The MobCardio System is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner on adult populations. The device is designed to collect, transmit, and display resting 12 lead EKG data. The clinical and diagnostic evaluation of acquired EKG signals should be made by a physician, who has experience or is specialized in Cardiology. No clinical interpretation of EKG is provided.

Device Description

The MobCardio System is comprised of an EKG acquisition module (connected via a PC-USB cable), a 12-lead EKG patient cable, a medical grade laptop, and the user software. The device is used to collect, transmit, and display resting 12-lead EKG data using FDA cleared disposable EKG electrodes and manufacturer supplied 12-lead EKG patient cable. The user software is pre-installed for the user and provides necessary menus and user interfaces for displaying and printing the acquired 12-lead EKG data. The MobCardio System is compatible with any desktop or notebook computer with a suitable USB port (1.0 or above) and Windows operating system. While we offer the EKG acquisition module and the medical grade laptop as a system, the user has the option to use a personal computer that fits the requirements listed in the device user manual. Without being connected to a computer, the EKG data acquired will not be displayed and no EKG prints out can be obtained.

AI/ML Overview

The provided document describes the MobCardio System, an electrocardiography device. However, it does not contain information about studies proving the device meets specific performance acceptance criteria, nor does it mention any AI components, human-in-the-loop studies, multi-reader multi-case studies, or the establishment of ground truth as would be relevant for an AI/ML device.

The document is a 510(k) summary for a Class II Electrocardiography device and focuses on demonstrating substantial equivalence to predicate devices based on intended use, technology, and basic functional and safety testing. It explicitly states, "No clinical interpretation of EKG is provided," indicating it's a data acquisition and display device, not one that performs analysis or requires complex validation as an AI/ML diagnostic tool would.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment are not present in the provided text because they are not applicable to the type of device described (a basic EKG data acquisition system without AI-driven interpretation).

Based on the provided text, here's what can be inferred and what information is missing:

Acceptance Criteria and Device Performance

Based on the provided 510(k) summary, the device is a standard electrocardiography system for acquiring, transmitting, and displaying 12-lead EKG data. It does not perform clinical interpretation or provide diagnostic outputs beyond displaying the raw EKG signals. Therefore, the "acceptance criteria" and "reported device performance" are primarily related to its ability to meet electrical safety, performance standards (like signal quality for display), and functional requirements rather than diagnostic accuracy metrics typically associated with AI.

The summary states: "Device components underwent safety and bench testing on both hardware and software and demonstrated acceptable functional and performance results. No safety and effectiveness issues were raised." This is a general statement of compliance, not a quantitative table of specific performance metrics against acceptance criteria.

A table of acceptance criteria and reported device performance, as would be expected for an AI device, cannot be constructed from the provided text. The document focuses on demonstrating compliance with recognized standards (IEC, AAMI) for medical electrical equipment and essential performance for EKG acquisition and display.

Study Details (as related to the provided text)

Since this device is for data acquisition and display, and explicitly states "No clinical interpretation of EKG is provided," the types of studies mentioned in the prompt (e.g., those involving AI performance, human reader improvement, or specific diagnostic accuracy) are not described in the provided 510(k) submission. The document relies on demonstrating substantial equivalence to predicate devices and general functional/safety testing.

Here's an analysis based on the information provided, and what is explicitly not available:

A table of acceptance criteria and the reported device performance:
- Not Available in a quantitative, AI-specific format. The document broadly states that "Device components underwent safety and bench testing on both hardware and software and demonstrated acceptable functional and performance results. No safety and effectiveness issues were raised." This implies reaching general functional and safety acceptance criteria for EKG devices (e.g., signal fidelity for display, electrical safety, adherence to standards like IEC 60601 series and AAMI EC11). No specific quantitative performance metrics like sensitivity, specificity, or AUC are provided, as the device does not offer interpretation.
Sample sizes used for the test set and the data provenance:
- Not Available. The document mentions "bench testing" and "safety testing" but provides no details on the sample size (e.g., number of EKG recordings or patients) or the provenance (country of origin, retrospective/prospective) of any data used for these tests. This is typical for a basic EKG acquisition device lacking interpretive algorithms.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Not Available. Since the device does not provide clinical interpretation, there is no "ground truth" establishment in the context of diagnostic accuracy for an AI/ML model. The ground truth for device performance would relate to the accuracy of signal acquisition (e.g., correctly capturing heart electrical activity) which is verified through engineering tests and compliance with standards rather than expert clinical consensus on interpretations.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable/Not Available. As there's no clinical interpretation and no expert panel for ground truth within the scope of this device, adjudication methods are not relevant or described.
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. The document explicitly states: "No clinical interpretation of EKG is provided." Therefore, there is no AI assistance to compare human reader performance against, and no MRMC study would be applicable or described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. "No clinical interpretation of EKG is provided." There is no standalone algorithm for interpretation described. The device's "standalone performance" refers to its ability to acquire and display EKG data accurately according to engineering specifications and safety standards.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable/Not Described in terms of clinical interpretation. For a device that only acquires and displays, the "ground truth" relates to physical and electrical properties (e.g., a known, calibrated electrical signal input resulting in accurate representation on display, or verified electrical safety). It's not a clinical diagnostic ground truth.
The sample size for the training set:
- Not Applicable/Not Available. This device does not have an AI/ML component that requires a training set for clinical interpretation.
How the ground truth for the training set was established:
- Not Applicable/Not Available. As above, no AI/ML training set is described for clinical interpretation.

In summary, the provided 510(k) summary is for a basic EKG data acquisition and display system. It does not include details on AI/ML performance, diagnostic accuracy studies, human reader studies, or the rigorous ground truth establishment processes that would be required for a device offering automated clinical interpretation. The "studies" mentioned refer to functional and safety bench testing to ensure the device meets general medical device standards for its stated function of acquiring and displaying EKG data.

Summary

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V. 510(k) Summary

This 510(k) summary is submitted in accordance to the requirements of 21 CFR 807.92.

The assigned 510(k) number is:

General Information

Criteria	Information
Trade Name	MobCardio System
Model Name	MHC2011.1.0
Common Name	Electrocardiography
Classification	Class II
510(k) Submitter	MobHealth Corporation5227 Village Circle Dr.Temple City, CA 91780
Contact Person	Patricia Lin, Director of Technology Marketingpatricial@mobhealth.com
Date Prepared	May 12th, 2011

Substantially Equivalent Devices

Manufacturer	Substantially Equivalent Device	510(k)
Kardiosis Ltd.	ARS-EKG 12KElectrocardiography System	K914206
ET Medical Devices Spa	Cardioline AR600	K051534
Midmark Diagnostic Group	Midmark IQecg	K103640

Predicate Device Comparison Summary:

The MobCardio System has in many instances, identical or nearly identical technological characteristics to the substantially equivalent devices. See device comparison table below:

Device name	ARS-EKG 12KECG System(K914206)	CardiolineAR 600(K051534)	MidmarkIQecg(K103640)	MobCardioSystem
Intended use	Acquisition anddisplay of resting12-lead ECG; nointerpretation	Acquisition,display, andinterpretation ofresting 12-lead ECG	Acquisition,display, andinterpretation ofresting 12-leadECG	Acquisition anddisplay of resting12-lead ECG; nointerpretation
Indicationsfor use	Prescription use bytrained physiciansand/or medicalpersonnel only	Prescription use bytrained physiciansand/or medicalpersonnel only	Prescription use bytrained physiciansand/or medicalpersonnel only	Prescription use bytrained physiciansand/or medicalpersonnel only
Targetpopulation	Adult	For non interpretiveapplications, nolimitations to age,sex and race	Adult and pediatric	Adult
Device name	ARS-EKG 12KECG System(K914206)	CardiolineAR 600(K051534)	MidmarkIQecg(K103640)	MobCardioSystem
Anatomicalsites	External surface ofchest and limbs	External surface ofchest and limbs	External surface ofchest and limbs	External surface ofchest and limbs
Where used	Healthcarefacilities/Hospitals	Healthcarefacilities/Hospitals	Healthcarefacilities/Hospitals	Healthcarefacilities/Hospitals
Energy usedand/ordelivered	PC powered (PCEKG add-on card)	AC Main/Externalbattery power	External batterypower/PC-USBpowered	USB powered/ACadapter andrechargeablebattery for medicalgrade laptop
Design	EKG dataacquisition module(PC-ISA) withsoftware for dataprocessing,display, storage,and print	EKG dataacquisition, storageand print device(infrared serial)with software forinterpretation,display, storage, andprint	EKG dataacquisition module(USB/RS232) withsoftware for dataprocessing,interpretation,display, storage,and print	EKG dataacquisition module(PC-USB) ANDmedical grade PCwith software fordata processing,display, storage,and print
Standardsmet	• IEC 60601-1:1990• AAMIEC11:1982• AAMIES1:1985	• IEC 60601-1:2006• IEC 60601-1-2:1993• IEC 60601-2-25:1995• IEC 60601-2-51:2003	• IEC 60601-1:2006• IEC 60601-1-2:2007• IEC 60601-2-25:1999• AAMIEC11:2007	• IEC 60601-1:2006• IEC 60601-1-2:2007• IEC 60601-2-25:1999• IEC 60601-2-51:2005• AAMIEC11:2007
Bio-compatibility	Not applicable	Not applicable	Not applicable	Not applicable
Sterility	Not applicable	Not applicable	Not applicable	Not applicable
Electrical/Compatibilityw/environment & otherdevices	Passed EMC test -met IEC 60601-1,AAMI ES11 andES1 requirements	Passed EMC andLVD tests - metIEC 60601-1, IEC60601-1-2, IEC60601-2-25requirements	Passed EMC andLVD tests - metIEC 60601-1, IEC60601-1-2, IEC60601-2-25requirements	Passed EMC andLVD tests - metIEC 60601-1, IEC60601-1-2, IEC60601-2-25requirements
Mechanicalsafety	ECG amplifiers(e.g. inputprotection againstdefibrillationshocks, type BFapplied part)	ECG amplifiers(e.g. inputprotection againstdefibrillationshocks, type CFapplied part)	ECG amplifiers(e.g. inputprotection againstdefibrillationshocks, type CFapplied part)	ECG amplifiers(e.g. inputprotection againstdefibrillationshocks, type BFapplied part)

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Summary of Substantial Equivalence

After comparing the indications for use, technology, and performance specifications of the listed predicate devices and the MobCardio System, we have concluded that the proposed device does not raise any new safety or effectiveness issues and is substantially equivalent to the listed predicate devices.

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Device Description

The user software is pre-installed for the user and provides necessary menus and user interfaces for displaying and printing the acquired 12-lead EKG data.

The MobCardio System is compatible with any desktop or notebook computer with a suitable USB port (1.0 or above) and Windows operating system. While we offer the EKG acquisition module and the medical grade laptop as a system, the user has the option to use a personal computer that fits the requirements listed in the device user manual. Without being connected to a computer, the EKG data acquired will not be displayed and no EKG prints out can be obtained.

Indications for Use

Functional and Safety Testing

Device components underwent safety and bench testing on both hardware and software and demonstrated acceptable functional and performance results. No safety and effectiveness issues were raised.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002

NOV 1 7 2011

MobHealth Corporation c/o Mr. Mark Job Reviewer Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 53313

Re: K113234

Trade/Device Name: MobCardio System Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: DPS Dated: November 1, 2011 Received: November 2, 2011

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined honice 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 (Act (Act to not require approval of a proval 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 misbillions and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Mark Job

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.hum.

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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IV. Indications for Use Statement

510(k) Number (if known):

Device Name: MobCardio System

Indications For Use:

K113234

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

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division d Cardiovasc I Devices 5 ! Onk) Nümber

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Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).