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QuikClot ACS - "Advanced Clotting Sponge" ™, is intended for emergency use only as an external traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.

The new mesh bags containing beads of QuikClot® Brand Hemostatic Agent, also called QuikClot ACS™ - "Advanced Clotting Sponge", are intended for emergency use as an external temporary traumatic wound treatment to achieve hemostasis and prevent blood loss.

The beads inside the mesh bags consist of a synthetic molecular sieve (zeolite) that accelerates the body's natural clotting processes by increasing the concentration of platelets and clotting factors at the wound site. Individual sieve particles of the hemostatic agent adsorb water molecules. As the water is removed from the blood, the platelets and clotting factors are concentrated. The platelets have been activated by the normal response to injury. This adsorption process is exothermic. The resultant increase in temperature at the site of application increases the rate of the clotting reactions and platelet aggregation and adhesion.

Both of the mechanisms described above, concentration of clotting factors and the increase in rates of platelet aggregation/adhesion, work together to increase the clotting rate. This would be consistent with what is known about the effects of temperature and concentration on coagulation enzyme activity and platelet function.

The product is designed and packaged to be easily packed, carried and applied using only one hand. It is well suited for moderate to large eviscerating wounds, to create hemostasis by coagulation.

Used in conjunction with direct pressure, QuikClot ACS™ reduces blood loss dramatically, and significantly increases survivability of high volume catastrophic wounds.

This application for Special 510(k) clearance concerns the same hemostatic agent, in bead form, but the beads have been placed inside a synthetic mesh bag in order to facilitate easier application and removal of the product. This device modification retains the benefits of the previous device modification, granules vs. beads, but instead of removing individual beads from a wound medical personnel only need to remove the mesh bag containing the beads.

The provided text is a 510(k) summary for the QuikClot ACS™ - "Advanced Clotting Sponge". It details the device, its intended use, and its substantial equivalence to a predicate device, but it does not contain detailed acceptance criteria or a study designed to explicitly prove the device meets specific performance metrics against those criteria in a tabular format as requested.

Instead, it focuses on demonstrating substantial equivalence to a previously cleared device. Therefore, much of the requested information regarding acceptance criteria and detailed study results cannot be extracted directly from this document.

However, I can extract the available information and highlight what is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document in a tabular format. The document describes the device's mechanism of action and states that "Tests demonstrated that the QuikClot ACS™ product performs at least as well as the current granular product in the swine femoral artery model." This implies a comparative performance but does not list specific acceptance criteria or quantitative performance metrics.

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

• Sample Size for Test Set: Not specified for the swine femoral artery model.
• Data Provenance:
  • Country of Origin: United States (Hartford Hospital in Connecticut, Portsmouth Naval Hospital in Virginia, the Naval Medical Research Center (NMRC) in Maryland, and Uniformed Services University of the Health Sciences (USUHS) in Maryland).
  • Retrospective or Prospective: Not explicitly stated, but "In-Vivo testing on swine was performed" suggests a prospective study.

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

This information is not provided. The "ground truth" in this context would likely be the objective measurement of hemostasis in the swine model, rather than expert consensus on images or diagnoses.

4. Adjudication Method for the Test Set

This information is not provided.

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

A MRMC comparative effectiveness study was not performed or described, as this device is a physical product (clotting sponge) and not an imaging or diagnostic AI tool. The study described is an in-vivo animal model comparison, not a human reader study.

6. Standalone Performance Study (Algorithm Only)

This is not applicable as the device is a physical product, not an algorithm. The in-vivo swine study could be considered a "standalone" performance study for the device itself.

7. Type of Ground Truth Used

The ground truth implicitly used for the in-vivo swine studies would be objective physiological measurements of hemostasis and blood loss in the animal model. The document states "Tests demonstrated that the QuikClot ACS™ product performs at least as well as the current granular product in the swine femoral artery model," indicating that direct measurements related to clotting and bleeding control were the basis of evaluation.

8. Sample Size for the Training Set

This is not applicable as the device is a physical product, not an AI/ML algorithm that requires a training set. The development of the product would have involved various design and testing phases, but not a "training set" in the context of machine learning.

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

This is not applicable as the device is a physical product, not an AI/ML algorithm.

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