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The Edwards Aquarius System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Edwards Aquarius system may also be used in Therapeutic Plasma Exchange (TPE) therapies.

The Edwards Aquarius system is indicated for use in a clinical setting and not for home use.

The Aquarius system is an Automated Fluid Balance Monitor, designed to be used with various extracorporeal treatments in the field of renal replacement therapies or plasma therapies. All therapies must be prescribed by a physician. The Aquarius system is divided into three circuits: the extracorporeal (blood) circuit, the substitution/dialysate circuit and the filtrate circuit. Toxic substances are removed by filters and clean blood is returned to the patient. The Aquarius system allows the patient to be positioned left or right of the instrument. The Aquarius system uses two scales to accurately measure and precisely balance filtration and substitution volumes. Heparin may be supplied to the extracorporeal circuit via an anticoagulant pump (Heparin pump). The prescribing physician may select continuous or intermittent options. The Aquarius protective system is designed as a 2-channel system to protect the patient from foreseeable danger. At the back of the scale system a removable hand-crank is mounted. This can be used to manually turn the blood pump in case a pump stops. The Aquarius system is portable. It has a wheeled base connected with a handle to move or carry the Aquarius.

The provided text is a 510(k) summary for the Edwards Aquarius system, detailing changes to software and labeling. It explicitly states that no clinical or non-clinical data is presented as part of this submission, and it is a special 510(k). Therefore, the document does not contain information about acceptance criteria or a study proving the device meets them in the context of performance metrics like accuracy, sensitivity, or specificity.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Edwards Aquarius system cleared under K070320) despite software and labeling updates.

Here's a breakdown based on the information provided and what is not present:

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

   • Not provided. The document does not define specific performance acceptance criteria (e.g., for fluid management accuracy, solute removal efficiency) for this special 510(k) submission, nor does it report specific device performance results against such criteria. The "Technology Characteristics" table (starting on page 3) compares general technical specifications (weight, dimensions, power supply, etc.) between the predicate and proposed device, noting they are largely the same or that updates (like software version) do not alter fundamental technology.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable / Not provided. No test set data or study details are provided in this special 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable / Not provided. No test set or ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable / Not provided. No adjudication method for a test set is described.

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 / Not provided. This device is a high permeability hemodialysis system, not an AI diagnostic imaging tool that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable / Not provided. Performance data, whether standalone or with human-in-the-loop, is not presented. The software updates are described as "performing the same functions as the predicate software."

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • Not applicable / Not provided. No ground truth is described because no performance study is detailed.

8. The sample size for the training set:

   • Not applicable / Not provided. No training set for an algorithm is discussed in the context of performance. This special 510(k) is about software updates for an existing device.

9. How the ground truth for the training set was established:

   • Not applicable / Not provided. No ground truth for a training set is described.

Summary of Device Performance and Acceptance Criteria (Based on the Document's Content):

Since this is a special 510(k) for software and labeling updates, the "acceptance criteria" and "proof" primarily revolve around demonstrating that these changes do not alter the fundamental scientific technology or the intended use and that the device continues to meet safety requirements of UL and EMC standards.

The key "performance" metrics implicitly accepted for this submission are the equivalence of the updated software's functions to the predicate, and that the physical and functional characteristics remain substantially similar.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document's purpose):

The study that "proves" the device meets these criteria is essentially the design control activities and risk/hazard analysis for software changes (Page 4) referenced in the document, which confirm that the modifications do not negatively impact safety or effectiveness or alter the fundamental technology and intended use, thus maintaining substantial equivalence. No separate performance study is described or provided in this special 510(k).

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The Edwards Aquarius System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Edwards Aquarius system may also be used in Therapeutic Plasma Exchange (TPE) therapies.

The Edwards Aquarius system is indicated for use in a clinical setting and not for home use.

The Edwards Aquarius System needs to be used in conjunction with a tubing set and a filter to provide Hemofiltration treatment to the patient.

The Aquarius system is an Automated Fluid Balance Monitor, designed to be used with various extracorporeal treatments in the field of renal replacement therapies or plasma therapies. All therapies must be prescribed by a physician.

The Aquarius system is divided into three circuits: the extracorporeal (blood) circuit, the substitution/dialysate circuit and the filtrate circuit.

Toxic substances are removed by filters and clean blood is returned to the patient.

The Aquarius system allows the patient to be positioned left or right of the instrument.

The Aquarius system uses two scales to accurately measure and precisely balance filtration and substitution volumes.

Heparin may be supplied to the extracorporeal circuit via an anticoagulant pump (Heparin pump). The prescribing physician may select continuous or intermittent options.

The Aquarius protective system is designed as a 2-channel system to protect the patient from foreseeable danger.

At the back of the scale system a removable hand-crank is mounted. This can be used to manually turn the blood pump in case a pump stops.

The Aquarius system is portable. It has a wheeled base connected with a handle to move or carry the Aquarius.

Acceptance Criteria and Device Performance for Edwards Aquarius System

The Edwards Aquarius System is an Automated Fluid Balance Monitor designed for extracorporeal treatments in renal replacement therapies or plasma therapies. The device's performance was evaluated against a set of specifications to demonstrate substantial equivalence to predicate devices (Baxter Accura System, Gambro Prisma System, B. Braun Diapact).

1. Acceptance Criteria and Reported Device Performance

The provided document details various performance specifications for the Edwards Aquarius System. The study supporting these claims is described as "Bench Testing."

Note: The reported device performance aligns perfectly with the acceptance criteria as presented, which is typical for a summary demonstrating compliance. The "Bench Testing" section explicitly states "This concludes that the two machines [Edwards Aquarius and Baxter Accura] have substantially equivalent performance," indicating the Edwards Aquarius met these criteria.

2. Sample size used for the test set and the data provenance

The document specifies "Comparative bench testing" was conducted using the Edwards Aquarius System and the Baxter Accura System, along with an Edwards Aqualine Sterile Tubing Set K063293.

• Sample size: The specific number of tests or runs performed during the bench testing is not explicitly stated in the provided text.
• Data provenance: The testing appears to be internal lab testing ("bench testing"). The parent company, Edwards Lifesciences, is based in Germany, and the device has been "marketed and developed in Europe for six years," suggesting the testing was likely conducted in Europe. The document does not specify if the data is retrospective or prospective, but bench testing typically involves prospective data collection under controlled conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This device is a medical machine with performance specifications related to fluid management, pressure monitoring, temperature control, and detection of operational issues (e.g., blood leak). The ground truth for such technical performance is established through engineering and calibration standards, not typically through expert consensus from medical professionals. The document does not mention any expert review process for establishing the ground truth of the technical specifications.

4. Adjudication method for the test set

Not applicable. As described above, the ground truth for performance specifications in bench testing is based on engineering standards and measurements, not subjective expert judgment that would require adjudication.

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. The Edwards Aquarius System is a hardware medical device (Hemofiltration System) and does not involve AI or human "readers" in its primary function, nor does it generate diagnostic images requiring interpretation. The study mentioned is a "comparative bench testing" for performance against a predicate device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a Hemofiltration System, a medical machine, not an algorithm. Bench testing evaluates the machine's inherent functionality and performance characteristics.

7. The type of ground truth used

The ground truth used for the performance parameters would be absolute physical measurements and engineering specifications. For example, a pump's accuracy is measured against known flow rates, scales are calibrated against known weights, and temperature sensors are verified against standard temperature references. The document explicitly mentions "Bench Testing" and "Electrical Safety and Electromagnetic Compatibility: Testing has been conducted following the IEC 60601 series of standards," further supporting the use of objective technical standards as ground truth.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-driven device, so there is no concept of a "training set" in the context of its performance validation. The device is validated based on its physical design and adherence to manufacturing and performance specifications.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

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The Edwards Aqualine Tubing Set is indicated for use with the Baxter Accura System for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Edwards Aqualine Tubing Set may also be used in Therapeutic Plasma Exchange (TPE) therapies. The Edwards Aqualine Tubing Sets are indicated for use in a clinical setting and not for home use. The Edwards Aqualine S Tubing Set is indicated for use where a lower flow rate and lower priming volume are desired.

The Edwards Aquaspike tubing set is indicated for use with the Edwards Aqualine Tubing Set and the infusion bags used for continuous solute and for fluid removal in patients with acute failure or fluid overload. Aquaspike is used to connect up to four infusion bags with the Aqualine Tubing

The Edwards Aquasafe is an Aqualine accessory (a three 25ml-empty-sterile bags disposable device) and it is used when it is necessary to decrease the pressure level inside Aqualine, prior its removal from the machine.

The Edwards Aqualine Tubing Sets are designed for use with the Baxter Accura System (K021615). The tubing pathway can be split up in to five separate sections: Access Blood path (Red), Return Blood path (Dark Blue), Filtrate (Effluent) path (Yellow), Dialysate Solution path (Green), Replacement (Substitution) path (Light Blue). The Edwards AqualineS Tubing Set is different from the Edwards Aqualine Tubing Set in total volume, length, and inner and outer diameters. The Edwards Aquaspike tubing set is indicated for use with the Edwards Aqualine Tubing Set and the infusion bags used for continuous solute and /or fluid removal in patients with acute failure or fluid overload. Aquaspike is used to connect up to four infusion bags with the Aqualine Tubing. The Edwards Aquasafe is an Aqualine accessory (a three 25ml-empty-sterile bags disposable device) and it is used when it is necessary to decrease the pressure level inside Aqualine, prior its removal from the machine.

The provided text describes a 510(k) premarket notification for the "Edwards Aqualine Sterile Tubing Set" and its accessories. This is a medical device submission, and the content focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria through a clinical or algorithmic study.

Therefore, many of the requested elements for describing an acceptance criteria study (like sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details) are not applicable (N/A) in this context. The submission's goal is to demonstrate that the new device is as safe and effective as existing legally marketed devices, primarily through comparison of design, materials, and intended use, along with functional bench testing.

Here's a breakdown of the information as it relates to the provided document:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices. The device performance is assessed through bench testing to ensure basic functionality and equivalence in critical parameters.

Study Details

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size: Not specified. The "test set" for this type of submission refers to the physical devices undergoing bench testing. The document states "Functional testing has been conducted with the Edwards Aqualine Tubing Sets" and "Rolling tests (mechanical resistance during the rolling pump action) have been conducted with the Edwards Aqualine, Edwards AqualineS and Baxter Accura (K021615) Tubing Sets." No specific number of units tested is provided.
   • Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing by the manufacturer or a contracted lab. The manufacturing entity, Haemotronic S.p.A., is in Italy, and the applicant is in Germany. It would be prospective testing on manufactured devices.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • N/A. The "ground truth" for this device comes from engineering specifications and performance standards for hemodialysis tubing sets, established by the manufacturer and validated through the testing performed. There is no mention of external human experts establishing ground truth in the context of a diagnostic or interpretative study.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • N/A. Adjudication methods are relevant for studies involving human interpretation or uncertain outcomes. Bench testing for medical device functionality typically relies on objective measurements against predetermined engineering specifications, not expert adjudication.

4. 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:

   • N/A. This device is a sterile tubing set, not an AI-powered diagnostic tool. Therefore, MRMC studies are not applicable.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • N/A. This device is a physical medical tubing set, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For the bench testing, the "ground truth" is defined by engineering specifications and established performance standards for hemodialysis tubing sets. This includes parameters like material properties (tensile strength), mechanical resistance to pumping, and sterile shelf-life. The predicate device's performance also serves as a de facto benchmark for substantial equivalence.

7. The sample size for the training set:

   • N/A. This is a hardware medical device, not a machine learning algorithm. There is no concept of a "training set."

8. How the ground truth for the training set was established:

   • N/A. Not applicable, as there is no training set for this type of device.

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