(19 days)
The D-Stat Dry 3X3 is applied topically and is indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds and for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
The Vascular Solutions D-Stat Dry 3x3 Hcmostatic Pad is intended to be a topical compression bandage for use under the direction of a healthcare professional and is indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds and for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
The D-Stat Dry 3x3 Hemostatic Pad consists of a: Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose and calcium chloride
The D-Stat Dry 3x3 Hemostatic Pad achieves its principal intended action (hemostasis) in the same manner as the other devices in the D-Stat Dry Product Family; it is applied directly over the source of bleeding therefore creating a physical barrier to blood flow through the application of adjunctive manual compression. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment in which a natural blood clot can build and form a physical barrier to bleeding. The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin.
The provided text is a 510(k) summary for the Vascular Solutions D-Stat - Dry™ 3x3 Hemostatic Pad. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document explicitly states that "No clinical evaluations of this product for this use have been conducted." Therefore, based on the provided text, it's not possible to describe acceptance criteria or a study that proves the device meets them in the context of clinical performance.
The "testing conducted" mentioned under "Summary of Non-Clinical Testing" refers to:
- Assessments of the physical properties of the lyophilized pad and packaging.
- The ability of the lyophilized components to achieve its intended use (clot blood).
These are non-clinical (laboratory/bench) tests, not clinical studies with human subjects.
Therefore, many of the requested details cannot be provided from this document.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Non-Clinical) |
|---|---|
| Physical properties of pad/packaging suitable for intended use | Confirmed suitable |
| Lyophilized components ability to clot blood | Confirmed suitable |
Note: Specific quantitative acceptance criteria or detailed performance metrics for these non-clinical tests are not disclosed in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable (N/A) for clinical data as no clinical studies were conducted.
- For non-clinical testing, the sample sizes and data provenance are not specified in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
N/A as no clinical studies were conducted. Ground truth for non-clinical lab tests is typically based on established scientific methods and controls, not expert consensus in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A as no clinical studies were conducted.
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
N/A - This device is a medical product (hemostatic pad), not an AI diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A - This device is a medical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical "clot blood" testing, the ground truth would be established by scientific methods to confirm the formation of a clot (e.g., visual inspection, coagulation assays). Specifics are not provided.
8. The sample size for the training set
N/A as no machine learning/AI training was involved for this type of medical device.
9. How the ground truth for the training set was established
N/A as no machine learning/AI training was involved.
N/A