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DSSTM Stabilization System - Rigid: The DSS™ Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrac 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 is intended to be used with autograft and/or allograft.

DSSTM Stabilization System - Slotted: The DSS™ 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 (Ti6AI4V).

The provided text describes a 510(k) submission for the DSS™ Stabilization System, a medical device. However, it does not include information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding performance metrics, sample sizes, ground truth establishment, or expert involvement as typically found in clinical validation studies for AI/software devices.

This document describes a spinal pedicle screw system, which is a physical implant, not an AI or software-based device. The approval process for such devices relies heavily on demonstrating substantial equivalence to predicate devices through design, function, material comparison, and mechanical testing, rather than clinical efficacy studies with ground truth derived from expert consensus or pathology, as would be the case for AI systems.

Therefore, many of the requested categories are not applicable to the information contained in this 510(k) summary for the DSS™ Stabilization System.

Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

Explanation: For a physical device like a pedicle screw system, "acceptance criteria" primarily revolve around demonstrating substantial equivalence to already-approved predicate devices in terms of safety and effectiveness. This is typically achieved through comparisons of design, materials, function, and mechanical testing results against established benchmarks or the predicate devices themselves. The document states that the device was shown to be "substantially equivalent" and "as mechanically sound" as predicates.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. The document describes mechanical testing, not a clinical study involving human patients or data sets. "Sample size" in this context would refer to the number of devices or components subjected to mechanical tests, which is not specified. There is no "data provenance" in the sense of patient data.

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)

• Not applicable / Not provided. This device's approval involved mechanical engineering assessments and regulatory review, not expert consensus on clinical data to establish a ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided. Adjudication methods are relevant for clinical studies where human experts interpret data, which is not described here.

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

• No. This is a physical medical device, not an AI system. Therefore, no MRMC study or assessment of AI assistance was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable for clinical ground truth. The "truth" for this device's approval revolved around engineering specifications, materials science, and mechanical performance validation, demonstrated to be equivalent to existing, legally marketed devices.

8. The sample size for the training set

• Not applicable. This device does not use a training set as it is not an AI/machine learning system.

9. How the ground truth for the training set was established

• Not applicable. No training set was used.

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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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