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TRAUMAGEL® is a hemostatic gel indicated for temporary external use for controlling moderate to severe bleeding.

TRAUMAGEL® is a single-use, hemostatic gel indicated for temporary external use only. The subject device is supplied as an individually pouched 30 mL hemostatic gel syringe, containing chitosan [poly (N-acetyl-D-glucosamine, D-glucosamine)] granules suspended in a sodium alginate hydrogel and is enclosed in a protective pouch. Each syringe is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10th. The hemostatic gel is viscous, opaque and tan in color.

The provided document is a 510(k) summary for the TRAUMAGEL® Hemostatic Gel. It primarily focuses on demonstrating substantial equivalence to a predicate device (CELOX Gauze Pro) based on design, technological characteristics, and non-clinical testing.

The document does not include the information requested regarding a study that proves the device meets specific acceptance criteria related to a human-in-the-loop or standalone AI/software performance. This is because TRAUMAGEL® is a medical device (hemostatic gel), not an AI or software-based medical device. Therefore, the questions about sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, AI assistance, training data, etc., are not applicable to this product and its regulatory submission.

The "Acceptance Criteria" described in the document relate to biocompatibility testing and performance bench testing for a physical medical device, not a software algorithm.

Here's a breakdown of the relevant information provided in the document:

1. A table of acceptance criteria and the reported device performance (for biocompatibility testing):

(Note: "Physical and/or Chemical Information" acceptance criteria is listed as N/A, as it's for information gathering, not a Pass/Fail test.)

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

• Sample Size: Not explicitly stated for each non-clinical test, but implied to be sufficient for the required ISO standards.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be non-clinical (laboratory and animal studies).

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

• Not applicable as this is not a diagnostic AI/software device requiring human expert annotation of images/data for ground truth. The "ground truth" for the non-clinical tests is established by the standardized test methods (e.g., ISO standards for biocompatibility) and direct measurement of physical or biological responses.

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

• Not applicable for non-clinical device testing.

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 device is a physical hemostatic product, not an AI/software.

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

• Not applicable; this is not a software algorithm.

7. The type of ground truth used:

• For biocompatibility: Adherence to ISO standards and observed biological responses.
• For performance bench testing: Physical and chemical properties measured against predefined specifications.
• For non-clinical animal studies: Direct observation of hemostatic performance in a porcine model. The document states: "testing demonstrated substantially equivalent performance between the device and the predicate."

8. The sample size for the training set:

• Not applicable; there is no AI/machine learning training set for this product.

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

• Not applicable.

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Cresilon Hemostatic Gel™ (CHG™) is a hemostatic gel for external use only.

Cresilon Hemostatic Gel™ (CHG™) is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations, and minor abrasions.

Cresilon Hemostatic Gel™ (CHG™) is a hemostatic gel for external use only, indicated for the local management of bleeding wounds such as minor cuts, minor lacerations, and minor abrasions.

CHG's hemostatic gel is comprised of poly(N-acetyl-D-glucosamine, D-glucosamine), sodium alginate, and water. CHG is supplied as individually pouched, sterile, pre-filled, single-use syringes. Each syringe is a single 5 mL hemostatic gel application. CHG is packaged in a box containing two (2) CHG applications.

After removal from the pouch, the cap is unscrewed, and the syringe is primed, the hemostatic gel is topically applied directly to the source of bleeding via the syringe.

The provided document is a 510(k) premarket notification from the FDA, specifically concerning the Cresilon Hemostatic Gel (CHG) device. It outlines the device's characteristics, intended use, and a comparison to a predicate device (Gel-E Flex) to demonstrate substantial equivalence.

However, the document does not contain information about:

• A "study that proves the device meets the acceptance criteria" in the context of an AI/machine learning device.
• "Acceptance criteria" as typically defined for the performance metrics of an AI/machine learning model (e.g., sensitivity, specificity, AUC).
• Details on a test set (sample size, provenance), expert ground truth establishment (number of experts, qualifications, adjudication), MRMC studies, standalone algorithm performance, or training set details.

This document pertains to a medical device (a hemostatic gel), not an AI/machine learning product. Therefore, the requested information points (1-9) are largely irrelevant to the content of this FDA 510(k) submission. Medical devices like this gel are typically evaluated based on biocompatibility, performance bench testing (e.g., in vivo animal efficacy), sterilization, and shelf-life, as detailed in the "Non-clinical Testing" section.

Based on the provided text, it is not possible to answer the questions about AI/ML device acceptance criteria and study details. The document is for a physical medical device (hemostatic gel), not a software or AI-powered diagnostic/therapeutic tool.

If the request implies searching for acceptance criteria and study data within the context of a traditional medical device rather than an AI/ML device, then the relevant information from the document would be as follows:

Acceptance Criteria and Device Performance (for a Traditional Medical Device):

The "acceptance criteria" for this traditional medical device are primarily related to its safety and functional performance as observed in non-clinical (biocompatibility and animal efficacy) testing, demonstrating it is "as safe, as effective, and performs as well as the predicate device."

Details of the Study (Non-Clinical Testing for a Traditional Medical Device):

The document describes non-clinical testing, but not in the format of an AI/ML study.

1. A table of acceptance criteria and the reported device performance: See table above.
2. Sample size used for the test set and the data provenance:
   • Biocompatibility Testing: Not specified as a "test set" in terms of number of samples, but tests were performed on "representative samples." Data provenance is not explicitly stated beyond being conducted per ISO 10993-1:2009.
   • In Vivo Animal Efficacy Testing: Conducted in a "porcine model of skin laceration." The number of animals or specific "sample size" is not provided. Data provenance is implied to be from this specific animal model, likely controlled lab conditions. "Retrospective or prospective" is not applicable in the AI/ML sense but would generally be a prospective animal study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance in animal models is typically objective (e.g., cessation of bleeding, lack of adverse reactions) or determined by veterinary professionals, not "experts" in the context of radiological interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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: Not applicable, as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used:
   • Biocompatibility: Compliant with ISO 10993-1:2009 standards for biological endpoints (cytotoxicity, irritation, sensitization, pyrogenicity, acute systemic toxicity, hemolysis).
   • In Vivo Animal Efficacy: Demonstrated functional performance (hemostatic effect) in a porcine laceration model. The "ground truth" is whether the device stopped bleeding as intended.
8. The sample size for the training set: Not applicable, as this is not an AI device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

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