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The multiFiltratePRO System is indicated for the following use: Continuous Renal Replacement Therapy (CRRT) for patients weighing 40 kilograms or more with acute renal failure with or without fluid overload.

All treatments administered by the multiFiltratePRO System must be prescribed by a physician.

The multiFiltratePRO System (hereinafter referred to as the "mFTPRO System") is designed to provide Continuous Renal Replacement Therapy (CRRT) dialysis.

The mFTPRO System consists of the following components:

• . mFTPRO Machine
• . mFTPRO HDF Cassette
• mFTPRO Accessories .
• । multiEffluent Bag, 10 L
• Adapter Hemofiltration (HF) Female Luer Lock Male ।
• Hemofiltration (HF) Female Spike Adapter -
• | Pressure Line for MTS (Medizin Tecknik Schweinfurt)
• । Vented Spike

The mFTPRO Machine is an electromechanical device. Software controls the machine during treatment, including fluid flow, mixing, heating, and alarms.

The mFTPRO HDF Cassette is single-use, ethylene oxide (EO) sterilized tubing cassette.

The mFTPRO System provides CRRT dialysis. The following CRRT modalities will be available with the mFTPRO System:

• CVVHD Continuous Veno Venous Hemodialysis .
• CVVH Continuous Veno Venous Hemofiltration, with pre-dialyzer dilution, post-● dialyzer dilution, and pre-post-dialyzer dilution
• . CVVHDF - Continuous Veno Venous Hemodiafiltration, with both pre-dialyzer dilution and post-dialyzer dilution

A high-resolution touchscreen monitor and four (4) operating buttons allow the user to view, monitor, input, and change parameters to manage the treatment on the mFTPRO Machine. In the extracorporeal blood circuit, blood is pumped from the patient through a dialyzer attached to the tubing cassette and back to the patient. Blood, filtrate, dialysate, substitution fluid, and heparin pumps are used as indicated to meet individual patient needs and various therapy modes. Integrated heaters can be used to heat the dialysate and/or substitution fluids as necessary.

The mFTPRO HDF Cassette is indicated for use with the mFTPRO System and can be used for the following CRRT treatment modes: CVVHD, CVVH, and CVVHDF. The cassette is part of the extracorporeal circuit. During treatment, the extracorporeal circuit transports blood from the patient's venous access (e.g., double or two (2) single lumen venous catheters) through a hemodialyzer and back to the patient's venous access.

Anticoagulation of the patient's blood is accomplished by systemic heparin anticoagulation via an integrated heparin pump. This pump can also be used to administer a bolus when required. An infusion line for anticoagulation is included in the cassette.

The acceptance criteria and study proving device performance are not explicitly detailed in the provided text in the format requested. The document is a 510(k) summary for the Fresenius Medical Care multiFiltratePRO System, focusing on demonstrating substantial equivalence to predicate devices rather than providing a detailed report of a single study with specific performance metrics and statistical analyses.

However, based on the information provided, I can extract the general categories of performance testing undertaken and state that "all testing met predetermined acceptance criteria." Specific performance values are given for some characteristics, which could be considered the "reported device performance."

Here's an attempt to structure the answer based on the provided text, while acknowledging the limitations in detail:

Acceptance Criteria and Device Performance Study for the multiFiltratePRO System

The multiFiltratePRO System underwent various performance tests to demonstrate substantial equivalence to its predicate devices (PrisMax cleared under K163350 for the system and Prismaflex HF 1000 Set/HF 1400 Set cleared under K042938 for the HDF Cassette). All testing met predetermined acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Since specific numerical acceptance criteria for each test (e.g., minimum required tensile strength, maximum allowable pressure deviation) are not provided, the table below lists the performance specifications or objectives that implicitly served as acceptance criteria, alongside the reported performance indicating these were met.

2. Sample Size for the Test Set and Data Provenance

The document does not specify the sample sizes used for each individual test. It lists various tests conducted (e.g., sterilization tests, structural integrity tests, biocompatibility tests), but the number of units or repetitions for each test is not disclosed.

• Provenance: This information is not explicitly stated. The tests were conducted by the manufacturer, Fresenius Medical Care Tidal Therapies Group, LLC. It is implied these are internal lab tests, not clinical data from patients.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable because:

• The document describes engineering bench testing, sterilization validations, and biocompatibility assessments, not a study involving expert readers to establish ground truth for image or clinical data interpretation.
• No experts were used to establish ground truth for a test set in the context of diagnostic interpretation, as this device is a therapeutic system (Continuous Renal Replacement Therapy).

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. There was no test set requiring human adjudication for diagnostic accuracy.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The device is a therapeutic system, not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not directly applicable. The "standalone" performance here relates to the mechanical, electrical, software, and biological performance of the multiFiltratePRO System itself as a medical device, which was extensively tested without human input influencing its intrinsic function once programmed. The software and machine functions were verified and validated independently.

7. Type of Ground Truth Used

The "ground truth" for the various performance tests was established through:

• Engineering specifications and standards: e.g., pressure ranges, flow rates, dimensions.
• Regulatory standards and guidance: e.g., ISO 10993 for biocompatibility, AAMI/ANSI/ISO 10993-7 for EO residuals, ANSI/AAMI/ST72 for bacterial endotoxin, ISO 11607-1 for sterile barrier testing, ISO 8637/8638 for connectors and color coding, ISO 80369-7 for connectors.
• Functional verification and validation protocols: Designed to confirm the device operates as intended.
• Human factors validation: Ensuring safe and effective use based on usability principles.

8. Sample Size for the Training Set

Not applicable. This device is a therapeutic system and does not involve AI/machine learning models that require a "training set" of data in the typical sense. Its software is verified and validated through traditional software engineering methods, not by training on a dataset.

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

Not applicable, as there was no training set in the context of an AI/machine learning model. The software's functionality and logic are based on predetermined algorithms and engineering designs, verified against specifications derived from medical, safety, and performance requirements.

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