(90 days)
The HemoHalt Hemostasis Pad is intended for the local management and rapid control of bleeding (hemostasis): for skin surface puncture sites for vascular procedures, percutaneous catheters and/or tubes; following hemodialysis treatments; for patients on anticoagulation therapy; and for lacerations, and nose bleeds. For use only on external bleeding wounds.
HemoHalt™ Hemostasis Pad is a soft, non-woven pad approximately 5 x 5 x 0.5cm in size, made of chitosan, a polysaccharide heteropolymer of poly-Dglucosamine and poly-N-acetyl-D-glucosamine. The HemoHalt™ Hemostasis Pad will be packaged in a paper surfaced, high barrier foil pouch for single use and terminally sterilized by E-beam radiation.
This document is a 510(k) summary for the HemoHalt™ Hemostasis Pad Wound Dressing. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel AI device. Therefore, much of the requested information cannot be extracted directly from this document.
However, I can provide the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" with numerical thresholds typically seen for new device performance validation studies. Instead, it relies on demonstrating performance that is "as well as or better than" a predicate device.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Hemostasis | Performs "as well as or better than" the predicate device | "performs as well as or better than the predicate" |
| Safety & Safety | No concerns regarding safety or effectiveness | "None of the differences raise any concerns regarding safety or effectiveness" |
| Biocompatibility | Assumed to be acceptable given the predicate comparison, though not explicitly stated as an acceptance criterion | Not explicitly detailed, but implied by the overall conclusion of substantial equivalence. |
| Sterility | Sterility (same as predicate) | Yes, terminal sterilization |
| Packaging | Similar packaging (same as predicate) | Foil pouch, single use |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document states that "In vivo and in vitro tests were performed," but it does not specify the sample sizes (e.g., number of animals for in vivo, number of replicates for in vitro) for these tests.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).
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. The studies performed were likely laboratory or animal studies, not human clinical trials requiring expert-established ground truth in the context of diagnostic interpretation.
4. Adjudication method for the test set:
This information is not provided. It's unlikely to be applicable in the context of these types of performance tests (in vivo/in vitro) where human expert adjudication for diagnostic accuracy is not the primary focus.
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 document is for a medical device (wound dressing), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This document is for a medical device (wound dressing), not an AI algorithm. Therefore, "standalone" algorithm performance is not applicable and was not done.
7. The type of ground truth used:
For the in vivo and in vitro tests, the "ground truth" would have been established through objective measurements (e.g., time to hemostasis, blood loss, biocompatibility markers) in experimental settings. The document does not specify the exact metrics or how they were defined as "ground truth."
8. The sample size for the training set:
This document is for a traditional medical device (wound dressing), not an AI/machine learning model. Therefore, there is no "training set" in the AI sense.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI model.
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