(30 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 dialogue.
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.
Here's an analysis of the provided text regarding the Health Buddy® Appliance, addressing your requested information:
Key Takeaway: The provided 510(k) summary for the Health Buddy® Appliance is for a special 510(k) of device modifications. This means it is based on modifications to an already cleared device and demonstrates substantial equivalence to predicate devices. As such, it does not contain a new study with acceptance criteria and device performance results in the way you might expect for an initial clearance or a comprehensive clinical trial. The focus is on demonstrating that the modifications do not introduce new questions of safety or effectiveness.
Therefore, many of your requested items (like a table of acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance studies) are not present or applicable to this specific type of submission as described.
Summary of Requested Information from the Provided Text:
1. A table of acceptance criteria and the reported device performance
- Not applicable/Not provided in this document. This special 510(k
) submission focuses on demonstrating substantial equivalence of modifications to an existing device, rather than presenting a de novo performance study against new acceptance criteria. The document asserts that the safety and effectiveness are "reasonably assured" based on equivalence to predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. No specific test set or data provenance is mentioned as this is a modification submission based on substantial equivalence.
3. 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)
- Not applicable/Not provided. No ground truth establishment for a test set is discussed in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No test set or adjudication method is discussed.
5. 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
- Not applicable/Not provided. This device is a data management system/accessory, not an AI-powered diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. The device's function is to collect and transmit historical data from other medical devices to healthcare professionals. It does not perform an "algorithm only" diagnostic function that would typically be evaluated in a standalone performance study. Its role is as an accessory and communication tool. The indication explicitly states it is "not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. As there is no new performance study described, there is no explicit mention of ground truth types. The device transmits historical data from other medical devices, so the "ground truth" for the data itself would derive from the accuracy of those connected medical devices (e.g., blood glucose meter, blood pressure cuff).
8. The sample size for the training set
- Not applicable/Not provided. The document describes a medical device for data transmission, not an AI/ML algorithm that would typically require a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. See the explanation for point 8.
Detailed Information from the Provided Text (Relevant to Device Description and Predicate):
Acceptance Criteria & Device Performance (Indirect):
Since this is a Special 510(k) for modifications, the "acceptance criteria" are generally understood to be that the modifications do not alter the fundamental operation or intended use such that the device is no longer substantially equivalent to its predicates, and that the modifications do not raise new questions of safety or effectiveness. The "performance" is implicitly deemed acceptable because it maintains substantial equivalence to already cleared devices.
| Acceptance Criteria (Implied for Special 510(k) Modification) | Reported Device Performance (Implied from Substantial Equivalence) |
|---|---|
| Modifications do not change the indications for use. | The device maintains its indicated use in non-clinical settings to collect and transmit historical medical information. |
| Modifications do not change the fundamental technology. | The core technology of connecting to a telephone line and transmitting data to a Data Center remains. Modifications relate to supporting additional medical devices via data port, wireless hub, or infrared. |
| Modifications do not raise new questions of safety/effectiveness. | Safety and effectiveness are "reasonably assured" as per the substantial equivalence conclusion. |
| Device maintains ability to retrieve and store data from specific medical devices. | The Health Buddy appliance continues to retrieve and store data from connected medical devices (blood glucose meters, non-invasive blood pressure cuffs, patient weight scales, peak flow meters, pulse oximeters) for transmission. |
Predicate Devices (Form the Basis of Equivalence, not a "study"):
- Health Buddy® appliance with Device Connectivity (#K063612, #K060843, #K050567, #K042273, #K040086)
- Health Buddy® with Buddylink (#K993128)
- CareMatix Wellness System (#K040966)
- Philips TeleMonitoring System, (#K041674)
Indication for Use:
"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."
Conclusion from the 510(k) Summary:
"The Health Buddy Appliance is substantially equivalent in technology, features, and indications for use to devices cleared under the Federal Food. Drug and Cosmetic Act. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance of this modified device."
§ 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).