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Hemodialysis with the FB-U Hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.

Device Description

The Nipro FB-U hemodialyzer is a medical device intended for use as an artificial kidney system for the treatment of patients with renal failure. During treatment, blood is circulated from the patient, through the extracorporeal system, into the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate.

AI/ML Overview

Device: Nipro FB-U Hemodialyzer

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Predicate)	Reported Device Performance (Nipro FB-U Hemodialyzer)
Clearances	Not explicitly stated, implied to be equivalent to predicate.	Demonstrated to be equivalent to predicate in non-clinical tests.
Ultrafiltration coefficient	Not explicitly stated, implied to be equivalent to predicate.	Demonstrated to be equivalent to predicate in non-clinical tests.
Volume of blood compartment	Not explicitly stated, implied to be equivalent to predicate.	Demonstrated to be equivalent to predicate in non-clinical tests.
Pressure drop	Not explicitly stated, implied to be equivalent to predicate.	Demonstrated to be equivalent to predicate in non-clinical tests.
Positive and negative pressure tests	Not explicitly stated, implied to be equivalent to predicate.	Passed (included in non-clinical tests).
Blood compartment integrity	Not explicitly stated, implied to be equivalent to predicate.	Passed (included in non-clinical tests).
Transportation tests	Not explicitly stated, implied to be equivalent to predicate.	Performed and results included in submission.
Biocompatibility	Not explicitly stated, implied to be equivalent to predicate.	Performed and results included in submission.
Shelf-life testing	Not explicitly stated, implied to be equivalent to predicate.	Performed and results included in submission.
Materials - Housing	Polypropylene/polycarbonate (for predicate and/or similar devices)	Polypropylene
Materials - Membrane	Polyether sulfone/Cellulose Triacetate (for predicate and/or similar devices)	Cellulose Triacetate
Design	Mechanical device consisting of a cylindrical rigid housing enclosing hollow fibers	Same
Intended Use	As part of an artificial kidney system for removal of toxins and excess water from blood	Same
Energy Source	To be used with dialysis machines equipped with an ultrafiltration controller or accurate fluid balancing system	Same

2. Sample Size Used for the Test Set and Data Provenance:

The document states "Non-clinical tests submitted," which include "dimensional and performance to include: positive and negative pressure tests, blood compartment integrity, clearances, Ultrafiltration coefficient, volume of blood compartment, and pressure drop." It also mentions "Other test items include: Transportation tests, biocompatibility, and shelf-life testing."

Sample Size: The document does not explicitly state the specific sample sizes used for each of these non-clinical tests.
Data Provenance: The tests are described as "non-clinical tests submitted," implying they were conducted by Nipro Medical Corporation as part of their submission. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective, though non-clinical tests are generally prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. The study relies on objective physical and chemical measurements (e.g., clearances, pressure tests) rather than expert interpretation of data for establishing ground truth in non-clinical testing.

4. Adjudication Method for the Test Set:

Not applicable. As the study primarily concerns non-clinical, objective measurements, an adjudication method for a "test set" (in the sense of human interpretation) is not relevant.

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. No MRMC study was conducted. This device is a hemodialyzer, not an AI-powered diagnostic or assistive technology for human readers.

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

Not applicable. This device is a physical hemodialyzer, and therefore the concept of a standalone algorithm or human-in-the-loop performance is not relevant. The performance evaluation is of the device's physical and functional characteristics.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical tests was established through objective physical and chemical measurements and engineering standards. For example:

Clearances were measured against established methods for filtration efficiency.
Pressure tests confirmed resistance to specified pressures.
Integrity tests confirmed the physical structural soundness.
Biocompatibility tests likely adhered to ISO standards (e.g., ISO 10993).
Shelf-life tests involved stability and performance over time.

The "ground truth" for showing substantial equivalence was the performance characteristics of the legally marketed predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set. The performance data is derived from testing of the physical device.

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

Not applicable, as there is no training set for this type of device.

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