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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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