(254 days)
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
| Acceptance Criteria (Primary Endpoint) | Reported Device Performance (Effectiveness) |
|---|---|
| Rate at which subjects achieve hemostasis (grade 0 bleed) through up to 10 minutes of application and compression at the bleeding site. | The report states: "QuikClot Control+® achieved clinical hemostasis in cardiac surgery for mild to moderate bleeding as compared to control (i.e., standard gauze)." Specific numerical rates are not provided in this summary. |
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.
§ 878.4454 Non-absorbable, hemostatic gauze for temporary internal use.
(a)
Identification. A non-absorbable, hemostatic gauze for temporary internal use is a prescription device intended to be placed temporarily for control of severely bleeding wounds such as surgical wounds and traumatic injuries. The gauze is coated or impregnated with a hemostatic material which may enhance hemostasis by physical means. The device is intended to be removed once the patient is stabilized.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Specifically testing must:
(i) Demonstrate that the device is able to achieve hemostasis;
(ii) Demonstrate that the device can be radiographically detected; and
(iii) Assess pertinent safety endpoints including vascular obstruction and adhesion formation.
(2) The device must be demonstrated to be biocompatible.
(3) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following tests must be performed:
(i) In vitro clot assessment;
(ii) Particulate release testing;
(iii) Physical characterization, including swelling percent and particulate size;
(iv) Chemical characterization;
(v) Radiopacity testing; and
(vi) Mechanical integrity testing, including tensile strength and tear strength.
(4) Performance data must demonstrate the sterility of the device.
(5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(6) Labeling must include the following:
(i) Instructions for use, including an instruction to remove all visible device components by irrigation;
(ii) The maximum amount of time the device may be left within the body;
(iii) A shelf life;
(iv) A contraindication for intravascular use of the device; and
(v) A warning regarding the potential for adhesion formation.