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The 2008K Hemodialysis Machine is indicated for acute and chronic dialysis therapy.
The 2008K@home Hemodialysis Machine is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home Hemodialysis Machine is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.
The bibag System is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008K@home Hemodialysis Machine and is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag System is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.
The Wireless Wetness Detector is indicated for use with the 2008K@home Hemodialysis Machine and is an optional accessory to aid in the detection of blood and water leaks during hemodialysis using the detector must be observed by a trained and qualified person as prescribed by their physician.
The 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.
The bibag system is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008T Hemodialysis Machine and is intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.
The Crit-Line Clip Monitor is used with the 2008T Hemodialysis Machine to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. The CLiC device measures hematocrit, percent change in blood volume and oxygen saturation 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 clinician. 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 complications of dialysis which include nausea, cramping and vomiting

The 2008K Hemodialysis Machine, the 2008K@home Hemodialysis Machine, and the 2008T Hemodialysis Machine are variations of the same basic mechanisms and design concepts, having different user interfaces and/or mechanical sub-systems. These machines are medical electrical systems controlled by software. They are used for performing dialysis therapy by pumping blood through an extracorporeal circuit with a semipermeable membrane to remove toxins and excess water. The extracorporeal blood circuit is monitored for venous and arterial blood pressures, and for the presence of air and blood. In the dialysate circuit, concentrates are mixed with purified water, heated, degassed, and delivered to the dialyzer. Balancing chambers control the incoming and outgoing flow of dialysate fluid during ultrafiltration. The hydraulic systems are composed of various plastic/rubber, metal, and glass materials that have indirect, prolonged contact, externally communicating with the dialysate circuit, which has prolonged, indirect blood contact.

This document is a 510(k) Pre-market Notification for updates to the Fresenius Medical Care 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, and 2008T Hemodialysis Machine. It does not describe a study involving an AI (Algorithm Only) or MRMC (Multi-Reader Multi-Case) comparative effectiveness study, nor does it detail acceptance criteria related to diagnostic accuracy or clinical outcomes that would typify such studies for most AI/medical imaging devices.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through verification and validation of modifications made to the existing hemodialysis machines. The "acceptance criteria" and "device performance" described are related to the engineering and functionality of the devices rather than AI performance metrics like sensitivity or specificity.

Here's an interpretation based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in the context of patient data or images. The testing described is engineering verification and validation of the hardware and software components of the hemodialysis machines themselves. Therefore, information regarding "country of origin of the data" or "retrospective/prospective" is not applicable. The sample size would be the number of modified devices or components tested. This number is not explicitly stated but is implied to be sufficient for demonstrating the functionality and reliability of the modifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable. The "ground truth" here is the expected functional behavior and performance of the machines based on engineering specifications and safety standards, not a medical diagnosis or interpretation by experts. The "experts" involved would be the engineers, quality assurance personnel, and regulatory specialists conducting and reviewing the tests.

4. Adjudication Method for the Test Set:

Not applicable, as the evaluation involves engineering tests against predefined specifications, not human interpretation requiring 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:

No MRMC comparative effectiveness study was done. This submission is for modifications to a hemodialysis machine, not an AI-powered diagnostic or assistive tool.

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

No standalone algorithm performance study was done in the typical sense of AI devices. The "software verification and validation testing" evaluates the machine's control software, which operates the machine automatically but is not an "AI algorithm" in the diagnostic sense.

7. The Type of Ground Truth Used:

The ground truth used in this context is the engineering specifications, design requirements, and established performance standards for the hemodialysis machines. These define what constitutes correct and safe operation of the device and its components.

8. The Sample Size for the Training Set:

Not applicable. This document describes the testing of physical devices and their control software, not the training of an AI model using a dataset.

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

Not applicable, as there is no AI training set discussed in this document.

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2008K@home Hemodialysis Machine: The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician. bibag System: The Fresenius Medical Care bibag system is used with Fresenius Medical Care three stream proportioning hemodialysis systems equipped with the bibag module such as the 2008K@home Hemodialysis Machine and is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag System is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription. Wireless Wetness Detector (Wet Alert): The Wireless Wetness Detector is indicated for use with the Fresenius 2008K@home Hemodialysis Machine and is an optional accessory to aid in the detection of blood and water leaks during hemodialysis. Home hemodialysis using the detector must be observed by a trained and qualified person as prescribed by their physician.

The 2008K@home Hemodialysis Machine with bibag System is intended for short term (acute) and long term (chronic) dialysis treatment in a clinical facility and at home. In the home, a trained and qualified person must observe treatment as prescribed by a physician: The 2008K@home Hemodialysis Machine with bibag System allows operators the option to prepare a saturated sodium bicarbonate solution online through automated mixing of dialysis grade water and dry sodium bicarbonate powder within the bibag source disposable. The bibag System comprises: (1) the sodium bicarbonate concentrate generator (known as the bibag module); and (2) the single-use disposable bag of dry sodium bicarbonate concentrate. A specialized bibag connector with a door is used to connect the single-use bibag disposable (650g/900g) filled with USP grade dry sodium bicarbonate powder to the bibag connector. The 2008K@home Hemodialysis Machine draws dialysis grade water into the bibag to produce a saturated solution of sodium bicarbonate online. This online generation of sodium bicarbonate can only be performed using a specially modified Fresenius 2008K@home Hemodialysis Machine with bibag System and can only be used with 45x (1:44) dilution. The bibag cannot be used with non-Fresenius hemodialysis machines capable of using cartridge type dry sodium bicarbonate because of the unique connection between the bibag disposable, the bibag connector, and the hemodialysis machine. Additionally, this submission includes minor hardware/software changes to the proposed device: Active pressure regulation, Acid/Heat Disinfect button; simplified Acid Clean program and alternate LCD display.

Here's a breakdown of the acceptance criteria and the study information for the Fresenius 2008K@home Hemodialysis Machine with bibag System, based on the provided text:

Important Note: The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed, novel clinical study results with specific performance metrics against an acceptance criterion in the way an AI/ML device submission might. Therefore, some of the requested information (like specific effect sizes for human readers with AI assistance) is not applicable or explicitly stated in this type of submission.

Acceptance Criteria and Reported Device Performance

The document states that "Test results demonstrated that the modified 2008K@home Hemodialysis Machine with bibag System functions as intended and met pre-determined acceptance criteria." It also lists various verification and validation tests performed. However, the specific quantitative acceptance criteria or detailed performance metrics are not explicitly presented in a table format within this 510(k) summary. Instead, the conclusion is a general statement of meeting criteria.

The device performance is generally reported as:

• "functions as intended"
• "met pre-determined acceptance criteria"
• "did not affect the essential performance of the device"
• "the device functions as intended"
• "differences... do not raise any new concerns with regard to safety or effectiveness."

Without explicit quantitative criteria, a table like the one requested cannot be constructed precisely from the provided text. The document refers to "existing FMCNA procedures, protocols, declared performance standards and guidelines of the quality system regulation (21 CFR Part 820)" as the basis for evaluation, implying internal, pre-defined criteria were used for the various tests.

Study Details

Given this is a 510(k) for a medical device (hemodialysis machine), not an AI/ML-driven diagnostic, many of the typical AI/ML study parameters (like test set size, data provenance, ground truth experts, MRMC, standalone performance) are not applicable or not detailed in this type of submission. The studies performed are primarily engineering verification and validation tests.

Here's an attempt to address your points based on the provided text, with clarifications where information is absent or irrelevant to a traditional medical device 510(k):

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated in a quantitative table. The document generically states that "pre-determined acceptance criteria" were met. These would typically be internal engineering specifications and regulatory standards (e.g., ISO, FDA regulations) for safety, performance, and functionality.
   • Reported Device Performance: The device "functions as intended" and there are no "new concerns with regard to safety or effectiveness" compared to the predicate devices. This is a qualitative statement of successful verification and validation.

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

   • Sample Size for Test Set: Not specified. The testing described includes "Functional Verification and Software Validation," "System Performance," "Heat Disinfection Testing," "Chemical Testing," "System Safety," "Reliability" (Accelerated Life, Mechanical Life, Elevated Temperature Testing), and "Summative Usability." These are internal engineering and usability tests, and the "sample size" would relate to the number of test units, cycles, or user participants, which is not detailed.
   • Data Provenance: Not applicable in the context of clinical data provenance. These are laboratory/engineering test results conducted by the manufacturer (Fresenius Medical Care North America, Waltham, MA).

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

   • Not applicable in the context of clinical ground truth. The "ground truth" for engineering and functional tests is established by documented specifications, regulatory standards, and expected operational behavior, which is assessed by engineers and technicians. For the "Summative Usability" study, "experts" would be the intended users and human factors specialists, but their number and qualifications are not specified.

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

   • Not applicable as this is not a diagnostic device assessment involving human interpretation. Adjudication methods are typically used for clinical study endpoints or image interpretations. Engineering and software tests follow predefined pass/fail criteria.

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:

   • No. This is a hemodialysis machine, not an AI-assisted diagnostic or interpretative device. This type of study is not relevant to this submission.

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

   • Not applicable. This is a physical medical device; the concept of an "algorithm only" performance study in this context is not relevant. The device has automated functions, which are verified through various tests (System Performance, Software Verification, Safety Systems Verification), but this is not an "AI algorithm" in the typical sense of a standalone diagnostic.

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

   • Ground truth for engineering/software performance: Established by design specifications, functional requirements, and compliance with industry standards (e.g., ISO, electrical safety standards).
   • Ground truth for usability: "Summative Usability" studies typically evaluate whether users can safely and effectively operate the device according to its intended use and training, with "ground truth" being defined as successful task completion and adherence to safety protocols.

8. The sample size for the training set:

   • Not applicable. This device is not an AI/ML device that undergoes a "training phase."

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

   • Not applicable.

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2008K@home Hemodialysis Machine Indications for Use

The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician .:

Wireless Wetness Detector (Wet Alert) Indications for Use

The Wireless Wetness Detector is indicated for use with the Fresenius 2008K@home Hemodialysis Machine and is an optional accessory to aid in the detection of blood and water leaks during hemodialysis. Home hemodialysis using the detector must be observed by a trained and qualified person as prescribed by their physician.

The 2008K@home Hemodialysis Machine with Wireless Detector is intended for short term (acute) and long term (chronic) dialysis treatment in a clinical facility and at home. In the home, a trained and qualified person must observe treatment as prescribed by a physician.

The 2008K@home Hemodialysis Machine is designed to provide hemodialysis treatment by controlling and monitoring both the dialysate and extracorporeal blood circuits. In the extracorporeal blood circuit, blood is continuously circulated from the patient through a dialyzer, where toxins are filtered out through a semi-permeable membrane, and returned to the patient. During this process, the extracorporeal blood circuit is monitored for venous and arterial blood pressures, and for the presence of air and blood.

The Wireless Wetness Detector system (branded as WetAlert) is an optional accessory to the 2008K@home. It is a multi-use, battery-powered device capable of detecting fluid leaks (i.e., blood or other conductive fluids). During treatment, the Wireless Wetness Detector transmits radio signals to the corresponding 2008K@home Hemodialysis Machine and will alert the 2008K@home Hemodialysis Machine if it detects a blood or water leak. During a wetness alarm, the 2008K@home Hemodialysis Machine will automatically stop the blood pump, close the venous clamp, and sound an alarm.

Modifications to the previously cleared 2008K@home with Wireless Wetness Detector system include:

• . 2008K@home Hemodialysis Machine- Replace the single receiver system with a dual antenna/receiver configuration for reception durability.
• . Wireless Wetness Detector- Change the Wireless Wetness Detector device body from a solid over-molded enclosure to a hollow, lighter weight, two-part bonded plastic case.
• . Wireless Wetness Detector- Modify the software to enhance the electrostatic immunity of the device.
• 2008K@home WetAlert Home User's Guide- The guide is being separated into a clinical . and a home version. Additional modifications include instructions and descriptions of changes.

The request describes the acceptance criteria and study that proves the device meets them, but the provided text does not contain detailed acceptance criteria or specific study results for quantitative performance metrics. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing exhaustive performance data.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria with corresponding performance metrics. Instead, it states that "All testing...met the acceptance criteria." The overall acceptance criterion is based on demonstrating "substantial equivalence" to the predicate device in terms of safety and effectiveness, and functioning "as intended."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size for the test set. It mentions "Design verification and validation tests were conducted," but does not provide details on the number of devices or scenarios used in these tests.

The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin. The testing was conducted "according to existing FMCNA procedures, protocols, declared performance standards and guidelines of the quality system regulation (21 CFR 820)" by the manufacturer (Fresenius Medical Care North America) based in Waltham, MA, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish ground truth for testing. The testing appears to be based on engineering and performance validation against predefined specifications and regulatory guidelines rather than expert consensus on subjective data.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of adjudication methods as the testing described is technical verification and validation, not involving human interpretation of data for ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document focuses on the technical performance of the device and its equivalence to a predicate, not on human reader performance with or without AI assistance. The device is a "Wireless Wetness Detector" for fluid leaks, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, standalone performance testing of the device was done. The "Wireless Wetness Detector system" is a device that autonomously detects fluid leaks, transmits signals, and triggers alarms and machine responses. The performance data discussed (wireless verification, electromagnetic compatibility, mechanical testing) all relate to the standalone function of the device and its components. The document explicitly states, "The performance of the modified 2008K@home machine and Wireless Wetness Detector (WetAlert) system was evaluated according to existing FMCNA procedures, protocols, declared performance standards and guidelines..." implying autonomous testing.

7. The Type of Ground Truth Used

The ground truth used for testing would be objective, measurable conditions for leak detection and system response. For example:

• Leak Detection: Actual presence or absence of conductive fluid (blood or water) in controlled experimental setups.
• Wireless Performance: Successful transmission and reception of signals under various conditions.
• Electromagnetic Compatibility: Adherence to established standards for emissions and immunity.
• Mechanical Integrity: Resistance to physical stress as per engineering specifications.

These are established by engineering standards and controlled experiments rather than expert consensus on subjective data.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This device is an electromechanical system with software for control and signal processing, not a learning-based AI system that requires a training set.

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

Not applicable, as there is no mention of a training set for an AI/machine learning model.

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