(41 days)
WoundStat™ is intended for emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.
WoundStat™ is a clay-based, granular hemostatic agent that is poured on or into a moderate to severe wound and held in place until it adheres to the wound and hemostasis is achieved. The device is packaged in a foil package and is provided sterile.
This document is a 510(k) premarket notification for the WoundStat™ device, comparing it to a predicate device, QuikClot®. It does not describe a study that uses acceptance criteria in the way a diagnostic AI device would. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device through pre-clinical testing, intended use, and mechanism of action.
Therefore, many of the requested fields regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert involvement, and ground truth establishment (which are typical for AI/diagnostic studies) are not applicable to this type of regulatory submission.
Here's the information that can be extracted or deduced from the provided documents:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics with thresholds (e.g., sensitivity > X%, specificity > Y%) in the context of a diagnostic or AI device study. The "acceptance criteria" here are generally meeting the requirements of substantial equivalence to the predicate device.
- Reported Device Performance:
"WoundStat™ has equivalent, if not better, hemostasis results in terms of speed and effectiveness as QuikClot®."
"The results of these tests demonstrate that WoundStat™ is safe for its intended use."
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in terms of patient or case numbers. Pre-clinical models were used.
- Data Provenance: Pre-clinical models.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. Ground truth was not established by human experts in a diagnostic reading context. The "truth" was determined during pre-clinical hemostasis and safety studies.
4. Adjudication method for the test set:
- Adjudication Method: 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:
- MRMC Study: No. This is not an AI device or a diagnostic device evaluated with human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a medical device (hemostatic agent), not an algorithm.
7. The type of ground truth used:
- Type of Ground Truth: Hemostasis results (speed and effectiveness) in pre-clinical models, and biocompatibility test results (systemic toxicity, cytotoxicity, intracutaneous studies).
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable.
In summary, this document is a regulatory submission for a physical medical device (hemostatic agent) and not an AI or diagnostic device. Therefore, the questions tailored for AI/diagnostic study evaluations are largely not relevant or applicable to the information provided. The "study" referenced is pre-clinical testing to demonstrate safety and effectiveness comparable to a predicate device.
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