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QuikClot® Interventional™ hemostatic bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 12 Fr.

QuikClot® Interventional™ hemostatic bandage is a kit that consists of a hemostatic pad and an adhesive bandage. The adhesive bandage is a 3M Tegaderm® 4" x 4-3/4" bandage (reference K973036). The hemostatic pad is a hemostatic dressing made of soft, white, kaolin impregnated gauze, configured in a 1 ½" long by 1 ½" wide by ½" thick multi-layer pad. The pad is held secured in place by stitching with polyester thread. QuikClot® Interventional™ hemostatic bandage is packaged in a plastic tray within a peelable foil pouch and irradiated to a SAL of 104.

The QuikClot® Interventional™ hemostatic bandage is intended for topical application as an adjunct to manual compression for the local management and control of surface bleeding from vascular access sites, percutaneous catheters, or tubes utilizing introducer sheaths up to 12 Fr.

Here's an analysis of the acceptance criteria and the study that supports the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: 25 vascular access procedures.
• Data Provenance: Pre-clinical porcine model testing (animal study). The country of origin is not specified but it is an animal-based study, not human. Given the context of a 510(k) submission, it is retrospective to the submission date.

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

• The document does not specify the number or qualifications of experts used to establish the ground truth for the pre-clinical porcine model testing. Given it's an animal model, the ground truth would typically be established by veterinarians, researchers, or technicians competent in animal surgery and hemostasis assessment.

4. Adjudication method for the test set:

• The document does not explicitly state an adjudication method. In a pre-clinical animal study, adjudication is often implicitly handled by the experimental design, observation protocols, and direct measurement of bleeding cessation by the researchers.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a hemostatic bandage, not an AI-powered diagnostic or assistive tool, so such a study would not be applicable.

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

• No, a standalone (algorithm only) performance study was not done. This device is a physical hemostatic product, not an algorithm.

7. The type of ground truth used:

• The ground truth used was the observed cessation of bleeding (hemostasis) in the pre-clinical porcine model following vascular access procedures. This is a direct outcome measurement.

8. The sample size for the training set:

• This information is not applicable and therefore not provided. The QuikClot® Interventional™ hemostatic bandage is a physical medical device, not an AI or machine learning model that requires a "training set." The studies conducted were for performance validation.

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

• This information is not applicable for the same reason as point 8.

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