(41 days)
The ThrombiGel thrombin/gelatin foam hemostat 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 percularedus and or tubes.
The ThrombiGel thrombin/gelatin foam hemostat consists of a lyophilized gelatin foam pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride. The ThrombiGel is applied directly over the source of bleeding, 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.
This document is a 510(k) summary for the ThrombiGel™ thrombin/gelatin foam hemostat. It provides information about the device, its intended use, and a comparison to a predicate device, but it does not contain the detailed acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or validation studies.
Therefore, I cannot provide the specific information requested about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies directly from the provided text.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the document. The document states: "Testing included assessment of the physical properties of the lyophilized pad and its ability to achieve its intended use. The results of the tests confirmed the suitability of the device for its intended use." This is a high-level summary and doesn't provide specific acceptance criteria or quantitative performance metrics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "confirmed the suitability of the device for its intended use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not present in the document. The "Summary of Non-Clinical Testing" mentions "assessment of the physical properties of the lyophilized pad and its ability to achieve its intended use," but it does not specify sample sizes or data provenance. The testing appears to be non-clinical, likely bench testing.
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):
This information is not present in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not present in the document.
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 present in the document. The device is a hemostat, not an AI-based diagnostic tool, so an MRMC study related to AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not present in the document. The device is a physical product (thrombin/gelatin foam hemostat), not an algorithm or software. Standalone performance as an algorithm is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not explicitly stated in the document. For a hemostat, "ground truth" would likely involve standardized bleeding models (in vitro or in vivo animal studies) where the cessation of bleeding is objectively measured. The document only vaguely refers to "assessment of the physical properties... and its ability to achieve its intended use."
8. The sample size for the training set:
This information is not present in the document. The device is a physical medical device, not a machine learning model, so the concept of a "training set" in the context of AI is not applicable.
9. How the ground truth for the training set was established:
This information is not present in the document, as the concept of a "training set" and "ground truth" for a training set is not applicable to this type of device.
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