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The Fresenius Liberty Cycler is indicated for acute and chronic peritoneal dialysis.

The Liberty Cycler is a computer-controlled electro-mechanical medical device designed for use in Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD). The Liberty Cycler design incorporates software-controlled pumping action for fluid movement. The Liberty Cycler heats the peritoneal dialysate solution prior to user infusion, measures and delivers a pre-determined amount of fluid to the user and monitors the drained volume from the user. The Liberty Cycler is designed as a table-top unit and is prescribed in both professional and home treatment settings. Modifications to the predicate Liberty Cycler include changes to the performance specifications to allow use of a 6-liter dialysate solution bag. The Liberty Cycler can now accommodate a 1 to 6-liter dialysate solution bag configuration. Additional modifications are included in this submission which are intended to enhance performance and data management within predicate specifications.

The provided text describes modifications to an existing medical device, the Fresenius Liberty Cycler, and the testing conducted to ensure its continued safety and effectiveness. It is not an AI/ML device, therefore, some of the information requested in the prompt is not available in the given text.

Here's an analysis of the acceptance criteria and study information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "Test results demonstrated that all modifications functioned as intended and met predetermined acceptance criteria" and that "The essential performance of the Liberty Cycler is not affected by the modifications." However, specific numerical acceptance criteria for each test and their corresponding reported performance values are not detailed in the provided text.

The text mentions several types of tests, implying that acceptance criteria were established for each. Here's a general table based on the information provided, noting the lack of specific numerical criteria:

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

• Test Set Sample Size: The document does not specify the sample size for any of the tests. For example, it doesn't mention how many units were tested for electrical safety or how many participants were involved in human factors testing.
• Data Provenance: The testing was conducted by Fresenius Medical Care North America according to their internal procedures, protocols, and quality system regulations (21 CFR 820). The country of origin of the data is implicitly the United States (Fresenius Medical Care North America is located in Waltham, MA) and is prospective for the modified device, as the testing was done to verify the modifications.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable and not provided in the document. The device is a medical cycler, not an AI/ML diagnostic tool that requires expert consensus for ground truth establishment. The "ground truth" here is compliance with engineering and safety standards.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert review of images or data to establish a ground truth, which is not relevant to the performance testing of a peritoneal dialysis cycler.

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

This information is not applicable and not provided in the document. An MRMC study is relevant for evaluating the impact of AI on human reader performance, which doesn't apply to this electromechanical device.

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

This information is not applicable to this device in the context of an AI algorithm. The device has software control for pumping and other functions, but it's not an AI/ML algorithm being evaluated in isolation. The "standalone performance" of the device refers to its ability to function according to specifications.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance testing is:

• Compliance with established engineering standards and regulations: UL 60601-1, IEC 62366, IEC 60601-2-39, IEC 60601-1-2.
• Meeting pre-determined internal Fresenius Medical Care acceptance criteria for system validation, software functionality, and functional performance (e.g., fluid measurement accuracy, heating capabilities, ability to accommodate a 6-liter bag).

8. Sample Size for the Training Set:

This information is not applicable and not provided in the document, as the device is not an AI/ML model that undergoes a "training set." The software within the device is validated, not trained in the machine learning sense.

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

This information is not applicable and not provided. As explained above, there is no "training set" in the context of an AI/ML model for this device. The software's functionality is verified against design specifications and industry standards.

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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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The Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The set is intended for use with a prescribed hemodialyzer. The BVM Hemodialysis Blood Tubing Set is intended for acute and chronic hemodialysis therapy. The set is intended for use with the Fresenius 2008 Series Hemodialysis Machines equipped with a BVM Module for monitoring patient blood volume during hemodialysis.

The Fresenius Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors, Catalog number 03-2795-7 (BVM Bloodline) is designed to work with Fresenius 2008 Series Hemodialysis Machines equipped with a BVM Module. The bloodline is a part of the extracorporeal circuit by which blood is transported from the patient through a hemodialyzer and back to the patient. The pump segment of the bloodline interfaces with the pump rotor mechanism of the hemodialysis machine which drives the flow of blood through the circuit. The bloodline contains interfaces to the machine safety mechanisms to ensure proper operation. These include transducer monitor lines for arterial and venous pressure monitoring, as well as a venous chamber for the detection of air in the blood path.

This is a 510(k) premarket notification for a medical device, specifically a hemodialysis blood tubing set. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where the device meets specific performance acceptance criteria through clinical or AI-based evaluation.

Therefore, many of the requested elements for a study proving device performance against acceptance criteria (such as sample size for test sets, expert ground truth, MRMC studies, standalone performance, and training set details) are not applicable to this type of submission.

The "Performance Data" section (G.) in the document describes validation and verification testing performed to support substantial equivalence to the predicate device, not to establish novel performance metrics or human-AI improvement.

Here's a breakdown of what can be extracted from the provided text based on the nature of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of precise numerical acceptance criteria alongside corresponding quantitative device performance results (e.g., a specific pressure tolerance in psi for structural integrity testing). Instead, it lists general categories of testing performed to demonstrate equivalence.

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

• Sample Size: Not specified in the provided summary. The document mentions "testing was selected through the application of a risk management process," implying a chosen sample size for various tests, but the actual numbers are not reported.
• Data Provenance: Not specified. As a device manufacturer, Fresenius Medical Care would conduct these tests in their own facilities or through contracted labs. The data would be internally generated for regulatory submission. It is not clinical data from patients or countries.

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

• Not Applicable. This document describes engineering and laboratory testing for device safety and performance, not a diagnostic or AI-driven system requiring expert-established ground truth for a test set. The "ground truth" for these tests would be established by validated test methods and measurement equipment.

4. Adjudication method for the test set

• Not Applicable. As above, this pertains to laboratory and engineering testing, not interpretation of clinical data by multiple experts.

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. This device is a physical hemodialysis blood tubing set. It is not an AI-based diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is irrelevant 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, not an algorithm.

7. The type of ground truth used

• For the performance testing mentioned (e.g., structural integrity, pressure testing, sterility), the "ground truth" is derived from established engineering principles, scientific measurements, and validated laboratory test methods. For example, a pressure test would have a defined acceptable pressure range, and the device either passes or fails based on direct measurement, not expert consensus or pathology.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.

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

• Not Applicable. (See point 8).

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Fresenius 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.

The Fresenius 2008T Hemodialysis Machine (K113427) is indicated for acute and chronic dialysis therapy. It 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 display screen of the 2008T Hemodialysis Machine is shared between the hemodialysis machine and the CDX PC (optional) running the third party MDDS (Medical Device Data Systems) program. The blue CDX Key located on the fold-down keyboard allows switching between the Dialysis Screen and the MDDS screen. The user interface of the 2008T machine which includes a keyboard, touchpad and touch-screen, is operational in both the dialysis mode and the CDX mode, whichever is actively displayed.

Modifications to the previously cleared 2008T Hemodialysis Machine include:

• . Heparin and Sodium Variation System (SVS) Status: Addition of visual indication (display) on the home screen and dialysate screen.
• . Dialysate Flow Button: Addition of Dialysate Flow ON-OFF button in the Dialysate Screen.
• Applications Installed Display: Addition of text identifying which applications . (Apps) have been loaded is added to the machine's opening screen.
• Configurator: Software modification to support the transfer of machine . configuration information between machines during installation or upgrade in service mode.
• . Sodium Variation System (SVS) as an Optional Feature: Addition of SVS selection in service mode to make the existing SVS feature optional.

The following modification was implemented following a regulatory assessment that the change did not affect the fundamental scientific technology or intended use of the device. Based on FDA guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device", Fresenius Medical Care North America determined that this modification did not necessitate a 510(k) submission:

• Wireless Adapter: A dual band (i.e. 2.5Ghz and 5Ghz) wireless adapter provides the . wireless network link for the CDX PC, and supports 802.11a/b/g/n. This new wireless adapter replaces the obsolete wireless adapter (unmodified device) and maintains the latest wireless technology.
  Additionally, this submission includes minor maintenance modifications made to the Functional Board Software (V.2.34) of the 2008T Hemodialysis Machine since the last clearance (K113427).

Treatment modalities for the modified Fresenius 2008T Hemodialysis Machine remain identical to those for the unmodified 2008T (K113427):
The 2008T Hemodialysis Machine is a hemodialysis system used for the treatment of patients with acute or chronic kidney failure, fluid overload or toxemic conditions. Therapies include hemodialysis, hemofiltration and hemo-concentration. The 2008T Hemodialysis Machine will accommodate the use of both low flux and high permeability, high flux dialyzers.

The provided text describes a 510(k) submission for modifications to the Fresenius 2008T Hemodialysis Machine. This submission focuses on demonstrating that the modified device remains substantially equivalent to the previously cleared predicate device and that the modifications do not negatively impact its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of predetermined acceptance criteria with specific quantitative targets for each performance aspect. Instead, it states that "Test results demonstrated that the modified 2008T Hemodialysis Machine functions as intended and met pre-determined acceptance criteria." It also mentions "functional validation," "summative usability testing," and "risk analysis" as evidence.

Based on the information provided, we can infer the reported performance as meeting these general criteria:

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

The document does not specify the sample size for any test sets. It mentions "Software Verification and Validation Testing" and "Summative Usability Testing" without detailing how many test cases, iterations, or users were involved.

The provenance of this data is internal to Fresenius Medical Care North America ("according to existing FMCNA procedures, protocols, declared performance standards and guidelines of the quality system regulation (21 CFR 820)"). It is implicitly retrospective in the sense that the testing was conducted on a device that had undergone modifications, and the data was collected to support the 510(k) submission. No country of origin for specific test subjects or users is mentioned.

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 a test set in the context of the device's technical or software performance. For "Summative Usability Testing," it is plausible that a group of representative users (e.g., dialysis technicians, nurses, or clinicians) would have been involved, but their number and specific qualifications are not provided. The types of tests conducted (e.g., software verification, regression) typically rely on predefined specifications and expected outputs rather than expert interpretation of results.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. Given the nature of the modifications (software updates, feature additions, component replacements) and the testing performed (functional, safety, usability), it's unlikely that a traditional expert adjudication process (like 2+1, 3+1) would be necessary as seen in diagnostic device evaluations. The testing appears to follow a pass/fail criteria based on predefined specifications and risk analysis outcomes.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This device is a hemodialysis machine, not an AI-powered diagnostic or interpretive system that would involve human "readers" or AI assistance in a clinical interpretation task. The modifications are to the machine's software, display, and optional features.

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

The device itself (hemodialysis machine) operates primarily as a standalone system to deliver therapy, albeit with human operators. The "Software Verification and Validation Testing" can be considered a form of standalone evaluation for the modified software components, ensuring they perform as programmed without human intervention beyond initiating tests and observing results. However, this is not an "algorithm-only" performance in the sense of an AI diagnostic tool. There is no mention of an "algorithm" being evaluated separately from the device's integrated function.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the tests performed would be based on:

• Design Specifications: The documented requirements and expected behavior of the software and hardware functions.
• Risk Analysis Outcomes: Identifying and verifying the mitigation of potential hazards.
• Predicate Device Performance: The unmodified 2008T Hemodialysis Machine served as the benchmark, implicitly providing the "ground truth" for expected performance, safety, and effectiveness. The testing aimed to confirm that the modified device's functions aligned with the predicate and its specifications.

8. The Sample Size for the Training Set

No training set is mentioned in the document. This is not an AI/ML device that requires training data. The modifications are software and component updates for an existing medical device.

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

Not applicable, as no training set was used.

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The Fresenius bibag system is used with Fresenius three stream proportioning hemodialysis systems equipped with the bibaq 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 Fresenius 2008T Hemodialysis Machine with bibag System is the cleared 2008T Hemodialysis Machine that has been modified to enable use of a specialized, single use, sealed bag (the "bibaq") containing USP grade dry sodium bicarbonate powder to produce a saturated solution of sodium bicarbonate. The addition of the bibag system to the hemodialysis machine allows operators the option of producing a saturated sodium bicarbonate solution on-line through automated mixing of AAMI grade water and dry sodium bicarbonate powder within the bibag source disposable rather than with liquid bicarbonate concentrates. The bibag system is comprised of: (1) the bicarbonate concentrate generator (known as the bibag module); and (2) the bag of dry sodium carbonate concentrate. A specialized bibag connector (is attached? to the hemodialysis machine.] The bibag disposable hangs on two nozzles located in the bibag connector.

The provided document describes the Fresenius 2008T Hemodialysis Machine with bibag™ system. The primary goal of the submission is to demonstrate that the modified hemodialysis machine, incorporating the bibag system, is substantially equivalent to predicate devices and functions as intended.

Here's an analysis of the acceptance criteria and the study details based on the provided text:

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 sample sizes for any of the individual tests. It states that "Verification and validation testing were performed," but details on the number of units or test cycles are not provided. The data provenance is implied to be from internal lab testing conducted by Fresenius Medical Care North America. There is no information regarding country of origin for data or whether it was retrospective or prospective. Given the nature of a 510(k) submission for device modification, the testing would typically be prospective, controlled laboratory testing.

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

This type of information is not applicable to this submission. The tests performed are objective engineering and performance validations (e.g., electrical safety, EMC, software validation, material biocompatibility, dissolution). These tests rely on predefined engineering standards and specifications, not on expert consensus or interpretation of medical images or outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. The tests described are objective and pass/fail based on meeting predefined thresholds and standards. There is no mention of subjective assessments requiring adjudication.

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

A MRMC comparative effectiveness study was not performed and is not applicable to this type of device modification. This is a technical modification to a hemodialysis machine, not a diagnostic or AI-assisted interpretation tool that would benefit from such a study.

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

This is not applicable as the device is a medical machine with integrated functionality, not a standalone algorithm. The "system performance testing" would be considered the standalone performance, but it refers to the entire machine and bibag system in operation.

7. Type of Ground Truth Used

The "ground truth" for the various tests was based on:

• Pre-determined acceptance criteria derived from
  • International and national medical device standards: IEC 60601-1-2 (EMC), UL 60601-1 (Electrical Safety), CAN/CSA-C22.2 No. 601.1-M90 (Electrical Safety).
  • Pharmacopoeial standards: USP requirements for dissolution testing of materials.
  • Biocompatibility standards: USP 32-NF26 biological tests .
  • AAMI standards: AAMI RD61:2006 for Bioburden & Endotoxin testing.
  • Internal engineering specifications: For software validation, regression testing, and overall system functionality.

8. Sample Size for the Training Set

This is not applicable. This device is a modified hemodialysis machine, not an AI/ML algorithm that requires a training set. The "training" for the device refers to its design and manufacturing processes, which are validated through the testing described.

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

This is not applicable for the same reason as point 8.

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