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The Hemofeel™-CH hemofilter is indicated for use in the prevention or treatment of fluid overload, electrolyte and acid/base imbalances in cases of acute renal failure or toxemia with oliguria or anuria. It may also be used when removal of excess fluid is indicated, such as patients in pulmonary edema or congestive heart failure refractory to diuretic therapy.

The Hemofeel-CH Hemofilter consists of highly permeable polymethylmethacrylate (PMMA) hollow fibers housed in a polystyrene casing and secured at each end with polystyrene headers. Blood enters the device through the arterial inlet port, passes through the hollow fibers and exits at the opposite end through the venous outlet port. The Hemofeel-CH hemofilter is provided in a range of sizes based on the surface area of the hollow fiber membrane. Hemofilter size should be selected by the physician according to the patient's body weight and medical condition. The device is gamma-ray sterilized and intended for single use only.

Toray Industries (America), Inc.'s Hemofeel™-CH Hemofilter study:

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Test Set (Clinical Study): 8 anuric critically ill patients.
• Data Provenance: The document does not specify the country of origin, but the clinical study was "in the clinical setting", suggesting a prospective clinical trial.

3. Number of Experts and Qualifications:

• Not Applicable. The document describes a medical device's performance, not an AI or diagnostic system requiring expert interpretation for ground truth. The "experts" involve the physicians overseeing the clinical study.

4. Adjudication Method:

• Not Applicable. This is a performance study for a medical device, not a diagnostic system requiring adjudication of interpretations. Outcomes were assessed in the clinical setting.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This is not an MRMC comparative effectiveness study. It's a study evaluating the performance of a medical device (hemofilter).

6. Standalone (Algorithm Only) Performance:

• No. The device is a physical medical device (hemofilter) and does not involve an algorithm with standalone performance.

7. Type of Ground Truth Used:

• Clinical Outcomes/Observations and In-Vitro Measurements:
  • For the clinical study, the ground truth was based on patient outcomes and observations regarding fluid and electrolyte management, and the occurrence of complications.
  • For in-vitro testing, the ground truth was based on laboratory measurements of various performance parameters (ultrafiltration coefficient, water permeability, pressure drop, hemolysis) against established scientific or engineering benchmarks.

8. Sample Size for the Training Set:

• Not Applicable. This is a medical device, not an AI or machine learning algorithm requiring a training set in that context. The device's design and manufacturing process would involve internal testing and development data, but not a "training set" as understood in AI studies.

9. How Ground Truth for the Training Set Was Established:

• Not Applicable. As explained above, there is no "training set" in the context of an AI algorithm for this device. The design and validation of the hemofilter would have involved engineering specifications, material science data, and pre-clinical testing, which serve a similar function to inform product development.

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