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The Fresenius bibag system is used with Fresenius three stream proportioning hemodialysis systems 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 Fresenius 2008T Hemodialysis Machine with bibag System is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure.

The 2008T 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); (2) the 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 2008T 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 2008T 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.

Modifications to the previously cleared 2008T Hemodialysis Machine with bibag System include:

• Active Pressure Regulation Feature: Increases the maximum acid/bicarbonate . concentrate inlet pressure specification from 2 psi to 10 psi. Provides an integrated process for regulating concentrate supply (inlet) pressures from central delivery systems.
• Active Venting Feature: Replaces the existing venting process requiring dialysate . flow bypass.
• . In-line Particulate Filter: Addition of an inline particulate filter between the bibag concentrate outlet and bicarbonate pump to eliminate the possibility of particulates from the disposable bag from entering the hydraulics.
• . Mute Once Feature: Users may elect to mute all conductivity and temperature audible alarms for up to 6 minutes (maximum) to allow a newly installed bibag disposable to reach operating temperature and conductivity.
• Acid Clean/Heat disinfection button: Allows users to initiate the acid/heat disinfect process with a single screen selection.

This submission also includes a description of software modifications to implement user interface changes. Modifications include: Heparin/SVS status. Dialysate On/Off button. Configurator, SVS Option and are intended to address user preferences and to provide additional user convenience. These changes were also described in K120505 (submitted 17 February 2012; cleared 6 March 2012).

Additionally, this submission includes minor software maintenance changes made to the 2008T Hemodialysis Machine with bibag System since the last clearance (K120017).

Treatment modalities for the modified Fresenius 2008T Hemodialysis Machine with bibag System remain identical to those for the unmodified device (K120017):

The 2008T Hemodialysis Machine with bibag System is a high permeability hemodialysis system used for the treatment of patients with acute or chronic kidney failure, fluid overload or toxemic conditions. Therapies include hemodialysis. hemofiltration and hemoconcentration. The 2008T will accommodate the use of both low flux and high flux dialyzers.

{"1. A table of acceptance criteria and the reported device performance": "The document primarily describes modifications to an existing device and verifies that these modifications do not compromise the device's safety and effectiveness. It states that "Test results demonstrated that the modified 2008T Hemodialysis Machine with bibag System functions as intended and met pre-determined acceptance criteria." However, specific quantifiable acceptance criteria (e.g., conductivity deviation must be less than X%) and their corresponding performance values are not detailed in the provided text. The performance data section broadly lists the types of tests conducted.\n\nGeneral Acceptance Criteria (Implied by Study Types):\n\n* Functional Verification and Software Validation: The device's new and existing functions operate as designed, and software changes do not introduce errors or unintended behavior.\n* System Performance: The overall system maintains its intended performance specifications (e.g., precise mixing of bicarbonate solution, delivery of dialysate).\n* Heat Disinfection Testing: The device's disinfection capabilities remain effective.\n* Chemical Testing: The device's chemical processes (e.g., concentrate preparation) meet specifications.\n* Equipment Safety: The device meets applicable safety standards.\n* Electromagnetic Compatibility: The device operates without undue electromagnetic interference.\n* Reliability: The device exhibits acceptable operational lifespan and robustness under various conditions.\n* Biocompatibility: Materials in contact with patients meet biocompatibility standards.\n* Summative Usability: The device is safe and effective for users, and the user interface changes are intuitive and do not lead to errors.\n* Risk Analysis (ISO 14971): Identified potential hazards are acceptably mitigated, and residual risks are within acceptable limits.", "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The document does not specify the sample sizes for the test sets used in verification and validation activities. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.", "3. 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)": "This information is not applicable to the provided document. The device is a hemodialysis machine, and the "ground truth" for its performance is established through engineering and systems testing against predefined specifications and safety standards, rather than expert interpretation of medical images or data from a human subject perspective.", "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "This concept is not applicable to the type of device and study described. Adjudication methods are typically used in clinical studies involving interpretation (e.g., by radiologists) where consensus or a tie-breaking mechanism is needed for ambiguous cases. The verification and validation testing for a medical device like a hemodialysis machine relies on objective measurements against engineering specifications.", "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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for AI-powered diagnostic tools where human interpretation is involved. The Fresenius 2008T Hemodialysis Machine is a therapeutic device, not a diagnostic AI system.", "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "This question is not applicable. The device is a hemodialysis machine, which is an integrated system of hardware and software designed for a specific medical therapy. It does not operate as an algorithm only; it is a physical device performing a medical function. The performance studies focused on the integrated system's safety and effectiveness after modifications.", "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The "ground truth" in this context refers to established engineering specifications, performance standards, regulatory requirements (e.g., 21 CFR 820, ISO 14971), and the intended function of the device. The device's performance was evaluated against these predetermined criteria through various tests (functional, safety, reliability, etc.). There is no mention of ground truth established by expert consensus (in a clinical interpretation sense), pathology, or outcomes data for the described studies, as these are typically associated with diagnostic or clinical effectiveness studies in human subjects.", "8. The sample size for the training set": "This question is not applicable to the provided document. The device is a hemodialysis machine, and the studies described are verification and validation of hardware and software modifications, not the training of a machine learning algorithm. Therefore, there is no "training set" in the AI/ML sense.", "9. How the ground truth for the training set was established": "This question is not applicable to the provided document, as there is no mention of a training set or machine learning components in the context of the device's modifications and testing."}

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

The Fresenius 2008T Hemodialysis Machine (K111639) 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, the 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. In the dialysate circuit, the dialysate acid and bicarbonate concentrates are mixed with purified water in predefined ratios, heated, degassed, and delivered to the dialyzer. Balancing chambers ensure that the incoming flow of the dialysate is volumetrically equal to the outgoing flow in order to control ultrafiltration from the patient. The front of the machine, with three main sections, contains all of the controls the operator needs access to during a hemodialysis treatment. The top section of the 2008T Hemodialysis Machine contains the control panel and houses the computer, which runs the treatment program and the separate CDX PC board, which provides the platform for users to utilize medical information software of their choice. The CDX PC is physically located in the 2008T machine's cabinet, but operates independently of the 2008T machine with no capacity to either control the operation of the 2008T hemodialysis machine or influence its programming. The control panel includes the touchscreen display, fold-down keyboard, touchpad and keypad which allow the operator/user to control the operation of machine by aiding the setting of treatment parameters, monitoring treatment and patient status during dialysis. The center section contains the modules used for the safe transfer of blood to and from the dialyzer. Dialysate management occurs in the bottom section of the 2008T hemodialysis machine, where the acid and bicarbonate concentrates used to make up the dialysate are mixed and pumped to the dialyzer. Modifications to the previously cleared 2008T Hemodialysis Machine (K111639) include: CDX as an Optional Feature and Proposed maintenance changes (Fn Lock Keyboard).

The provided text describes a Special 510(k) Notification for modifications to the Fresenius 2008T Hemodialysis Machine. This submission focuses on engineering changes rather than clinical performance comparisons. Therefore, much of the requested information regarding clinical study design (sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth for test and training sets) is not applicable or cannot be extracted from this document, as the submission primarily addresses the safety and effectiveness of hardware and software modifications.

However, I can extract the acceptance criteria and a summary of the performance testing that demonstrates the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

• Regression testing completed.
• Safety Systems Verification completed.
• Simulated Dialysis Treatment completed.
• Production Test Procedure completed.
• Unstructured and Static Code Verification completed. |
  | Safety | - EMC Testing (ESD immunity, emissions) completed.
• Risk Analysis completed, potential hazards identified and mitigated, and deemed acceptable after mitigation. |
  | Durability/Reliability (Fn Lock Keyboard - Elastomer) | - Unit Testing (Fn Lock Keyboard) completed.
• Physical Testing (Fn Lock Keyboard) completed, including High Tear Elastomer Use Life (Shelf Life) and Life Cycle. |
  | Overall Device Functionality | - The modified 2008T Hemodialysis Machine functioned as intended and met pre-determined acceptance criteria.
• The modifications do not impact the essential performance, and the device functions as intended. |
  | Substantial Equivalence | - The modified device is substantially equivalent to the named predicate device (K111639) and remains safe and effective for its intended use. |

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

• Not Applicable/Not Provided. The document describes engineering verification and validation testing for hardware and software modifications to an existing hemodialysis machine. It does not mention a clinical "test set" in the context of patient data or clinical outcomes. The performance testing involves various technical tests (e.g., software verification, safety, durability), not a study on a patient population.

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

• Not Applicable/Not Provided. Ground truth (in a clinical sense) is not established or discussed for the types of engineering verification tests performed.

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

• Not Applicable/Not Provided. Adjudication methods are not relevant to the described engineering verification and validation testing.

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/Not Provided. This submission is for modifications to a hemodialysis machine, not an AI-assisted diagnostic device. No MRMC study was conducted or is relevant.

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

• Not Applicable/Not Provided. (See point 5).

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

• Not Applicable/Not Provided. For engineering verification, the "ground truth" would be objective engineering specifications, design requirements, and regulatory standards, rather than clinical ground truth types.

8. The sample size for the training set:

• Not Applicable/Not Provided. The document describes modifications to an existing medical device, not a machine learning model requiring a "training set."

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

• Not Applicable/Not Provided. (See point 8).

Study Proving Device Meets Acceptance Criteria:

The document section "G. Performance Testing" and "H. Conclusion" describe the study and its results:

• Study Title: "Performance Testing" of the 2008T Hemodialysis Machine with CDX as an Optional Feature and other modifications.
• Objective: To ensure that the modifications (CDX as an optional feature, Fn Lock Keyboard, new elastomer material) do not impact the essential performance of the device and that the device functions as intended, meeting pre-determined acceptance criteria.
• Methodology: Design verification and validation testing, conducted according to existing FMCNA procedures, protocols, declared performance standards, and guidelines of the quality system regulation (21 CFR 820).
  • Tests Performed:
    • Software Verification and Validation Testing: Functional Tests, Regression, Safety Systems Verification, Simulated Dialysis Treatment, Production Test Procedure, Unstructured and Static Code Verification.
    • Safety Testing: EMC Testing (ESD immunity, emissions).
    • Unit Testing: Fn Lock Keyboard.
    • Physical Testing: Fn Lock Keyboard (High Tear Elastomer: Use Life, Life Cycle).
    • Risk Analysis: Completed to identify and mitigate potential hazards.
• Results (as stated in Section H. Conclusion): "The test results demonstrated that the modified 2008T Hemodialysis Machine functioned as intended and met pre-determined acceptance criteria. Results of functional and software validation, performance testing, risk analysis, and usability evaluation indicate that the modified Fresenius 2008T Hemodialysis Machine is substantially equivalent to the named predicate device and remains safe and effective for its intended use."

The study described is an internal verification and validation process, typical for modifications to existing medical devices to ensure they continue to meet established performance and safety specifications. It explicitly states that "Design verification and validation testing were conducted to ensure that the modifications described in this submission will not impact the essential performance of the device and the device functions as intended."

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The modified Fresenius 2008T Hemodialysis Machine has the same indications for use as the unmodified device. It is indicated for acute and chronic dialysis therapy.

The Fresenius 2008T Hemodialysis Machine (K093902) 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, the blood is continuously circulated from the patient through a dialyzer, where toxins are filtered out through a semi-permeable membrane before being 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. In the dialysate circuit, the dialysate acid and bicarbonate concentrates are mixed with purified water in predefined ratios, heated, degassed, and delivered to the dialyzer. Balancing chambers ensure that the incoming flow of the dialysate is volumetrically equal to the outgoing flow in order to control ultrafiltration from the patient.

The provided application describes the integration of several modifications to the Fresenius 2008T Hemodialysis Machine (K093902), focusing on ergonomic enhancements and reliability for the user/operator interface. These modifications include a touch screen user interface (activation of existing functionality), a dialysate sample port, a modified shunt interlock system and Hansen connectors, a larger wheel lock pedal, and a reset board.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list quantitative acceptance criteria in a dedicated table. Instead, it describes various tests conducted to ensure the safety and effectiveness of the modified device and confirms that the device "met pre-determined acceptance criteria." For each modification, a set of tests was performed to verify its functionality, safety, and compatibility with the existing system. The "performance" column below summarizes the type of testing described.

Summary Conclusion on Performance: "Test results demonstrated that the modified 2008T Hemodialysis Machine functioned as intended and met pre-determined acceptance criteria."

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

The document does not specify exact sample sizes for the test sets used for each of the performance tests. It broadly mentions "Design verification and validation testing" and lists the types of tests conducted.

The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for device modifications, these tests would typically be performed internally by the manufacturer (Fresenius Medical Care North America, located in Waltham, MA, USA), likely in a controlled, prospective manner using newly manufactured or modified device components.

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

The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth. Usability testing is mentioned for several components (Touch Screen, Dialysate Sample Port, Modified Shunt Interlock System & Hansen Connectors, Wheel Lock Pedal), which implies user feedback was gathered to assess ease of use and functional design from the perspective of intended users (e.g., nurses, technicians operating the machine). However, the details of these "experts" (users) are not provided. Other tests, such as chemical testing, strength testing, and electrical testing, would have been conducted by engineers and laboratory personnel with relevant expertise.

4. Adjudication Method for the Test Set:

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The nature of the tests (functional, chemical, mechanical, electrical, software validation) suggests that results were determined by objective measurement and verification against predetermined specifications, rather than subjective interpretation requiring multi-expert adjudication. Usability testing would involve collecting feedback, but the method for resolving conflicting feedback or formal adjudication is not specified.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The modifications are primarily ergonomic and reliability-focused for device operation, not related to interpretive diagnostic tasks that would typically involve human readers and require such a study (e.g., medical imaging AI). Therefore, there is no information about the effect size of human readers improving with or without AI assistance.

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

The device is a hemodialysis machine, which is a life-support system with direct physical interaction and monitoring by human operators. The changes described are enhancements to the user interface and mechanical components. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" as typically applied to AI-driven diagnostic tools is not directly relevant here. The device's operation inherently involves human interaction for setup, monitoring, and intervention. Software validation and functional verification were performed on the embedded software for the touch screen and reset board, which can be considered "standalone" in verifying the code's function, but this is within the context of hardware interaction rather than an independent diagnostic algorithm.

7. Type of Ground Truth Used:

The ground truth for the various tests would be based on:

• Engineering specifications and design requirements: For functional, mechanical, and electrical tests (e.g., pressure holding, cycle testing, strength, electrical testing for the shunt, software validation).
• Chemical and biological standards: For fluid path chemical testing, surface disinfectant chemical testing, residual chemical testing, and biocompatibility.
• User expectations/standards: For usability testing (e.g., ease of use, intuitive navigation).
• Industry standards: Such as ISO 8637;2004 mentioned for the Hansen connector.
• Regulatory requirements: For safety testing and risk analysis.

Ultimately, the goal was to ensure the modified device maintained "essential performance" and "functioned as intended," aligning with the predicate device's established performance and safety profile.

8. Sample Size for the Training Set:

The document does not describe any machine learning or AI components that would require a distinct "training set" in the conventional sense. The "software validation" and "functional verification" tests are for embedded software that controls the device's operation, not for adaptive learning algorithms. Therefore, there is no mention of a training set sample size.

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

As there is no mention of a "training set" in the context of machine learning, this question is not applicable. The software was validated against pre-defined functional specifications and performance requirements established through engineering design, risk analysis, and regulatory standards.

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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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