(208 days)
The MyHealthPoint Telehealth Manager is an accessory software that wirelessly collects, records and transmits biometric data (including glucose, blood pressure, weight, body composition, activity, body temperature, ECG and pulse oximeter readings) from a variety of supported home-monitoring devices as well as supporting manual uploading of data. The MyHealthPoint application uses the same data repository platform that is already cleared, MyGlucoHealth Software System (K081703).
MyHealthPoint TeleHealth Manager is intended to be used by patients in non-clinical settings (e.g. home) to collect, record and transmit their biometric data to a remote secure server. Stored data is accessible by healthcare professionals and caregivers for analysis, messaging and intervention using standard digital communication technologies and protocols. Patients may also view the data to assist in self-management of their specific health condition. The MyHealthPoint Telehealth Manager is intended to be used in combination with a variety of external vital sign devices.
The MyHealthPoint Telehealth Manager is intended to be used by patients identified by their healthcare organization that would benefit from remote monitoring. It is not intended as a replacement of the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring. It does not measure, interpret or make any decisions on the data that it conveys.
The MyHealthPoint Telehealth Manager is a software platform accessible via PC or mobile smart phone that collects member's biometric data such as activity, blood pressure, blood glucose, ECG, body temperature, body composition/weight and pulse oximetry, and has the ability to send medication reminders. The MyHealthPoint TeleHealth Manager can be used by patients during their daily lives to collect biometric readings from various personal health monitors from a variety of manufacturers to assist in maintaining wellness regimens and the clinical monitoring of patients with chronic disease. The system can be accessed by members, clinicians and caregivers for analysis and intervention using standard digital communication technologies and protocols. The MyHealthPoint Telehealth Manager is intended for use in remote monitoring of patient biometrics and supports messaging between member's, clinicians and caregivers. In addition to monitoring, MyHealthPoint TeleHealth Manager supports reminders, alerts, and online graphical reports to help patients and their healthcare professionals better understand and manage their conditions.
The provided document is a 510(k) premarket notification for the MyHealthPoint TeleHealth Manager, a software platform. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for an AI algorithm.
Here's a breakdown of the requested information based on the provided text, with explicit notes where information is not available or not applicable to this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Specifications | Product meets product performance and functional specifications. | "Verification testing that product meets product performance and functional specifications." (Implies successful completion, but no specific quantitative metrics are provided.) |
| Data Integrity | Biometric data from personal home-use devices are captured (wirelessly or manually), transmitted, and stored properly to maintain data integrity (e.g., no loss of data or corruption). | "Verification that biometric data submitted by personal home-use devices are captured (wirelessly or manually), transmitted and stored properly to maintain data integrity (e.g. no loss of data or corruption)" (Implies successful completion, but no specific quantitative metrics, such as error rates or data loss percentages, are provided.) |
| Instructional Utility | Adequate instructional utility of the User Manual. | "User performance testing to demonstrate adequate instructional utility of the User Manual." (Implies successful completion, but no specific metrics, such as completion rates or error rates by users, are provided.) |
| Safety | No new issues of safety identified after extensive testing. | "After extensive bench testing to performance requirements and criteria established in accordance with application of EN14971 risk analysis, no new issues of safety, performance, technology or intended use were identified." (Broad statement, no specific safety metrics or thresholds.) |
| Performance (General) | No new issues of performance identified after extensive testing. | "After extensive bench testing to performance requirements and criteria established in accordance with application of EN14971 risk analysis, no new issues of safety, performance, technology or intended use were identified." (Broad statement, no specific performance metrics or thresholds for the software's functional capabilities.) |
| Substantial Equivalence | Device is substantially equivalent to identified predicate devices. | "Therefore the MyHealthPoint TeleHealth Manager is concluded to be substantially equivalent to the identified predicates." (This is the primary conclusion of the 510(k) submission, based on comparisons of intended use, technological characteristics, and features, rather than specific performance metrics against pre-defined thresholds for a novel algorithm.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The submission describes "extensive bench testing" and "user performance testing" but does not provide any details on the number of cases, data points, or users involved in these tests.
- Data Provenance: Not specified. The document does not mention the country of origin of any data, nor whether it was retrospective or prospective. Given the nature of a 510(k) for a software platform emphasizing substantial equivalence and verification of data transfer/storage, the focus is on functional testing rather than clinical data from a patient population.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable / Not Specified. The submission does not detail any expert-derived ground truth or clinical interpretations. The "performance" assessment focuses on the software's ability to capture, transmit, and store data correctly, and the usability of the manual. It's a technical verification, not a clinical validation requiring expert ground truth.
4. Adjudication Method for the Test Set
- Not Applicable / Not Specified. No adjudication method is mentioned as there's no indication of a diagnostic or interpretive task requiring expert consensus for ground truth establishment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study was not done. The device is a data management and communication system, not an AI algorithm performing diagnostic interpretations that would typically be evaluated in an MRMC study. The document states it "does not measure, interpret or make any decisions on the data that it conveys."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Partially Applicable / Not Explicitly Described as "Standalone Study". The "Verification testing that product meets product performance and functional specifications" and "Verification that biometric data submitted by personal home-use devices are captured (wirelessly or manually), transmitted and stored properly" essentially describe standalone testing of the software's core functionalities (data handling, transmission, storage). However, it's not structured as a typical "standalone algorithm performance study" for an AI diagnostic device, as the MyHealthPoint TeleHealth Manager itself is not an AI diagnostic algorithm.
7. Type of Ground Truth Used
- Functional/Technical Verification. The "ground truth" for the tests described would be based on expected software behavior and data integrity rather than clinical outcomes, pathology, or expert consensus on a medical diagnosis. For example, for data integrity, the ground truth would be that the transmitted data perfectly matches the source data. For functional specifications, the ground truth would be the defined expected behavior of the software.
8. Sample Size for the Training Set
- Not Applicable / Not Specified. The MyHealthPoint TeleHealth Manager is described as a software platform for data collection and display, not a machine learning or AI algorithm that requires a training set. There is no mention of an algorithm being trained on data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Specified. As there is no mention of a training set or an AI algorithm requiring training, the establishment of ground truth for such a set is not discussed.
§ 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).