(64 days)
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:
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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.
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Sample size used for the test set and the data provenance: Not specified.
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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.
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Adjudication method for the test set: Not applicable.
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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.
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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.
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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.
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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.
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How the ground truth for the training set was established: Not applicable.
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”