(120 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Successful control of bleeding in internal use cases | 98.7% |
| Successful control of bleeding in external use cases | 97% |
| Acceptable rates of device-specific adverse events (e.g., hematoma, thrombus formation, thromboembolism) | Hematoma: 0.5% (internal), 1% (external). No thrombus formation or thromboembolism reported. |
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.
§ 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.