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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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