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The NxStage Connected Health System is for use by chronic hemodialysis patients remotely in combination with the NxStage System One and a variety of devices such as blood pressure monitor and weight scale upon the prescription of a licensed physician or healthcare practitioner. The Connected Health System serves as the data repository and communication link to the server software which is utilized by the healthcare facility. The healthcare facility may include the physician or licensed healthcare practitioner, other clinicians, or a disease management center.

The purpose of the system is to collect, accumulate, store and transmit medical information such as flowsheet data, vital signs, blood pressure, weight and dialysis data from the patient and transmit these results to their healthcare practitioner at another facility. The system also provides online labeling, treatment status, trending and supports education and messaging.

The device is not intended to provide time sensitive data or alarms and does not control the System One Cycler. This system may not be used as a substitute for direct medical intervention or emergency care.

Interpretation of the information collected and transmitted requires clinical judgment by an experienced medical professional.

The NxStage Connected Health system collects, stores, and transmits medical information such as flowsheet data, vital signs, blood pressure, weight, and dialysis treatment data from the patient and transmits these results to their healthcare practitioner at another facility. The system also provides online labeling, treatment status, trending and supports education, has the ability to add picture attachments through the notes in a flowsheet, and the ability for the Clinician to remotely access snapshots of patient's treatment data while the treatment is taking place.

The internet server receives the patient data from the home setting or remote location where it is made available to the healthcare facility to track, graph, trend, note variances, set alert criteria, and receive alerts when parameters are outside the criteria set.

The provided documentation is a 510(k) Premarket Notification for the NxStage Connected Health System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results often seen in PMA (Premarket Approval) submissions. Therefore, the information regarding acceptance criteria and performance studies is primarily related to non-clinical verification and validation testing, and does not involve AI or human reader studies.

Here's a breakdown of the requested information based on 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 (e.g., country of origin of the data, retrospective or prospective)

The document describes non-clinical verification and validation testing, not a clinical study involving a "test set" of patient data in the sense of a dataset for AI evaluation.

• Sample size: Not applicable in the context of a "test set" of patient data for AI. The testing involved various software verification tests, simulated use scenarios, and design validation activities rather than a sample of patient data.
• Data provenance: Not applicable. The testing is described as internal verification and validation of software and system functionalities by the manufacturer.

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 is not applicable as the document describes non-clinical software and system validation, not a study requiring expert-established ground truth for a diagnostic AI.

• Design Validation Testing (for "Link" and "Remote View" functionalities) involved "Clinicians at Dialysis Clinics and NxStage Technical Support personnel." Specific numbers or detailed qualifications are not provided beyond "Clinicians" and "Technical Support personnel."

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

Not applicable. The description refers to internal verification and validation testing with predetermined pass/fail criteria, not a clinical study with an adjudication process for ground truth establishment.

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 MRMC study was done. This submission is for a data collection and communication system, not an AI-powered diagnostic device. The device does not involve "human readers" or "AI assistance" in the diagnostic context.

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

Not applicable. The device is a system for collecting, storing, and transmitting medical information, not a standalone diagnostic algorithm. It explicitly states it is "not intended to provide time sensitive data or alarms and does not control the System One Cycler" and "Interpretation of the information collected and transmitted requires clinical judgment by an experienced medical professional."

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

Not applicable in the context of diagnostic ground truth. The "ground truth" for the verification and validation described here would be the pre-defined product specifications and requirements that the system was tested against. The software functionality was verified to meet these specifications.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." It is a data collection and communication system.

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

Not applicable. As noted above, there is no training set for this type of device.

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The NxStage Connected Health System is for use by chronic hemodialysis patients remotely in combination with the NxStage System One and a variety of devices such as blood pressure monitor and weight scale upon the prescription of a licensed physician or healthcare practitioner. The Connected Health System serves as the data repository and communication link to the server software which is utilized by the healthcare facility. The healthcare facility may include the physician or licensed healthcare practitioner, other clinicians, or a disease management center.

The purpose of the system is to collect, accumulate, store and transmit medical information such as flowsheet data, vital signs, blood pressure, weight and dialysis data from the patient on the completion of their dialysis treatment and transmit these results to their healthcare practitioner at another facility. The system also provides online labeling, treatment status, trending and supports education and messaging.

The device is not intended to provide time sensitive data or alarms and does not control the System One Cycler. This system may not be used as a substitute for direct medical intervention or emergency care.

Interpretation of the information collected and transmitted requires clinical judgment by an experienced medical professional.

The NxStage Connected Health system collects, stores, and transmits medical information such as flowsheet data, vital signs, blood pressure, weight, and dialysis data from the patients on the completion of their dialysis treatment and transmits these results to their healthcare practitioner at another facility. The system also provides online labeling, treatment status, trending and supports education and messaging.

The internet server receives the patient data from the home setting or remote location where it is made available to the healthcare facility to track, graph, trend, note variances, set alert criteria, and receive alerts when parameters are outside the criteria set.

Here's an analysis of the provided text regarding the NxStage Connected Health System's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) Premarket Notification for a telemedicine system, not a diagnostic AI device with specific performance metrics like sensitivity or specificity. Therefore, the "acceptance criteria" discussed are related to the system's ability to reliably collect, store, and transmit medical data, and its substantial equivalence to a predicate device. The performance is assessed through functional testing rather than clinical diagnostic accuracy.

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

The document does not specify a sample size for a "test set" in the context of clinical performance evaluation (like for an AI diagnostic algorithm). The testing described is non-clinical bench testing for functional performance, software readiness, design review, and usability. Therefore, concepts like country of origin for data or retrospective/prospective study design are not applicable here.

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

This information is not applicable to this submission. The device is a data collection and transmission system, not a diagnostic tool that requires ground truth established by experts for performance evaluation. The "ground truth" for this type of device would be its ability to accurately and reliably perform its stated functions.

4. Adjudication Method for the Test Set

This information is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are used in studies involving expert reviews for diagnostic accuracy, which is not the type of study presented for this 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

No, an MRMC comparative effectiveness study was not done. This device is a data management system, not an AI-powered diagnostic tool, so a study of human readers improving with AI assistance is not relevant to its function.

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

The device itself is a "standalone" system in terms of its ability to collect, store, and transmit data without continuous human intervention during the data transfer process. However, this is not a standalone diagnostic algorithm performance study. The system's function is to facilitate data flow to human healthcare practitioners for their interpretation.

7. The Type of Ground Truth Used

For this device, the "ground truth" is its functional correctness and reliability in performing its stated tasks: collecting, storing, and transmitting the specified medical information. This is verified through non-clinical bench testing (software readiness, design review, usability). There is no "pathology" or "outcomes data" ground truth in the traditional sense for a diagnostic device.

8. The Sample Size for the Training Set

This information is not applicable. This device is a data management and communication system, not an AI/machine learning algorithm that requires a "training set" of data to learn from.

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

This information is not applicable, as there is no "training set" for this type of device.

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