(394 days)
The HANC™ Network is intended to be used as a clinical tool to provide a method of monitoring a patient's health status at home and a method for transferring the data to a nurse for review. The HANC™ Network is indicated for use for patients that require medical observation and monitoring while at home, who have medication or therapy compliance issues, and who need training reinforcement. The HANC™ Network is not a patient emergency response system. It does not analyze patient information and does not offer medical advice to the patient. It collects, stores, and transmits patient information to the health professional.
The HANC™ Network is a patient-support system designed to enhance the quality and lower the cost of healthcare services. The system consists of two parts: (1) a programmable device called the Home Assisted Nursing Care ("HANC"M") unit that monitors and transmits health information from a remote site such as a patient's home; and (2) a Remote Nursing Interface that receives, stores, and prints data for nurse or physician review.
The HANC™ unit is a speech and/or touch screen-activated device designed to monitor and assist patients in their homes. It coaches the patient in a conversational manner and manages patient schedules, takes vital signs, and has the ability to communicate over phone lines with an off-site Remote Nursing Interface that provides monitoring of the patient. The HANC™ unit may be used to perform measurements of pulse, blood pressure, temperature, blood oxygen saturation, and electrocardiogram (ECG). In addition, the HANC™ unit incorporates other features such as recording stethoscope sounds, capturing a video image, reminding patients to take medications, coaching screens, inputing data manually, and calling the nurse.
Acceptance Criteria and Study for the HANC™ Network Device
Based on the provided K952979 510(k) summary, the HANC™ Network is a patient-support system designed to monitor and transmit health information from a remote site to a nurse for review. The summary focuses on demonstrating the substantial equivalence of the HANC™ Network to a predicate device (The Buddy System) and the individual vital sign components to their stand-alone FDA-cleared counterparts.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of specific numerical acceptance criteria for the HANC™ Network's performance. Instead, it states that the device "performed as expected" and "passed the test performed." The acceptance criteria can be inferred from the stated purpose of the vital sign testing: "to demonstrate that the HANC™ unit is able to accurately and reliably measure vital sign parameters" and "to ensure that integration of the previously cleared stand-alone components into the HANC™ unit will not affect the performance or operation of those components."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Accurate and reliable measurement of vital sign parameters (pulse, blood pressure, temperature, blood oxygen saturation, ECG) | "In all instances the HANC™ unit performed as expected and passed the test performed." |
| Integration of previously cleared vital sign components into the HANC™ unit does not affect their performance or operation. | "The vital sign tests have shown that integration of the vital sign components into the HANC™ unit does not in any way affect their performance characteristics." |
| Safety and effectiveness of electrical, mechanical, and environmental performance in the home environment. | "In addition, the electrical, mechanical and environmental testing has shown that the HANC™ unit is both safe and effective in the home environment." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the vital sign testing or electrical, mechanical, and environmental testing.
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) summary, it is highly likely that the testing was prospective and conducted by HealthTech Services Corporation or a contracted entity for regulatory submission purposes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts or the establishment of ground truth by experts for the vital sign testing. The testing appears to be focused on direct comparison to known measurements or the performance of the integrated OEM components.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The focus of the performance data section is on the device's ability to measure vital signs accurately and reliably, and the impact of integration on OEM component performance. There is no mention of human readers, AI assistance, or comparative effectiveness with or without AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The performance data described appears to be a standalone (algorithm only) evaluation, although the term "algorithm" is not explicitly used. The testing focuses on the HANC™ unit's ability to measure vital signs independently and the performance of integrated components. The description does not suggest a "human-in-the-loop" scenario in the context of the device's measurement capabilities during testing, but rather the overall system's function of sending data to a nurse for review.
7. Type of Ground Truth Used
The type of ground truth used for vital sign testing can be inferred as:
- Reference measurements from calibrated equipment: For vital sign accuracy, this would typically involve comparing HANC™ unit readings to gold- standard or highly accurate reference devices for blood pressure, pulse, temperature, etc.
- Performance specifications of the predicate device and OEM components: For demonstrating that integration does not affect performance, the expected performance characteristics of the individual cleared OEM components (e.g., Nellcor Symphony™ N-3100 BP Monitor) would serve as a form of ground truth or benchmark.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. This is likely because the HANC™ Network is not described as an AI/machine learning device that requires extensive training data. Its primary function is to collect, store, and transmit data, and its vital sign measurement capabilities rely on integrated, previously cleared OEM components.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, the method for establishing its ground truth is not applicable.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).