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The Hemoflow F3 and F4 dialyzers are intended for hemodialysis of patients, including pediatric patients, with acute or chronic renal failure when conservative therapy is judged to be inadequate. Consider body and dialyzer surface area, blood flow, body weight, and extracorporeal blood volume when selecting dialyzers for use with pediatric patients.

The Hemoflow F3 and F4 dialyzers are low-flux, single-use, ethylene oxide (EO) sterilized hemodialyzers. The dialyzers are provided blood pathway sterile and non-pyrogenic. The membrane surface areas of the F3 and the F4 dialyzers are 0.3 m2 and 0.7 m2, respectively.

The Hemoflow F3 and F4 dialyzers are low-flux, sterile devices designed for single-use acute and chronic hemodialysis. The dialyzers are configured to connect to a bloodline set which connects to a patient's vascular access system when used with a hemodialysis machine equipped with ultrafiltration control. During hemodialysis, blood is pumped from the patient's body through an extracorporeal circuit, one component of which is the dialyzers contain a semi-permeable membrane that allows for diffusion and/or ultrafiltration to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate compartment. Dialyzers utilize a counter-current flow in which dialysate and blood flow in opposite directions in the dialyzer. The counter-current flow maintains the concentration gradient across the membrane for waste and fluid removal.

The provided text is related to a 510(k) premarket notification for Hemoflow F3 and F4 Dialyzers, not a study describing acceptance criteria and device performance in the context of AI or software. Therefore, much of the requested information (like sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable or present in this document.

However, I can extract the relevant performance data and highlight the acceptance criteria as stated for the dialyzers themselves and the summary of compliance.

Here's an attempt to structure the available information, noting where information is not present as per your request related to an "AI device":

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

For medical devices like dialyzers, performance is typically demonstrated through various tests meeting established standards. While specific numerical acceptance criteria (e.e.g. "urea clearance must be >X") are not explicitly listed in easily interpretable tables for each test, the text states the ultimate acceptance: "All testing met predetermined acceptance criteria." and "Results of the proposed devices' design verification tests met the requirements and demonstrated that, like the predicate device, the Hemoflow F3 and F4 dialyzers are safe and effective for their intended use."

The key performance characteristic highlighted and its reported value are:

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

The document mentions "A retrospective data analysis performed on the Hemoflow F3 and F4 dialyzers included 10 pediatric ESRD patients on HD treated for 12 consecutive weeks." This appears to be a clinical "test set" for the clinical effectiveness aspect (adequate clearance), not for the engineering performance tests.

• Sample Size (Clinical): 10 pediatric ESRD patients
• Data Provenance (Clinical): Retrospective. Country of origin not specified.

For the engineering performance tests listed in Table 2, the sample size of dialyzers tested is not explicitly stated.

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. This document describes a medical device (dialyzers), not an AI device that relies on expert human interpretation for ground truth.

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

Not applicable. This document describes a medical device, not a diagnostic or AI system requiring adjudication of expert interpretations.

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

Not applicable. This document is for a medical device (dialyzers), not an AI-assisted diagnostic tool.

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

Not applicable. This document is for a medical device (dialyzers), not an AI algorithm.

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

For the clinical study mentioned: "adequate clearance" with a mean spKt/V of 1.78 (F3) and 2.18 (F4) served as the "ground truth" or outcome measure for the clinical effectiveness aspect. This is outcomes data (clinical efficacy in terms of clearance).
For the engineering performance tests, the "ground truth" is typically established by physical measurements and adherence to established engineering standards (e.g., ISO 8637:2010) and regulatory guidance.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI device.

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

Not applicable. There is no mention of a training set as this is not an AI device.

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