(30 days)
The M3810A Philips TeleMonitoring System with eDevice BridgeD130 is intended to be used upon prescription of a licensed physician or authorized healthcare provider by patients as a means to automatically collect and transmit medical information, such as weight, blood pressure, and non-diagnostic ECG, over normal residential telephone lines or cellular connectivity, between a patient, typically at home, and a health care professional at the authorized provider. The device does not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
The M3810A Philips TeleMonitoring System with eDevice BridgeD130 is indicated for patients at home, who are capable and willing to self administrate this device, upon the prescription of their healthcare provider, to collect and transmit medical information such as weight, blood pressure (including pulse rate) and non-diagnostic ECG rhythm strip to the healthcare provider at another location. The patient takes these measurements, typically once per day, and the information is transmitted automatically via normal telephone lines or cellular connectivity to the healthcare provider. The device may be used for the management of congestive heart failure, hypertension, ischemic heart disease, weight management, cardiovascular risk management, post cardiovascular surgery, post myocardial infarction, and other post cardiac events. The device does not send any real time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
The M3810A Philips Telemonitoring System with eDevice BridgeD130 is a system that automatically collects and transmits medical information such as weight, blood pressure, and non-diagnostic ECG from a patient at home to a healthcare professional. The eDevice BridgeD130 is an external wireless communication device that transmits data to the backend clinical server.
The provided text describes a 510(k) premarket notification for the "M3810A Philips Telemonitoring System with eDevice BridgeD130". The primary modification is the addition of a wireless communication option (eDevice BridgeD130) to transmit data.
Based on the provided information, I can answer some of your questions, but it's important to note that this document is a 510(k) summary for a modification of an existing device. As such, the performance data presented focuses on demonstrating that the modified device maintains substantial equivalence to the predicate device, rather than providing an exhaustive de novo performance study.
Here's the breakdown of the information you requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states: "Acceptance criteria were based on the specification cleared for the predicate device, the specifications of the subject device and test results showed substantial equivalence." It does not provide a specific table with quantitative acceptance criteria and corresponding performance metrics for individual parameters (like blood pressure accuracy or ECG interpretation accuracy).
Instead, it refers to broad categories of testing and general compliance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Specifications cleared for the predicate device | Test results showed substantial equivalence |
| Specifications of the subject device (M3810A + eDevice BridgeD130) | Test results showed substantial equivalence |
| Compliance with applicable standards | Completed electrical safety testing, EMC testing, mechanical durability, safety (operator and patient), temperature/humidity and radio telemetry testing and user evaluations for consumer accuracy demonstrated compliance with applicable standards. |
| Reliability requirements and performance claims | Meets all reliability requirements and performance claims |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). The testing focused on functional verification and validation of the hardware and software changes, not a clinical trial with a patient population.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided. The study described is a technical verification and validation, not a clinical study requiring expert ground truth for interpretation of physiological data in a clinical context. The device collects non-diagnostic ECG and other physiological data, which are then interpreted by a healthcare professional.
4. Adjudication Method for the Test Set
This information is not provided because the testing described is not a clinical study involving human interpretation needing adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document describes technical verification and validation, not a comparative effectiveness study involving human readers with and without AI assistance. The device is for data collection and transmission, not for automated interpretation or diagnosis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a data collection and transmission system. The "algorithm" in this context refers to the system's ability to accurately acquire and transmit data. The performance claims are related to the accuracy of the measurements and the reliability of the transmission, which are evaluated in a standalone manner (device functioning correctly) but don't involve an "algorithm" in the sense of AI for image or signal interpretation. The document states: "The device does not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered." This clearly indicates it's not a standalone diagnostic algorithm.
7. The Type of Ground Truth Used
For the instrumentation itself (weight, blood pressure, ECG signal acquisition), the "ground truth" would be established by reference standards or highly accurate laboratory equipment during calibration and functional testing. For example, blood pressure monitors are often tested against mercury sphygmomanometers, or using pressure simulators. ECG acquisition would be verified against known signal inputs. The document generally refers to "specifications," implying that performance was measured against predetermined engineering or regulatory benchmarks.
8. The Sample Size for the Training Set
No training set is mentioned or applicable in the context of this device. This is not an AI/machine learning device that learns from a training set. It is a physiological monitoring and transmission system.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).