(186 days)
Hemogrip™ Patch is indicated for use, under the direction of a healthcare professional, in the management of bleeding wounds such as vascular access sites and percutaneous catheters or tubes.
The Hemogrip™ Patch Hemostasis Pad is a non-invasive topical bandage intended to promote hemostasis when in contact with a bleeding wound. Hemogrip™ Patch is composed of a soft, sterile, palmitoyl-N-acetylglucomasine substrate/backing coated with a freeze-dried layer of poly N-acetylglucosamine (chitosan). The environment of use for the Hemogrip™ Patch is at a healthcare facility/hospital under the direction of a healthcare professional.
The Hemogrip™ Patch Hemostasis Pad promotes the control of bleeding wounds in patients. This is achieved by applying proximal pressure to the puncture site and placing a Hemogrip™ Patch over the puncture site using a sterile folded gauze. Firm compression is applied over the puncture site until hemostasis is achieved. Proximal pressure can be released after 2 to 3 minutes. Once hemostasis is achieved, pressure is released and a dry gauze is placed over the Hemogrip" Patch. The site is then covered with an appropriate dressing. Within 24 hours, Hemogrip™ Patch should be soaked with water and gently removed.
The Hemogrip™ Patch is sterilized via y-irradiation and is for single use only.
The provided document is a 510(k) summary for the Hemogrip™ Patch, a topical hemostasis pad. It focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria and detailed performance metrics as one might find for a novel AI/software medical device.
Therefore, the information requested, particularly regarding acceptance criteria, specific performance metrics (like sensitivity, specificity, or AUC), sample sizes for test/training sets, expert adjudication details, and MRMC studies, is not available in this document. The document describes a non-clinical animal study to demonstrate performance similarity, and biocompatibility testing.
Here's an analysis based on the provided text, highlighting what is (and isn't) present:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria in terms of quantitative performance metrics for human use, such as time to hemostasis, success rates in a clinical population, or statistical thresholds. Instead, the performance evaluation is based on demonstrating similarity to a predicate device in an animal model and meeting biocompatibility standards.
| Acceptance Criteria (Implicit from Study Design) | Reported Device Performance |
|---|---|
| Hemostasis Performance: No statistically reliable difference compared to the predicate device in ability to promote hemostasis in an acute splenic hemorrhage swine model. | "Analysis of the results indicated no statistically reliable difference in the performance of the Syvek Patch and Hemogrip™ Patch in their ability to promote hemostasis. In all instances, the Hemogrip™ Patch functioned as intended and the control of bleeding observed was as expected." |
| Biocompatibility: Meet requirements of ISO 10993 standards (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity). | "Hemogrip™ Patch met the requirements of biocompatibility for each of these tests." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated as a number of animals. The study refers to "a controlled acute swine model," implying multiple animals were used, but the exact count is not provided.
- Data Provenance: The study was an "animal study... in a controlled acute swine model of splenic hemorrhage." The location of the study (e.g., country of origin) is not specified. It is a prospective animal study as it involved conducting tests for the purpose of this submission.
- No human data (retrospective or prospective) for a "test set" is mentioned for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This was an animal study evaluating hemostasis, not a study requiring human expert assessment of images or clinical outcomes that would typically establish ground truth for a diagnostic device. The "ground truth" here would be the observed hemostatic outcome in the animal model.
4. Adjudication method for the test set
- Not applicable. See point 3.
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
- No. This is a physical medical device (hemostasis patch), not an AI/software medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical medical device. Performance relates to its physical interaction with wounds, not an algorithm.
7. The type of ground truth used
- The ground truth for the hemostasis performance study was the observed hemostatic outcome in the acute splenic hemorrhage swine model.
- For biocompatibility, the ground truth was meeting the criteria specified by ISO 10993 standards (e.g., absence of cytotoxicity, irritation, sensitization, or acute systemic toxicity).
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
N/A