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Machine:
The 5008X™ system is indicated for intermittent hemodialysis treatment for patients with acute and chronic renal failure in a healthcare facility. Therapy options for patients weighing more than 40 kg include: Hemodiafiltration (HDF), Hemodialysis (HD), Hemofiltration (HF) and Isolated Ultrafiltration.

The 5008X Machine is equipped with a bibag system, but it may also be used with liquid bicarbonate using the connector included with the machine.

The bibag System is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. The bibag System is intended to be used as one component in the preparation of dialysate according to a physician's prescription in a 3-stream proportioning hemodialysis machine equipped with the bibag module. The 5008X Machine is available equipped with a Crit-Line Clip (CLiC) Monitor System.

The optional CLiC system is used to non-invasure hematocrit, oxygen saturation and percent change in blood volume in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the dialysis technician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e. increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.

DIASAFEPlusUS Filter:
The DIASAFE®plusUS is intended for the preparation of ultrapure dialysate and sterile, non- pyrogenic substitution fluid from pretreated water and is not intended to provide primary purification. Attention must still be given to the chemical and microbiological quality of water and concentrates and the maintenance of supply systems (e.g. RO system, central delivery system).

The microbiological quality (microbial count |CFU/mL] and endotoxin measurement |EU/mL]) of the incoming water should be < 200 CFU/mL and < 2 EU/mL, respectively.

The DIASAFE®plusUS can only be used with Fresenius Medical Care dialysis machines fitted for use with DIASAFE®plusUS.

5008X Tubing Set:
The blood tubing sets are intended to be used only with the Fresenius Medical Care 5008X Hemodialysis Device, which is indicated for intermittent hemodialysis treatment for patients with acute kidney disease in a healthcare facility. Therapy options include: hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration.

The blood tubing sets are indicated for use with a prescribed hemodialyzer. For use with a compatible hemodialyzer, as per the labeling.

Additional Indications for Use for the blood tubing set equipped with Twister AFRC

The Fresenus Twister Access Flow Reversing Connector (AFRC) is indicated for use during hemodialysis to reverse the blood flow to and from the arterial and venous vascular access devices in order to obtain an access flow measurement. Additional Indications for Use for the blood tubing set equipped with CLiC

The blood tubing set is intended to be used with the Crit-Line Clip Monitor System (CLiC) on the 5008X Hemodialysis Device.

The CLiC is used to non-invasively measure hematocrit, oxygen saturation, and percent change in blood volume in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the dialysis technician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e., increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.

CitraSure Disinfectant:
CitraSure is intended for thermal disinfection of the Fresenus Medical Care 5008X Hemodialysis System when delivered and diluted per the 5008X heat disinfection program.

The 5008X Hemodialysis System consists of the following:

• The 5008X hemodialysis machine
• Two (2) DIASAFE® plusus Filters (hereinafter referred to as the "Diasafe filter(s)")
• The 5008X Hemodialysis Bloodlines (hereinafter referred to as "5008X Bloodlines") are available in three (3) configurations:
  • -5008X HDF Hemodialysis blood tubing set catalog number 03-5100-7 (hereinafter referred to as the "Standard Bloodline")
  • -5008X HDF Hemodialysis blood tubing set with access flow reversing connector (Twister®) catalog number 03-5150-2 (hereinafter referred to as the "Twister Bloodline")
  • 5008X HDF Hemodialysis blood tubing set with CLiC™ blood chamber catalog number 03-5100-7C (hereinafter referred to as the "CLiC Bloodline")
• CitraSure™ Disinfectant

The 5008X Hemodialysis Machine is an electromechanical device. Software controls the machine during hemodialysis treatment, including fluid flow, mixing, heating, and alarms.

The Diasafe filter is a non-sterile dialysis fluid filter that produces ultrapure dialysate and sterile, non-pyrogenic substitution fluid as defined in ANSI/AAMI/ISO 11663. The filter reduces microbial contaminants including endotoxins in the dialysate during hemodialysis treatment. The Diasafe filters are installed and exchanged on the 5008X Hemodialysis Machines using the DIAFIX™ Lock System. The DIAFIX™ Lock System is a standard feature on 5008X Hemodialysis Machines and is installed during machine production.

The 5008X Bloodlines are single-use, ethylene oxide (EO) sterilized bloodlines.

CitraSure™ disinfectant is a liquid chemical disinfectant for chemical heat disinfection of the 5008X Hemodialysis Machine.

The provided document is a 510(k) premarket notification for the Fresenius Medical Care 5008X Hemodialysis System, which includes the machine, Diasafe filters, 5008X Bloodlines, and CitraSure disinfectant. This type of document is a submission to the FDA to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device.

It does not describe a study that uses a test set with ground truth established by experts to prove the device meets specific acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning algorithm.

Therefore, I cannot provide the requested information, as the document does not contain details about:

1. A table of acceptance criteria and reported device performance for an AI/ML algorithm. The "Key Performance Specifications/Characteristics" table (Table 4) lists engineering specifications for the hemodialysis system components (e.g., flow rates, temperature ranges, filtration efficiency for the Diasafe filter, mechanical properties of bloodlines), not performance metrics for an AI system.
2. Sample size used for the test set and data provenance: This is relevant for AI/ML validation, which is not described.
3. Number of experts used to establish ground truth and their qualifications: Not applicable as there's no mention of expert-labeled ground truth for an AI/ML system.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted as this is not an AI/imaging device.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable, as this is not an AI/ML model.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices through various engineering tests, biocompatibility testing, electrical safety, software verification, and human factors validation for a hemodialysis system, not an AI/ML-driven diagnostic or therapeutic device.

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