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AnsCare ChitoClot Gauze (prescription use): For use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations.

AnsCare ChitoClot Gauze (over-the-counter use): To control bleeding of lacerations, minor cuts and abrasions.

The AnsCare ChitoClot Gauze is made of a non-woven fabric derived from chitosan fibers. The device is made of 100% chitosan - it is not coated or impregnated with chitosan granules. Chitosan is a naturally occurring polysaccharide usually derived from shellfish, and its hemostatic properties are widely recognized in the biomedical field. When applied directly on a wound with firm pressure, the AnsCare ChitoClot Gauze will turn into a gel-like condition to absorb the blood and seal the wound. The AnsCare ChitoClot Gauze also contains acetic acid as an acidity regulator and Polysorbate 20 as a surfactant.

The provided text does not contain information about acceptance criteria for a device's performance that would typically be described with metrics like accuracy, sensitivity, or specificity, nor does it include a study that proves the device meets such criteria.

The document discusses the regulatory approval (510(k)) of the "AnsCare ChitoClot Gauze" device, asserting its substantial equivalence to predicate devices based on non-clinical testing. The non-clinical testing included biocompatibility tests, bench performance tests, and animal testing. However, the exact acceptance criteria for these tests and their numerical results are not provided.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: The document lists types of tests conducted but does not provide specific criteria or performance metrics in a quantifiable way.
2. Sample size used for the test set and the data provenance: No details about sample sizes for the "test set" (which here refers to non-clinical testing as opposed to a clinical AI model test set) or data provenance are given.
3. Number of experts used to establish the ground truth... and their qualifications: This information is not relevant to the type of non-clinical testing described.
4. Adjudication method: Not relevant to the non-clinical testing described.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: This type of study is used for diagnostic algorithms or medical imaging devices involving human readers and AI performance, which is not applicable to the "AnsCare ChitoClot Gauze" as described.
6. Standalone (i.e. algorithm only without human-in-the loop performance) study: Again, this is for AI algorithms, not the type of medical device described.
7. The type of ground truth used: The "ground truth" in the context of this device's testing would be the measured outcomes of the non-clinical tests (e.g., cytotoxicity, pH, hemostasis in animal models). No specific ground truth definition is stated beyond the test results themselves.
8. The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on demonstrating substantial equivalence for regulatory purposes, primarily through comparisons of intended use, materials, design, and general safety/performance claims with already cleared predicate devices.

Information that can be extracted related to testing:

Non-clinical Testing Conducted (listed in Section 5.8):

• Biocompatibility testing:
  • Cytotoxicity Test
  • Skin Irritation Test
  • Skin Sensitization Test (Closed-patch Method)
  • Acute Systemic Toxicity (intraperitoneal and intravenous)
  • Hemolysis Test Report
  • Pyrogen, Protein content and Residual solvent Testing Report
• Bench performance testing:
  • Absorb Test
  • pH
  • Tensile Strength (wet and dry)
  • Platelet Aggregation
  • Extreme Environmental Conditions Test
  • Competitor analysis
• Animal Testing:
  • In-vivo Hemostasis Test

The conclusion states: "All the test results demonstrate that AnsCare ChitoClot meet the requirements of its pre-defined acceptance criteria and intended uses." However, the specific acceptance criteria and the detailed test results are not enumerated in this document.

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