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The Cardiva Medical VasoStasis™ Vascular Closure System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The VasoStasis Vascular Closure System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures, using 5 or 6 Fr introducer sheaths.

The VasoStasis Vascular Closure System consists of the following components: (1) a sterile. disposable catheter (VasoStasis™ VCS Catheter), and (2) a sterile, disposable tensioning device (VasoStasis™ VCS Tensioner). The VasoStasis Vascular Closure System, in conjunction with manual compression, provides hemostasis at femoral access sites after femoral arterial catheterization while allowing continued perfusion of the lower extremities. The VasoStasis VCS Catheter is a single lumen, low profile catheter with an elastomeric membrane at the distal tip. The membrane is covered by a tip guide, which protects the membrane as the cledeployed catheter is inserted into the artery through a previously placed introducer sheath. A small loon handle is at the proximal end of the device and moves axially to deploy or de-deploy a Nitinol coil within the membrane. Once the catheter is introduced into the vessel, the membrane is positioned distal to the introducer sheath and deployed by pushing the loop handle forward. In its fully deployed state, the membrane nominally achieves 13 F in diameter. The Cardiva VasoStasis VCS Tensioner clips on the VasoStasis VCS Catheter shaft on the surface of the skin at the entrance to the arteriotomy and holds the catheter secure while the membrane is deployed in the vessel.

Acceptance Criteria and Study for Cardiva Medical VasoStasis™ Vascular Closure System

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the Cardiva Medical VasoStasis™ Vascular Closure System does not explicitly state pre-defined acceptance criteria in terms of specific numerical thresholds for success rates or complication rates against which the observed performance was directly measured. Instead, it refers to "performance requirements" that the system met or exceeded, and then presents the clinical study results as evidence of safety and effectiveness, implying these results are within acceptable ranges.

However, based on the narrative, the implicit acceptance criteria can be inferred from the positive statements made about the study outcomes.

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

• Sample Size for Clinical Test Set: A total of 441 patients were included across four clinical studies (one enrolled but not treated).
  • German clinical evaluation: 144 patients (post-market study).
  • US II, US I, and Canadian Clinical Studies: 278 consecutive phase patients (prospective studies).
• Data Provenance:
  • Initial clinical evaluations: Conducted in Germany and Canada.
  • Followed by two Non-Significant Risk (NSR) studies: US I (sponsored by BioInterventional) and US II (sponsored by Cardiva Medical), conducted in the United States.
• Study Design:
  • German clinical evaluation: Post-market study.
  • US II, US I, and Canadian Clinical Studies: Prospective studies.
  • The data from the prospective Canadian Clinical Study was retrospectively analyzed using the same outcome definitions as the US I Studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The provided document does not specify the number of experts used to establish ground truth for the clinical test set, nor does it detail their qualifications (e.g., radiologist with X years of experience). The clinical studies evaluated "safety and effectiveness" based on device success rates, complication rates, and time metrics, which would typically be assessed by treating physicians and study investigators rather than independent experts establishing a "ground truth" in the diagnostic sense.

4. Adjudication Method

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1, none) for the test set outcomes. Given the nature of a vascular closure device study evaluating success/complication rates and time metrics, these are often directly observed and recorded by the clinical staff involved in the procedure and patient follow-up, rather than requiring a separate adjudication panel for "ground truth" per se.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted in the context of human readers improving with AI vs. without AI assistance. This device is a mechanical vascular closure system, not an AI-powered diagnostic tool. The comparison made was between the VasoStasis VCS (as an adjunct to manual compression) and manual compression alone (based on literature control), evaluating device performance and patient outcomes.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

Yes, a form of standalone performance was assessed through bench performance testing and animal studies.

• Bench performance testing: Demonstrated that the "System meets or exceeds the performance requirements for the intended clinical use of the device" and "satisfies all of its performance requirements."
• Animal studies: Included acute animal studies, chronic animal studies, and device performance verification studies. These evaluated aspects like control of bleeding, promotion of hemostasis, prolonged placement and tension, and specific performance characteristics such as positioning techniques and membrane pull-through force. These studies assess the device's inherent mechanical performance.

7. Type of Ground Truth Used

The "ground truth" for evaluating the clinical performance of the VasoStasis VCS was based on:

• Clinical Outcomes Data: Observed device success rates, major complication rates, direct manual compression time, and time to ambulation, as determined by the clinical investigators and recorded during the patient follow-up.
• Biocompatibility Testing: Adherence to established ISO standards (ISO 10993-1, ISO 10993-4) for biological evaluation.
• Bench Testing: Engineering performance requirements for the device's mechanical function.
• Animal Models: In-vivo observations of hemostasis, tissue response, and specific device characteristics.

8. Sample Size for the Training Set

The document does not mention or imply the use of a "training set" in the context of machine learning or AI. This device is a mechanical medical device, and its development and evaluation followed traditional engineering and clinical study methodologies, not machine learning paradigms requiring training sets for algorithm development.

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

Since there was no "training set" in the machine learning sense, this question is not applicable. The device's design and mechanism are based on mechanical principles and physiological understanding of hemostasis, not on learning from a dataset.

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