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.

Device Description

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.

AI/ML Overview

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.

Summary

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Confidential

K952979

Attachment 7

JUL 25 1996

ATTACHMENT 7

510 (k) SUMMARY

This Attachment contains the HealthTech Services Corporation summary of the HANCTM Network 510(k) Submission

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510(k) SUMMARY THE HANC™ NETWORK

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

HealthTech Services Corporation

85 Revere Drive, Suite A Northbrook, Illinois 60062 Telephone: (708) 205-2530 Facsimile: (708) 205-1970

Michael J. Glynn, President & CEO Contact Person:

Date Prepared: June 24, 1995

Name of Device and Name/Address of Sponsor

The HANCTM Network

HealthTech Services Corporation 85 Revere Drive, Suite A Northbrook, Illinois 60062

Home Assisted Nursing Care (HANCTM) Common or Usual Name:

Classification Name: FDA has not specifically classified the device, however based on communications with the Agency, HealthTech Services Corporation was advised to make the HANC™ Network an accessory to a Semi-Automatic Indirect Blood Pressure Monitor. Semi-Automatic Indirect Blood Pressure Monitors along with their accessories, are classified under 21 C.F.R. § 870.1130 as Class II devices. The product code for such devices is 74DXN.

HealthTech Services Corporation 85 Revere Drive, Suite A · Northbrook, IL 60062 708.205.2530 • 708.205.1970 fax

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Predicate Devices:

Overall Predicate

The Buddy System 510(k) #: K864318

Vital Sign Component Predicates

Blood Pressure	Nellcor Symphony™ N-3100 BP Monitor	K945947
ECG	BCI 9100 Multigas Monitor	K921388/B
ECG electrodes	NDM Tracets 3000	K875015
Temperature	BCI 9100 Multigas Monitor	K921388/B
Temperature Probe	Criticon Dinamap™ 8100T Vital Signs Monitor	K874378
Pulse Oximetry	BCI 9100 Multigas Monitor	K921388/B
Electronic Stethoscope	Andries Tek Electronic Stethoscope	Pre-1976
		Device

Intended Use

Technological Characteristics and Substantial Equivalence

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HealthTech

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.

The HANC™ Network is substantially equivalent to the Buddy System, referenced above. The HANC™ Network and its predicate both have the same general intended use, similar principles of operation, and similar technological characteristic. Both are intended to assist patients in managing their health at home and to provide a method for the clinician to gather medical data remotely. Both home devices utilize previously cleared Original Equipment Manufacturer (OEM) components to measure blood pressure, ECG, temperature and both products contain additional features such as medication reminders, coaching screens, and symptom reporting.

Likewise, in addition to the HANC™ Network's overall substantial equivalence to the Buddy System, each vital sign component of the HANC™ unit also is substantially equivalent to the pertinent cleared device in stand-alone form. The individual vital sign components of the HANC™ unit are OEM components that are each currently used in other previously cleared medical devices. Thus, each of the vital sign components integrated into the HANC™ unit is substantially equivalent to its stand-alone FDA-cleared counterpart.

The differences between the HANC™ Network and its predicate device are very minor. For example, the HANC™ Network incorporates additional features such as an electronic stethoscope, a pulse oximeter, and a camera, as well as newer and more advanced electronics. Therefore, HealthTech Services believes that the minor differences between the HANC™ Network and its predicate device do not substantially change either the performance of the HANC™ unit as compared to the Buddy unit, or the safety, efficacy, or intended use of the HANC™ Network as compared to the Buddy System.

Performance Data

HealthTech Services has performed vital sign testing, and electrical, mechanical and environmental testing. The vital sign testing was designed to validate the design of the HANCTM unit and to demonstrate that the HANC™ unit is able to accurately and reliably measure vital sign parameters. It also was designed 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. The electrical, mechanical, and environmental testing performed was designed to demonstrate the safety and effectiveness of the performance characteristics of the product.

In all instances the HANC™ unit performed as expected and passed the test performed. 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. In addition, the electrical, mechanical and environmental testing has shown that the HANC™ unit is both safe and effective in the home environment.

Regulation Number and Section

§ 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).