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Hemodialysis with these dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It may also be indicated in the treatment of patients intoxicated with poisons or drugs. This dialyzer is indicated for single use or reuse. If the dialyzer is reused on the same patient, the reuse procedure and disinfectant specified in the Direction Insert must be followed. No other reuse procedure or disinfectant has been evaluated for clinical acceptability.

Models CA-90, CA-110, CA-130, and CA-150 Hemodialyzers

The provided text describes a 510(k) summary for the CA® Cellulose Acetate Hollow Fiber Dialyzer. The information focuses on the device's equivalence to a predicate device and its compliance with various standards and regulations. However, it does not contain the specific details required to answer your questions about acceptance criteria, device performance from a test set, ground truth establishment, or studies showing performance metrics as typically expected for AI/ML device evaluations.

This document is for a medical device (hemodialyzer) from 1997, which predates many of the standardized evaluation methodologies common for AI/ML-driven devices. Therefore, the information you're requesting regarding "acceptance criteria and reported device performance" (with specific metrics like sensitivity, specificity), "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication methods," "MRMC studies," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" is not present in the provided text.

The closest analogue to "acceptance criteria" and "device performance" in this document refers to how the device meets biological requirements, sterilization levels, residue limits, pyrogen testing, particle limits, and functional testing against manufacturing specifications, rather than performance in detecting a condition or making a diagnosis. The study mentioned, "Clinical data was collected according to the FDA Guidance for Hemodialyzer Reuse Labeling," is focused on the reuse aspect, not on a diagnostic or AI-driven performance metric.

Given the nature and age of the document, it's not possible to extract the information you've requested in the format applicable to modern AI/ML device evaluations.

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