(254 days)
Rx Only: HemCon GuardaGel™ is intended for management of wounds and for emergency external use for the temporary control of minor bleeding from skin surface wounds.
OTC: HemCon GuardaGel™ First Aid is intended for management of wounds and for emergency external use for the temporary control of minor bleeding from minor topical cuts and lacerations.
HemCon GuardaGel™ is intended for the management of wounds and for emergency external use in the temporary control of minor bleeding from the skin and other surface wounds where temporary control of bleeding is required. It is a homogenous aqueous, viscous opaque gel comprised of pectin, m.doc™ (HemCon's proprietary hemostatic oxidized cellulose formulation), potassium sorbate, glycerol and 5 %w/w ethanol. The gel comes in a sterile pre-filled syringe.
The available document is a 510(k) summary for the HemCon GuardaGel™ and does not contain a comprehensive study report with detailed acceptance criteria and performance data in the format requested. However, based on the information provided, I can extract the following:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions that HemCon has "demonstrated the ability to repeatedly product that the meets existing acceptance criteria," but it does not explicitly list these acceptance criteria or specific numerical performance targets for hemostatic efficacy. It only provides the actual results observed in a rabbit study.
| Acceptance Criteria | Reported Device Performance (HemCon GuardaGel™) |
|---|---|
| Hemostatic Efficacy | Time for cessation of bleeding: 23.1 s ± 5.8 s (compared to 106.8 s ± 18.6 s for untreated wounds) |
| Biocompatibility | Demonstrated according to ISO 10993 (Cytotoxicity, irritation, and sensitization testing performed). |
| Sterility | Sterility validations completed following ISO 11137:2006 requirements to demonstrate a 10^-6 SAL using the VDmax25 method. |
2. Sample size used for the test set and the data provenance
- Hemostatic Efficacy (in vivo): The document states "The average time for cessation of bleeding of wounds treated with HemCon GuardaGel™ was 23.1 s ± 5.8 s compared to 106.8 s ± 18.6 s for untreated wounds." The specific sample size (number of rabbits or wounds) is not provided.
- Data Provenance: The study was "in vivo in rabbits," which implies animal testing, not human data. The location is not specified, but the applicant is HemCon Medical Technologies Europe Ltd., suggesting it could be Europe. It is a prospective study as it's part of premarket notification for a new device.
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 document, as the hemostatic efficacy study was an animal model, not a clinical study involving human expert assessment of a ground truth.
4. Adjudication method for the test set
- This information is not applicable and not provided as the hemostatic efficacy study was an animal model, not a clinical trial requiring adjudication of human assessments.
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 as the device is a hemostatic gel, not an AI software intended for image interpretation or diagnosis. No MRMC study was mentioned or performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This information is not applicable as the device is a hemostatic gel and does not involve an algorithm or AI.
7. The type of ground truth used
- For hemostatic efficacy (in vivo): The "ground truth" was the observed time to cessation of bleeding in an animal model (rabbits), measured directly.
- For biocompatibility: The ground truth was defined by the adherence to ISO 10993 standards and the results of specified tests (cytotoxicity, irritation, sensitization).
- For sterility: The ground truth was defined by the demonstration of a 10^-6 SAL (Sterility Assurance Level) according to ISO 11137:2006.
8. The sample size for the training set
- This information is not applicable as the device is a physical medical device (hemostatic gel), not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- This information is not applicable for the reasons stated above.
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