(44 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 percutaneous catheters or tubes.
The ThrombiGel foam hemostat consists of a lyophilized gelatin foam pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride. The ThrombiGel foam hemostat works in the same manner as the D-Stat Dry 3x3 hemostatic Pad and the D-Stat Flowable Hemostat. It 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 describes a 510(k) premarket notification for the ThrombiGel™ thrombin/gelatin foam hemostat. However, it does not contain the specific details of acceptance criteria or a study that directly proves the device meets such criteria in the format requested.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the given documents. The 510(k) summary (page 4) states: "No performance standards have been developed under section 514 for this device." and "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 does not contain specific acceptance criteria or quantitative performance reports.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document mentions "Summary of Non-Clinical Testing" but does not detail sample sizes, study design (retrospective/prospective), or data provenance.
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 provided. The device is a topical hemostat, and the testing described is non-clinical. The concept of "experts establishing ground truth for a test set" usually applies to diagnostic devices or AI algorithms that rely on human interpretation, which is not the case here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As mentioned above, the testing is non-clinical and thus adjudication methods as typically understood for clinical or diagnostic studies are not applicable.
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/not provided. The ThrombiGel device is a physical hemostat, not an AI-assisted diagnostic tool. Therefore, MRMC studies and "human readers improving with AI assistance" are not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This device is a physical medical device, not an algorithm, so "standalone algorithm performance" is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated beyond "results of the tests confirmed the suitability of the device for its intended use." Given the nature of a hemostat, the "ground truth" would likely involve objective measurements of hemostasis (e.g., time to hemostasis, blood loss, re-bleeding rates in an animal model or in vitro setting), but these specifics are missing.
8. The sample size for the training set
This is not applicable/not provided. The ThrombiGel device is a physical hemostat and does not involve a "training set" in the context of an AI/ML algorithm.
9. How the ground truth for the training set was established
This is not applicable/not provided. As above, the concept of a training set and its ground truth is not relevant to this type of device submission.
Summary of what the document does provide:
- Device Name: ThrombiGel™ thrombin/gelatin foam hemostat
- Intended Use/Indications for Use: Applied topically 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.
- Device Description: A lyophilized gelatin foam pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride. It works by creating a physical barrier with manual compression and facilitating a natural blood clot through thrombin's action.
- Predicate Devices: D-Stat Dry Hemostatic Bandage (K030836) and D-Stat Flowable Hemostat (K012293).
- Conclusion for Substantial Equivalence: The ThrombiGel foam hemostat pad is substantially equivalent to the predicate devices based on a comparison of indications for use and technological characteristics.
- Testing: "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." (However, no details of these tests are provided).
In conclusion, this 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, rather than providing detailed acceptance criteria and a study report with quantitative performance data typically seen for novel device approvals or AI-enabled technologies.
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