(25 days)
Health Buddy® Appliance is indicated for use in non-clinical settings to collect and transmit historical medical information to healthcare professionals to help support effective management of their patients.
The Health Buddy appliance is a communications product that connects to a telephone line. It is used by patients in conjunction with the Health Hero Online service to answer questions and furnish information to their healthcare professional(s) between office visits. The Health Buddy appliance contains software that can be activated to function with specific medical devices (including blood glucose meters, non-invasive blood pressure cuffs, patient weight scales, peak flow meters and pulse oximeters). The Health Buddy appliance retrieves data from a specific medical device and stores it for transmission to a healthcare provider. The physiologic patient parameters available for retrospective display and evaluation include blood pressure, blood glucose level, weight, and Peak Expiratory Flow (PEF) and FEV1 (forced expiratory volume) measurements, and blood oxygen saturation (%SpO₂) and pulse rate using a digital pulse oximeter. The Health Buddy receives connections from these medical devices, and through the data port, wireless hub, or infrared device, downloads readings from the identified attached device and transmits the responses over the phone lines at predetermined times to the patient's health care professional.
The Health Buddy appliance is a simple, user-friendly device that connects to the patient's standard home telephone line. The device connects to a Data Center via a toll-free number to send patient responses since the previous data transfer and to retrieve the new dialoque.
The screen displays information and asks questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons. The Health Buddy will respond to the patient's answers with education, reinforcement and messages that prompt patient action. The patient responses are sent to the patient's health care provider.
The provided text describes a 510(k) premarket notification for a modification to the Health Buddy® Appliance. However, it does NOT contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets those criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
The submission focuses on establishing substantial equivalence to previously cleared devices for a modification to the software to support the connection of additional medical devices. This is a regulatory pathway that relies more on demonstrating that the changes do not introduce new questions of safety or effectiveness, rather than providing new performance data for the device as a whole.
Therefore, many of the requested details are not present in the provided document.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The 510(k) submission for this device modification focuses on establishing substantial equivalence rather than presenting new performance data against specific acceptance criteria. The document explicitly states: "This submission represents a modification to the software in the Health Buddy® Appliance to support the connection of additional medical devices."
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. No specific test set or study details with sample sizes are mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. There is no mention of experts or ground truth establishment for a test set.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable/provided. The Health Buddy Appliance is a data management and communication system for physiological parameters, not an AI-assisted diagnostic tool that would typically involve an MRMC study comparing human readers with and without AI. It collects and transmits historical data for healthcare professionals to support patient management.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This information is not provided in the document. The device primarily functions as a data conduit and communication tool, not an autonomous algorithm requiring standalone performance evaluation in the typical sense of a diagnostic or therapeutic algorithm.
7. The Type of Ground Truth Used
This information is not provided in the document. Given the nature of the device as a data transmission system, the "ground truth" would likely relate to the accuracy of data transmission and correlation with the attached medical devices, but specific details are not outlined.
8. The Sample Size for the Training Set
This information is not provided in the document. There is no mention of a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document.
Summary of the Device and its Regulatory Review:
The Health Buddy® Appliance is a communication product that connects to a telephone line. It functions by retrieving data from various medical devices (blood glucose meters, blood pressure cuffs, scales, peak flow meters, pulse oximeters) and transmitting this historical patient information to healthcare professionals. It also allows healthcare providers to send questions and educational messages to patients.
This specific 510(k) submission (K063612) is a modification to the software of an already cleared Health Buddy® Appliance to support the connection of additional medical devices. The regulatory review relies on demonstrating substantial equivalence to previously cleared Health Buddy versions and other similar telemonitoring systems.
The core assertion for clearance is that the modified device is "substantially equivalent in technology, features, and indications for use to devices cleared under the Federal Food, Drug and Cosmetic Act," and therefore its "safety and effectiveness are reasonably assured." This implies that the performance characteristics (e.g., accuracy of data transmission, reliability of communication) of the modified device are considered to be comparable to those of the predicate devices without requiring new, extensive performance studies to define new acceptance criteria and prove them.
§ 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).