Search Results

Ask a specific question about this device

Optiflux Dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

The Optiflux dialyzers are part of the FMCRTG family of single use dialyzers, which allow for the transfer of water and solutes between blood and the dialysate through a semi-permeable membrane. The Optiflux dialyzers are available in four (4) sizes. The sizes are differentiated by membrane surface area.

The proposed Optiflux dialyzers are single use dialyzers manufactured from Advanced Fresenius Polysulfone, polycarbonate, silicone and polyurethane. The dialyzers are provided with the blood pathway sterile and non-pyrogenic. The dialyzers are sterilized using e-beam radiation.

The principle of hemodialysis involves the diffusion of solutes across a semi-permeable membrane. Dialyzers use a counter-current flow, where the dialysate is flowing in the opposite direction to the blood flow in the extracorporeal circuit. Counter-current flow maintains the concentration gradient across the membrane for waste removal (diffusion) and fluid removal (ultrafiltration).

The provided document is a 510(k) premarket notification for a medical device (Optiflux Dialyzers). It details the device's characteristics, intended use, and comparison to a predicate device, along with the performance data demonstrating substantial equivalence. However, this document does not contain information about a study proving that the device meets acceptance criteria related to an AI/Software as a Medical Device (SaMD) context.

The document is for a physical medical device (dialyzer) and the performance data presented (e.g., urea clearance, structural integrity, biocompatibility) are relevant to the dialyzer's function in hemodialysis. There is no mention of an algorithm, AI, or software as a core component of the device being evaluated against specific performance metrics for diagnostic or therapeutic applications typically associated with AI/SaMD.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI/SaMD device meets those criteria from this text. The questions posed in your prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are highly specific to the validation of AI/SaMD products, which is not the subject of this 510(k) submission.

To directly address your request, based on the provided text, the answer is that the document does not contain the information required to fulfill the prompt.

Ask a specific question about this device

The CRIT-LINE Clip (CLiC) Blood Chamber is a sterile, single use, disposable, optical cuvette designed for use with the CLiC Monitor's sensor clip during acute and chronic hemodialysis therapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation. The blood chamber is connected between the arterial bloodline and the dialyzer within the extracorporeal circuit during hemodialysis treatment.

Like the predicate, the modified CRIT LINE Clip (CLiC) Blood Chamber is a non-invasive, disposable, optical cuvette with transparent lenses designed to connect between the arterial bloodline and the dialyzer in the extracorporeal circuit during hemodialysis treatment. The chamber's two (2) clear polycarbonate viewing lenses serve to secure the CLiC Monitor's sensor clip and provide a uniform cross section, allowing a clear view of the blood passage for the CLiC Monitor to transmit light through the blood. The CLiC Monitor uses the principle of light absorption and scattering to measure oxygen saturation (O2 SAT) and hematocrit (HCT) levels in the blood.

The proposed device is the same as the predicate. CRIT LINE Clip (CLiC) Blood Chamber (K141281) with a change only to the internal geometry (taper) of the dialyzer connector (also referred to as the 'female DIN connector').

The provided document is a 510(k) premarket notification for a medical device called the "CRIT-LINE Clip (CLiC) Blood Chamber." This document is a submission to the FDA for a device that is largely the same as a previously cleared device, with a minor modification to the internal geometry of the dialyzer connector.

The document does not describe a study that proves the device meets acceptance criteria in the context of a human-in-the-loop AI system or standalone AI algorithm, as the prompt's questions suggest. Instead, it details engineering verification and validation tests to ensure that the modified physical device (a blood chamber) continues to meet performance and safety standards, particularly concerning its connection integrity.

Therefore, many of the questions asked in the prompt, which are highly relevant for AI/ML device evaluations (e.g., sample size for test/training set, expert qualifications, MRMC studies, ground truth establishment), are not applicable to the content of this document.

However, I can extract information related to the acceptance criteria and the engineering tests performed as described in the document.

Here's the analysis based on the provided document:

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

The document provides a table of "Verification Test" and "Pass/Fail" results, effectively serving as acceptance criteria and reported performance for the engineering changes.

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

The document does not specify the sample size for each test. It refers to "verification and/or validation testing" but does not give numerical sample sizes for the mechanical and performance tests. The data provenance is implied to be from the manufacturer's internal testing. There is no mention of country of origin of data or whether it was retrospective or prospective, as these are not clinical studies.

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

Not applicable. This is not an AI/ML device requiring clinical expert ground truth. The ground truth for these engineering tests is established by physical measurement against engineering specifications and international standards (e.g., ISO, ANSI/AAMI).

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

Not applicable. This is not a clinical study requiring adjudication of expert readings.

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 is not an AI-assisted device.

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

Not applicable. This is not an AI algorithm.

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

The ground truth for these engineering performance tests is based on adherence to established international standards (ISO 8638:2010, ISO 594-2, ISO 8368:2010) and internal product specifications. These are objective engineering measurements, not clinical ground truths.

8. The sample size for the training set

Not applicable. This device does not use a training set as it is not an AI/ML device.

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

Not applicable. This device does not use a training set.

Ask a specific question about this device

Optiflux Dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

The Optiflux dialyzers are part of the FMCRTG family of single use dialyzers, which allow for the transfer of water and solutes between blood and the dialysate through a semi-permeable membrane. They Optiflux dialyzers are available in four (4) sizes. The sizes are differentiated by membrane surface area.

Medical Device: Optiflux Dialyzers F160NR, F180NR, F200NR, and F250NR

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Performance testing was conducted in accordance with ISO 8637:2010. Results of the testing listed below support the determination of substantial equivalence." This implies that the acceptance criteria for these tests are the standards outlined in ISO 8637:2010 and the results met those standards, demonstrating equivalence to the predicate.

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

   • The document does not specify the sample sizes used for each specific test (e.g., clearance testing, structural integrity, biocompatibility).
   • The data provenance is from in vitro testing. The country of origin of the data is not specified, but the manufacturer is Fresenius Medical Care North America (Waltham, MA, USA). The study is retrospective in the sense that it relies on bench testing as opposed to prospective clinical trials.

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

   • This information is not provided in the document. The tests performed are primarily bench-top (in vitro) and adherence to recognized standards (ISO 8637:2010) and biocompatibility principles. Ground truth in this context is typically established by laboratory testing protocols and established scientific methods, rather than expert interpretation of results.

4. Adjudication Method for the Test Set

   • An adjudication method similar to 2+1 or 3+1 is not applicable for the reported performance tests. These are objective laboratory measurements against defined standards or comparisons.

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

   • No, an MRMC comparative effectiveness study was not performed.
   • This type of study is not relevant for this device, which performs a physical function (blood filtration) rather than requiring human interpretation of diagnostic images or data.

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

   • Yes, the performance reported is a standalone performance of the device. The device functions mechanically/chemically based on its design and materials. There is no human interaction during the "performance" measurement itself.

7. Type of Ground Truth Used

   • The ground truth used for performance evaluation is based on objective laboratory measurements as defined by recognized standards (e.g., ISO 8637:2010) and established scientific principles for measuring physical parameters (clearance, ultrafiltration, structural integrity) and biological compatibility. It is not based on expert consensus, pathology, or outcomes data in the usual sense for diagnostic devices.

8. Sample Size for the Training Set

   • This information is not applicable as the device is not an AI/ML algorithm that requires a training set. The "training" for such a device is its design, manufacturing processes, and adherence to engineering specifications.

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

   • This information is not applicable for the same reasons as above.

Ask a specific question about this device

The Wand Assemblies are intended to be used with the 2008 Series Hemodialysis Machines to provide a fluid pathway for the concentrates and acetic acid from the canisters to the acid and bicarbonate lines of the 2008 Series Hemodialysis Machines. The Wand Assemblies are designed to be used as an accessory to the 2008 Series Hemodialysis Machines for the patients receiving dialysis therapy for acute and chronic renal failure.

The Acid Concentrate, Bicarbonate Concentrate and Acetic Acid wands are sub-assemblies intended to be used with the concentrate and acetic acid canisters as accessories to the 2008 Series Hemodialysis Machines. The wands allow the 2008 Series Hemodialysis Machines to attach to the canisters and supply bicarbonate (blue wand), acid concentrate (red wand), and acetic acid (white wand). During a dialysis treatment, the blue and red Canister-Wand Assemblies provide connectivity to supply the 2008 Series Hemodialysis Machines with Acid Concentrate and Bicarbonate Concentrate solutions. The Hemodialysis Machine will dilute these solutions with Reverse Osmosis (RO) water to produce the final dialysate solution. The white acetic acid Wand Assembly is used to supply Acetic Acid to the 2008 Series Hemodialysis Machines while running an Acid Cleaning Program as part of regular maintenance procedures. The Acid Clean Program flushes the machine with white distilled vinegar, 5% acetic or 5% citric acid for 10-60 minutes to prevent build of bicarbonate in the hydraulic system after treatment. During the cleaning program, the patient is not connected to the hemodialysis machine.

Here's a breakdown of the acceptance criteria and the study details for the Wand Assemblies, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document does not explicitly list specific quantitative acceptance criteria or corresponding device performance values in a table format. Instead, it describes a general approach to demonstrating substantial equivalence through testing. The overarching "acceptance criteria" here is that the device should not raise new concerns regarding safety or effectiveness compared to the predicate device.

Study Information

The provided text details a Traditional 510(k) submission, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with human subjects. Therefore, many of the requested items related to human reader studies or large-scale clinical trials are not applicable in this context.

1. Sample Size used for the test set and the data provenance:

   • The document does not specify explicit sample sizes for the "Performance Functional Verification" or "Biological Safety" testing. It mentions "testing was selected through the application of a risk management process, applicable guidance documents and relevant standards."
   • Data Provenance: Not explicitly stated, but it would have been conducted internally by Fresenius Medical Care – Renal Therapies Group, LLC, or by contracted labs. The testing is retrospective, comparing the new device against established safety and performance benchmarks.

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

   • Not Applicable. This type of study does not involve human expert interpretation for "ground truth" in the way a diagnostic imaging AI algorithm would. "Ground truth" here would be established by the engineering and quality control teams based on validated test methods and specifications.

3. Adjudication method for the test set:

   • Not Applicable. As there are no human experts interpreting data, an adjudication method for consensus is not relevant. The results of the functional and biological safety tests would be objectively assessed against pre-defined criteria.

4. 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 a medical device for fluid transfer in hemodialysis, not an AI-powered diagnostic tool. Therefore, MRMC studies are not relevant.

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

   • Not Applicable. This is a physical medical device, not a software algorithm.

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

   • Engineering Specifications and Regulatory Standards: The "ground truth" for this device's performance and safety is derived from established engineering specifications (e.g., flow rates, leak integrity, connection strength) and adherence to regulatory standards (e.g., ISO 10993 for biocompatibility, FDA's G95-1 guidance). Functional tests confirm the device meets these specifications, and biological safety tests confirm compliance with biocompatibility requirements.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device, so there is no "training set."

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

   • Not Applicable. There is no training set.

Ask a specific question about this device

The Optiflux Ultra dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

The Optiflux Ultra dialyzers are the next generation of the Fresenius Optiflux family of single use dialyzers, which allow for the transfer of water and solutes between the blood and the dialysate through a semipermeable membrane. Available in five sizes, the dialyzers are differentiated by membrane surface area.

The provided text describes the 510(k) notification for the Optiflux Ultra Dialyzers, a medical device used for hemodialysis. This document is a regulatory submission for substantial equivalence to legally marketed predicate devices, rather than a clinical study evaluating AI performance. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable or cannot be extracted from this specific document.

Here's the information that can be extracted or deduced from the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for a clinical study comparing performance outcomes. Instead, it details that testing was conducted to support the determination of substantial equivalence to predicate devices. The "reported device performance" is essentially that the device was found to be "substantially equivalent" to its predicates based on the outlined tests.

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: The document does not specify general "sample sizes" for its performance tests. It mentions "results of validation and verification testing," which are typically internal engineering and laboratory tests and often don't refer to large patient cohorts in the way clinical studies might. Specific numbers of units tested are not provided.
• Data Provenance: Not specified, but likely laboratory/manufacturing data. No information on country of origin or whether it's retrospective or prospective. This is not a study on clinical data.

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)

Not applicable. This is not a clinical study involving expert interpretation of data. The "ground truth" for device performance is based on established engineering and biocompatibility standards and comparison to predicate devices, not expert consensus on medical images or diagnoses.

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

Not applicable. This document describes regulatory clearance based on engineering and performance testing for substantial equivalence, not a clinical trial requiring adjudication of patient outcomes or interpretations.

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 document is for a physical medical device (dialyzer), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This document is for a physical medical device (dialyzer), not an AI algorithm.

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

The "ground truth" for the performance of the Optiflux Ultra dialyzers is based on technical specifications, established industry standards (e.g., for sterility, biocompatibility, filtration efficiency), and direct comparison to the performance characteristics of previously cleared predicate devices. It is not based on clinical expert consensus, pathology, or patient outcomes data in the context of this 510(k) summary.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning study, so there is no "training set."

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

Not applicable. This is not an AI/machine learning study, so there is no "training set" or ground truth for it.

Summary of Study (as described in the document):

The "study" described in the document is a series of validation and verification tests conducted by Fresenius Medical Care North America (the manufacturer) to demonstrate that their new Optiflux Ultra dialyzers are substantially equivalent to legally marketed predicate devices (Fresenius Optiflux F250NR and Baxter Xenium XPH dialyzers).

The tests covered:

• Sterility and non-pyrogenicity
• Structural integrity (filter assembly positive and negative pressure testing, blood compartment integrity/transmembrane pressure testing)
• Performance (clearance testing, ultrafiltration performance testing, membrane performance)
• Biological Safety (Biocompatibility testing)

The objective of these tests was to show that the Optiflux Ultra dialyzers are equivalent in design, principle of operation, technology, materials, intended use, indications for use, and performance to the predicate devices, thereby being safe and effective for their intended use. This is a regulatory submission process, not a clinical trial.

Ask a specific question about this device

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.

Ask a specific question about this device

The Fresenius Medical Care Dry Acid Dissolution Unit mixes Fresenius Medical Care distributed dry acid concentrate products with hemodialysis quality water. The resulting liquid acid concentrates are intended for use in three-stream hemodialysis machines calibrated for acid and bicarbonate concentrates.

Not Found

I am sorry, but the provided text does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for a medical device (Fresenius Dry Acid Dissolution Unit) and outlines regulatory information, but it does not include details about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert qualifications as would be found in a study report.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device