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The purpose of the TCx-I Remote Care Management System is to collect and transmit medical information such as weight, blood pressure and pulse rate, and blood glucose and other devices from the patients on completion of their testing and transmit these results to their healthcare provider at another facility. The system supports videoconferencing, multimedia education and messages. 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.

TCx-I Remote Care Management system collects and transmits measurement information such as weight, blood pressure and pulse rate, and Blood Glucose data from the patients on completion of their testing and transmit these results to their healthcare provider at another facility.

This 510(k) summary does not contain the kind of detailed information about acceptance criteria and specific study results that you are requesting. This document is a declaration of substantial equivalence, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria with detailed clinical studies.

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

• No acceptance criteria tables or performance data: The document discusses "Software verification and validation" and "Electrical safety and Electromagnetic compatibility tests" but provides no specific acceptance criteria (e.g., accuracy, sensitivity, specificity, data transmission rates, error rates) or the quantitative results of these tests.
• No clinical or comparative effectiveness study details: The submission explicitly states "Summary of nonclinical testing," indicating that the verification and validation were primarily non-clinical. There is no mention of studies involving human subjects for evaluating the device's performance, let alone multi-reader multi-case (MRMC) studies or standalone algorithm performance.
• Focus on data transmission, not diagnostic accuracy: The device, TCx-I Remote Care Management system, is described as a system to "collect and transmit measurement information such as weight, blood pressure and pulse rate, and Blood Glucose data." Its function is data transfer, not making diagnostic interpretations itself. Therefore, concepts like "ground truth," "expert consensus," "sample size for test/training sets," or "adjudication methods" for diagnostic accuracy are not relevant to the described function of this device and are not elaborated upon. The document clearly states, "Interpretation of the information collected and transmitted requires clinical judgement by an experienced medical professional."

In summary, the provided text establishes substantial equivalence for a data transmission system through non-clinical testing, but it does not detail performance acceptance criteria or provide the results of clinical studies to prove those criteria are met for diagnostic or interpretative purposes.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answers to the other specific questions about studies, ground truth, and expert involvement, as this information is not present in the provided 510(k) summary.

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The purpose of the TCx-I Remote Care Management 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. The system supports videoconferencing, multimedia education and messages. 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 judgment by an experienced medical professional.

TCx-I Remote Care Management system collects and transmits measurement information such as weight, blood pressure and pulse rate, and Blood Glucose data from the patients on completion of their testing and transmit these results to their healthcare provider at another facility.

The BL Healthcare Inc. TCx-I Remote Care Management System (RCMS) is a telemedicine system designed to collect and transmit medical information (weight, blood pressure, pulse rate, blood glucose) from patients to healthcare providers. The provided document is a 510(k) summary and submission acceptance letter, which details its regulatory approval based on demonstrating substantial equivalence to predicate devices, rather than a full clinical study with specific acceptance criteria and performance metrics for an AI algorithm.

Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test/training sets, ground truth establishment methods, expert qualifications, adjudication methods, MRMC studies, and standalone performance for an AI-powered device is not applicable or not provided in this document. The device described here is a data collection and transmission system, not an AI diagnostic or assistive tool in the way current AI medical devices are typically evaluated.

Here's what can be extracted from the document based on your questions:

1. Table of acceptance criteria and the reported device performance

Based on the document, there are no specific numeric acceptance criteria or reported device performance metrics in terms of accuracy, sensitivity, specificity, etc., as typically associated with AI performance. The "acceptance criteria" here relate to regulatory compliance and the system's ability to correctly transmit data.

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

• Sample size for test set: Not applicable/Not provided. The evaluation was based on non-clinical software validation and risk-based verification testing, not a clinical "test set" of patient data in the context of an AI algorithm.
• Data provenance: Not applicable/Not provided in the context of an AI algorithm's test data. The testing focused on the system's functional integrity.

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

Not applicable. Ground truth, in the sense of expert-labeled data for algorithm evaluation, was not established for this type of system validation. The "ground truth" implicitly was whether the system correctly collected and transmitted the input data.

4. Adjudication method for the test set

Not applicable. No adjudication method for a test set was mentioned, as it was not a study evaluating human interpretation or AI performance on medical images/signals.

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 comparative effectiveness study was done. 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

No standalone performance evaluation (in the context of an AI algorithm's diagnostic or predictive capabilities) was done. The focus was on the reliability of data transmission.

7. The type of ground truth used

The "ground truth" for this system's validation would be the accurate transmission and display of the measured physiological parameters (weight, BP, pulse, blood glucose). This is established through engineering and software testing protocols, verifying that what is measured at the patient end is accurately reflected at the healthcare provider end. It does not involve expert consensus, pathology, or outcomes data in the typical sense of AI evaluation.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that undergoes "training" on a dataset. Its primary function is data acquisition and transmission.

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 TCx-I-DV Remote Care Management system is for use by patients remotely in combination with a variety of monitoring devices such as blood pressure monitor, NxStage System One Hemo Dialysis system, and weight scale upon the prescription of a licensed physician or healthcare provider. The TCx-I-DV 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 dialysis data from the patients on completion of their testing and transmit these results to their healthcare provider at another facility.

TCx-I-DV Remote Care Management system collects and transmits measurement information such as weight, blood pressure and pulse rate, and dialysis data 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) submission summary for the "TCx-I-DV Remote Care Management system." This device is a telemedicine system designed to collect and transmit medical information (weight, blood pressure, pulse rate, dialysis data) from patients remotely to their healthcare providers.

The document does not contain acceptance criteria or a study that proves the device meets specific performance criteria in terms of accuracy or clinical effectiveness. Instead, the submission focuses on demonstrating "substantial equivalence" to legally marketed predicate devices.

Here's a breakdown based on your request, highlighting what is (and isn't) present in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document refers to "Verification activities including substantial equivalence testing," but provides no details on the sample size used for this testing.
• Data Provenance: Not specified. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.

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/not provided in this submission. The device is a data transmission system, not a diagnostic or interpretive device requiring expert ground truth for its performance evaluation in the context of this 510(k). The document notes, "Interpretation of the information collected and transmitted requires clinical judgement by an experienced medical professional," implying that the device itself is not making interpretations that would need expert ground truth for its own validation.

4. Adjudication method for the test set

• Not applicable/Not provided. As stated above, the submission focuses on functional equivalence rather than clinical performance adjudication.

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 transmission system, not an AI-assisted diagnostic tool.

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

• Not applicable/Not provided. The device's primary function is to collect and transmit data; it is not presented as an algorithmic diagnostic tool that would have standalone performance measured in this context. Its function is to facilitate communication, with interpretation explicitly stated to require a human experienced medical professional.

7. The type of ground truth used

• Not applicable/Not provided. Given the nature of the device (data transmission), the concept of "ground truth" for clinical outcomes or diagnostic accuracy is not directly relevant to this 510(k) submission, which focuses on functional equivalence and safe transmission of data.

8. The sample size for the training set

• Not applicable/Not provided. This device is not described as utilizing a machine learning algorithm that requires a "training set."

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

• Not applicable/Not provided. As there is no mention of a machine learning algorithm or training set, this information is not relevant to the provided text.

In summary: The provided 510(k) document emphasizes the functional equivalence of the TCx-I-DV Remote Care Management system to existing predicate devices. It clearly states the device's purpose is to collect and transmit data and that interpretation requires clinical judgment. It does not present a study with specific acceptance criteria, performance metrics, or ground truth establishment as would be seen for a diagnostic or AI-powered device. The "study" referenced is "Verification activities including substantial equivalence testing," which confirmed its functionality and intended use were comparable to predicate devices.

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The purpose of the Telephone based BL Healthcare Remote Care Management System is to collect and transmit medical information such as weight, blood pressure and pulse rate, blood glucose, SPO2, FEV1 and PEF 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.

Telephone based BL Healthcare Remote Care Management system serves as the communication link between compatible devices and the server software at a compatible healthcare facility. The purpose of the system is to collect and transmit patient vital signs and other physiological data and transmit these results to their healthcare provider at another facility. The healthcare provider is able to access the data for retrospective review and monitoring.

Here's an analysis of the provided text regarding the BL Healthcare Remote Care Management System (K052608), focusing on acceptance criteria and the study proving it:

Important Note: The provided document is a 510(k) Summary and the corresponding FDA clearance letter. It is a regulatory submission, not a detailed scientific study report. As such, it focuses on demonstrating "substantial equivalence" to predicate devices rather than providing in-depth performance studies with acceptance criteria, sample sizes, and ground truth establishment in the way a clinical trial would.

Therefore, many of the requested details (especially quantitative performance metrics, sample sizes, ground truth specifics, and MRMC studies) are not present in this type of document. The 510(k) process for this device type primarily relies on demonstrating that the new device's technology, intended use, and performance are similar enough to legally marketed devices that it doesn't raise new questions of safety or effectiveness.

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for a remote monitoring system, the "acceptance criteria" are more conceptual regarding functionality and safety rather than specific diagnostic performance metrics found in imaging or AI device clearances. The "reported device performance" is framed in terms of achieving substantial equivalence.

Study Details

The document refers to "Non-clinical testing" as the study that demonstrates substantial equivalence.

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

   • Sample Size: Not specified. This typically involves technical testing of the device's components and system functionality, rather than patient data in the sense of a clinical trial.
   • Data Provenance: Not specified. It would be internal testing by BL Healthcare.
   • Retrospective or Prospective: Not applicable in the context of this type of non-clinical testing. It would be a prospective test of newly manufactured devices/software.

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

   • Not applicable/specified. For a device like this, ground truth would relate to the accuracy of data transmission and device connectivity, confirmed by engineering and quality assurance personnel, not medical experts establishing a diagnosis.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods (like 2+1) are for human interpretation of data, often in diagnostic imaging, not for testing the fundamental data transmission and connectivity of a remote monitoring system.

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

   • No. An MRMC study is designed to compare the performance of human readers, typically in diagnostic tasks, with and without the assistance of AI. This device is a data transmission system, not an AI for diagnostic interpretation.

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

   • Yes, in spirit. The "Non-clinical testing" assessed the device's technical functionality (its ability to collect and transmit data) in a standalone manner, without requiring a human medical professional to be in the loop of the testing itself to achieve the functional goal. The output of the device (the transmitted data) is intended for human review, but the device's core function of transmission is tested independently.

6. Type of Ground Truth Used:

   • Technical Specifications/Predicate Device Equivalence. The ground truth for this device's performance would be successful data collection and transmission as verified against internal engineering specifications and, importantly, by demonstrating that its performance is equivalent to that of the predicate devices in terms of its ability to perform its stated functions.

7. Sample Size for the Training Set:

   • Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data in the conventional sense. It's a communication system.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable, as there is no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" referenced in the 510(k) is "Non-clinical testing." This testing was conducted to demonstrate that the functionality of the Telephone based BL Healthcare Remote Care Management system is "substantially equivalent" to its predicate devices (BL Healthcare Remote Care Management Systems, Zymed EasyView telemetry system, Motion Media Care Station 126S Videophone, and Carematix Modified System). This equivalence means it performs the same intended functions (collecting and transmitting vital signs like weight, blood pressure, pulse rate, blood glucose, SpO2, FEV1, and PEF) without introducing new questions of safety or effectiveness.

The explicit details typically found in an AI/ML or diagnostic device study (like specific performance metrics, clinical sample sizes, physician ground truth, etc.) are absent because the device's classification and the 510(k) pathway rely on demonstrating equivalence for a data communication and remote monitoring system, not on proving de novo diagnostic accuracy for an algorithm. The acceptance criteria are broadly met by showing that the device works as intended for its specified functions and is comparable to existing cleared devices.

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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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