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The Stryker® iVAS Inflatable Vertebral Augmentation System (system) is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.

The Stryker® iVAS balloon catheter is a bone tamp with an inflatable component (balloon) at the distal end. The balloon is inflated to create a void within the vertebral hody.

Here's an analysis of the provided text regarding the Stryker® iVAS, focusing on acceptance criteria and supporting studies:

This 510(k) submission (K130430) is for a modification to an existing device, the Stryker Inflatable Vertebral Augmentation System (iVAS), specifically an 11 Gauge balloon catheter. It's important to note that this is a submission for substantial equivalence to predicate devices, not a de novo clearance for a completely new device. This means the primary evidence relies on demonstrating that the new device performs as safely and effectively as previously cleared, similar devices, rather than presenting a novel clinical study to establish new performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Key takeaway: The acceptance criteria for this 510(k) are centered around demonstrating that the modified 11-gauge balloon catheter is substantially equivalent to the previously cleared 10-gauge iVAS balloon catheters. This means it must meet the same safety and performance profiles as those already on the market. The reported performance asserts that this substantial equivalence has been met through non-clinical testing and risk assessments.

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

• Sample Size for Test Set: Not applicable. No clinical testing (which would typically involve a "test set" of patients or samples) was deemed necessary for this 510(k) submission. The evaluation was based on non-clinical testing and comparison to predicate devices.
• Data Provenance: Not applicable. Since no clinical testing was performed, there is no patient data provenance (e.g., country of origin, retrospective/prospective). The data primarily comes from non-clinical bench testing conducted by Stryker Instruments.

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

• Number of Experts: Not applicable. There was no clinical ground truth established for a test set in this submission, as no clinical testing was performed.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Without a clinical test set requiring human interpretation or assessment, no adjudication method was employed.

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

• MRMC Study: No. This device is a physical medical instrument (an inflatable bone tamp/balloon catheter), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI effect size are not relevant to this submission.

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

• Standalone Study: No. As mentioned, this is a physical medical device, not an algorithm. Standalone performance studies are not applicable.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Type of Ground Truth: For the purpose of this 510(k), the "ground truth" is not a clinical diagnosis or outcome, but rather the established performance and safety characteristics of the predicate devices. The new device (11-gauge iVAS balloon catheter) is being compared against these known, legally marketed predicate devices through non-clinical testing. This implicitly relies on the original ground truth (clinical safety and effectiveness) that led to the approval of the predicate devices. The "ground truth" for the current submission is compliance with engineering specifications and performance metrics of the predicate devices based on bench testing and risk assessment.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. As this is not an AI/machine learning device, there is no concept of a "training set" in the context of this 510(k) submission.

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

• How Ground Truth for Training Set Was Established: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is non-clinical testing, risk assessment (design and use FMEAs), and a substantial equivalence comparison to legally marketed predicate devices.

• Nature of the Study:

  • Non-clinical testing: The document states, "The Stryker® iVAS balloon catheter meets the specification and performance characteristics and are substantially equivalent to the predicate devices." This refers to bench testing to verify material properties, dimensions, inflation characteristics, strength, durability, and other engineering specifications, ensuring the 11-gauge catheter performs identically or acceptably to the 10-gauge predicates.
  • Risk Assessment: "Risk assessment of the modifications in the form of design and use failure modes and effects analysis (design and use FMEAs) has been conducted in accordance with EN ISO 14971. Stryker has determined that the modifications to the predicate device raise no new questions of safety or effectiveness." This analysis demonstrates that the minor design changes (balloon wall thickness, spiral cut, color) do not introduce new risks or affect fundamental performance.
  • Substantial Equivalence Comparison: The core of the submission is to demonstrate that the new 11-gauge device is "substantially equivalent in intended use, technological characteristics, safety, and effectiveness to the previously cleared Stryker® iVAS Balloon Catheters and the Kyphx Xpander Inflatable Bone Tamp." This involves a direct comparison of specifications, materials, and intended use.

• Proof: The combination of these non-clinical tests and risk assessments served as the evidence presented to the FDA to demonstrate that the modified device is as safe and effective as the predicate devices, thereby meeting the acceptance criteria for a 510(k) clearance based on substantial equivalence. The FDA's clearance letter (K130430, dated May 23, 2013) confirms their agreement with this assessment.

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