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The Gambro Medical lines QuickSet® Bloodlines are single use sterile medical devices intended to provide extracorporeal blood circuit for hemodialysis treatment. QuickSet® Bloodlines can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge.

The Gambro medical lines QuickSet® are tubing sets (bloodlines) employed in the hemodialysis equipments extracorporeal circulation: they convey the patient's blood from the arterial-venous access fistula to the dialyzing filter (arterial line) and back after purification (venous line). The Gambro Medical lines QuickSet® Bloodlines are single use sterile medical devices intended to provide extracorporeal blood circuit for hemodialysis treatment. QuickSet® Bloodlines can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge.

Here's a breakdown of the acceptance criteria and study information for the Gambro QuickSet® Bloodlines, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided summary focuses on demonstrating substantial equivalence through non-clinical bench testing. It does not list specific numerical acceptance criteria for each test in a dedicated table, but rather states that the tests were "successful" in demonstrating safety and effectiveness.

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

• Sample Size for Test Set: The document does not specify the exact sample sizes used for each non-clinical test (e.g., number of bloodlines tested for flow rate, number of samples for biocompatibility).
• Data Provenance: The data provenance is from non-clinical bench testing. The country of origin is not explicitly stated, but the submission is to the US FDA by Gambro Renal Products, a US-based company, suggesting the testing was likely conducted in the US or in compliance with US regulatory standards. The testing is prospective in nature, as it was conducted to support the 510(k) submission for a new device.

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

This information is not applicable as the study described is a non-clinical bench test, not a study involving human or image-based ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable as the study described is a non-clinical bench test, not a study involving human readers or expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done; Effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a medical bloodline system, not an AI-powered diagnostic or assistive tool for human readers.

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

No, a standalone algorithm performance study was not done. This device is a physical medical component, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was established by engineering specifications, recognized standards, and established laboratory methods for evaluating the performance, safety, and compatibility of medical devices like bloodlines. For example:

• Biocompatibility: Complies with ISO standards for biological evaluation of medical devices.
• Sterility: Absence of microorganisms, confirmed by validated sterility tests.
• Flow Rate: Meeting predefined flow rate specifications.
• Mechanical Hemolysis: Meeting acceptable levels of red blood cell damage.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is a physical medical device, not a machine learning algorithm.

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

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

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