(22 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 or Ethernet connection. 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 pulse rate, blood pressure, blood glucose level, weight, and Peak Expiratory Flow (PEF) and FEV1 (forced expiratory volume) measurements, and blood oxygen saturation (%SpO2). 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 telephone or Ethernet connection 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 or an Ethernet connection to send patient responses since the previous data transfer and to retrieve the new dialogue.
The screen displays information sent by the patient's healthcare provider and asks questions about vital signs, symptoms and behaviors, 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) submission for the Health Buddy® Appliance, which is a communication product designed to collect and transmit patient data from various medical devices to healthcare professionals.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide specific numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it states that "Verification and validation testing activities were conducted to establish the performance, functionality and reliability characteristics of the Health Buddy Appliance." And concludes that "The Health Buddy Appliance performed as intended."
The core "performance" of this device is its ability to communicate and transmit data correctly. The acceptance criteria, therefore, would be that these functions work as expected.
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Functional Performance | - Ability to correctly connect to medical devices (blood glucose meters, BP cuffs, weight scales, peak flow meters, pulse oximeters) | "The Health Buddy Appliance performed as intended." |
| - Ability to retrieve data from connected medical devices | "The Health Buddy Appliance performed as intended." | |
| - Ability to store retrieved data | "The Health Buddy Appliance performed as intended." | |
| - Ability to transmit data to healthcare professionals via telephone or Ethernet connection at predetermined times | "The Health Buddy Appliance performed as intended." | |
| - Ability to display information to the patient and receive responses via buttons | "The Health Buddy Appliance performed as intended." | |
| - Ability to respond to patient answers with education, reinforcement, and messages | "The Health Buddy Appliance performed as intended." | |
| Reliability | - Consistent operation over time | "Verification and validation testing activities were conducted to establish the... reliability characteristics of the Health Buddy Appliance." |
| Safety | - Electrical safety compliance | "Testing included electrical safety..." |
| - EMC environmental testing compliance | "...EMC environmental testing..." | |
| Integration | - Proper integration with infrared, Ethernet network connectivity, and new LCD technologies | "Integration testing..." |
| Signal Integrity | - Accurate and unaltered transmission of data from medical devices | "Signal integrity testing..." |
| System Functionality | - Overall system operation as a complete unit | "System testing..." |
| Physical Durability | - Ability to withstand shipping and distribution conditions | "Shipping/distribution..." |
| Risk Mitigation | - Identification and mitigation of hazards through design or labeling | "A hazard risk analysis was also performed and associated risks mitigated through design or labeling." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "Verification and validation testing activities."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention using experts or establishing ground truth in the context of clinical performance for the test set. This device is an accessory for data transmission, not a diagnostic tool requiring expert interpretation of results. Its performance is evaluated based on its technical functionality (e.g., proper data relay), rather than clinical accuracy adjudicated by experts.
4. Adjudication Method for the Test Set:
Given that the device's function is data transmission and not diagnostic interpretation, an adjudication method for a test set (like 2+1 or 3+1) is not applicable and not mentioned in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study is not applicable and not mentioned. The Health Buddy Appliance is not an AI-powered diagnostic tool that assists human readers in interpreting medical images or data. Therefore, there is no "human readers improve with AI vs without AI assistance" effect size to report.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
A standalone performance study focused on the algorithm itself was implicitly done through the "Verification and validation testing activities." The software within the Health Buddy Appliance was tested to ensure it correctly handled data retrieval, storage, and transmission. However, the document doesn't quantify this performance with typical standalone metrics like sensitivity or specificity because the device's primary function is communication, not diagnostic interpretation. Its "standalone" performance is its ability to perform its communication tasks correctly.
7. Type of Ground Truth Used:
For the Health Buddy Appliance, the "ground truth" would be related to the correctness of data transmission and device functionality. This would involve:
- Known input data: Inputting specific physiological data from medical devices and verifying that the exact same data is received by the healthcare professional's system.
- Functional specifications: Verifying that all programmed features (e.g., displaying questions, receiving button presses, responding with messages, connecting via Ethernet/phone) work according to their design specifications.
- Electrical and environmental standards: Compliance with relevant industry standards for electrical safety and electromagnetic compatibility.
This is not "expert consensus," "pathology," or "outcomes data" in the traditional clinical sense, but rather a verification against defined technical and functional requirements.
8. Sample Size for the Training Set:
The Health Buddy Appliance appears to be a rule-based or firmware-driven device for data transmission, not an AI/machine learning product that requires a "training set" in the conventional sense. Therefore, the concept of a training set sample size is not applicable and not mentioned in the document.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set for an AI/ML algorithm, the method for establishing its ground truth is not applicable and not mentioned.
§ 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).