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The Thrombi-Paste® Thrombin/gelatin powder paste hemostat is applied topically for temporary control of moderate to severely bleeding wounds and for the local management of surface bleeding from vascular access sites and percutaneous tubes and catheters.

Each Thrombi-Paste Thrombin/gelatin powder paste hemostat includes the following components; A 10 mL syringe with attached mixing luer filled with 550mg of powdered absorbable gelatin sponge, USP (manufactured by Vascular Solutions, Inc. (VSI)), A vial of Bovine-derived Thrombin (5,000 IU, supplied to VSI by King Pharmaceuticals, U.S. license # 977), A diluent vial (5 mL, Supplied to VSI by Chesapeake Biological Laboratories, U.S. registration # 1123903), Mixing accessories (10 mL syringe and needleless, non-coring vial access device) and Applicator tips (1 - small bore tip, 1 - large bore tip). The pouch containing the syringe with gelatin powder also contains a desiccant packet to maintain low moisture levels.

The provided text is a 510(k) summary for the Thrombi-Paste® Thrombin/gelatin powder paste hemostat. It states that no human clinical testing was required for this device, which means there is no study that proves the device meets specific acceptance criteria based on human performance. The summary focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative format for the performance of the device in comparison to its intended use (hemostasis). Instead, it lists non-clinical tests performed to confirm the suitability of the device, implying that the device met the internal criteria for these tests.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes for each non-clinical test (e.g., how many syringes were tested for delivery force). The data provenance is internal, as "Vascular Solutions, Inc." manufactured the absorbable gelatin sponge and sourced other components. The tests are non-clinical (bench testing) and do not involve human data.

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

Not applicable. The "ground truth" for non-clinical bench testing is established by engineering specifications and objective measurements, not by human experts interpreting results in the way clinical studies require.

4. Adjudication method for the test set

Not applicable for non-clinical bench testing. Adjudication methods are typically used in clinical studies where expert consensus is needed to determine outcomes or classifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. The document explicitly states, "No human clinical testing was required for this device."

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

Not applicable. This device is a medical product (hemostat), not an algorithm or AI-based diagnostic tool. Performance is assessed through physical and chemical properties and basic functional tests, not by an algorithm.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" would be established by the defined specifications and measurement standards for each physical and chemical property being tested (e.g., a specific pH value range is acceptable). This is based on scientific and engineering principles rather than a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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