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The Flower™ Infusion Catheter is indicated for the delivery of therapeutic agents into the peripheral vasculature. It is not indicated for use in coronary or cerebral vasculature. It is not intended for use with thrombolytics. It is not intended for use with power injection pumps.

The Flower™ Infusion Catheter is a multi-lumen, over-the-wire device designed to locally deliver fluids into the peripheral vasculature.

Acceptance Criteria and Device Performance for Flower™ Infusion Catheter:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify the exact sample sizes for each physical test. It broadly states "All testing results were within product engineering and marketing specifications." For the animal testing, the sample size is also not explicitly stated, but it implies a sufficient number of animals were used to assess placement and thrombus accumulation.
• Data Provenance:
  • Physical Testing: The data provenance for physical testing is internal to the manufacturer, Interventional Innovations Corp., as it refers to "product engineering and marketing specifications."
  • Biocompatibility Testing: The data provenance is from laboratories performing standard biocompatibility tests.
  • Animal Testing: The data provenance is from an animal study conducted by or on behalf of Interventional Innovations Corp. The country of origin is not specified but is presumably where the company is located or where they contracted the study. The study appears to be prospective as it was conducted to assess the device's performance.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• This submission does not involve human interpretation or subjective assessment that would require experts to establish ground truth for a test set in the traditional sense (e.g., medical image interpretation). The "ground truth" for the physical and animal studies would be objective measurements and observations performed by engineers, lab technicians, and veterinarians using established protocols.

4. Adjudication Method (Test Set)

• Not applicable as this is not a study requiring adjudication of expert interpretations. The "adjudication" for physical tests is based on objective measurements against predefined specifications. For the animal study, it would be based on veterinary observations and potentially pathological analysis, but no multi-reader adjudication process is described.

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

• No MRMC comparative effectiveness study was done. This type of study is typically performed for diagnostic devices that involve human interpretation (e.g., AI in radiology). The Flower™ Infusion Catheter is a physical medical device for fluid delivery, not a diagnostic tool requiring human interpretation comparison.

6. Standalone Performance Study

• Yes, the described "Testing" section outlines standalone performance of the device. The physical tests (dimensional, deployment, flow rate, bond strength, flexural fatigue, radial force, trackability, compatibility) and the biocompatibility tests represent the device's standalone performance against defined engineering and biological criteria. The animal study also demonstrates the standalone performance of the device in a physiological environment regarding placement and thrombus accumulation.

7. Type of Ground Truth Used

• Physical Testing: Engineering specifications, objective measurements, and established testing protocols.
• Biocompatibility Testing: Standards for biocompatibility (e.g., ISO standards), laboratory assays, and pathological evaluation of tissue response (if applicable).
• Animal Testing: Direct observation, physiological measurements, and potentially histopathological analysis of tissues from the animal model to assess device placement and thrombus formation. This is essentially "outcomes data" within an animal model.

8. Sample Size for Training Set

• Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set. The "training" in the context of device development would typically involve iterative design, prototyping, and testing, where early prototypes might be considered "training" for the final design, but not in the sense of a dataset.

9. How Ground Truth for Training Set Was Established

• Not applicable, as there is no training set mentioned in the context of an AI/ML algorithm for this device.

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