(65 days)
The Thrombix™ Patch is applied topically and is indicated as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
The Thrombix " Patch thrombin hemostasis patch consists of a lyophilized patch containing bovine derived thrombin as an aid to hemostasis (King Pharmaceuticals license number 0977), sodium carboxymethylcellulose (CMC), and calcium chloride.
The Thrombix" Patch 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 Thrombix™ Patch, a thrombin hemostasis patch. It describes the device, its intended use, and comparative studies with predicate devices.
Here's an analysis based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for performance. Instead, it describes internal quality control tests and biocompatibility assessments. The "reported device performance" is essentially that the device was found suitable for its intended use based on these tests, and substantially equivalent to predicate devices.
| Acceptance Criteria (Inferred from tests) | Reported Device Performance |
|---|---|
| Moisture Content within specified limits | Confirmed suitability |
| Thrombin Activity post 4 hours pot-life | Confirmed suitability |
| Wetting Time within specified limits | Confirmed suitability |
| pH within specified limits | Confirmed suitability |
| Biocompatibility (MEM Elution, Intrac. Inj. Test, Systemic Inj. Test, Kligman Skin Sensitization) | Biocompatible |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses bench testing for physical properties and biocompatibility.
- Test Set Sample Size: Not explicitly stated for each test, but implied to be sufficient for internal quality control. No "test set" in the context of clinical data for performance assessment.
- Data Provenance: The tests are likely performed by Vascular Solutions, Inc. or their contracted labs. The country of origin of this internal testing data is not specified, but the company is based in Minneapolis, MN, USA. The data is retrospective in the sense that it was generated prior to submission for clearance.
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)
Not applicable. The document describes bench testing and biocompatibility assessments, not a study where expert ground truth was established for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication is relevant for studies involving human interpretation or clinical outcomes, which were not conducted for this submission (as stated in Section 6).
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 for hemostasis, not an AI-assisted diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is geared towards AI/software as a medical device. The Thrombix™ Patch is a physical hemostatic device. The "standalone" performance refers to the device's intrinsic function as a hemostat, which was assessed through the non-clinical bench testing. No human-in-the-loop performance study was conducted or required.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" was established by standardized laboratory test methods and scientific principles for assessing physical properties (e.g., moisture content measurement, pH measurement, thrombin activity assay) and established biocompatibility testing protocols (e.g., MEM Elution, Intracutaneous Injection Test). There was no clinical ground truth (like pathology or outcomes data) used as no human clinical testing was required.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning model. There is no "training set" for this device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there's no ground truth to establish for it.
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