(32 days)
HemCon™ Bandage is a hemostatic dressing for the external temporary control of severely bleeding wounds intended for emergency use. In addition, the HemCon™ Bandage also controls bleeding in patients following hemodialysis.
The HemCon™ Bandage is applied to the wound and held in place until it adheres to the wound and hemostasis is achieved. Then, an outer bandage is applied to secure the dressing on the wound site. The HemCon™ Bandage is manufactured from ChitoClear™ chitosan ,a material consisting of cellulosic polymer, poly-N-acetylglucosamine. This device is packaged in a foil package and is provided sterile. It is sterilized by gamma irradiation at 15 kGy ensuring a SAL of 10°.
This document is a 510(k) summary for the HemCon™ Bandage, which means it describes the device's substantial equivalence to existing legally marketed devices rather than providing detailed clinical study results and acceptance criteria as would be found in a Premarket Approval (PMA) application. Therefore, much of the requested information regarding acceptance criteria, specific study design, and performance metrics is not explicitly detailed in the provided text.
However, based on the information available in the 510(k) summary, here's what can be inferred and stated:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria. Instead, it relies on demonstrating that the HemCon™ Bandage "out-performed the gauze control in all criteria" and showed "no statistical difference in the pre-injury animal characteristics" compared to predicate devices in animal models. The reported performance is qualitative and comparative rather than against predefined numerical thresholds.
| Acceptance Criteria (Inferred from Comparative Statement) | Reported Device Performance (Comparative) |
|---|---|
| Superior to gauze control | Out-performed the gauze control in all criteria |
| Comparable to predicate devices (RDH Bandage, SyvekPatch®) | Expected to achieve the same safety and effectiveness as the predicate devices mentioned above. (Implies performance is at least equivalent to these.) |
| Reduced post-treatment blood loss | Exhibited a lower rate of post-treatment blood loss (compared to gauze control) |
| Reduced fluid use | Exhibited a reduction in fluid use (compared to gauze control) |
| Higher survival rate | Exhibited a higher rate of survival (compared to gauze control) |
| Higher hemostasis rate | Exhibited a higher rate of hemostasis (compared to gauze control) |
| No statistical difference in pre-injury characteristics | No statistical difference in the pre-injury animal characteristics (between HemCon™ Bandage and control groups) |
2. Sample size used for the test set and the data provenance
The document states, "The HemCon™ Bandage has been tested in several settings utilizing accepted and approved animal models of hemorrhage..." However, it does not provide any specific sample sizes for these animal studies.
The data provenance is stated as "accepted and approved animal models of hemorrhage," implying animal studies rather than human clinical trials. The country of origin of the data is not specified. It is likely a retrospective analysis of animal study data submitted for 510(k) purposes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the 510(k) summary, as the studies mentioned are animal models, not human clinical trials requiring expert ground truth for interpretation of human data.
4. Adjudication method for the test set
This information is not provided and is generally not applicable to the type of animal studies described in a 510(k) for substantial equivalence.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not relevant to this device. The HemCon™ Bandage is a hemostatic dressing, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable to the HemCon™ Bandage, as it is a physical medical device (hemostatic dressing), not an algorithm or AI system.
7. The type of ground truth used
For the animal studies, the "ground truth" would be the direct physiological outcomes measured in the animal models, such as actual blood loss, survival rates, and observed hemostasis. This is a form of outcomes data directly observed and measured in the study subjects (animals).
8. The sample size for the training set
This information is not provided. The concept of a "training set" is typically associated with machine learning or AI algorithm development, which is not applicable to the HemCon™ Bandage. The reported "studies" are likely preclinical animal studies rather than data sets used to train a model.
9. How the ground truth for the training set was established
As the concept of a training set is not applicable, this information is not provided.
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