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QuikClot Control+ is indicated for temporary control of external and identifiable sites of internal mild, moderate, severe, and life-threatening bleeding.

QuikClot Control+™ Hemostatic Device consists of a white to yellow, sterile, X-Ray detectable hemostatic dressing and is packaged for aseptic removal.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the primary endpoint of the study, which was "successful control of bleeding." The reported performance directly addresses this.

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

• Sample Size: 603 patient cases.
  • Internal uses: 404
  • External uses: 199
• Data Provenance: Retrospective observational study of real-world data (RWD) from medical records. The data was collected from healthcare professionals at 74 individual sites across 27 states in the United States.

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

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for the test set. It mentions "healthcare professionals from 74 individual sites...who performed the clinical procedures in which the device was used." This implies that the ground truth (successful control of bleeding, adverse events) was established by the treating healthcare professionals at the point of care, rather than a separate panel of experts reviewing the cases.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). Given it's a retrospective observational study where healthcare professionals recorded outcomes at the time of treatment, formal adjudication by a separate group of experts is unlikely to have occurred. The "ground truth" appears to be based on the clinical assessment and documentation by the treating clinicians.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This section is not applicable. The device is a hemostatic dressing, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to readers improving with AI assistance would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. The device is a physical medical device (hemostatic dressing), not an algorithm or software. Its performance is inherent in its physical action and chemical properties, not in a standalone algorithm.

7. The Type of Ground Truth Used

The ground truth used was clinical outcomes data (successful control of bleeding, rates of hematoma, thrombus formation, and thromboembolism) as recorded in the medical records by treating healthcare professionals.

8. The Sample Size for the Training Set

The document does not refer to a "training set" in the context of this study. The device is a physical product, and the study described is for clinical performance evaluation, not for training a machine learning model.

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

As there is no mention of a "training set" or a machine learning model, this question is not applicable.

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