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Hemodialysis with Althin capillary dialyzers are indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

The A-18 Hemodialyzer is a conventional hemodialyzer that is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure. The blood from a patient flows through the arterial tubing of the extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the patient. The hemodialyzer has semipermeable hollow fibers which divide the device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer.

Each A-18 Hemodialyzer is packaged in a plastic bag and 20 hemodialyzers are packed in a cardboard box.

It is sterilized by gamma radiation and intended, and labeled, for single use only.

The Althin Medical AB A-18 Hemodialyzer is a conventional hemodialyzer used to treat patients with acute or chronic renal failure. The device was deemed substantially equivalent to the Althin Medical Inc Altra Nova 170 Hemodialyzer (K945621).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the functional testing. It only mentions "functional testing has been conducted to evaluate the functional performance of the A-18 Hemodialyzer."
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective.

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

This information is not provided in the document. The document refers to "specifications cleared for the predicate device" as the basis for testing, implying a comparison against established performance standards rather than expert-defined ground truth for specific cases.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. The submission focuses on demonstrating substantial equivalence to a predicate device through functional and biocompatibility testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a hemodialyzer, a physical medical device, not an algorithm or AI system. Therefore, standalone performance in the context of AI algorithms is not relevant. The "functional testing" described evaluates the device's physical performance.

7. The Type of Ground Truth Used

The ground truth for the functional testing appears to be based on the specifications and performance characteristics of the legally marketed predicate device (Altra Nova 170 Hemodialyzer), along with established industry standards for biocompatibility (ISO10993). This is a comparative "ground truth" rather than an expert consensus, pathology, or outcomes-based ground truth typical for diagnostic AI.

8. The Sample Size for the Training Set

This question is not applicable as the A-18 Hemodialyzer is a physical medical device and does not involve a training set in the context of machine learning or AI.

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

This question is not applicable for the same reason as point 8.

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