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The NxStage System One is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The NxStage System One is also indicated for hemodialysis with or without ultrafiltration in the home.

All treatments must be administered under physician's prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

The NxStage System One dialysis system consists of an electro-mechanical cycler and a disposable Cartridge Extracorporeal Blood and Fluid Circuit (NxStage Cartridge). The NxStage Cartridge is available with a pre-attached high permeability dialyzer, together referred to as the "NxStage Cartridge Express".

The NxStage Cartridge Express filter is made up of a fiber bundle maintained within a polyethylene terephthalate glycol (PETG) dialyzer housing. The polysulfone fiber bundle is a semipermeable, hollow fiber membrane through which water molecules and smaller molecular weight solutes pass from the blood to the dialysate, but larger molecular weight solutes (such as proteins) do not. Uremic toxins and waste products are removed from the patient's blood by means of diffusion during hemodialysis.

The NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) received a 510(k) clearance (K232803) for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. This device is an updated version of the legally marketed predicate device, NxStage System One with Cartridge Express (K061837). The device is a gamma-sterilized, single-use device, and the dialyzer is provided with the blood pathway sterile and nonpyrogenic.

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

1. Acceptance Criteria and Reported Device Performance

The submission indicates that performance testing was conducted according to ISO 8637-1 First Edition 2017-11 and the FDA's "Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, August 1998." All testing met predetermined acceptance criteria, demonstrating that the NxStage Cartridge Express is safe and effective for its intended use, similar to the predicate device.

Specifically, key performance indicators for dialyzers are Urea, Creatinine, and Vitamin B12 clearance. The provided table details the in vitro clearance performance data for various blood and dialysate flow rates. Additionally, ultrafiltration rate information is presented for different transmembrane pressures.

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

The document does not explicitly state the specific sample sizes for the "test set" in terms of number of devices or experimental replicates for the performance and structural integrity testing. However, it indicates these were in vitro tests using bovine blood for ultrafiltration rate measurements (Hct. 32%; Total Protein 6 gm/dL; Temperature 37° C). The data provenance is described as in vitro testing. It does not mention any specific country of origin for the data provided from the in-vitro studies.

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

Not applicable. The reported performance data appears to be based on objective, quantitative in vitro measurements, not on expert assessment of images or interpretations that would require a "ground truth" established by experts.

4. Adjudication Method for the Test Set

Not applicable, as this was not an expert-based subjective assessment.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical hardware/disposable (dialysis cartridge), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned or would be relevant.

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

Not applicable. This is not an algorithm-only device.

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

The "ground truth" in this context refers to the objectively measured values from the in vitro performance and structural integrity tests of the dialyzer (e.g., measured clearance rates of specific molecules, ultrafiltration rates, integrity test results). Biocompatibility was assessed against established ISO standards.

8. The Sample Size for the Training Set

Not applicable. This device is hardware and does not utilize a "training set" in the sense of machine learning algorithms.

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

Not applicable for the reasons stated above.

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The NxStage System One is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The System is also indicated for home hemodialysis, including home nocturnal hemodialysis and solo home hemodialysis during waking hours. All treatments must be administered under physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

The NxStage System One is comprised of the NxStage Cycler, an electromechanical control unit; the NxStage Cartridge, a sterile, single-use extracorporeal blood and fluid management circuit (with or without a pre-attached high permeability filter) that mounts integrally within the NxStage Cycler. The combined system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration in an acute or chronic care facility. The NxStage System One is also indicated for home hemodialysis, including home nocturnal hemodialysis.

The provided text describes a 510(k) premarket notification for the NxStage System One, an hemodialysis system. The submission focuses on expanding the indications for use to include "solo home hemodialysis during waking hours." The study conducted is a Patient Preference Information (PPI) survey to support this indication expansion, not a typical performance study of an AI/ML device.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves an AI/ML device meets those criteria are not applicable to this document. This document is about a medical device (hemodialysis system) and an expansion of its usage, supported by patient preference data, not an AI/ML algorithm.

However, I will attempt to extract what is relevant and indicate where information is not present or not applicable based on this specific document.

Analysis of the Provided Document for AI/ML Device-Specific Criteria:

This document is a 510(k) summary for the NxStage System One, a hemodialysis device. The study described is a patient preference information (PPI) survey, not a study of an AI/ML device's performance. Therefore, many of the requests about AI/ML specific acceptance criteria, ground truth, expert adjudication, MRMC studies, standalone performance, and training sets are not applicable to the content of this document.

The "acceptance criteria" here refer to the willingness of patients to accept certain risk profiles for solo home hemodialysis.

Here's an attempt to answer the questions based on the provided text, highlighting what is (and isn't) present:

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

The "acceptance criteria" in this context are thresholds of risk tolerance for solo home hemodialysis based on patient preferences. The 'performance' is indicated by the percentage of patients willing to choose Solo HHD under varying risk scenarios.

Note: The "acceptance criteria" here are patient thresholds, not device performance metrics in a traditional sense. The 'performance' is how many patients still opt for Solo HHD at various risk levels.

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: 142 evaluable responses from patients.
• Data Provenance: All dialysis centers and patients were located in the United States of America.
• Study Design: This was a prospective survey conducted electronically with current HHD patients.

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 study is a patient preference survey, not a study evaluating a medical image or diagnostic output that would require expert ground truth. The "ground truth" here is the patient's stated preference regarding risk tolerance.

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

Not applicable. There was no expert adjudication in this patient preference survey. Patient responses were the direct data.

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 was not an MRMC study and did not involve human readers evaluating AI assistance.

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

Not applicable. This study did not involve an algorithm with standalone performance.

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

The "ground truth" for this study was patient preference information (PPI), specifically their stated willingness to choose solo home hemodialysis given varying hypothetical risk profiles (death, needle dislodgement).

8. The sample size for the training set

Not applicable. This study did not involve a machine learning model with a separate training set. It was a survey to gather patient preference data.

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

Not applicable. As there was no training set for a machine learning model, this question is not relevant to the described study.

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The NxStage System One Plus is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility.

The System is also indicated for home hemodialysis, including home nocturnal hemodialysis.

All treatments must be administered under physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician

The NxStage System One Plus is comprised of the NxStage Cycler, an electromechanical control unit; the NxStage Cartridge, a sterile, single-use extracorporeal blood and fluid management circuit (with or without a pre-attached high permeability filter) that mounts integrally within the NxStage Cycler. The combined system is designed to deliver hemodialysis and/or ultrafiltration in an acute or chronic care facility. The NxStage System One Plus is also indicated for home hemodialysis, including home nocturnal hemodialysis.

The provided document is a 510(k) premarket notification for a medical device called "NxStage System One Plus," a hemodialysis system. It details the device's substantial equivalence to a predicate device, its indications for use, and a summary of non-clinical testing.

However, the document does not contain the information requested regarding acceptance criteria related to device performance based on a study comparing it to a ground truth, especially for an AI/ML-based device. The tests listed are primarily related to general electrical safety, software verification, and mechanical performance for a hardware device, not the type of performance evaluation typically seen for AI/ML devices involving ground truth and human reader comparisons.

Therefore, I cannot fulfill the request using only the provided text. The requested information such as a table of "acceptance criteria and reported device performance" (in the context of AI/ML metrics like sensitivity, specificity, or image quality), sample sizes for test/training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types are not present in the provided document.

It appears the request is tailored for an AI/ML device approval, while the document describes a traditional hardware-based medical device (hemodialysis system).

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The NxStage System One is indicated for the treatment of acute and chronic renal failure, or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility.

The System is also indicated for home hemodialysis, including home nocturnal hemodialysis.

All treatments must be administered under physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

The NxStage System One is comprised of the NxStage Cycler, an electromechanical control unit; the NxStage Cartridge, a sterile, single-use extracorporeal blood and fluid management circuit (with or without a preattached high permeability filter) that mounts integrally within the NxStage Cycler. The combined system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration in an acute or chronic care facility. The NxStage System One is also indicated for home hemodialysis, including home nocturnal hemodialysis.

This document is a 510(k) Premarket Notification for the NxStage System One, a high permeability hemodialysis system. It seeks to demonstrate substantial equivalence to a previously cleared predicate device (K141752).

Based on the provided document, here's an analysis regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison of technological characteristics between the proposed device and the predicate device in Table 1. However, this table does not directly state acceptance criteria in terms of performance metrics (e.g., minimum accuracy, maximum allowable deviation) against which the proposed device was tested. Instead, it states that the "Proposed Device (NxStage System One)" is "Same" for most parameters compared to the "Predicate Device (NxStage System One)".

The closest the document comes to defining acceptance criteria is under "Effluent Volume Accuracy" for the predicate device, where specifications for different software versions are provided. However, it only states that the proposed device is "Same," implying it meets these same specifications without explicitly presenting the proposed device's performance against them.

Therefore, a table of acceptance criteria and reported device performance cannot be fully constructed from the provided text as the explicit acceptance criteria and quantitative performance results for the proposed device are not detailed, beyond stating they were "met."

Inference of Acceptance Criteria (from Predicate Device Specifications as implied by "Same"):

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

The document states: "No Clinical testing was conducted." All testing mentioned is "Non-Clinical Test/Performance Testing - Bench."

• Sample Size: Not explicitly stated for bench testing. The document refers to "Simulated treatments" but does not give a number of simulations or samples used.
• Data Provenance: Not applicable as no clinical data was used. All testing appears to be in-house bench testing.

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

Not applicable. Since no clinical testing was conducted and all testing was "Non-Clinical Test/Performance Testing - Bench," there was no need for expert ground truth establishment in a clinical context. The "ground truth" for bench testing would be established by the engineering specifications and validated test methods.

4. Adjudication Method for the Test Set

Not applicable, as no clinical testing with human subjects or expert review was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a 510(k) for a medical device (hemodialysis system), not an AI-powered diagnostic or interpretive device that would involve human readers.

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

Not applicable in the context of an "algorithm only" performance that would typically compare to human clinicians. This device is a treatment system. The "Non-Clinical Test/Performance Testing - Bench" can be considered a form of standalone performance assessment against engineering specifications, but it's not "algorithm only" in the sense of a software-as-a-medical-device (SaMD) context. It's the performance of the integrated electromechanical control unit with its software and cartridge.

7. The Type of Ground Truth Used

For the non-clinical bench testing, the "ground truth" would be established by:

• Engineering specifications and design requirements: The device's performance was measured against these predefined technical standards and parameters (e.g., flow rates, pressure monitoring ranges, accuracy for effluent volume).
• Physical measurements and simulated conditions: The testing simulates treatment conditions and measures the device's output against expected physical and chemical outcomes.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model that requires a "training set" in the conventional sense. The "training" for a traditional medical device involves its design, development, and iterative testing/refinement against engineering principles and specifications.

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

Not applicable, as there is no "training set" for an AI/ML model. The "ground truth" for the device's design and development (analogous to a training process for an AI) comes from established medical standards for hemodialysis, regulatory requirements, risk analysis, and engineering principles.

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The NxStage System One is indicated for the treatment of acute and chronic renal failure, or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility.
The System is also indicated for home hemodialysis, including home nocturnal hemodialysis.
All treatments must be administered under physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

The NxStage System One is comprised of the NxStage Cycler, an electromechanical control unit; the NxStage Cartridge, a sterile, single-use extracorporeal blood and fluid management circuit (with or without a preattached high permeability filter) that mounts integrally within the NxStage Cycler. The combined system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration in an acute or chronic care facility. The NxStage System One is also indicated for home hemodialysis, including home nocturnal hemodialysis.

This document describes the NxStage System One, a hemodialysis system. The FDA 510(k) clearance (K141752 dated December 19, 2014) indicates that the device is substantially equivalent to a previously cleared NxStage System One (K140526).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the chosen "primary effectiveness endpoint" and "primary safety endpoint" of the pivotal clinical study.

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

• Sample Size: A total of 58 End Stage Renal Disease (ESRD) patients participated in the clinical study. 39 completed the study period, and 19 discontinued.
• Data Provenance: The study was a US prospective, multi-center clinical study.

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

This information is not explicitly provided in the document. The "ground truth" for the clinical study was based on patient outcomes, delivered therapy volumes, and reported adverse events during the observational clinical trial. The study was conducted "under physician's prescription," implying medical oversight, but specific details about expert adjudication for individual patient data points are not detailed.

4. Adjudication Method for the Test Set

This information is not explicitly provided. The clinical study collected data on delivered therapy and adverse events. The assessment of these outcomes would have been part of the clinical trial protocol, but there is no specific mention of an independent adjudication committee for all events or for the effectiveness endpoint.

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

This question is not applicable to the provided document. The NxStage System One is a hemodialysis device, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in the interpretation of medical images or data. The study compared two different treatment regimens (Nocturnal Hemodialysis vs. Daily Hemodialysis) using the same device, not human performance with and without AI.

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 system, not an algorithm, and it always involves a human-in-the-loop (trained and qualified person, prescribing physician, and patient). The "effectiveness" measurement was based on the system's ability to deliver therapy, not an independent algorithmic output.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the clinical study was based on patient outcomes data, specifically:

• Effectiveness: Measured by the actual delivered volume of therapy compared to the prescribed volume.
• Safety: Measured by the occurrence and rates of intradialytic and interdialytic adverse events.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI. For the clinical study, the patients (all 58 of them) effectively served as the "test set" for evaluating the performance of the device in the two different treatment regimens. If "training set" refers to data used for initial device development and non-clinical testing, that information is not detailed here beyond "System Verification and Software Validation" and "Simulated dialysis treatments."

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

As there is no explicit "training set" described in the context of a machine learning or AI algorithm, this question is not fully applicable. For the non-clinical testing (System Verification and Software Validation, Regression testing, etc.), the ground truth would have been established through engineering specifications, validated test protocols, and simulated conditions to ensure the device performs as designed.

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The NxStage System One is indicated for the treatment of acute and chronic renal failure, or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The NxStage System One is also indicated for hemodialysis with or without ultrafiltration in the home. All treatments must be administered under physician's prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

The NxStage System One is comprised of the NxStage Cycler, an electromechanical control unit; the NxStage Cartridge, a sterile, single-use extracorporeal blood and fluid management circuit (with or without a preattached high permeability filter) that mounts integrally within the NxStage Cvcler. The combined system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration in an acute or chronic care facility. The NxStage System One is also indicated for hemodialysis with or without ultrafiltration in the home.

The provided text describes a 510(k) premarket notification for the NxStage System One, a hemodialysis system. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with new acceptance criteria and performance data.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily compares technological characteristics to a predicate device (K122051). While it mentions "predetermined acceptance criteria was met" for performance, it does not explicitly list the acceptance criteria or specific performance values for the new device against those criteria in a table format. Instead, it largely states that the proposed device has "Same" characteristics as the predicate or lists the predicate's specifications as a de facto benchmark.

Therefore, a table that perfectly fits the request cannot be generated from the given information because the specific acceptance criteria values for the current submission's device are not enumerated, nor are detailed "reported device performance" values presented for novel criteria. The comparison is mainly a feature-by-feature match to the predicate.

However, based on the provided "Technological Characteristics Comparison Table," we can infer the "acceptance criteria" were essentially "to match or be equivalent to the predicate device's specifications."

Note: The Blood Leak Detector sensitivity for the proposed device cites 0.35 ml/min leak rate compared to the predicate's 0.45 ml/min. This appears to be a slight improvement in sensitivity, meaning it can detect smaller leaks, which would meet or exceed the predicate's performance.

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

The document mentions "Performance, verification and validation testing was conducted" and that "Results of this testing have documented that the proposed NxStage System One is substantially equivalent." However, it does not provide any specific sample sizes for test sets or details about data provenance (e.g., country of origin, retrospective/prospective). The study appears to be entirely bench testing.

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

This information is not provided in the document. Given that the submission is focused on demonstrating substantial equivalence through bench testing, it is unlikely that "experts" were used in the way one might for clinical ground truth establishment (e.g., radiologists interpreting images).

4. Adjudication Method for the Test Set:

This information is not provided. Again, this is a bench testing submission, so adjudication methods typical for clinical studies would not apply.

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

No MRMC comparative effectiveness study was mentioned or conducted. The submission is not about human reader performance with or without AI assistance but rather about the technical specifications and safety of a medical device (hemodialysis system).

6. Standalone (Algorithm Only) Performance Study:

Since this is a physical medical device (hemodialysis system) with software components, not an AI algorithm for interpretation, the concept of a "standalone" or "algorithm-only" performance study in an AI context does not apply in the traditional sense. The device's performance relies on the integrated electromechanical control unit and cartridge. The software functionality itself was presumably validated as part of the overall device's performance testing (e.g., software version 4.9 compared to 4.8).

7. Type of Ground Truth Used:

The "ground truth" for this submission appears to be engineering specifications and performance standards for the hemodialysis system components and overall function, as established and validated during the design and testing phases. This is evidenced by the detailed comparison of parameters like flow rates, pressure monitor ranges, and detector sensitivities.

8. Sample Size for the Training Set:

This information is not provided. This device is not an AI/ML algorithm that is "trained" on a dataset in the conventional sense. Its functionality is based on pre-programmed parameters and electromechanical design, not machine learning model training.

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

As this is not an AI/ML device that undergoes "training," this question is not applicable. The "ground truth" for its design and operation would be based on established medical and engineering principles, regulatory requirements, and the performance of the predicate device.

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NxStage System One: The NxStage System One is indicated for the treatment of acute and chronic renal failure, or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The NxStage System One is also indicated for Therapeutic Plasma Exchange in a clinical environment. All treatments must be administered under physician's prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician. NxView: NxView is a computer-based touch screen user interface that provides on-line instructions for use, summarized system information and remote access. NxView is contraindicated as the sole method of monitoring a patient during treatment.

The NxStage System One is comprised of the NxStage Cycler, an electromechanical control unit; the NxStage Cartridge, a sterile, single-use extracorporeal blood and fluid management circuit (with or without a preattached high permeability filter) that mounts integrally within the NxStage Cycler: and NxView, a flat panel touch screen interface which is mounted on top of the cycler and provides online instructions for use, summarized system information, and remote viewing of treatment information. The combined system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration in an acute or chronic care facility. The NxStage System One with NxView is also indicated for Therapeutic Plasma Exchange in a clinical environment.

The provided text describes a 510(k) premarket notification for the "NxStage System One with NxView," a hemodialysis system. The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to showcase a new device's performance against detailed acceptance criteria using a study.

Therefore, much of the requested information regarding acceptance criteria and performance studies (like sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies) is not applicable or not available in this document.

However, I can extract information related to the device's technical characteristics and how its performance is compared to the predicate device.

Here's a summary based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on demonstrating that the "NxStage System One with NxView" has the same technological characteristics or comparable specifications to its predicate device (NxStage System One (K122051)). Therefore, the "acceptance criteria" are implicitly defined by the predicate device's established performance and specifications. The "reported device performance" for the proposed device is its sameness or similarity to these predicate specifications.

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

• Not explicitly stated. The document refers to "Performance, verification and validation testing" (G. Summary of Non-Clinical Test/Performance Testing - Bench) to characterize the proposed device. However, specific sample sizes, study designs, or data provenance (e.g., country of origin, retrospective/prospective) for this testing are not detailed. It is bench testing, suggesting in-lab rather than clinical data.

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

• Not applicable. This information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical diagnoses). This submission is for a hemodialysis system based on technological characteristics and bench testing.

4. Adjudication method for the test set

• Not applicable. See point 3.

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 not an AI-based diagnostic device undergoing human-in-the-loop evaluation. The NxView is a user interface, not an AI diagnostic tool.

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

• No, not in the context of an "algorithm-only" performance for diagnostic accuracy. The "testing" mentioned is to verify the hardware and software functionality of the hemodialysis system against engineering specifications.

7. The type of ground truth used

• For the non-clinical testing ("bench testing"), the "ground truth" would be the engineering specifications and established performance characteristics of the predicate device and internal design requirements. The device's performance observed in testing was compared against these predefined physical and functional benchmarks.

8. The sample size for the training set

• Not applicable. This submission describes a medical device, not a machine learning model that undergoes "training."

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

• Not applicable. See point 8.

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The NxStage System One is indicated for the treatment of acute and chronic renal failure, or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The System is also indicated for hemodialysis with or without ultrafiltration in the home.

The NxStage System One is also indicated for Therapeutic Plasma Exchange in a clinical environment.

All treatments must be administered under physician's prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

The NxStage System One is comprised of the NxStage Cycler, an electromechanical control unit and the NxStage Cartridge, a sterile, singleuse extracorporeal blood and fluid management circuit (with or without a preattached high permeability filter) that mounts integrally within the NxStage Cycler. The combined system is designed to deliver hemofiltration. hemodialysis and/or ultrafiltration in an acute or chronic care facility and is also indicated for hemodialysis with or without ultrafiltration in the home. The NxStage System One is also indicated for Therapeutic Plasma Exchange in a clinical environment.

This submission describes a Special 510(k) Device Modification for the NxStage System One, a hemodialysis system. The modification involves increasing the therapy fluid pump rate from 200 ml/min (12 L/hr) to 300 ml/min (18 L/hr).

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document states that "All predetermined acceptance criteria were met" for the performance, verification, safety, and software testing. However, the specific acceptance criteria and detailed device performance metrics are not explicitly listed in the provided 510(k) summary. The summary only broadly states that the device is "adequately designed for the labeled indications for use" and "is substantially equivalent to the predicate device."

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the non-clinical performance testing. It generally refers to "Performance, verification and validation testing."

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

This information is not applicable as the provided document details non-clinical bench testing for a device modification, not a study involving human expert reading of data to establish ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable as the provided document details non-clinical bench testing for a device modification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The submission focuses on non-clinical testing to demonstrate the safety and performance of a device modification and its substantial equivalence to a predicate device. It is not an AI-assisted diagnostic device where human reader improvement would be measured.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This information is not explicitly stated in the context of "algorithm only" performance. The device is a hemodialysis system, and the testing described is for the system's operational parameters (pump rate) and overall safety/performance. It's not a standalone diagnostic algorithm. The non-clinical testing likely evaluated the device's performance in an automated/standalone manner, but the term 'algorithm' may not be directly applicable in the same way as an AI diagnostic.

7. The Type of Ground Truth Used:

For the non-clinical test/performance testing, the "ground truth" would be established by engineering specifications, regulatory standards, and the performance characteristics of the predicate device. The testing aimed to verify that the modified device's performance aligned with these established benchmarks.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a hemodialysis system, and the modification involves a physical parameter (pump rate) and associated software/hardware, not a machine learning model that requires a "training set."

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

This information is not applicable as there is no mention of a training set for a machine learning model.

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The NxStage System One Low Volume Cartridge Express is indicated for use only with the NxStage System One in a chronic care dialysis facility or acute care unit. It is indicated for use in adult patients for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration.

All treatments must be administered under a physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

The NxStage System One Low Volume Cartridge Express is a single-use extracorporeal blood circuit and fluid management device with a pre-attached high flux (permeability) hollow-fiber filter that mounts integrally within the NxStage Cycler.

The provided 510(k) summary for the NxStage System One Low Volume Cartridge Express details non-clinical bench testing to demonstrate substantial equivalence to predicate devices. However, it does not explicitly define specific quantitative acceptance criteria or provide the detailed results of each test in a table format as requested. Instead, it offers a general statement that "All predetermined acceptance criteria were met."

Therefore, I cannot populate a table with specific acceptance criteria and reported device performance directly from the provided text. I can only infer the types of testing performed and the general outcome.

Here's a breakdown of the information that can be extracted based on your request:

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

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

The text mentions "Performance, verification and validation testing was conducted" and refers to "bench" testing. It does not specify the sample size for any of the tests, nor does it provide information about the data provenance (e.g., country of origin, retrospective or prospective study design). This appears to be non-clinical, in-vitro testing.

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 section is not applicable. The study described is a non-clinical bench test of a medical device (dialysis cartridge), not a study involving expert assessment of patient data or images to establish a ground truth.

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

This section is not applicable. Adjudication methods are typically associated with studies requiring human interpretation or subjective assessment. The tests performed are objective, quantitative bench tests.

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

This section is not applicable. An MRMC study is not mentioned as this submission is for a medical device (dialysis cartridge), not an AI-assisted diagnostic tool or an imaging device requiring human interpretation.

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

This section is not directly applicable in the context of an "algorithm only" performance because the device is a physical medical component, not a software algorithm. However, the bench testing conducted can be considered "standalone" in that it evaluates the device's performance independently, without human interaction during the test itself (though humans operate the testing equipment).

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

The "ground truth" for the bench tests would be the established scientific and engineering principles, material specifications, and regulatory standards for a high permeability hemodialysis system. For instance, for "priming volume assessment," the ground truth would be the accurately measured volume according to standardized procedures. For "pressure drop," the ground truth is the physically measured pressure differential. These are objective physical measurements rather than subjective assessments.

8. The sample size for the training set

This section is not applicable. The device is a physical medical device, not a machine learning model, so there is no training set.

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

This section is not applicable as there is no training set for this type of device submission.

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The NxStage System One is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The System is indicated for hemodialysis with or without ultrafiltration in the home.

The NxStage System One is also indicated for Therapeutic Plasma Exchange in a clinical environment.

All treatments must be administered under a physician's prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

The NxStage System One with Therapeutic Plasma Exchange Cartridge provides therapeutic plasma exchange therapy when used with a commercially available TPE filter. The machine that controls the therapy is called the Cycler. The blood tubing set is the NxStage TPE Cartridge. The TPE Cartridge is a single use extracorporeal blood circuit and fluid management device without a pre-attached filter. Therapeutic plasma exchange requires the use of a commercially available therapeutic plasma exchange filter such as the Asahi Plasmaflo.

The provided text describes the NxStage System One with Therapeutic Plasma Exchange Cartridge. While it details the device's indications, substantial equivalence, and general performance claims, it does not include specific acceptance criteria or the study details to prove those criteria were met in a structured format.

The document states:
"Perfication and validation testing was conducted to characterize performance of the proposed device and the predetermined acceptance criteria was met. Results of this testing have documented that the proposed NxStage System One with TPE Cartidge is substantially equivalent to the predicate devices and is suitable for the labeled indications for use."

However, it does not enumerate what those "predetermined acceptance criteria" were or provide any specifics about the "verification and validation testing" such as sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot populate the requested table and answer many of the specific questions about the study design because that information is not present in the provided text.

Based on the provided text, here's what can be extracted and what remains unknown:

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and the data provenance: Not specified in the text. The document refers to "verification and validation testing" but does not give details about "test sets" or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the text.

4. Adjudication method for the test set: Not specified in the text.

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. The device described is a medical system for therapeutic plasma exchange, not an AI-assisted diagnostic device requiring human reader performance evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical system, not an algorithm in the traditional sense for standalone performance evaluation against a ground truth in diagnostic imaging, for example.

7. The type of ground truth used: Not specified in the text. The testing appears to be primarily bench testing for characterizing device performance, rather than clinical ground truth for diagnostic accuracy.

8. The sample size for the training set: Not applicable/Not specified. This is a medical device, not a machine learning algorithm that typically uses a "training set" in the context of AI.

9. How the ground truth for the training set was established: Not applicable/Not specified.

In summary, the provided text confirms that "verification and validation testing" was performed and that "predetermined acceptance criteria" were met, leading to a determination of substantial equivalence. However, the specific details of these criteria and the methodology of the testing (including sample sizes, ground truth, and expert involvement) are not elaborated upon.

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