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The Vessel Occluder is intended to be used to internally occlude blood vessels during anastomosis.

The Vessel Occluder is composed of two silicone rubber bulbs on the distal ends of a flexible shaft. A tab on a tether is attached to the midpoint of the flexible shaft forming a "T" configuration. Vessel Occluders are useful in coronary artery bypass procedures to create a bloodless field at the anastomosis. The occluder bulbs are inserted proximally and distally through the vessel opening. The occluder bulbs allow a dry field to be maintained during the anastomosis of bypass graft.

Here's a breakdown of the acceptance criteria and study information for the CHASE VESSEL OCCLUDER:

Acceptance Criteria and Device Performance

Study Details

The provided information focuses on substantial equivalence to a predicate device (Bio-Vascular "Flo-Rester" vessel occluder - K883696) and verification of specific product characteristics rather than a traditional clinical study with a "test set" in the context of diagnostic or AI performance.

1. Sample size used for the test set and the data provenance:

   • Test Set: Not applicable in the context of this traditional medical device submission. The "test set" here refers to samples of the device itself and its packaging undergoing specific engineering and material tests, not a set of patient data.
   • Data Provenance: The tests are performed by the manufacturer, CHASE MEDICAL INC., in Richardson, TX. The data origin is internal testing related to manufacturing and quality control.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This is not applicable. "Ground truth" in this context isn't established by human experts interpreting clinical data. Instead, it's established by recognized engineering standards (e.g., tensile strength minimums, ASTM standards for package integrity, NSTA standards for shipping) or by direct comparison to a predicate device's established characteristics.

3. Adjudication method for the test set:

   • Not applicable. The tests are objective measurements against predefined standards or direct comparison to the predicate device.

4. 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 MRMC comparative effectiveness study was done. This device is a physical vessel occluder, not an AI diagnostic or assistive tool.

5. 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.

6. The type of ground truth used:

   • The "ground truth" for this device's safety and effectiveness relies on:
     • Substantial Equivalence: Conformance to characteristics of a legally marketed predicate device (Bio-Vascular "Flo-Rester").
     • Engineering Standards: Meeting established tensile strength thresholds, ASTM international standards for packaging, and National Safe Transit Assoc. standards for shipping/distribution.
     • Validation of Processes: Successful validation of the sterilization cycle.

7. The sample size for the training set:

   • Not applicable. There is no AI model or "training set" in this submission.

8. How the ground truth for the training set was established:

   • Not applicable. There is no AI model or "training set" for this device.

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