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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 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 consists of the NxStage Cycler and the NxStage Cartridge Extracorporeal Blood and Fluid Circuit. The NxStage Cycler is an electro-mechanical device that interfaces with the NxStage Cartridge. The NxStage Cartridge is a single-use extracorporeal blood circuit and fluid management device that mounts integrally within the NxStage Cycler. The NxStage Cartridge Express is a single-use extracorporeal blood circuit and fluid management device with a pre-attached high flux (permeability) hollow-fiber filter.

The provided text is a 510(k) summary for a medical device (NxStage Cartridge Express) and does not contain information about studies to prove device performance against acceptance criteria.

The document states this is a "Special 510(k) Device Modification" where "Design validation testing has been performed to ensure that the modified NxStage Cartridge Express meets design specifications." However, it does not provide details about these design specifications (acceptance criteria) or the results of the design validation testing.

Therefore, I cannot populate the requested table or answer the specific questions about the study design, sample size, ground truth, or expert involvement. The document primarily focuses on demonstrating substantial equivalence to a predicate device (K050727) based on descriptive and technological characteristics and compliance with design control requirements, rather than presenting a performance study against specific acceptance criteria.

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The NxStage System One is indicated for treatment of renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. All treatments must be administered by a health care provider, under physician's prescription.

The NxStage System One consists of the NxStage Cycler and the NxStage Cartridge Extracorporeal Blood and Fluid Circuit.

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

This is an interesting case where the provided document (a 510(k) summary for a medical device) doesn't contain a conventional study demonstrating the device meets specific performance acceptance criteria. Instead, it details a "Special 510(k) Device Modification" which relies on different evidence.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

This document does not present a table of specific quantitative acceptance criteria (e.g., "filtration rate >= X L/hr") and corresponding reported device performance values. Instead, the "acceptance criteria" here is met through a "design control certification" and demonstration of "substantial equivalence" to a predicate device.

The overarching acceptance criterion is Substantial Equivalence to the predicate device (cleared in K032356). The device performance is deemed acceptable because it meets design specifications and the modified device (NxStage Cartridge Express) is found to be substantially equivalent to the baseline device (the predicate).

Study Details

Given this context of a "Special 510(k) Device Modification," many of the standard study questions for a new device's efficacy or diagnostic accuracy are not applicable in the usual sense.

1. Table of Acceptance Criteria and Reported Device Performance

As explained above, no such quantitative table is provided in this document. The "acceptance criteria" revolve around demonstrating design control compliance and substantial equivalence.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly mentioned as a distinct "test set" for performance evaluation in the traditional sense. The document refers to "Design validation testing," which implies testing was done, but the sample size of units/cartridges tested is not specified.
• Data Provenance: Not specified. It's implied to be internal testing by NxStage Medical, Inc.

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

Not applicable. This is not a study requiring expert readers or ground truth establishment for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring expert reader adjudication.

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

No, an MRMC comparative effectiveness study was not done, as this is not a diagnostic imaging device requiring human interpretation.

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

Not applicable. This is an electro-mechanical device and fluid circuit, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the typical sense of a diagnostic or predictive device. The "ground truth" here is compliance with "design specifications" and the functionality/performance matching that of the predicate device for "substantial equivalence."

8. Sample Size for the Training Set

Not applicable. This document does not describe a machine learning algorithm or a "training set."

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

Not applicable.

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The NxStage Therapy System is indicated for treatment of renal failure or fluid overload using hemofiltration and/or ultrafiltration. The NxStage Cartridge Express is part of the NxStage Therapy System and is intended for use with the NxStage Cycler.

The NxStage Cartridge Express is an extracorporeal blood tubing set with preconnected high flux (permeability) hollow-fiber filter.

The provided text describes the NxStage Cartridge Express, a medical device, and its regulatory clearance. However, it does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically seen for AI/ML-based devices.

Here's why the requested information cannot be extracted from the provided text:

• Device Type: The NxStage Cartridge Express is described as an "extracorporeal blood tubing set with preconnected high flux (permeability) hollow-fiber filter," which is a physical medical device, not an AI/ML algorithm or system.
• Study Details: The document explicitly states "Clinical Data: Not applicable" and refers to "in vitro testing" to characterize performance and establish substantial equivalence to predicate devices. This type of testing for a physical device focuses on performance characteristics (e.g., filtration rates, biocompatibility), not on metrics like sensitivity, specificity, or reader improvement seen in AI/ML studies.
• Acceptance Criteria for AI/ML: The concepts of "acceptance criteria," "test set," "ground truth," "expert consensus," "MRMC studies," "standalone performance," and "training set" are primarily relevant to the validation of AI/ML algorithms, not to the in vitro testing of a physical hemifilter.

Therefore, I cannot provide the requested information in the format specified because it is not present in the provided document, as the device is not an AI/ML product.

The summary states:

• Summary of Non-clinical Test: "In vitro testing was conducted to characterize performance of the NxStage Hemofilter to provide a basis of comparison to the predicate devices. Results of in vitro studies have documented that the NxStage Cartridge Express is substantially equivalent to the predicate devices and is suitable for the intended use specified."
• Clinical Data: "Not applicable"

This indicates that the clearance was based on non-clinical, in-vitro testing demonstrating substantial equivalence to predicate devices, rather than a clinical study with detailed performance metrics against specific acceptance criteria for AI algorithms.

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