(152 days)
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):
| Biological endpoint | Acceptance criteria | Test Result |
|---|---|---|
| Cytotoxicity | Non-cytotoxic | Pass |
| Sensitization | Non-sensitizing | Pass |
| Irritation | Non-irritating | Pass |
| Material Mediated Pyrogenicity | Non-pyrogenic | Pass |
| Acute Systemic Toxicity | Non-toxic | Pass |
(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.
N/A