(209 days)
AnsCare ChitoClot Pad is indicated for use of bleeding wound management. It promotes rapid control of wound bleeding and exudates absorption.
AnsCare ChitoClot Pad is indicated for use in wound management and to provide barrier to bacteria.
It is indicated for the following wounds, including lacerations, abrasions, hemodialysis wound and puncture sites for vascular procedures.
AnsCare ChitoClot Pad is made from cross-linked chitosan with glutaraldehyde. It works as a topical wound dressing intended to promote hemostasis when in contact with a bleeding wound. AnsCare ChitoClot Pad is made from chitosan whose hemostatic effect is independent of anticoagulant. Chitosan has a long clinical history of safety and effectiveness.
The provided text describes the AnsCare ChitoClot Pad, a wound dressing intended to promote hemostasis and provide a bacterial barrier.
Here's an analysis of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
The document states, "All the test results demonstrate that AnsCare ChitoClot Pad meet the requirements of its pre-defined acceptance criteria and intended uses." However, it does not explicitly list specific numerical or qualitative acceptance criteria for each test performed. It only lists the tests themselves. Therefore, a table comparing acceptance criteria to reported performance cannot be fully constructed from the provided text.
The reported device performance, in a general sense, is that it "meet[s] the requirements of its pre-defined acceptance criteria and intended uses."
Table of Tests Performed and General Performance:
| Test Category | Test | Reported Performance |
|---|---|---|
| Biocompatibility | In Vitro Cytotoxicity Test | Met requirements (implied by overall statement) |
| Skin Irritation Study in White Rabbits | Met requirements (implied by overall statement) | |
| Skin Sensitization Study in Guinea Pigs | Met requirements (implied by overall statement) | |
| Acute Intravenous Systemic Toxicity Study in Mice | Met requirements (implied by overall statement) | |
| Acute Intraperitoneal Systemic Toxicity Study in Mice | Met requirements (implied by overall statement) | |
| Hemolysis Test | Met requirements (implied by overall statement) | |
| Pyrogen Test in White Rabbits | Met requirements (implied by overall statement) | |
| Bench Performance | Absorbency Testing | Met requirements (implied by overall statement) |
| pH Testing | Met requirements (implied by overall statement) | |
| Dimension and weight Testing | Met requirements (implied by overall statement) | |
| Barrier to bacteria Testing | Met requirements (implied by overall statement) | |
| Competitor analysis | Met requirements (implied by overall statement) |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for any of the non-clinical tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for these tests. The animal studies mentioned (white rabbits, guinea pigs, mice) imply laboratory conditions, but no further details are given.
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 tests described are primarily non-clinical (biocompatibility and bench performance) and do not typically involve human expert interpretation for ground truth establishment in the way clinical studies with image analysis or diagnostics would.
4. Adjudication method for the test set
This information is not applicable/not provided. The listed tests are laboratory-based and generally have objective endpoints rather than requiring adjudication methods like those used in clinical trials with human readers.
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
There is no mention of an MRMC comparative effectiveness study, AI assistance, or human readers in the context of this device. The device is a wound dressing, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical wound dressing and does not involve an algorithm.
7. The type of ground truth used
For the non-clinical biocompatibility and bench performance tests, the "ground truth" would be established by the standard scientific and regulatory protocols for each specific test (e.g., cell viability assays for cytotoxicity, physiological responses for irritation, specific absorption measurements for absorbency, microbial growth inhibition for barrier to bacteria). These are objective measurements rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
This information is not applicable/not provided. The device is a physical wound dressing, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This information is not applicable/not provided, as there is no training set for this type of device.
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