(143 days)
The HealthInterlink® Beacon® device is for use by patients to collect and transmit general health information, physiological measurements such as blood pressure, weight, glucose and SpO2 using commercially available FDA cleared wireless medical devices designed for home use, and other data between themselves and a caregiver.
The HealthInterlink® Beacon® makes no diagnosis. Clinical judgment and experience are required to check and interpret the information transmitted. HealthInterlink® Beacon® is not intended as a substitute for medical care.
The HealthInterlink Beacon is a software application. Once installed on a commerciallyavailable device, the HealthInterlink Beacon software uses standard communication protocols to exchange information with other medical devices (peripherals). Data collected from the medical devices is transmitted to a server database for review by a caregiver. The HealthInterlink Beacon software has a user interface which allows the patient and caregiver to communicate using methods which include questions, answers, and messages.
HealthInterlink Beacon is not intended for emergency use or real-time monitoring.
The HealthInterlink Beacon is a remote patient monitoring system. Given the provided documentation, there is no specific acceptance criteria or study that proves device performance in the traditional sense of a clinical trial for diagnostic devices.
This device is not a diagnostic tool and does not make diagnoses. Its function is to collect and transmit general health information and physiological measurements from other FDA-cleared wireless medical devices to a caregiver.
Here's a breakdown based on the information provided, with an emphasis on what is not present given the nature of the device and its clearance:
1. Table of Acceptance Criteria and Reported Device Performance
As HealthInterlink Beacon is a data collection and transmission software, its "performance" is assessed more in terms of its functionality and integration rather than clinical metrics like sensitivity or specificity.
| Acceptance Criteria (Implied from Submission) | Reported Device Performance (Implied from Submission) |
|---|---|
| Ability to collect and transmit general health information and physiological measurements from commercially available FDA cleared wireless medical devices. | Ensured by design control verification and validation testing, confirming system works with each type of user accessory medical device (blood pressure monitor, scale, thermometer, glucose, pulse oximeter) including integration to Beacon Clinical Care Access (CCA) backend software application. |
| Functionality of all executable code. | Confirmed through design control verification and validation testing. |
| All identified risks adequately addressed by software functionality, user interface, documentation, or user SOP. | Confirmed through design control verification and validation testing. |
| System works with specified accessory medical devices (blood pressure monitor, scale, thermometer, glucose, pulse oximeter). | Confirmed through verification plan execution. |
| Output of design control verification analysis documents meet requirements and design specifications. | The output met requirements and design specifications as intended. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of clinical performance evaluation. The "test set" for this device's validation refers to its software components, integration points, and compatibility with various medical peripherals. The document mentions "testing of all executable code and functionality" and verification with "each type of user accessory medical device."
- Data Provenance: Not applicable as there was no clinical study involving patient data collection for performance evaluation of this device. The device acts as an intermediary for data from other FDA-cleared medical devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. For a device that collects and transmits data, ground truth is typically established by verifying data integrity, transmission accuracy, and functional performance, rather than through expert medical interpretation of generated data.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Software and system functionality testing does not typically involve an adjudication method in the same way a diagnostic image interpretation study would. Any discrepancies found during verification and validation would be addressed through standard software development and quality assurance processes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done.
- Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable, as this device is a remote patient monitoring system software and not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Yes, the validation performed primarily assessed the standalone functionality of the HealthInterlink Beacon software system (algorithm only, without human interpretation of the device's own output for diagnosis). The device itself performs no diagnosis and is not intended for real-time monitoring; it is a data collection and transmission utility. Its performance is entirely "standalone" in this context of data handling.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this device's validation was based on the design specifications and requirements of the software and its integration with existing, FDA-cleared external medical devices. This includes verifying that data is collected accurately, transmitted correctly, and that the software functions as designed. This is a functional and technical ground truth, not a clinical one based on pathology, expert consensus on patient conditions, or outcomes data.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. The HealthInterlink Beacon is not an AI/ML device that requires a "training set" for model development. It is software that performs defined functions of data collection and transmission.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of software 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).