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NxStage PureFlow Solution is indicated for use with NxStage renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis for chronic care patients.

The NxStage PureFlow Solution is a family of premixed dialysate solution formulations which are sterile, non-pyrogenic, fully constituted dialysate solutions provided in 5L single use flexible bags.

The provided text describes the 510(k) premarket notification for the NxStage PureFlow Solution, a pre-mixed dialysate for hemodialysis. However, the document does not contain information about a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.

The document discusses performance testing for the NxStage PureFlow Solution, which is a physical medical device (a liquid solution in a bag), not a software or AI-driven diagnostic device. Therefore, the acceptance criteria and study details requested in the prompt (e.g., sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance) are not applicable to the content of this document.

The performance data mentioned in the document for the NxStage PureFlow Solution are related to:

• Analytical testing: per device specifications and applicable sections of USP and EP.
• Physical testing of container (bag): per device specifications.
• Container closure integrity testing: per ISO 11607-1.
• Temperature excursion testing: per device specifications.
• Stability/Shelf-life testing: per ICH Q1A to support a 24-month shelf life.
• Ship testing: per ASTM D4169-22.
• Biocompatibility testing: in accordance with ISO 10993-1 and FDA guidance, including chemical characterization, toxicological risk assessment, cytotoxicity, sensitization, irritation, pyrogenicity, hemocompatibility, and systemic toxicity.
• Human Factors Validation Testing: in accordance with FDA guidance and AAMI/ANSI/EC 62366-1.
• Electrical Safety and EMC: Not Applicable (the device has no electronic features).
• Software Verification and Validation Testing: Not Applicable (the device has no software features).
• Animal Studies: Not Applicable.
• Clinical Studies: Not Applicable.

The conclusion states that "Verification and validation was conducted to characterize the proposed device and the predetermined acceptance criteria were met." However, the document does not enumerate specific quantitative acceptance criteria or the specific performance metrics achieved in these tests, only the types of tests conducted.

Therefore, I cannot provide the requested information about AI acceptance criteria and study details based on the provided document.

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The NxStage system 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 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 VersiHD with GuideMe Software is comprised of the NxStage Cycler, an electromechanical control unit and the NxStage Cartridge (disposable) 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. It is also indicated for home hemodialysis, including home nocturnal hemodialysis and solo home hemodialysis during waking hours.

Based on the provided text, the device in question is the VersiHD with GuideMe software, which is a modification to an existing hemodialysis system (specifically, a software-only modification to the graphical user interface). This submission is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness from scratch.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of demonstrating safety, effectiveness, and non-inferiority compared to the predicate device, especially regarding the software modification and its human factors.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for performance metrics in a pass/fail table format, nor does it provide numerical "reported device performance" against those criteria in the way one might see for a diagnostic algorithm. Instead, it details that testing was conducted to demonstrate compliance with specifications and equivalence to the predicate.

The closest equivalent to "acceptance criteria" derived from the text are the regulatory and engineering requirements that the device must meet, and the "reported device performance" is indicated by the statement that these requirements were met.

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

• Sample Size: The document does not specify a numerical sample size for "test sets" in terms of patient data or case numbers. The testing described (simulated treatments, software V&V, system V&V, human factors validation) are engineering and usability tests, not clinical performance studies with patient cohorts.
• Data Provenance: Not applicable in the context of patient data. The origin of the testing itself would be the manufacturer (NxStage Medical, Inc.). The simulated treatments were described as "Simulated home hemodialysis treatments were performed in a simulated use environment (dialysis center/clinic or home setting)." This indicates a lab-based simulation rather than real patient data collection. The study specifically states "N/A. No clinical studies were conducted," and "N/A. No animal studies were conducted."

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. Given that no clinical studies or animal studies were conducted, and the device is a software modification (GUI change) to an existing system, the "ground truth" would likely relate to engineering specifications, safety standards, and usability engineering principles, rather than clinical diagnostic ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical imaging studies to establish ground truth from multiple expert reads. Since no clinical studies were performed with patient data, such a method would not be relevant here.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• Was it done?: No. The document explicitly states: "N/A. No clinical studies were conducted." MRMC studies are clinical studies involving human readers interpreting cases.
• Effect Size of Human Readers Improvement with AI vs. without AI assistance: Not applicable, as no MRMC study was performed. The "GuideMe" software appears to be an instructional aid, not an AI for diagnostic interpretation.

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

• Was it done?: This concept isn't directly applicable in the same way it would be for a diagnostic AI algorithm. The "GuideMe" software is described as a "new optional 'Guide Me' feature in which step-by-step instructions are available for users if they press the 'Guide Me' button on the updated user interface." It assists the human operator, rather than performing an independent task that could be evaluated in isolation like a diagnostic algorithm.
• The software's performance was verified and validated as part of the overall system and human factors testing, demonstrating its functionality and safety within the human-in-the-loop context.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" relevant to this submission is primarily:

• Engineering specifications and pre-determined performance specifications: For software and system verification and validation.
• International standards (e.g., IEC 60601 series): For electrical safety and EMC.
• FDA Human Factors guidance: For usability and safe interaction.

There is no mention of clinical ground truth derived from expert consensus, pathology, or outcomes data, as no clinical studies were conducted.

8. The Sample Size for the Training Set

• Not applicable / Not provided. This device is not described as a machine learning or AI model trained on a data set in the typical sense for image interpretation or diagnosis. The "GuideMe" feature is a software modification providing step-by-step instructions. Therefore, there wouldn't be a "training set" like for a deep learning model.

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

• Not applicable / Not provided. As there's no mention of a training set for an AI/ML model, the establishment of ground truth for such a set is irrelevant here. The software's functionality and content (the "Guide Me" instructions) would have been developed based on existing procedural knowledge for operating the hemodialysis system and validated through engineering and human factors testing.

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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 care facility.

The NxStage Cartridge Express with Speedswap is an optional accessory device to be used exclusively with the NxStage System One for facilitating the removal and replacement of a flow-compromised filter during to acute and chronic renal failure or fluid overload. The device would be used when hemodialysis, and /or ultrafiltration may become disrupted.

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 Cartridge Express with Speedswap is a single use extracorporeal blood circuit and fluid management device with a pre-attached detachable high permeability hollow-fiber. The proposed feature, "Speedswap" is a feature in the cartridge design that will allow the user to exchange the filter that is becoming clotted or clogged with a new filter that has been manually primed.

A kit will be required to perform the filter exchange. The proposed optional kit will consist of a filter with tubing connections for manual priming along with a waste bag to collect used saline. The nurse has the option of using the proposed cartridge without using the Speedswap feature. The functionality of the proposed cartridge is the same as the predicate Cartridge. Exchanging a used filter is optional and the facility can choose to dispose of the entire cartridge instead of exchanging the Filter.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: NxStage Cartridge Express with Speedswap

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific, quantitative performance acceptance criteria with numerical targets. However, the testing performed implicitly aims to meet the regulatory and safety standards expected for such a device.

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

The document does not explicitly state the sample sizes for the individual performance, biocompatibility, or human factors tests. It refers to "testing" and "studies" but doesn't quantify the number of units or participants.

The data provenance is industrial testing, likely conducted in a laboratory setting by the manufacturer (NxStage Medical, Inc. in Lawrence, MA), and is therefore considered retrospective to the submission date. There is no information about country of origin for specific test data beyond the manufacturer's location.

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

This type of information is not applicable to the studies described. The "ground truth" here is based on engineering specifications, regulatory standards (e.g., ISO, ASTM), and established biological/chemical safety protocols, rather than expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set:

Not applicable. The tests described are objective measurements against defined criteria (e.g., pass/fail for leak tests, adherence to ISO standards, or clear results for biocompatibility). There is no ambiguity or subjective interpretation that would require an adjudication method.

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 accessory for a hemodialysis system, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies related to human reader performance with or without AI assistance are irrelevant 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, not a standalone algorithm.

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

The "ground truth" for the various tests relies on established scientific principles, engineering standards, and regulatory guidelines:

• Engineering Specifications: For integrity, kink resistance, priming volume, chemical resistance, and system performance.
• International Standards (e.g., ISO 8638:2010): For performance testing.
• Biocompatibility Standards (e.g., ISO 10993 series implicitly): For cytotoxicity, sensitization, reactivity, pyrogenicity, genotoxicity, hemocompatibility, etc.
• Risk Analysis and Usability Engineering Principles: For human factors validation.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML product that undergoes a training phase with a dataset.

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

Not applicable, as there is no training set for this type of device.

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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 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 TPE Cartridge is indicated for use only with the NxStage System One 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 TPE Cartridge provides therapeutic plasma exchange therapy when used with a commercially available TPE filter. The blood tubing set is the NxStage TPE Cartridge. The TPE Cartridge is a single use extracorporeal blood circuit and fluid management device available without a pre-attached filter. Therapeutic plasma exchange requires the use of a commercially available Therapeutic Plasma Exchange filter such as such as the Asahi Plasmaflo OP-05W (A) wet filter (PMA P820033 S005 approved on March 16, 2010).

The provided document describes the NxStage Therapeutic Plasma Exchange (TPE) Cartridge and its path to 510(k) clearance. The focus of the study is to demonstrate substantial equivalence to a predicate device, not to prove clinical efficacy through a comparative effectiveness study involving human readers or standalone AI performance.

Therefore, many of the requested categories are not applicable to this submission.

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

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

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

The document specifies "The following tables outline the testing performed on the CAR-510-C to support the determination of substantial equivalence to the predicate device." However, specific sample sizes for each test within the performance and functional tables (Table 2 and Table 3) are not explicitly stated. The testing described appears to be laboratory-based engineering and material testing, not patient data trials. Therefore, data provenance such as country of origin or retrospective/prospective is not applicable in the context of this device.

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

This point is not applicable. The "ground truth" for the tests described relates to engineering specifications and material properties, not diagnostic interpretations from experts. The testing involved measuring physical properties and verifying performance against predefined technical requirements.

4. Adjudication method for the test set

This point is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical studies involving expert interpretation of medical images or patient outcomes. The tests in this document are technical performance evaluations.

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 point is not applicable. This submission is for a medical device (a TPE Cartridge) and is not an AI/CADe/CADx device that involves human readers or AI assistance.

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

This point is not applicable. This device is a Therapeutic Plasma Exchange Cartridge, not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the various performance and functional tests (e.g., pressure leak, endurance, tensile strength, priming volume, hemocompatibility, packaging integrity) was based on pre-defined engineering specifications, regulatory standards, and manufacturing tolerances. For biocompatibility, it was based on accepted biological evaluation standards (ISO 10993).

8. The sample size for the training set

This point is not applicable. This device does not involve a training set as it is not an AI/machine learning device.

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

This point is not applicable for the same reason as 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 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 Medisystems Dual Lumen Needle is indicated for use as a vascular access device for dialysis procedures. The Medisystems Dual Lumen Buttonhole Needle is indicated fo use as a vascular access device for dialysis procedures using a constant-site or "buttonhole" method of needle insertion.

The proposed devices are to be used as a vascular access device for dialysis procedures using either a standard needle insertion technique (for Dual Lumen Needle) or a constant-site or "buttonhole" method of insertion (for Dual Lumen Buttonhole Needle).

This document is a 510(k) premarket notification for a medical device -- a dual lumen needle for dialysis. Based on the provided text, this is not an AI/ML medical device. Therefore, the questions related to AI/ML device performance criteria, training sets, expert review, MRMC studies, and ground truth establishment are not applicable to this document.

The document discusses the substantial equivalence of the proposed devices (Medisystems Dual Lumen Needle and Medisystems Dual Lumen Buttonhole Needle) to predicate devices already on the market (Medisystems Buttonhole Needles cleared under K990803 and Cordis Corp. Bionics Bi-Flo double lumen needle cleared under K801355).

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical bench testing for a physical medical device, not a software algorithm.

Here's the relevant information that can be extracted from the document:

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

The document broadly states:

Note: The document itself does not provide the specific "predetermined acceptance criteria" or the detailed "results of this testing" for the bench tests. It only states that they were conducted and met.

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: Not specified in the provided text. The document refers to "Performance, verification and validation testing," which implies a test set, but the size is not mentioned.
• Data Provenance: Not applicable in the context of this type of testing for a physical device. It would involve laboratory bench testing, not patient 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 a physical medical device, not an AI/ML algorithm requiring expert annotation for ground truth.

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

• Not applicable. This relates to expert review of data for AI/ML, not bench testing of a physical device.

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/ML device.

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

• Not applicable. This is not an AI/ML device.

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

• Not applicable. For a physical device, "ground truth" would relate to engineering specifications, material properties, and functional performance metrics established through bench testing, rather than medical "ground truth" like disease presence.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device; there is no "training set" in the AI/ML sense.

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

• Not applicable. Again, this is for AI/ML devices.

Summary based on the document:

The document serves as an FDA 510(k) clearance letter and summary for a physical medical device. It attests that "Performance, verification and validation testing was conducted to characterize performance of the proposed devices and the predetermined acceptance criteria was met." However, it does not provide the specifics of these tests, such as sample sizes, detailed criteria, or specific results, as this information would typically be contained in the full 510(k) submission, not the summary letter itself.

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The NxStage Express Fluid Warmer and Express Fluid Warmer Disposable Set are accessories to the NxStage System One Cycler used to warm dialysate prior to administration.

The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm dialysate prior to administration. The Express Fluid Warmer is for use with the NxStage System One only and is not used to warm blood or blood products. The Express Fluid Warmer consists of an electro-mechanical warming unit and a single-use disposable.

The provided text describes a 510(k) submission for a medical device, the NxStage Express Fluid Warmer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria and detailed performance reporting in the same way a de novo device might.

Based on the provided document, here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a quantitative manner with corresponding performance results. Instead, it demonstrates substantial equivalence to a predicate device (NxStage Travel Warmer) through a comparison of technological characteristics and non-clinical performance testing. The "reported device performance" is essentially the determination that it functions similarly to the predicate.

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

• Sample Size: The document does not specify a numerical sample size for "test sets" in the context of clinical data. It states, "Performance, verification and validation testing was conducted to characterize performance of the proposed NxStage Express Fluid Warmer to provide a basis of comparison to the predicate device." These would be bench tests.
• Data Provenance: The testing described is "Non-Clinical Test/Performance Testing - Bench." This indicates that the data is from laboratory (bench) experiments, not human or animal subjects, and is neither retrospective nor prospective in a clinical sense. The location of the manufacturer is given as Lawrence, MA, USA, so presumably, the bench testing was conducted there or at an approved facility.

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

• This information is not applicable to this submission. The device is a fluid warmer, and the evaluation is based on engineering and performance specifications demonstrable through bench testing, not expert interpretation of diagnostic images or clinical outcomes.

4. Adjudication method for the test set:

• This information is not applicable to this submission, as it relates to expert consensus for ground truth establishment, which is not relevant for this type of device and study.

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 information is not applicable to this submission. The device is a medical accessory (fluid warmer), not an AI-powered diagnostic tool, so MRMC studies are irrelevant.

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

• This information is not applicable to this submission. The device is not an algorithm or AI system.

7. The type of ground truth used:

• The "ground truth" for this device's evaluation is its measured physical performance and functional characteristics (e.g., temperature range, alarm activation, flow rates) as compared to the established specifications of the predicate device. This would be based on engineering specifications and direct measurements from bench testing.

8. The sample size for the training set:

• This information is not applicable to this submission. The device does not employ machine learning or AI that requires a "training set."

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

• This information is not applicable to this submission, as there is no training set for this device.

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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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