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The Diacap® Polysulfone HiFlo 23 Hemodialyzer is designed for single use in acute and chronic hemodialysis.

The Diacap® Polysulfone HiFlo 23 Hemodialyzer is a high permeability dialyzer intended to be used in acute and chronic hemodialysis. It is composed of polysulfone hollow fiber capillary membranes in a polycarbonate housing with a polyurethane potting resin and a silicone O-ring. The proposed Diacap HiFlo 23 hemodialyzer will be available in one model, the 23, which represents the effective surface area of 2.3m². The dialyzer is intended for single use and is provided sterile.

The provided text is a 510(k) summary for the B. Braun Avitum AG Diacap Polysulfone HiFlo 23 Hemodialyzer. It focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, device performance metrics, or a study that quantitatively proves the device meets those criteria in the way typically expected for AI/ML device evaluations.

Instead, the document states:

"Verification and validation testing for the proposed dialyzer have been completed and all acceptance criteria have been met. The testing demonstrated that there are no differences between the predicate and the proposed device that raise new issues of safety or effectiveness."

This indicates that internal testing was conducted, and the results satisfied predefined acceptance criteria. However, the document does not provide a table of these criteria, the reported device performance, or details about the study design that would allow for a comprehensive answer to your request in the context of an AI/ML device.

Therefore, I cannot provide the requested information regarding sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided document.

The document focuses on the regulatory approval process for a medical device based on substantial equivalence, rather than a detailed scientific study proving performance against specific quantitative metrics for an AI/ML algorithm.

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