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The Aquadex FlexFlow™ System is indicated for:
• Temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and
• Extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization.
All treatments must be administered by a health care provider, under physician prescription, both of whom having received training in extracorporeal therapies.

The Aquadex FlexFlow System removes excess fluid from the patient in fluid overload by ultrafiltration of blood across a hollow-fiber hemofilter at the clinician selected rate. The system is comprised on a console mounted on a cart, proprietary software and accessories (venous access catheters, extensions and a blood pump circuit). Patient access is obtained via either peripheral or central venous veins.

The provided document does not contain detailed acceptance criteria for the Aquadex FlexFlow™ System's performance, nor does it describe a specific study that proves the device meets such criteria in terms of quantitative performance metrics.

Instead, the document primarily focuses on the 510(k) submission for a software change to the Aquadex FlexFlow™ System and a labeling change incorporating a catheter compatibility chart. The "Safety & Performance" section states:

"Regression testing was performed to verify and validate the software change and to generate data in support of the labeling change which incorporates a catheter compatibility chart using the principles of ISO 14971:2000 "Medical devices - Application of risk management to medical devices. Data generated demonstrated the Aquadex FlexFlow System continues to be safe and effective."

This statement indicates that a study (regression testing) was performed, but it doesn't provide specific acceptance criteria or quantitative performance results relevant to the device's functional operation (e.g., fluid removal rate accuracy, filter efficiency).

Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.

Based on the available text:

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated in quantitative terms. The general criterion appears to be "continues to be safe and effective" after software and labeling changes.
   • Reported Device Performance: "Data generated demonstrated the Aquadex FlexFlow System continues to be safe and effective." No specific performance metrics or values are provided.

2. Sample size used for the test set and the data provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no external ground truth establishment is described for performance evaluation. The "data generated" would likely pertain to internal testing.

4. Adjudication method for the test set: Not applicable.

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. This device is an ultrafiltration system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The "software change" was validated, but the overall system's operation always involves human interaction and monitoring.

7. The type of ground truth used: For the regression testing, the "ground truth" would likely be the expected function and output of the device following the software and labeling changes, verified against design specifications and established safety/effectiveness parameters of the predicate device. This is internal testing, not external ground truth from patient data or experts.

8. The sample size for the training set: Not applicable. This is not a machine learning model requiring a training set in the typical sense. The "training" here refers to the device's internal software development and testing, not a dataset for model training.

9. How the ground truth for the training set was established: Not applicable.

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The Aquadex FlexFlowTM System is indicated for:
• Temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and
• Extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization.
All treatments must be administered by a health care provider, under physician prescription, both of whom having received training in extracorporeal therapies.

The Aquadex FlexFlow System removes excess fluid from the patient in fluid overload by ultrafiltration of blood across a hollow-fiber hemofilter at the clinician selected rate. The system is comprised on a console mounted on a cart, proprietary software and accessories (venous access catheters, extensions and a blood pump circuit). Patient access is obtained via either peripheral or central venous veins.

This document describes regulatory information for the Aquadex FlexFlow System, specifically related to a software update (Rev. K). It is a 510(k) summary and an FDA clearance letter. It does not contain information about specific acceptance criteria, device performance, or a study proving that acceptance criteria were met.

The "Safety & Performance" section states:
"Regression testing was performed to verify and validate the software change and to generate data in support of the labeling change which incorporates a catheter compatibility chart using the principles of ISO 14971:2000 'Medical devices - Application of risk management to medical devices. Data generated demonstrated the Aquadex FlexFlow System continues to be safe and effective."

This statement indicates that testing was done to ensure the software update maintained safety and effectiveness, but it provides no further details regarding:

1. A table of acceptance criteria and the reported device performance: No specific criteria or performance metrics are listed.
2. Sample sized used for the test set and the data provenance: No sample size or data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a ground truth for a test set in this context.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This device is an ultrafiltration system, not an imaging device requiring human reader interpretation in an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a physical system with software, not a standalone algorithm in the typical sense for performance evaluation (e.g., image analysis). Regression testing of the software was done.
7. The type of ground truth used: Not explicitly stated, but for a physical device software update, "ground truth" would likely relate to system functionality, safety parameters, and output accuracy, confirmed through engineering tests and potentially clinical data if new features warranted it. The document mentions a "catheter compatibility chart" implying performance related to different catheters.
8. The sample size for the training set: Not applicable, as this is a software update for an existing physical device, not an AI model requiring a training set in the typical machine learning sense.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document confirms the FDA clearance of a software update for an existing device based on regression testing, but it does not provide the detailed study information requested.

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