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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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