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Prescription Use: QuikClot® eX™ is intended for temporary external use to control traumatic bleeding. Over-The-Counter Use: QuikClot® eX™ is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.

QuikClot® eX™ consists of standard non-woven medical gauze that has a clay mineral (Kaolin) bound to the gauze with Glycerin. Kaolin promotes hemostasis in a similar mechanism as QuikClot® Hemostatic Agent (K013390), but without the associated heat generation and risk of burning. QuikClot® eX™ is packaged as a four ply square sponge 4" x 4" sealed in a foil pouch and irradiated to a SAL of 10-6. The foil package has the same material composition and construction as the QuikClot® Hemostatic Agent package.

This document is a 510(k) summary for the QuikClot® eX™ device, which describes its substantial equivalence to predicate devices based on in-vitro, in-vivo, and biocompatibility testing. It is a regulatory submission, not a study report, and therefore does not contain acceptance criteria in the typical sense of a clinical trial or algorithm performance study.

Here's an analysis of the provided information in the context of your request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria in the format of a table. Instead, it describes the data used to support substantial equivalence and implies that "effectiveness" and "safety" are the underlying criteria.

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

The document does not explicitly state specific sample sizes for the "test set" in the context of an AI-driven device. However, it mentions:

• In-vitro testing: "whole sheep's blood" - no specific quantity mentioned. Provenance: laboratory.
• In-vivo testing: "swine model transection of the femoral vessels" and "liver, spleen and mesenteric injuries" - no specific number of animals mentioned. Provenance: laboratory/animal study.

This is a pre-market notification (510(k)) for a medical device (hemostatic gauze), not an AI algorithm. Therefore, "test set" and "data provenance" as typically understood in AI studies (e.g., country of origin of patient data, retrospective/prospective) are not applicable or detailed in this type of submission. The data provenance is from laboratory and animal studies.

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

This information is not provided in the document. For a physical device like a hemostatic gauze, the "ground truth" would be objectively measured physiological outcomes (e.g., time to hemostasis, blood loss, tissue healing) rather than expert interpretation of images or data needing adjudication.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable and not mentioned. Adjudication methods are typically used in studies where human readers provide interpretations (e.g., radiology studies). Here, the "ground truth" is measured directly through laboratory and animal experiments.

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

Not applicable and not mentioned. This type of study is for evaluating the impact of AI algorithms on human reader performance, which is not relevant for a physical hemostatic device.

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

Not Applicable. This device is not an algorithm. Its performance is inherent to its physical and chemical properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the "studies" mentioned appears to be based on:

• In-vitro: Direct measurement of clotting time in sheep's blood.
• In-vivo: Direct observation and measurement of hemostasis (stopping bleeding) in a swine model, and assessment of tissue injuries (liver, spleen, mesenteric).
• Safety: Biocompatibility testing results (laboratory tests) and lack of heat generation.

These are essentially direct physiological outcomes data from controlled laboratory and animal experiments.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a "training set."

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

Not applicable. No training set for an AI algorithm is mentioned or relevant here.

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