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The dialyzer is intended for use in hemodialysis for the treatment of chronic and acute renal failure.

This device is intended for use in hemodialysis for the treatment of acute and chronic renal failure. The membrane used in this device is a blend of polyarylethersulfone (PAES) and polyviny)pyrrolidone(PVP). Blood enters a blood inlet port where it is distributed to the hollow fibers. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port. By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the membrane, plasma water along with certain lower and middle molecular weight solutes pass through the membrane and into the dialysate or filtrate compartment of the device. Uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the membrane and into the countercurrent flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.

The provided document is a 510(k) summary for the Gambro Polyflux HD-C4 SMALL Dialyzer for Single Use. This document outlines the premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed acceptance criteria study with the specifics requested in your prompt (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance metrics like sensitivity/specificity).

Here's an analysis of what is available in the document related to your request:

Acceptance Criteria and Study Details for Gambro Polyflux HD-C4 SMALL Dialyzer for Single Use

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in terms of performance metrics with specific thresholds (e.g., "urea reduction ratio must be > X%" or "clearance must be > Y ml/min"). Instead, the acceptance criterion is implicitly tied to demonstrating substantial equivalence to the predicate device, the Polyflux HD-C4 (BIG) Hemodialyzer (K060195).

The device performance is reported as meeting this equivalence through "in vitro testing."

The document explicitly states that the device's membrane (a blend of polyarylethersulfone (PAES) and polyvinylpyrrolidone (PVP)) is "equivalent to the membrane utilized in the Gambro Polyflux HD-C4 (BIG) single use hemodialyzers." This implies that the critical component responsible for filtration performance is considered equivalent, leading to equivalent overall performance. |

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not specified. The document only mentions "In vitro testing was conducted." No details regarding the number of units tested or specific experimental conditions are provided.
• Data Provenance: Not specified, but given the nature of in vitro testing, it would be laboratory-generated data rather than patient-derived data from a specific geographical region. It would be prospective in the sense that the tests were conducted specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. For a device like a hemodialyzer, ground truth is established through physical and chemical performance measurements (e.g., clearance rates, ultrafiltration rates, membrane integrity, biocompatibility) rather than expert interpretation of images or clinical assessments. The comparison is against established performance benchmarks of the predicate device, typically measured by laboratory instruments.

4. Adjudication Method

• Not Applicable. As ground truth is established by objective physical and chemical measurements of device performance, there is no human adjudication process involved.

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

• No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images. This device is a treatment device, and its performance is assessed through in vitro and potentially in vivo (though not detailed here) functional metrics, not reader interpretation. The document explicitly states "Summary of Clinical Tests: N/A."

6. Standalone Performance Study

• Yes, implicitly. The "in vitro testing" mentioned is a standalone performance study in the sense it evaluates the device's performance characteristics (e.g., clearance, ultrafiltration) in a laboratory setting, independent of human interaction or a "human-in-the-loop" application. However, detailed results (e.g., specific clearance values, ultrafiltration rates) are not provided in this summary. The results are summarized as being "safe, effective and perform as well as the predicate devices."

7. Type of Ground Truth Used

• Objective Performance Metrics (derived from laboratory testing) of the Predicate Device. The "ground truth" for the new device's performance is essentially the established performance profile and safety of the predicate device (Polyflux HD-C4 (BIG)). The goal is to demonstrate that the small version performs equivalently.

8. Sample Size for the Training Set

• Not Applicable. This is a hardware medical device (dialyzer), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How Ground Truth for the Training Set Was Established

• Not Applicable. Again, this is not an AI/ML device, so no training set or its associated ground truth establishment process applies.

In summary, this 510(k) application focuses on demonstrating substantial equivalence through non-clinical (in vitro) testing of the physical and functional characteristics of the hemodialyzer, comparing it to an already cleared predicate device. The detailed statistical and expert-driven study elements you requested are typically found in submissions for diagnostic AI/ML software or other complex diagnostic tools, not for a device of this nature.

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