The Melys Atrial Fibrillation Monitor is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing, atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.

Device Description

The Melys Atrial Fibrillation Monitor is a lightweight portable device for measuring and displaying heart irregularity and pulse rate. The device consists of the following - 1) Atrial Fibrillation Monitor, 2) Finger Sensor (K101692), 3) Power Supply and 4) Instruction Manual.

The Melys Atrial Fibrillation Monitor device receives physiological data relating to heart rhythm from a finger sensor (K101692) attached to the patient's finger. The device captures, processes and records this data. Once sufficient data has been captured the device will run a mathematical analysis on the data and presents an indicative result of the patient's likelihood of suffering from atrial fibrillation or other heart irregularity.

The monitor contains a rechargeable battery, and a power supply is provided with the monitor for charging the monitor's battery. The finger sensor is connected to the monitor and with the pressing of the start button is ready to deliver trace measurements within 10 seconds. Each measurement is shown in a large display with a light and a number (the Arrhythmia Index Result). A history results bar at the bottom of the monitor will show the results of the previous 8 analyses with each light indicating each separate result by a green, amber, or red light. In the upper right corner of the display is an indication of the input signal strength and the level of battery charge.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Reported Device Performance (Melys Atrial Fibrillation Monitor)
Safety and Effectiveness	Compliant to IEC 60601-1 (1988), 200 Edition, Medical Electrical Equipment, Part 1: General Requirements for Safety +A1(91) + A2(95). Two clinical trials demonstrated safe and effective identification of arrhythmia in patients with atrial fibrillation (compared to EKG diagnosis).
Heart Rate Accuracy	± 1 BPM
Arrhythmia Detection Match with Predicate Device	Matched the predicate device in all tests, detecting and indicating atrial fibrillation similarly. In Tests 9 and 10, the Melys device correctly indicated no atrial fibrillation was present, differentiating itself from the predicate's unspecified results in those cases.
Ease of Use and Label Comprehension	100% agreement among 20 volunteers that the device was easy to use and instructions were clear and understandable.
Functional Design Equivalence	Considered equivalent to the predicate device based on similarities in functional design, method of use for self-monitoring, and indications for use.
Electrical, Mechanical, and Software Performance	Conducted and data collected in accordance with applicable standards to ensure the device performs according to specification and is suitable for home use.

2. Sample Size Used for the Test Set and Data Provenance

Comparative Test: The text implies a test set was used for comparison with the predicate device, but the sample size for this test set is not explicitly stated. The data provenance (country of origin, retrospective/prospective) is also not mentioned.
Human Factor Study: The test set consisted of 20 volunteers. The provenance of these volunteers (e.g., country) and whether the study was retrospective or prospective is not specified.
Clinical Trials: The text states "Two clinical trials were conducted," but the sample size of patients in these clinical trials is not explicitly provided. The data provenance is also not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For the comparative test (device vs. predicate) and clinical trials (device vs. EKG), the ground truth for atrial fibrillation detection was established by EKG examination. The number of experts interpreting the EKGs and their qualifications are not specified.
For the Human Factor Study, the ground truth for ease of use and label comprehension was established by the feedback of 20 volunteers, who are described as "users" or "patients" but not necessarily "experts" in the medical sense.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for any of the studies mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The text describes a "comparative test" between the subject and predicate device, and "clinical trials" comparing the device to EKG diagnosis. These are standalone performance evaluations against either a comparator device or a clinical gold standard (EKG), not studies assessing the improvement of human readers with AI assistance. Therefore, an effect size of human readers improving with/without AI assistance is not applicable here. The device itself is designed for self-testing and provides direct output to the user.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, standalone performance was done. The entire description of the device's function, the comparative test, and the clinical trials evaluates the device's ability to measure and analyze heart rhythms and present an indicative result on its own. The device is indicated for "self-testing," implying its standalone performance in providing information to the user. The "Arrhythmia Index Result" and light indicators (green, amber, red) are direct outputs of the algorithm.

7. Type of Ground Truth Used

Expert Consensus / Clinical Diagnosis: For the clinical trials, the ground truth was established by EKG examination. This serves as a clinical gold standard, typically interpreted by medical experts (e.g., cardiologists).
User Feedback: For the Human Factor Study, the ground truth for ease of use and label comprehension was user feedback from 20 volunteers.

8. Sample Size for the Training Set

The document does not explicitly mention a training set sample size. This suggests that the device's algorithm might have been developed and tested on internal datasets not disclosed in this 510(k) summary, or that it might use more established signal processing techniques rather than a machine learning model that requires explicit "training."

9. How the Ground Truth for the Training Set Was Established

Since a training set sample size is not mentioned, the method for establishing its ground truth is also not described.

Summary

{0}------------------------------------------------

AAR 1 9 2014

510(k) Summary 807.92(c)

SPONSOR		807.92(a)(1)
Company Name:	Advanced Fluidics, LLC
Company Address	8860 Columbia 100 Parkway, Suite 204Columbia, MD 21045
Telephone:	(443) 864-5295
Contact Person:	Surya Raghu, Ph.D.
Summary Preparation Date: June 28, 2013

Summary Preparation Date: June 28, 2013

DEVICE NAME

Trade Name: Common/Usual N Classification Nar Regulation Numb Product Code: Device Class:

807.92(a)(2)

	Melys Atrial Fibrillation Monitor
Name:	Atrial Fibrillation Monitor
	Telephone electrocardiograph transmitter and receiver
	21 CFR 870.2920
	DXH
	Class II

PREDICATE DEVICE

807.92(a)(3)

Legally Marketed Equivalent Device

K Number	Device	Manufacturer
K052767	AfibAlert Atrial Fibrillation Detector	Technologies Research, LLC

DEVICE DESCRIPTION

807.92(a)(4)

{1}------------------------------------------------

DEVICE INDICATIONS FOR USE

807.92(a){5)

COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a){6)

{2}------------------------------------------------

	Subject	Predicate
Parameters	Melys AFS Ltd.	Lechnologies Research, Inc.	Similarities and Differences
510(k) Number		K052767
Indications for Use	The Melys Atrial Fibrillation Monitor isindicated for self-testing by patients, whohave been diagnosed with, or aresusceptible to developing, atrial fibrillationand who would like to monitor and recordtheir heart rhythms on an intermittentbasis.	The AfibAlert™ is indicated for self-testingby patients who have been diagnosed with,or are susceptible to developing atrialfibrillation and who would like to monitorand record their heart rhythms on anintermittent basis.	Same
Regulation Name	Telephone electrocardiograph transmitterand receiver	Telephone electrocardiograph transmitterand receiver	Same
Product Code	DXH	DXH	Same
intended User	Adult	Adult	Same
Prescription device forhome use	yes	yes	Same
Single Patient Use	yes	yes	Same
Monitors regularity ofheartbeat	yes	yes	Same
Alerts user to anirregularity in theirpulse through a lightindicator.	yes	yes	Same
Principle of Operation	The monitor passes light through thefingertip sensor and receives data fromwhich the waveform is directly created.Displays regularity or irregularity with alight indicator.	The monitor creates an electrocardiographreading from the data received from thethumb, wrist or chest sensor from which awaveform is derived.Displays regularity or irregularity with alight indicator.	The Melys monitor receives itsinformation from the finger ratherthan the thumb, wrist or chest, usinga familiar, pulse oximeter style fingersensor.
Device Design	Monitor obtains waveform via fingersensor and displays waveform in real timeon the monitor with an arrhythmia index.	Cardiac event recorder with thumb, wrist,or chest sensor that displays results by lightindicator (green, red), but no pulse	Different acquisition of waveformbut same result and light indicatordisplay of heart regularity or

{3}------------------------------------------------

page 4 of 6

Functional Features	Light display (green, amber, or red) indicates heart regularity or irregularity.Last 8 tests are stored on the display by light indicator not Arrhythmia Index number.	waveform.Records, stores and transmits results over the telephone wire.	irregularity.
User programmable	No	No	Same
Recording length	10 seconds(Recommended four (4) consecutive measurement should show same indication (red, amber or green) before a conclusion is drawn)	45 seconds	Melys Atrial Fibrillation MonitorInstructions recommends four (4) consecutive measurement should show same indication (red, amber or green) before a conclusion is drawn
Low battery detection	Yes	Yes	Same
Heart rate accuracy	$\pm$ 1 BPM	$\pm$ 1 BPM (average for data collected, updated every three (3) seconds)	Same
Physical and Environmental
Weight (w. Batteries)	200g 7.05 oz.	4.6 oz.	Slight difference does not affect safety & efficacy
Size	4.52" x 4.13" x 1.37"	5.88" x 2.75" x 1.11"	Slight difference does not affect safety & efficacy
OperationalTemperature	20°C to 40° C	0°C to +45° C (+32° F to 113°F)	Slight difference does not affect safety & efficacy
Storage & Transport	0-20°C	-120°C to +60°C (-4°F to 140°F)	Slight difference does not affect safety & efficacy
Power
Battery type	Lithium-ion Polymer Battery (Minamoto)3.7 V	Two (2) AAA 1.5 V Eveready x -92	Both use battery as power source
Battery Life	40 days continuous	90 days nominal used 1 x per day	Difference does not affect safety & efficacy
Differences
Memory Capability	No	Yes	The subject device displays the last eight Indicator lights on the monitor face but not the arrhythmia Index.
Transmission of Data	No	Yes	The subject devices does not transmit data

{4}------------------------------------------------

page 5 of 6

Patient Interface	Finger Sensor	Thumb, or wrist sensor, and direct chestcontact	Most users will have encountered afingertip sensor such as the MelysAFS Ltd fingertip sensor andtherefore require little instruction onhow to correctly use it. The fingersensor passes light through thefingertip and creates a waveformfrom this data. The Lechnologiesthumb, wrist and chest sensorsrequire user education to usecorrectly. The chest sensor requiresthat the patient removes clothingand is therefore less convenient thana fingertip sensor.
Waveform display	Waveform shown in real time on themonitor screen.	Waveform is not shown on the monitor,but is available by a download-from theLechnologies Research, Inc's website.	While the waveform is available tothe user, the subject device is theonly device with the display in realtime.

{5}------------------------------------------------

page 6 of 6

NON-CLINICAL PERFORMANCE DATA

807.92(b)(1)

Safety Testing

The Melys Atrial Fibrillation Monitor is compliant to the safety standards. IEC 60601-1 (1988), 200 Edition, Medical Electrical Equipment, Part 1: General Requirements for Safety +A1(91) + A2(95)

Comparative Test

A comparative test was conducted between the subject and predicate device. The Melys Atrial Fibrillation Monitor matched the predicate device in all tests, giving the same heart rate measurements and the same indications towards atrial fibrillation in all but Tests 9 and 10, where the Melys Atrial Fibrillation Monitor correctly indicated that no atrial fibrillation was present.

Human Factor Study

A Human Factor Study was performed with 20 volunteers to evaluate ease of use and label comprehension. There was a 100% agreement that the device was easy to use and the instructions were clear and understandable.

CLINICAL PERFORMANCE DATA

Two clinical trials were conducted for verification of Melys Atrial Fibrillation Monitor, safely and effectively identifying as having an arrhythmia those patients identified by EKG examination as having atrial fibrillation.

The Clinical Trial results show the EKG diagnosis compared with the Melys Atrial Fibrillation Monitor predictions.

CONCLUSION

807.92(b)(3)

807.92(b)(2)

Electrical, mechanical and software testing was conducted and data collected in accordance with applicable standards to ensure that the device performs in accordance with applicable standards to ensure that the device performs according to specification and to verify that the device is suitable for home use. A Human Factor Study was conducted to verify Ease of Use and Label Comprehension

Advanced Fluidics considers the Melys Atrial Fibrillation Monitor to be equivalent to the predicate device. This conclusion is based upon the devices' similarities in functional design, method of use for self-monitoring and indications for use.

{6}------------------------------------------------

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Cantrol Center - WO66-G609 Silver Spring, MD 20993-0002

Image /page/6/Picture/3 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

March 19, 2014

Advanced Fluidics, LLC c/o E J Smith 1468 Harwell Ave Crofton, MD 21114 US

Re: K132206 Trade/Device Name: Melys Atrial Fibrillation Monitor Regulation Number: 21 CFR 870.2920 Regulation Name: Atrial Fibrillation Detector Regulatory Class: Class II Product Code: DXH Dated: February 12, 2014 Received: February 14, 2014

Dear E J Smith,

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free

{7}------------------------------------------------

number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours

Image /page/7/Picture/4 description: The image shows a logo with the letters FDA. The letters are stylized and overlapping, with a geometric design. The logo is black and white and appears to be a vectorized image.

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

Enclosure

{8}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) KI32206

Device Name Melys Atrial Fibrillation Monitor

Indications for Use (Describe)

The Melys Atrial Fibrillation Montor is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing, atrial florillation and who would like to monitor and record their heart thythms on an internitient basis.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concur

Date: 2014.03.19
15:24:12 -04'00'
for Bram Zuckerman

FORM FDA 3881 (1/14)	Page 1	PRC Publishing Services (301) 443-6740 EF
----------------------	--------	-------------------------------------------

Regulation Number and Section

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).