(36 days)
The Hermes System is intended to be used by out-of-hospital patients as a means to collect and transmit medical measurements (such as blood glucose level, weight, and blood pressure) to their healthcare provider and to receive returned educational and motivational messages to help them better understand and manage their chronic condition. The Hermes System is to be used only upon prescription of a licensed physician or other authorized healthcare provider.
The Hermes System is an accessory device that collects data from a range of supported monitoring devices. The data is collected and sent using standard wireless technologies and maintained on an associated database server located within the healthcare facility. Based on patient specific parameters set by the healthcare provider, educational and motivational messages are returned to the patient.
The Hermes System is not intended for emergency calls or for transmission or indication of any real-time alarms or time-critical data. This device is not intended as a substitute for direct medical supervision or emergency intervention.
Hermes is not intended to provide automated treatment decisions, nor to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
The Hermes System is an accessory device that collects data from a range of supported measurement devices. The data is collected and sent using standard wireless technologies and maintained on an associated database server located within the healthcare facility. Based on patient specific parameters set by the healthcare provider, educational and motivational messages are returned to the patient. Hermes is used by the patient to collect data from one or more off-the-shelf measurement devices. Hermes currently supports a glucometer, a noninvasive blood pressure cuff and a weight scale.
Hermes is a software system composed of two components, a Collector module and a Server module. The Collector module is a software program that runs on a cell phone and provides the data collection, transmission and message display capabilities. The Server module is a software program that runs on standard web server hardware. The Server module receives the data sent to it by the Collector module and provides the set-up, data management, and message delivery capabilities.
Hermes messages remind the user of good health habits such as taking all prescribed measurements and maintaining a healthy lifestyle. Hermes can send email to the patient's doctor and/or guardian if good habits are not maintained.
The provided text describes a medical device called "The Hermes System" and its intended use, but it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance.
- Sample sized used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
What the document does state regarding testing:
The document briefly mentions safety and effectiveness testing in Section 6:
"An extensive collection of tests has been conducted and successfully completed, including usability and pilot studies, software unit, integration, system and load/performance testing and document verification."
However, this is a general statement and does not provide any specific acceptance criteria, performance metrics, or details about the methodology, sample sizes, ground truth, or expert involvement in these tests. The conclusion infers that these tests support substantial equivalence, but doesn't present the data itself.
§ 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).