(85 days)
The HemCon™ Bandage OTC Is indicated for the local management of bleading such as laceration and minor bleeding.
The HemCon™ Bandage OTC is manufactured from chilosan, a material consisting of callulosic polymer, poly-N-acetylgiucosamine. The HemCon™ Bandage OTC device is packaged in a foll package and are provided sterile.
The provided document is a 510(k) premarket notification for the HemCon™ Bandage OTC. It confirms the device's substantial equivalence to predicate devices and does not contain detailed information about a specific study proving acceptance criteria. Instead, it refers to performance data previously submitted for a referenced device.
Therefore, many of the requested elements about acceptance criteria, study design, and ground truth cannot be extracted directly from this document. However, I can infer some points based on the nature of a 510(k) submission for this type of device.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not explicitly state acceptance criteria or provide a table of reported device performance. For a device like a hemostatic bandage, common performance criteria would likely revolve around its ability to stop bleeding, biocompatibility, and safety. The document states:
- "Performance data for the HemCon™ Bandage OTC has been previously submitted in the referenced device submission."
- "In summary, the HemCon™ Bandage OTC is expected to achieve the same safety and effectiveness as the predicate devices mentioned above."
Therefore, the acceptance criteria would implicitly be that the device performs equivalently to the predicate devices in terms of safety and effectiveness for its intended use (local management of bleeding such as laceration and minor bleeding).
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not available in the provided text. A 510(k) summary typically doesn't include specific details on sample sizes or data provenance for studies, especially if relying on previous submissions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not available in the provided text. For a medical device like a bandage, clinical trials or material safety tests would typically involve medical professionals (e.g., surgeons, emergency room physicians) if human studies were conducted, or lab personnel for bench testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not available in the provided text.
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 describes a hemostatic bandage, not an AI-powered diagnostic or assistive device. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not applicable and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
This is not applicable as the HemCon™ Bandage OTC is a physical medical device, not an algorithm, and does not involve human-in-the-loop performance in the context of an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not explicitly stated. For a hemostatic bandage, ground truth would likely be established through objective measures of bleeding cessation, wound healing, safety (e.g., infection rates, allergic reactions), and biocompatibility, often compared against established standards or predicate device performance. Outcomes data (e.g., time to hemostasis, adverse event rates) would be a key component.
8. The sample size for the training set
This information is not available in the provided text, as this is a physical medical device and the concept of a "training set" (as used in machine learning) does not apply in the same way. Performance data would likely come from pre-clinical (in vitro, in vivo animal) and possibly clinical human studies.
9. How the ground truth for the training set was established
This information is not available in the provided text for the reasons mentioned in point 8.
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