(147 days)
The intended use of the HA System is for the collection, transmission, and persistence of medical measurement data and patient care data for the sole purpose of encouraging and tracking a patient's progress against the goals set between the Healthcare Professional and the patient. The goals would be established independent of the HA System in the pursuit of providing care for a chronic or post acute condition and/or to promote patient wellness.
The HA System would enable Healthcare Professionals to make use of the persisted information as a guide in delivering ongoing feedback to their patients, to set periodic reminders for patients to act on scheduled activities such as taking a vital measurement, and to receive notifications for events they configure such as ar out of range vital measurement.
The HA System can record physiological information such as:
- Blood pressure measurements
- Pulse rate measurements
- Body weight measurements
- Blood glucose levels
- Body temperature measurements
- Blood oxygen saturation (%SpO2) levels
The HA System can be used by Healthcare Professionals to create health related questionnaires, exercise plans and nutrition plans; to forward these items to the patients; and to receive the patient responses for the related questionnaires, exercise activities, and nutrition activities.
The HA System is not intended for diagnosis or as a substitute for medical care; it is also not intended to provide real-time data. The data is not used for time-critical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.
The Healthanywhere (HA) System is a user-friendly software system which provides the ability to remotely monitor basic wellness parameters. The HA System is comprised of an HA Client Application, anHA Server and the Healthcare Professional Portal (HCPP).
The HA Client Application provides capabilities to perform data collection, data transmission, message display, reminders/notifications, and reporting. It is used to collect data including vital measurements from noninvasive, commercially available, off-the-shelf, wireless medical peripherals, and patient care updates. The user data is transmitted though the HA Client Application to the HA Server using off-the-shelf. FCCapproved wireless/cellular/wired connectivity (including but not limited to GPRS, CDMA, WiFi, or Wired Ethernet) which is provided through the FCC-approved host hardware platform or through an external FCC approved wireless adapter.
The HA Server hosts the Healthcare Professional Portal (HCPP), a web application which is used to administer the HA System and users. The HCPP application provides user registration, care management, us configuration set-up, and data management. Based on specific parameters set by Healthcare Professionals, reminders and messages are scheduled and sent from the HA Server to the HA Client Applications.
The provided document is a 510(k) summary for the Healthanywhere (HA) System, which is a software system for remotely monitoring basic wellness parameters. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies with detailed acceptance criteria and statistical analysis.
Based on the document, here's what can be extracted and what information is not provided:
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Table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or reported device performance in a measurable format often seen for diagnostic or AI-driven systems. Its focus is on the functional equivalence and safety of collecting, transmitting, and persisting medical data, rather than on the accuracy of an automated interpretation or diagnosis. The "performance" demonstrated is the ability to successfully perform these data management functions. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission is for a data collection and transmission system, not an analytical or diagnostic device that typically requires a test set of medical data for performance validation. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided and is not applicable to the type of device described. The HA System's purpose is to collect data, not to interpret or diagnose it using AI, thus no "ground truth" established by medical experts for a test set is relevant to this submission. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable, as there is no test set for diagnostic accuracy or interpretation mentioned. -
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A MRMC study was not mentioned and is not applicable. The HA System is a data management tool, not an AI-assisted diagnostic tool that would involve human readers interpreting cases. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm was not mentioned and is not applicable. The device's primary function is data collection and transmission, with human healthcare professionals ultimately using the data for guidance. There isn't an "algorithm-only" performance to evaluate in the context of diagnostic accuracy. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided and is not applicable. The device collects physiological data from FDA-approved peripherals; the ground truth for that data would be inherently provided by the measurement from the peripheral itself, not by a separate expert consensus or pathology review related to the HA System's function. -
The sample size for the training set
This information is not provided and is not applicable. The HA System is a software system for data management and transmission, not a machine learning model that requires a training set. -
How the ground truth for the training set was established
This information is not provided and is not applicable, as there is no mention of a training set for a machine learning model.
Summary of the study/evidence provided (based on the document):
The Healthanywhere (HA) System's review focuses on demonstrating substantial equivalence to an existing predicate device, The Hermes System (K050929).
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Acceptance Criteria (Implied for Substantial Equivalence):
The implicit acceptance criteria are that the HA System functions similarly to the predicate device in its intended use, technological characteristics, and safety profile. This means it can:- Collect, transmit, and persist medical measurement data and patient care data.
- Support the specified physiological information (Blood pressure, Pulse rate, Body weight, Blood glucose, Body temperature, Blood oxygen saturation).
- Enable Healthcare Professionals to create questionnaires, exercise plans, and nutrition plans, and receive patient responses.
- Operate within the specified hardware and software platforms and connectivity methods.
- Maintain the same limitations and contraindications as the predicate (e.g., not for diagnosis, real-time data, or time-critical care).
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Study/Proof of Acceptance:
The "study" or evidence presented for FDA clearance is a 510(k) comparison to a predicate device (The Hermes System, K050929). The document states:- "The Healthanywhere System is substantially equivalent to The Hermes System (K050929) in that it allows patients to record data from equivalent devices using equivalent methods." (Page 3)
- The comparison focuses on the "intended use" and "technological characteristics" being similar.
This means the device meets its "acceptance criteria" by demonstrating that its fundamental nature, functionality, and safety are the same as another device already cleared by the FDA. There is no mention of a formal clinical performance study with statistical endpoints, sample sizes, or expert adjudication related to the HA System's data management capabilities in this document. The performance is assessed by showing it can successfully integrate with approved medical peripherals and transmit data reliably, similar to the predicate.
§ 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).