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The PS 150 Hemodialyzer is intended for hemodialysis in patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate.

The PS 158 Hemodialyzer consists of approximately 13,000 polysulfone hollow fibers encapsulated in polyurethane resin with an outer housing and headers made of Polycarbonate. The device is packaged in a blister package composed of Glycol modified Polyethylene Terephtalate for the bottom web, and a foil laminater for the top web. The PS 15® Hemodialyzer has two compartments, the blood compartment and the dialysate compartment, separated by the polysulfone permeable membrane and and flows from the patient access site through the tubing of the extracorporeal. system and accessories to the blood compartment of the dialyzer. From the blood compartment, undesirable substances in the blood pass through the membrane into the dialysate compartment of the dialyzer. Circulation and monitoring of dialysate into flow through the dialysate compartment is controlled by the dialysate delivery system, while the ultrafiltration controller prevents excessive loss of yeater from the patient's blood.

This document describes the acceptance criteria and study that proves the PS 15® Hemodialyzer meets these criteria. The device is intended for hemodialysis in patients with acute or chronic renal failure.

1. Acceptance Criteria and Reported Device Performance

The PS 15® Hemodialyzer was evaluated against a predicate device, the Altrex 170 Hemodialyzer, and in some functional tests, also against the Fresenius F60 Polysulfone Dialyzer. The acceptance criteria are implicitly defined by demonstrating substantial equivalence to these legally marketed predicate devices through comparable functional and biocompatibility test results.

Table: Acceptance Criteria (as demonstrated by predicate device performance) and PS 15® Hemodialyzer Performance

Note: The acceptance criteria for functional tests are based on the reported values of the predicate devices, with the expectation that the PS 15® Hemodialyzer performs comparably. For biocompatibility, the acceptance criterion is a "Pass" result, indicating the device meets established safety standards.

2. Sample Size and Data Provenance for Test Set

The document does not explicitly state the sample size for each functional and biocompatibility test. However, the tests are described as in vitro (e.g., clearance tests) or in vivo (e.g., animal biocompatibility studies in guinea pigs, rats, rabbits, and mice). The data provenance is not specified beyond being "functional testing" and "biocompatibility testing." Given the nature of a 510(k) submission, these tests would typically be laboratory-based and conducted under controlled conditions to demonstrate device performance and safety, rather than drawing from real-world patient data. It is implied these are prospective studies conducted specifically for this submission. The country of origin for the data is not mentioned but assumed to be the manufacturer's location or a recognized testing facility.

3. Number of Experts and Qualifications for Ground Truth

This submission does not involve clinical data or medical image analysis requiring expert ground truth establishment. The "ground truth" for the functional tests comprises measured physical and chemical properties and clearance rates obtained through standardized in vitro methods. For biocompatibility tests, the ground truth is established by standardized testing protocols (e.g., USP, ISO) and the associated pass/fail criteria, which are expert-defined industry standards for medical devices, not specific human experts adjudicating individual cases.

4. Adjudication Method for Test Set

Not applicable. The reported tests are objective measurements and standardized biological/chemical assays, not subjective assessments requiring expert adjudication.

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

Not applicable. This is a medical device clearance for a hemodialyzer, not an AI or diagnostic imaging device that would typically involve human readers or MRMC studies.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical hemodialyzer, not an algorithm. The reported performance metrics are for the device itself.

7. Type of Ground Truth Used

The ground truth used for performance evaluation is derived from:

• Performance Benchmarks: Comparison to established specifications and the reported performance of legally marketed predicate devices (Altrex 170 Hemodialyzer and Fresenius F60 Polysulfone Dialyzer) for functional characteristics.
• Standardized Test Results: Pass/fail criteria from recognized in vitro and in vivo biocompatibility testing protocols (e.g., USP, ISO standards) for safety.

8. Sample Size for Training Set

Not applicable. This is a physical medical device, not a machine learning model. There is no "training set" in the context of this submission. The manufacturing process of the device would be subject to quality control, but this is distinct from a training set for an algorithm.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set.

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