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, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid Coupler is intended to be used with autograft and/or allograft.

This 510(k) adds additional screw sizes to the DSS™ Stabilization System. The DSSTM 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).

Here's an analysis of the provided text regarding the Paradigm Spine DSS™ Stabilization System and its 510(k) submission (K090408), focusing on the acceptance criteria and the study (or lack thereof) proving the device meets them:

No clinical performance study or specific acceptance criteria are described in the provided 510(k) summary documents.

The provided documents are a 510(k) summary and the FDA's clearance letter. For a Class III device like a pedicle screw spinal system, the FDA typically determines substantial equivalence based on a comparison to a legally marketed predicate device. This often involves demonstrating equivalent technological characteristics and performance through non-clinical (e.g., mechanical) testing, rather than extensive clinical efficacy trials, especially for devices introducing minor modifications (like additional screw sizes as stated here).

Therefore, many of the requested categories related to clinical study design and performance metrics cannot be filled from the given text.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided documents, specific acceptance criteria for clinical performance and reported device performance are NOT detailed.

The approval is based on "substantial equivalence" to a predicate device (K080241). The performance stated is that:

Note: "Mechanical Soundness" implies that the device met certain mechanical testing standards (e.g., fatigue, static strength), but the specific criteria (e.g., force levels, cycles) are not provided in this summary.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size for Test Set: Not applicable/not provided for clinical performance. The "test set" would refer to mechanical testing samples, which are not detailed here.
• Data Provenance: Not applicable/not provided for clinical performance. The mechanical testing data would likely be from the manufacturer's internal labs.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Not applicable, as no clinical test set requiring expert ground truth establishment is described.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done or described in these documents. This is a mechanical orthopedic device, not an imaging AI diagnostic device, so MRMC studies are generally not relevant for 510(k) clearance of this type of product.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This is a medical implant device, not an algorithm.

7. The Type of Ground Truth Used

• Not applicable for clinical performance. For mechanical testing, the "ground truth" would be the engineering specifications and performance benchmarks derived from the predicate device and established standards for pedicle screw spinal systems.

8. The Sample Size for the Training Set

• Not applicable. This is a medical implant device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. This is a medical implant device, not an AI/ML algorithm.

Summary of 510(k) Clearance for K090408:

The K090408 submission was a Special 510(k), specifically to add additional screw sizes to an already cleared DSS™ Stabilization System (predicate K080241). The primary basis for clearance was a demonstration of substantial equivalence to the predicate device in terms of:

• Mechanical Soundness: Testing indicated the new screw sizes were "as mechanically sound as predicate devices."
• Indications for Use: The system maintained the same indications as the predicate.
• Design, Function, and Materials: These were also consistent with the predicate.

The FDA's review concluded that there was a reasonable likelihood that the device could be used for spinal stabilization without fusion, which could cause harm. Therefore, a specific Warning was mandated in the labeling: "The safety and effectiveness of this device has not been established for the intended use of spinal stabilization without fusion. This device is only intended to be used when fusion with autogenous bone graft is being performed at all instrumented levels." This indicates a careful consideration of the intended use and potential off-label use, even in the absence of a de novo clinical trial for this specific 510(k).

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