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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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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.

Cardiac surgical procedures: for temporary control of mild and moderate bleeding in cardiac surgical procedures, as well as in patients displaying class III or class IV bleeding.

Bone surfaces following sternotomy: to control bleeding from bone surfaces following a sternotomy.

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 and configurations. The device is available in single or multipacks.

The document provided is a 510(k) summary for the QuikClot Control+® Hemostatic Dressing, seeking approval for expanded indications. It does not describe an AI medical device. Therefore, the requested information about acceptance criteria, study details, ground truth, and MRMC studies related to AI performance cannot be extracted from this document.

However, I can provide the clinical acceptance criteria and the summary of the clinical study presented in the document for the QuikClot Control+® Hemostatic Dressing in relation to its expanded indications.

Here's the information based on the provided text, structured as closely as possible to your request, but acknowledging the device is not an AI device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set (Clinical Study Participants):
  • Total Randomized Subjects: 231
  • QuikClot Control+® (Test Article): 153 subjects
  • Standard Gauze (Control): 78 subjects
  • Additional Roll-in Subjects (not randomized, treated with QuikClot Control+®): 21 (3 per site)
• Data Provenance: The study was a "prospective, randomized, open-label, multicenter, pivotal, evaluation." The country of origin is not explicitly stated, but clinical trials for FDA submissions are often conducted in the US or include international sites adhering to Good Clinical Practice (GCP) guidelines.

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

This information is not applicable as the study involves a physical medical device (hemostatic dressing) and direct clinical observations of bleeding, not an AI output requiring expert ground truth establishment for diagnostic accuracy. The "ground truth" here is the direct clinical observation of hemostasis by the surgical team.

4. Adjudication Method for the Test Set

This information is not applicable as the study involves direct clinical observation of hemostasis, not AI output requiring expert 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

This information is not applicable as the device is not an AI medical device and therefore no MRMC study was performed in the context of AI assistance to human readers.

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

This information is not applicable as the device is not an AI medical device.

7. The type of ground truth used

The "ground truth" for the clinical study was based on direct clinical observation of hemostasis (grade 0 bleed) by the surgical team during elective cardiac surgical procedures.

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI medical device and therefore does not have a "training set" in the context of machine learning.

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

This information is not applicable as the device is not an AI medical device.

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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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