The Electronic House Call System (Electronic House Call Device + Electronic House Call Application + Electronic House Call Website) is a remote, retrospective monitoring tool for supplement in a patients' care. The Electronic House Call Device together with the Electronic House Call Application is intended to be a simple "store and forward" communications platform that allows clinicians and privileged users to access a patients' information for review through the Electronic House Call Website. The Electronic House Call Device is a tool to monitor patients' remotely and motivate them through education and reminders. The Electronic House Call System allows patients to measure vital signs without assistance from their healthcare provider. The Electronic House Call System is not intended to replace existing treatments or consultations, nor is it to be used as a substitute for a qualified healthcare professional's judgment/treatment plan. The Electronic House Call System is also not intended to act as an emergency response system.

Device Description

The Express MD Electronic House Call™ System is comprised of a home unit, legally marketed diagnostic peripherals, and a server. The home unit is a communications device that collects data from the diagnostic peripherals and the patient in the home and transmits the data to the server over the home's existing telephone line or other identified method (existing high-speed connection in patients' home). The diagnostic peripherals comprise a wide range of legally marketed medical electronic devices capable of measuring patient parameters such as blood pressure, pulse rate, weight, etc. The server application responds to calls from the home units, collects the data, and then compares the data to preset thresholds. The healthcare practitioners and privileged users access the server through a secure website.

If a patient is found to be outside of a pre-set parameter, the healthcare practitioner will respond according to their set policies. In addition, an email will be sent to the clinician. This email indicates that the nurse/clinician should review the website. This is not a real time alert or an alarm but an email that does not identify a patient, parameter or clinical state.

AI/ML Overview

Here's an analysis of the provided text regarding the Electronic House Call™ System's acceptance criteria and studies:

Analysis based on the provided document (K090801):

The provided 510(k) summary for the "Electronic House Call™ System" is a premarket notification document. For devices of this nature, the focus of the FDA review, and thus the content of the 510(k) submission, is primarily on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing clinical safety and effectiveness through a traditional "study" with detailed performance metrics and acceptance criteria in the way one might expect for a novel therapeutic or diagnostic device.

Therefore, the document does not explicitly define acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic outcome) or provide a detailed study report that "proves" the device meets these criteria. Instead, it relies on demonstrating that the device functions similarly to predicate devices and that core functionalities have been verified and validated.

Here's how to address your points based on the available information:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implicit from Substantial Equivalence and Verification/Validation):

Acceptance Criterion (Implicit)	Reported Device Performance (Summary from 510(k))
Functional Equivalence: Device performs core functions like data collection, transmission, and display similar to predicate devices.	The device collects data from diagnostic peripherals, transmits it to a server, displays information, takes vital signs, asks questions, and provides education/reinforcement, similar to predicate devices (Health Buddy, Neptec System, RTX device).
Data Transmission Reliability: Data is transmitted without affecting safety or effectiveness.	Transmission protocols (telephone line, Cingular 8525 cell phone, high-speed Ethernet) have been validated and "do not affect safety or effectiveness of the device."
Compatibility with Peripherals: Works with legally marketed diagnostic peripherals.	Compatible with non-invasive blood pressure cuffs, patient weight scales, blood glucose meters, and legally marketed ECG devices using standard digital communication. Verification and validation testing performed.
Software Functionality: Server application responds to calls, collects data, compares to preset thresholds, and provides secure access to healthcare practitioners.	Server application responds to unit calls, collects data, compares to thresholds. Healthcare practitioners access via a secure website.
Safety & Effectiveness: Device functions as intended and is safe and effective for its intended use (as a remote, retrospective monitoring tool).	"Verification, validation and electrical safety/electromagnetic compatibility testing was performed to determine that the Electronic House Call™ System functions as intended and is safe and effective for its' intended use."

Note: The document emphasizes functional equivalency to predicate devices. The "performance" described is about the device's ability to execute its technical functions rather than clinical accuracy or diagnostic performance, as it is a communication platform.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The 510(k) summary does not provide details on specific sample sizes or data provenance for any "test set" in the context of a clinical study. The "testing" mentioned refers to engineering verification and validation (V&V) and electrical safety/EMC testing. These typically involve testing the device functionalities in a lab or simulated environment, not clinical data sets from patients.
- Sample Size for Test Set: Not specified, as it's not a clinical study.
- Data Provenance: Not applicable in the context of clinical data. The V&V would be performed by the manufacturer (Express MD Solutions).
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):

This information is not applicable or provided. Since there is no clinical "test set" involving patient data and diagnostic outcomes, there's no need for experts to establish ground truth in the traditional sense. The "ground truth" for V&V would be whether the device correctly performs its programmed functions (e.g., correctly transmits data, accurately displays readings from connected peripherals).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This is not applicable or provided. Adjudication methods are relevant for clinical studies where subjective interpretations or ambiguous cases need a consensus among experts. As explained above, this 510(k) focuses on V&V of a communication system, not diagnostic accuracy.
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:

No MRMC comparative effectiveness study was done or reported.
- This device is a "store and forward" communications platform for remote monitoring. It does not incorporate AI for diagnostic interpretation or assist human readers in a diagnostic task in the way an AI algorithm for radiology would.
- Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this device's function or the claims being made.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This device is not an "algorithm only" device. It's a system comprised of hardware (home unit, peripherals), software (server application), and a website. Its primary function is communication and data display. While the server application compares data to "preset thresholds," this is a straightforward programmatic comparison, not an "algorithm" in the sense of a complex AI or diagnostic algorithm whose standalone performance needs to be assessed. Therefore, a "standalone algorithm performance" assessment as typically conceived for AI/diagnostic tools was not performed or reported. The "standalone" performance here refers to the system's ability to accurately collect and transmit data from peripherals, which is covered under general V&V.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For this device, the "ground truth" in its verification and validation is primarily functional correctness and adherence to specifications.
- Functional Ground Truth: Did the device successfully collect the data? Was the data transmitted accurately? Was it displayed correctly on the website? Did the server correctly identify values outside preset thresholds?
- This is not "expert consensus, pathology, or outcomes data" as typically used for diagnostic or predictive devices. It's about the technical integrity of the communication and data presentation system.
The sample size for the training set:

Not applicable or provided. This device does not use machine learning or AI models that require a "training set" of data. Its functionality is based on programmed logic and communication protocols.
How the ground truth for the training set was established:

Not applicable or provided. As there is no training set, there's no ground truth for it to be established.

Summary of Device and 510(k) Context:

The Electronic House Call™ System is a telehealth system designed for remote monitoring, acting as a "store and forward" communication platform. Its 510(k) submission successfully demonstrated substantial equivalence to predicate devices primarily through:

Comparison of technological characteristics: Showing similar components (home unit, peripherals, secure website) and communication methods.
Verification and validation (V&V) testing: Ensuring the system functions as intended, including data transmission, compatibility with peripherals, and electrical safety/EMC. This V&V is engineering-focused to confirm the device performs its specified technical functions reliably, not a clinical study to assess diagnostic accuracy or clinical outcomes.

The document does not detail acceptance criteria or study results in the manner of a diagnostic device that relies on complex algorithms or clinical interpretation, but rather confirms the technical and functional performance of a communication and data presentation system.

Summary

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K090801

APR - 8 2009

510(k) Summary

for

Electronic House Call™ System

1. SPONSOR

Express MD Solutions, LLC 2001 Bomar Drive Suite 3 Palm Beach Gardens, FL 33408 Contact Person: Chris Doherty Telephone: (617) 595-2700

2. DEVICE NAME

Proprietary Name:	Electronic House Call™ System
Common/Usual Name:	Telehealth System
Classification Name:	Physiological Signal Transmitters and Receiver

3. PREDICATE DEVICES

. Health Buddy with Glucose Connectivity (K993128)
. Health Buddy with BuddyLink (K040086)
Health Buddy with Device Connectivity(K042273) .
Health Buddy Appliance (K050567) .
. Health Buddy Appliance, Health Hero Network (K060843)
. Neptec Care Companion Nurse and Patient Station K022274 and K023286
. RTX DLM112 Daylink Monitor (K062304)
. ZOLL M-Series NIBP Option (K032363)
. ZOLL E-Series NIBP Option (K042007)
. March Healthcare HMK (K060194)

DEVICE DESCRIPTION 4.

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patient in the home and transmits the data to the server over the home's existing telephone line or other identified method (existing high-speed connection in patients' home). The diagnostic peripherals comprise a wide range of legally marketed medical electronic devices capable of measuring patient parameters such as blood pressure, pulse rate, weight, etc. The server application responds to calls from the home units, collects the data, and then compares the data to preset The healthcare practitioners and privileged users access the server thresholds. through a secure website.

5. INTENDED USE

The Electronic House Call™ System (Electronic House Call™ Device + Electronic House Call™ Application + Electronic House Call™ website) is a remote, retrospective monitoring tool to supplement a patients' care. The Electronic House Call™ Device together with the Electronic House Call™ Application is intended to be a simple "store and forward" communications platform that allows clinicians and authorized users to access a patients' information for review through the Electronic House Call™ website. The Electronic House Call™ Device is a tool to monitor patients remotely and motivate them through education and reminders. The Electronic House Call™ System allows patients to measure vital signs without assistance from their healthcare provider. The Electronic House Call™ System is not intended to replace existing treatments or consultations, nor is it to be used as a substitute for a qualified healthcare professional's judgment or treatment plan. The Electronic House Call™ System is not intended to act as an emergency response system.

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The proposed Electronic House Call™ System and the predicate devices all consist of a home unit, peripheral devices, and a secure website. Both the proposed and predicate devices connect to a telephone line at the subject's home or assisted living The peripheral devices that are compatible with the Electronic House facility. Call™, the Neptec System, the RTX device and Health Buddy System include non-

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invasive blood pressure cuffs, patient weight scales, and blood glucose meters. The proposed Electronic House Call™ System and the predicate Health Buddy devices are simple, user friendly devices that connect to a standard home telephone line. In addition to the standard phone line, the proposed Electronic House Call™ can connect to a Cingular 8525 cell phone or existing high-speed Ethernet line. These transmission protocols have been validated and do not affect safety or effectiveness of the device. The proposed and predicate device screens display information, take vital signs, and ask questions about symptoms and behaviors. Both the Electronic House Call™ System and the Health Buddy predicate devices provide education and reinforcement to the patient while delivering evaluation by a medical professional. Both the proposed Electronic House Call™ System and the RTX DLM112 Daylink Monitor include the option of communication using ECG systems. This option provides the user the ability to transmit ECG data from legally marketed ECG devices using standard digital communication technologies to the healthcare provider. This feature of the proposed and predicate devices does not raise any safety or effectiveness issues since verification and validation testing have been performed to support the function and compatibility of the ECG with the Electronic House Call™ System.

Like the proposed Electronic House Call™ System, the Health Buddy System includes software to record patient information and devices designed to receive information from the peripheral devices and then transfer the information to a secure website.

Additionally, a comparison of the intended use and technical characteristics of the proposed device with the Suntech Advantage Model 2 Blood Pressure kit and the Nonin IPod and their predicate devices demonstrates that the Electronic House Call™ System is substantially equivalent to both the ZOLL M-Series NIBP Option and the ZOLL E Series devices which utilize the Suntech Advantage Model 2 Blood Pressure kit and the March Healthcare HMK device which utilizes the Nonin iPod.

7. PERFORMANCE TESTING

Verification, validation and electrical safety/electromagnetic compatibility testing was performed to determine that the Electronic House Call™ System functions as intended and is safe and effective for its' intended use.

Express MD Solutions 510(k) Electronic House Call™ System March 11, 2009

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 8 2009

Express MD Solutions LLC c/o Interteck Testing Services NA, Inc. 2307 E. Aurora Rd. Unit B7 Twinsburg, OH 44087 Attn: Daniel Lehtonen

Re: K090801

Trade/Device Name: Electronic House Call System Regulation Number: 21 CFR 870.2910 Regulatory Class: Class II Product Code: DRG Dated: March 23, 2009 Received: March 24, 2009

Dear Mr. Lehtonen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Daniel Lehtonen

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Electronic House Call System

Indications for Use:

Prescription Use ___ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Atilla Msz for B Zuckerman

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number 09080

Express MD Solutions 510(k) Electronic House Call System

Regulation Number and Section

§ 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).