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QuikClot Control+® Hemostatic Dressing is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries.

QuikClot Control+® Hemostatic Dressing is a prescription use non-absorbable device containing kaolin (hemostatic agent) bound to gauze. The hemostatic dressings are x-ray detectable and are provided as a single-use sterile device available in various sizes. The device is available in single or multipacks.

This document is a 510(k) summary for the QuikClot Control+ Hemostatic Dressing, which is a device used for temporary control of internal organ space bleeding and severely bleeding wounds. The summary focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to the requested information about acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance specifications but doesn't present them in a direct table format with explicit acceptance criteria values alongside reported performance values. Instead, it states that the device "meets the required specifications" generally. Here's a reconstructed table based on the provided text:

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

• Sample Size:
  • Bench Testing: Not specified for each test (tensile strength, elongation, clotting, kaolin release).
  • Biocompatibility Tests: Sample sizes are inherent to the specific ISO 10993 tests mentioned (e.g., L929 cells for cytotoxicity, guinea pigs for sensitization, rabbits for implantation, mice for genotoxicity). Specific numbers are not provided in this summary.
  • Preclinical Animal Study: "Three GLP large animal (swine), to include a survival model" and "one non-GLP study." The specific number of animals per GLP study is not detailed beyond "three."
• Data Provenance: The studies are preclinical (animal studies) and bench tests. The document does not specify country of origin for the studies, but they were conducted under GLP (Good Laboratory Practice) for the animal studies, indicating a controlled and ethical environment. They are inherently prospective for the purpose of this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The studies described are preclinical animal studies and bench tests, not human reader studies requiring expert adjudicated ground truth. The "ground truth" for these studies is derived from direct measurements, observations, and histological/pathological analyses by qualified laboratory personnel and veterinarians within the study protocols.

4. Adjudication Method for the Test Set

This is not applicable as the studies are preclinical animal studies and bench tests, not clinical studies involving human interpretation or adjudication.

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

There is no mention of an MRMC comparative effectiveness study or any AI component in this document. The device is a hemostatic dressing, not an AI-powered diagnostic or assistive tool.

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

This is not applicable as the device is a physical hemostatic dressing and does not involve any algorithm or AI.

7. The Type of Ground Truth Used

• For Biocompatibility: Laboratory results (e.g., cell viability, tissue reactions, genetic mutations) from established ISO 10993 standard test methods.
• For Bench Testing: Direct physical measurements (e.g., tensile strength, elongation), in vitro clotting assays, and chemical analysis for kaolin release.
• For Preclinical Animal Study:
  • Physiological observations: Direct assessment of hemostasis (cessation of bleeding).
  • Laboratory analyses: Blood chemistry (hematology, serum, coagulation panel results).
  • Pathological examinations: Macroscopic and microscopic tissue/organ examinations by veterinary pathologists for adhesion, thromboembolism, and kaolin migration.

8. The Sample Size for the Training Set

This is not applicable as the device is a physical medical device and does not involve machine learning or a training set.

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

This is not applicable as the device is a physical medical device and does not involve machine learning or a training set.

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