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SC+ Hemodialysis Device/ Dialysate Cartridge:

The SC+ Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription, by a trained clinician who is competent in the use of the device. The SC+ Hemodialysis System is also indicated for use in the home by trained patients in tandem with a trained care partner.

Blood Tube Set

The SC+ Blood Tube Set is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The Blood Tubeset is compatible only with the SC+ Hemodialysis System.

The SC+ is a haemodialysis delivery system intended for the provision of acute and chronic dialysis therapy, with or without ultrafiltration. The SC+ system utilises incoming Dialysis Water from an external source, with industry standard dialysis concentrate consumables, to manufacture the dialysis fluid used to deliver the treatment. The SC+ system is for use in patients with arteriovenous (AV) fistulas or central venous catheter access.

The SC+ system consists of the SC+ Machine, a single use disposable Dialysate Cartridge, and a sterile, single use, disposable Blood Tubeset.

The SC+ Machine consists of a water circuit (heater, de-aeration module, etc) blood leak detector, air in blood detector, a pneumatic interface for the dialysate cartridges, a peristaltic blood pump and various other sensors. The dialysate cartridge contains the following: conductivity monitors, interfaces for pressure and temperature measurement. membrane pumps to perform mixing/proportioning in order to produce dialysis fluid and the controlled removal of fluid from a patient with acute and/or chronic renal failure based on a physician's prescription. The dialysate fluid is manufactured using dialysis water purified externally by reverse osmosis that is heated to approximately 37℃ and subsequently deaerated within the machine before entering the cartridge.

The SC+ Blood Tubeset is a single use, sterile device consisting of an arterial line, a venous line, connections to a standard dialyzer, a saline line, three pressure transducer pods integrated into a single unit, a venous drip chamber, and a line for heparin infusion.

The provided text is a 510(k) summary for the Quanta Dialysis Technologies SC+ Hemodialysis Device, Dialysate Cartridge, and Blood Tube Set. The core of this submission is to expand the indications for use of the SC+ Hemodialysis System to include home use.

This document does not include information about AI/ML device performance, interpretation by human readers, or specific quantitative acceptance criteria for features like accuracy, sensitivity, or specificity. Instead, it describes acceptance criteria related to safety and effectiveness for a medical device in a new use environment (home healthcare) and for new user groups (patients and caregivers).

Therefore, a table of acceptance criteria and reported device performance (in the context of AI metrics) cannot be extracted directly from this document. Similarly, details on sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable to the information provided.

However, I can extract the information related to the clinical study supporting the new indication for use, which serves as the "study that proves the device meets the acceptance criteria" in the context of this device.

Here's a breakdown of the relevant information from the document:

Study That Proves the Device Meets the Acceptance Criteria:

The study conducted to support the expansion of indications to home use was the HOME RUN clinical trial (G200362).

• Type of Ground Truth Used: Clinical outcomes data (mean standardized weekly Kt/V for effectiveness, and rate of AEs for safety).
• Sample Size Used for the Test Set (Clinical Study):
  • Evaluable Population: n = 32 subjects. This included all subjects who were enrolled in the study and successfully completed at least 75% of their dialysis treatments.
• Data Provenance:
  • Country of Origin: Multi-center study in the US (13 sites).
  • Retrospective or Prospective: Prospective.
• Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts: Not applicable in the context of "ground truth" for an AI model. However, an Independent Safety and Clinical Ethics Committee (SCEC) was created to oversee trial safety.
  • Qualifications of Experts: Comprised nephrologists with experience of hemodialysis, one of whom had significant experience in home hemodialysis.
• Adjudication Method for the Test Set: The SCEC was blinded to whether AEs occurred in the in-clinic or in-home phase and had the authority to recommend changes to the trial. Details on specific adjudication rules for AEs (e.g., 2+1, 3+1) are not provided, but the SCEC served an oversight and review role.
• 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 is not an AI/ML device in the context of diagnostic interpretation. The study compared device performance (safety and effectiveness) in two settings (in-clinic vs. in-home).
• If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, and its performance is the "algorithm" in action (the hemodialysis process). The study evaluated its use by human users (patients/caregivers/clinicians).
• The Sample Size for the Training Set: Not applicable. This document describes a clinical trial for device efficacy and safety, not an AI model requiring a training set.
• How the Ground Truth for the Training Set was Established: Not applicable.

Acceptance Criteria and Reported Device Performance (as related to the clinical study):

The acceptance criteria for the expanded indication were based on demonstrating comparable safety and effectiveness in the home setting as in the clinic, considering the new use environment and user groups.

In summary, this FDA clearance document primarily focuses on the clinical validation and human factors validation required to expand the intended use of a hemodialysis device to a home setting, rather than AI/ML performance metrics. The "acceptance criteria" here relate to demonstrating equivalent safety and effectiveness in the new use environment.

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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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2008K@home 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 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 Fresenius 2008K@home machine is a modified version of the 2008K 3stream hemodialysis machine. Modifications to the device interface are designed to improve and simplify the training and process of performing hemodialysis. This modified user interface is intended to make it easier for patients and/or their caregivers to deliver hemodialysis safely and effectively in the home environment.

Additionally, the wireless wetness detector (WetAlert), an optional accessory to the 2008K@home, is a disposable device that detects leaks. During treatment, the WetAlert device transmits radio signals to the corresponding 2008K@home hemodialysis machine and alerts the 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.

The provided text describes the acceptance criteria and the study that proves the device meets them for the Fresenius 2008K@home with Wireless Wetness Detector.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Clinical Safety Data: Over 500 in-center and 500 home hemodialysis treatments were evaluated for safety. The provenance (country of origin) is not explicitly stated, but the submission is from "Fresenius Medical Care North America," suggesting the data is likely from North America. The data is retrospective, as it mentions "collected and evaluated safety data."
• Clinical Treatment Adequacy and Safety: 29 subjects who transitioned from in-center to home hemodialysis were evaluated. The provenance is not explicitly stated. The study type (retrospective/prospective) is not specified.
• Usability Testing: Conducted in "clinic and home settings." The sample size for usability testing is not specified. The provenance is not explicitly stated.
• Non-clinical Testing (Software, EMC, Electrical Safety, Full System): The sample size for these tests is not quantified in terms of units tested, but rather refers to the comprehensive nature of the testing. The data provenance is not specified.

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

The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth for any of the clinical or non-clinical studies. The clinical studies evaluated "safety data" and "treatment adequacy," implying clinical assessment by qualified medical professionals, but this is not detailed.

4. Adjudication Method

The adjudication method for any of the test sets (clinical or non-clinical) is not specified in the provided text.

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

No MRMC comparative effectiveness study is mentioned in the provided text, nor is there any discussion of AI assistance or human reader improvement with/without AI. This device is a hemodialysis machine with a wetness detector, not an AI-assisted diagnostic tool.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

The document describes non-clinical performance (software, EMC, electrical safety, full system validation) and clinical performance studies, which involve the device functioning. The Wireless Wetness Detector functions "automatically stop the blood pump, close the venous clamp, and sound an alarm" during a wetness alarm. This indicates a standalone algorithmic function for detection and response.

7. The Type of Ground Truth Used

• Non-clinical Data: The ground truth for non-clinical tests (software validation, EMC, electrical safety, full system validation) would be based on engineering specifications, regulatory standards, and pre-determined functional requirements. "Pre-determined acceptance criteria" are explicitly mentioned.
• Clinical Safety Data: The ground truth for safety would be based on clinical outcomes, adverse event reporting, and standard medical safety assessments.
• Clinical Treatment Adequacy: The ground truth for treatment adequacy would be established by clinical measures of dialysis effectiveness (e.g., clearance rates, patient well-being, lab results), likely compared against established medical standards for hemodialysis.
• Usability Testing: The ground truth for usability would be based on observations of user interaction, task completion rates, error rates, and user feedback, evaluated against pre-defined usability criteria for safe and effective operation in both clinic and home environments.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. The device described does not appear to be an AI/ML-based diagnostic or prognostic tool that would typically involve a separate training set for algorithm development. The "performance data" refers to validation and evaluation of the device as a whole.

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

As there is no explicit mention of a "training set" for an AI/ML algorithm, this question is not applicable based on the provided text. The ground truth for the device's intended function and performance was established through the various non-clinical and clinical testing methods described above, against pre-determined acceptance criteria and established medical standards for hemodialysis.

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