(14 days)
Alcatel-Lucent TeleHealth Manager is a Remote Patient Monitoring solution intended to provide monitoring services of patient vital signs and other physiological data by remote data transmission from a patient to the practitioner.
The system can be used by patients during their daily lives and allows the collection, recording and transmission of physiological information such as blood glucose levels, using a glucometer, and non-invasive blood pressure measurements.
The transmission of data to a secure server hosting platform is carried out over existing telecommunications infrastructure via common telephone lines and mobile networks. The data is collected in a secure server hosting platform, which stores the information and allows its remote access by the patient and/or health care professional.
Alcatel-Lucent TeleHealth Manager is intended as an aid for the continuous monitoring of physiological processes and is not intended as a replacement of the medical oversight of a trained healthcare professional.
Alcatel-Lucent TeleHealth Manager is a software system that collects patient physiological data such as blood pressure and blood sugar levels, via Bluetooth technology combined with cellular or plain old telephone system (POTS) home access point, for transmission to a secure central storage server which can be accessed by health care professionals for analysis and intervention. This data is also available to the patient for viewing purposes and as an aid in the self management of their specific health condition.
As Alcatel-Lucent TeleHealth Manager main function is to relay a reading to the appropriate users without alteration or post processing of the measurement, it is the responsibility of the patient-user to verify that the reading has been correctly executed.
With respect to patient data privacy, patient data is encrypted by the Alcatel-Lucent TeleHealth Manager system in such a way that it can be securely accessed only by the authorized users.
The provided document describes the Alcatel-Lucent TeleHealth Manager, a software system that collects patient physiological data via Bluetooth and cellular/POTS for transmission to a secure central storage server. The document serves as a 510(k) summary for FDA clearance.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy percentages, latency thresholds). Instead, it broadly describes the expected performance and the types of testing conducted.
| Acceptance Criterion (Implicit from text) | Reported Device Performance and Study Findings (from "Testing" and "Conclusion" sections) |
|---|---|
| Reliable Remote Patient Monitoring Functionality: The ability to provide continuous monitoring of physiological processes. | "Alcatel-Lucent has conducted extensive validation testing of the Alcatel-Lucent TeleHealth Manager system, as a telemonitoring system that is capable of providing reliable remote patient monitoring functionalities." |
| "The system incorporates the necessary communication protocols to enable the patient to use home medical monitoring devices such as a blood pressure monitor or a glucometer." | |
| "Alcatel-Lucent TeleHealth Manager is a Remote Patient Monitoring solution intended to provide monitoring services of patient vital signs and other physiological data by remote data transmission..." | |
| Proper Storage of Physiologic Data: Data received from patient measuring devices is stored correctly. | "Testing was carried out to [...] verify that the physiologic data received by the patient measuring devices is stored properly..." |
| Secure and Integral Transmission of Data: Data is transmitted to the healthcare practitioner in a manner that maintains security and integrity. | "Testing was carried out to [...] verify that the data is transmitted to the healthcare practitioner in a manner that maintains the security and integrity of the information." |
| "With respect to patient data privacy, patient data is encrypted by the Alcatel-Lucent TeleHealth Manager system in such a way that it can be securely accessed only by the authorized users." | |
| Safe and Effective Overall System Operation: The system as a whole provides all capabilities necessary to operate safely and effectively. | "All of the different components of Alcatel-Lucent TeleHealth Manager have been stress tested to ensure that the system as a whole provides all the capabilities necessary to operate safely and effectively." |
| "The Alcatel-Lucent TeleHealth Manager device raises no new safety or effectiveness issues." | |
| Substantial Equivalence: To predicate devices in terms of indications for use, performance, technological characteristics, and communication methods. | The device was found substantially equivalent to the Carematix Wellness System (K040966) for indications for use, performance, and technological characteristics, and to Confidant 2.5 (K072698) for communication method with the hosting server. |
| No Alteration or Post-processing of Measurement: The device acts as a relay without changing the data. | "Alcatel-Lucent TeleHealth Manager main function is to relay a reading to the appropriate users without alteration or post processing of the measurement..." This isn't a performance metric as much as a fundamental design principle that would be verified through functional testing. |
Important Note: The document lacks specific quantitative metrics or thresholds for the acceptance criteria. It describes the types of performance considerations but not the levels of performance achieved (e.g., "99% data integrity" or "less than 1-second latency").
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Alcatel-Lucent has conducted extensive validation testing" and that "All of the different components of Alcatel-Lucent TeleHealth Manager have been stress tested." However, it does not specify the sample size used for the test set (e.g., number of patients, number of data transmissions, duration of tests) or the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be internal validation rather than a clinical trial with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a ground truth for a test set. The validation described focuses on the technical performance of the system (data storage, transmission, security) rather than clinical accuracy against a "ground truth" derived from expert consensus or clinical outcomes. The device's function is to relay data, not interpret it clinically.
4. Adjudication Method for the Test Set
Since there is no mention of experts or a ground truth established by them, there is no adjudication method described for a test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No MRMC comparative effectiveness study is mentioned. The device is a data transmission system, not an interpretive AI tool designed to assist human readers in diagnosing cases. Its purpose is to facilitate the delivery of physiological data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The entire system is essentially "standalone" in its core function of collecting, transmitting, and storing data without human intervention in that specific process. The device description highlights that its main function is to "relay a reading to the appropriate users without alteration or post processing of the measurement." The "algorithm" here is the software system managing data flow. Users (patients) are responsible for taking readings, and healthcare professionals access the data for analysis. There is no mention of an algorithm making diagnostic decisions that would typically require validation as a "standalone" AI medical device.
7. The Type of Ground Truth Used
The document describes testing to verify the technical functionality and integrity of the system (e.g., proper storage, secure transmission, operational effectiveness). The concept of a "ground truth" in the clinical sense (e.g., pathology, outcomes data, expert consensus) is not applicable or mentioned given the device's function as a data relay system. The "truth" being validated is whether the system accurately and securely moves data from point A to point B without corruption.
8. The Sample Size for the Training Set
The document describes "extensive validation testing" and "stress testing" for the system, but it does not mention a training set or a sample size for one. This indicates that the device is likely a rules-based software system or a system integrating existing communication protocols, rather than a machine learning/AI model that requires a distinct training phase.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set or a machine learning component, this information is not provided.
§ 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).