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Remote Care is a patient management web based application device for use with the Analogic FETALGARD Lite™ to record and graphically display maternal abdominal contractions and the fetal heart rate by means of a display in the format of a graphic or PDF strip file. The data is intended to aid in assessing the well being of the fetus during the final trimester of pregnancy (Non-Stress Test). This device is for trained medical personnel located in hospitals, clinics, doctor's offices and in the patient's home.

Remote Care is intended to be used only with the Analogic Fetalgard Lite to assist in the transmission and graphical display of maternal abdominal contractions and fetal heart rate. Remote Care receives the strip data from the monitoring system via a modem or the CareStation video phone. This strip data is then transmitted to the Remote Care web site for viewing by the health care provider.

Remote Care does not provide real-time capabilities or alerts. The device is intended for use to communicate strip data which can be used to aid in assessing the well being of the fetus in the final trimester of pregnancy. Healthcare professionals must apply clinical judgment and experience to assess the data transmitted. The device is not intended as a replacement for professional medical care. It should not be used for patients requiring emergency intervention.

Remote Care is an internet database application and repository for the storage and archival of patient information with their physiological data that relates to the Remote Care OB customers' prenatal experience. "Remote Care" receives data from the Analogic FETALGARD Lite™ and makes the data available to the medical professional through the World Wide Web.

The "Remote Care" device is an internet database application for storing, archiving, and displaying patient information with physiological data related to prenatal experience, specifically maternal abdominal contractions and fetal heart rate. It receives data from the Analogic FETALGARD Lite™ device and makes it available to medical professionals via the World Wide Web.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document (K050234 510(k) Summary) does not explicitly state formal acceptance criteria or quantifiable performance metrics for the "Remote Care" device. Instead, the "Discussion of functional testing" section generally states:

The primary "performance" discussed is the comparison of features between "Remote Care" and its predicate device, Analogic FETALGARD Lite™. This comparison indicates that "Remote Care" offers more advanced features like increased security, a scalable patient database solution, and World Wide Web accessibility.

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

The document does not specify a sample size used for a test set. There is no mention of patient data (e.g., number of cases, geographical origin) being used for formal testing of the "Remote Care" system's accuracy or efficacy. The "functional testing" appears to refer to internal verification that the system operates as designed and functions similarly to the predicate device in terms of displaying data.

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

The document does not mention the use of experts to establish a "ground truth" for a test set. Since the functional testing focuses on the system's ability to receive and display data from the monitoring device, rather than diagnostic accuracy, this type of expert assessment is not described.

4. Adjudication Method:

No adjudication method is mentioned, as there is no description of a clinical study involving interpretation or evaluation of data by multiple experts.

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

No MRMC comparative effectiveness study is mentioned. The submission focuses on the "Remote Care" system as an accessory for data transmission and display, not as a diagnostic aid that would involve human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The document does not describe a standalone performance study. The device is explicitly stated to "aid in assessing the well being of the fetus" and that "Healthcare professionals must apply clinical judgment and experience to assess the data transmitted." This indicates it's designed as a tool for human professionals, not for independent diagnostic decisions.

7. Type of Ground Truth Used:

No specific "ground truth" (e.g., pathology, outcomes data) is mentioned in relation to the functional testing of the "Remote Care" system. The testing likely focused on the technical fidelity of data transmission and graphical representation in comparison to the predicate device.

8. Sample Size for the Training Set:

The document does not refer to a "training set." The "Remote Care" device is an internet database application and display system, not a device that employs machine learning or AI that would typically require a training set.

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

Not applicable, as no training set or machine learning components are described in the provided information.

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The BL Healthcare Remote Care Management system is for use by patients remotely in combination with a variety of monitoring devices such as blood pressure monitor, blood glucose monitor, and weight scale upon the prescription of a licensed physician or healthcare provider. The BL Healthcare Remote Care Management system serves as the communication link between the compatible devices and the server software at a compatible healthcare facility. The healthcare facility may include healthcare provider, other caregivers, or a disease management center.

The purpose of the system is to collect and transmit medical information such as weight, blood pressure and pulse rate, and blood glucose from the patients on completion of their testing and transmit these results to their healthcare provider at another facility.

This system is installed by or with support from trained professionals.

This device is not intended to provide time sensitive data or alarms. 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 judgement by an experienced medical professional.

BL Healthcare Remote Care Management system serves as the communication link between FDA approved compatible devices such as Blood Pressure monitor, Blood Glucose Instrument and Weight Scale, and the server software at a compatible healthcare facility. The healthcare facility may include healthcare provider, other caregivers, or a disease management center. The system enables video conferencing over broadband and a TV Interface between the Healthcare provider and the patient. The Healthcare provider may also enable video clips, automatic medication reminders and other training materials for the user to view. The TV interface provides this information on a specific TV channel and the user is informed of new updates or videoconferencing request via audio-visual indicators on the TV Interface remote.

The purpose of the system is to collect and transmit measurement information such as weight, blood pressure and pulse rate, and blood glucose from the patients on completion of their testing and transmit these results to their healthcare provider at another facility.

The provided text is a 510(k) summary for the BL Healthcare Remote Care Management system, focusing on its substantial equivalence to predicate devices rather than a detailed performance study with specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets them, especially in the context of an AI/ML device, cannot be extracted directly from this document.

The device described is a telemedicine system that acts as a communication link to transmit data from FDA-approved medical devices (blood pressure monitor, blood glucose instrument, weight scale) to healthcare providers. It also offers video conferencing and medication reminders. It is not an AI/ML diagnostic device that would typically have performance metrics like sensitivity, specificity, or AUC a study design for AI.

Here's an attempt to answer the questions based on the available information, noting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present explicit acceptance criteria or a performance table in the way one would for a diagnostic or AI/ML device. The "performance" being evaluated here is the functional equivalence of the communication system to predicate telemedicine devices.

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

• Sample Size: Not applicable. This submission describes substantial equivalence testing for a communication system, not a clinical trial with a "test set" of patient data or samples. The "testing" referred to is functional testing, not statistical evaluation with a patient cohort.
• Data Provenance: Not applicable for the reasons above. The document does not mention data from specific countries or whether it was retrospective or prospective.

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

• Number of Experts: Not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant to this type of device submission. The device's function is data transmission, not interpretation or diagnosis.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no "test set" in the context of clinical data requiring adjudication mentioned in this submission.

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

• MRMC Study: No, an MRMC study was not done.
• Effect Size: Not applicable. This device is a data transmission system, not an AI-assisted diagnostic tool.

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

• Standalone Performance: Not applicable. This device is not an algorithm performing a standalone diagnostic function. It is a communication device; human interpretation is explicitly part of its intended use ("Interpretation of the information collected and transmitted requires clinical judgement by an experienced medical professional.").

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable. The concept of "ground truth" (e.g., pathology, outcomes data) is not relevant for demonstrating the substantial equivalence of a communication device for remote monitoring. The "truth" here relates to the reliable and accurate transmission of data from existing, FDA-cleared medical devices.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not employ machine learning that would require a "training set" of data.

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

• Ground Truth Establishment for Training Set: Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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