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The ThrombiGe1® 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® thrombin/gelatin foam hemostat consists of a lyophilized absorbable gelatin sponge, USP containing thrombin, sodium carboxymethylcellulose (CMC), and calcium chloride.

The ThrombiGel® thrombin/gelatin foam hemostat 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.

The ThrombiGel® thrombin/gelatin foam hemostat is wetted before use with sterile water for injection or saline (not provided.) There are three versions of the pad which differ in their dimensions. The ThrombiGel® 10 thrombin/gelatin foam hemostat is approximately 10 cm³, the ThrombiGel® 40 thrombin/gelatin foam hemostat is approximately 40 cm² and the ThrombiGel® 100 thrombin/gelatin foam hemostat is approximately 100 cm . A desiccant is added to the package to maintain the moisture content.

This document is a 510(k) premarket notification for the ThrombiGel® thrombin/gelatin foam hemostat. The information provided outlines non-clinical testing performed to demonstrate the device's substantial equivalence to a predicate device, rather than defining specific acceptance criteria for performance metrics or presenting a study that proves it meets those criteria.

Therefore, the requested information elements cannot be fully populated as they pertain to clinical performance studies and specific acceptance thresholds, which are not detailed in this submission for this type of device and regulatory pathway.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria for device performance in the manner requested (e.g., sensitivity, specificity for diagnostic devices, or specific clinical endpoints for therapeutic devices). It lists physical and biocompatibility tests whose results confirmed the suitability of the device for its intended use, but not explicit numerical targets.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified for non-clinical tests.
• Data Provenance: The tests are described as "Bench testing" and "biocompatibility assessment," implying laboratory-based testing, not human-related data. No country of origin for the data is mentioned, but the submitter is Minneapolis, Minnesota, USA. The tests are non-clinical and would be considered prospective for the purposes of this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth as typically understood for diagnostic/clinical studies (e.g., expert reads, pathology) is not relevant for the non-clinical physical and biocompatibility testing described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are for reconciling differing expert opinions in clinical studies, which were not performed here.

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

Not applicable. This is a medical device (hemostat), not an AI/diagnostic software. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" would be established by the standardized protocols and acceptance criteria of the respective physical and biocompatibility tests themselves (e.g., ISO standards, pharmacopeial methods).

8. The sample size for the training set

Not applicable. This submission describes non-clinical testing for a medical device's substantial equivalence, not a machine learning model.

9. How the ground truth for the training set was established

Not applicable. No training set for a machine learning model was involved.

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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.

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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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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