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For OTC applications, Algisite M may be used for the management of minor conditions such as: Lacerations, Abrasions, Skin Tears, Minor Burns. Under the care of a healthcare professional, Algisite M may be used for the management of full and partial thickness wounds including: Leg Ulcers, Pressure Ulcers, Diabetic Foot Ulcers, Surgical Wounds.

Algisite M - Calcium Alginate Dressing

The provided text describes a 510(k) summary for the Algisite M - Calcium Alginate Dressing. It focuses on demonstrating the substantial equivalence of Algisite M to predicate devices through technological characteristics and biocompatibility testing. There is no information in the document about a study that assesses device performance against specific acceptance criteria in the context of clinical efficacy or diagnostic accuracy. Instead, the studies presented are primarily for biocompatibility and sterility.

Therefore, many of the requested sections regarding clinical performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies cannot be answered from the provided document.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria for clinical performance or a direct comparison of device performance against such criteria. The reported performance is related to biocompatibility and sterility.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cytotoxicity: Mouse L929 cells (in vitro).
• Skin Irritation: Rabbit skin (animal model).
• Sensitization: 20 guinea pigs (animal model).
• Acute Systemic Toxicity: Mouse (animal model).
• Haemolysis: In vitro test using blood.
• Sterilization: Not applicable for a "test set" in the sense of clinical data. This refers to the product itself and its manufacturing process.

The data provenance is from laboratory/animal studies, not human clinical data. No country of origin for the studies is explicitly stated, though "British Standard" and "U.S. National Formulary" are mentioned, implying international standards were followed. These are prospective laboratory and animal studies.

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)

Not applicable. The ground truth for these biocompatibility tests is established by standardized laboratory assay results and observations (e.g., cell viability, skin reactions, animal responses, hemolysis percentages). No human expert consensus for interpreting device performance in a clinical context is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical endpoints or image interpretation where human expert disagreement needs to be resolved. The studies described are laboratory-based and follow standardized protocols.

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

No such study was performed or described. This document pertains to a medical dressing and its biocompatibility, not an AI-assisted diagnostic or interpretative device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the biocompatibility studies is based on established biological and chemical indicators as defined by the respective standards and protocols (e.g., cell viability, absence of skin irritation, absence of systemic toxicity, specific hemolysis percentages).

8. The sample size for the training set

Not applicable. There is no training set in the context of this device. The product undergoes manufacturing processes and quality control, not machine learning model training.

9. How the ground truth for the training set was established

Not applicable, as there is no training set mentioned.

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