ReadMyHeart OTC version is intended to record, store and transfer Lead I ECG signals, and display three ECG parameters for home health care use. The intended users are adults above 20 years old. This device is not intended to substitute for a hospital diagnostic ECG. This device is also not intended for recording and transmission of user's ECG signal simultaneously. Users with implanted pacemaker are not recommended to use this device. The ReadMyHeart OTC version has simple software user interface without ECG trace viewing function.

Device Description

ReadMyHeart is a handheld, personalized use, dry electrode and affordable ECG recording device that records user's cardiac functions for daily health check. It takes signals of users with the device and automatically stores the last 15 seconds signals into the build-in memory, while three parameters measured, mainly, Heart Rate, ST segment and RRS interval of cardiac ECG signal, displays on LCD of the device. User may also record ECG signals optionally through auxiliary external electrode which will be provided separately. ReadMyHeart is powered by battery source. Users may activate the device to acquire ECG Lead I information voluntarily and mutually.

AI/ML Overview

Unfortunately, the provided text does not contain the detailed study information required to populate the requested table and answer all the questions. The document is a 510(k) summary for a modification to an existing device, ReadMyHeart, and focuses primarily on demonstrating substantial equivalence to the predicate device.

Here's what can be extracted and what is missing:

Missing Information:

Acceptance Criteria: While the document mentions conformity to various IEC standards and performance tests against the "MIT-IBH database and simulators," it does not explicitly state specific quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy, or specific thresholds for heart rate detection accuracy).
Reported Device Performance: No specific performance metrics (like percentage accuracy for heart rate, R-R interval, etc.) are reported from any tests, clinical or otherwise, for the modified device. It only states that the performance "meets the requirements" of the MIT-IBH database.
Sample Size for Test Set: Not mentioned.
Data Provenance for Test Set: Not mentioned (e.g., country of origin, retrospective/prospective). The MIT-IBH database is a known public dataset, but details of how it was used for this specific device's test are absent.
Number of Experts for Ground Truth: Not mentioned.
Qualifications of Experts: Not mentioned.
Adjudication Method: Not mentioned.
MRMC Comparative Effectiveness Study: Not mentioned. The document explicitly states "no clinical validation for ECG parameters is required" due to the algorithm and hardware being the same as the original cleared device. This strongly suggests no human-in-the-loop study with AI assistance.
Standalone Performance: While it mentions testing against the MIT-IBH database, no specific standalone performance metrics are reported.
Type of Ground Truth Used: For the MIT-IBH database, the ground truth would typically be expert annotations on ECGs. However, this isn't stated for this specific submission.
Sample Size for Training Set: Not mentioned.
How Ground Truth for Training Set was Established: Not mentioned.

What can be inferred from the document:

Device Name: ReadMyHeart OTC version
Predicate Device: ReadMyHeart (K042814)

Table of Acceptance Criteria and Reported Device Performance (Based on available info):

Acceptance Criterion	Reported Device Performance	Study that Proves Device Meets Acceptance Criteria
Operating Specification, Safety & EMC Requirements	Conforms to applicable standards: - IEC 60601-2-25 - IEC 60601-1 - IEC 60601-1-2 - IEC 60601-2-47 - IEC 60601-2-51	Internal Testing & Documentation of Conformity: - All Safety test according to IEC 60601-2-25 & IEC 60601-1 - EMC tests according to IEC 60601-1-2 - Performance tests according to IEC 60601-2-47 and IEC 60601-2-51 voluntarily - Environment tests are tested to comply with the safety requirements
ECG Parameter Performance (Heart Rate, R-R interval)	Meets the requirements (implicit equivalence to predicate)	Testing with MIT-IBH database and simulators: - "The performance is also tested with MIT-IBH database and simulators and meets the requirements." Previous Clearance of Predicate Device: - "Since the ECG parameters algorithm and hardware design in this device is exactly the same as in the original cleared device, ReadMyHeart, no clinical validation for ECG parameters is required."

Detailed Answers to Questions (based on the provided text):

A table of acceptance criteria and the reported device performance: See table above. Critically, specific numerical acceptance criteria and performance metrics are not provided in this document. The stated "acceptance" is primarily conformity to standards and "meeting requirements" of the MIT-IBH database, implying sufficient accuracy without quantifying it in this summary.
Sample sized used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: The MIT-IBH database is mentioned. This is a public database of ECG recordings, typically with expert annotations. The document does not specify which recordings from the database were used or if any additional specific patient data was included.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated in this document. For the MIT-IBH database, the ground truth would have been established by experts (likely cardiologists or electrophysiologists), but this information is not provided within this specific submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned. Given the use of a public database, the ground truth would have been pre-established.
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, "Since the ECG parameters algorithm and hardware design in this device is exactly the same as in the original cleared device, ReadMyHeart, no clinical validation for ECG parameters is required." This indicates no new clinical study, especially one involving human readers with AI assistance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Yes, in part. The document states, "The performance is also tested with MIT-IBH database and simulators and meets the requirements." This indicates a standalone (algorithm only) performance assessment, but specific results are not provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the MIT-IBH database, the ground truth would typically be expert annotations on the ECG signals.
The sample size for the training set: Not mentioned. It's possible the original ReadMyHeart was trained on data, but this document is a modification filing and doesn't detail the training for the unchanged algorithm.
How the ground truth for the training set was established: Not mentioned.

Summary

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DEC 16 2005

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Premarket Notification: Modification to ReadMyHeart

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in
telling of 510(k) safety and ex and ex 9007 02 This Summary of 810(1) == '.
accordance with the requirements of SMDA and 21 CFR §807.92

1.0 Submitter's Indentification:
Submitter's Name:	DailyCare BioMedical Inc.
Address:	8F, 25-3, Ji-Lin Road, Chungli 320, Taiwan
TEL:	+886-3-2621688
FAX:	+886-3-2617688
Contact:	Mr. Daniel J. H. Chang

2.0	Device Name:	ReadMyHeart
	Trade Name:	Handheld ECG monitor
	Common Name:	Electrocardiograph (per 21 CFR 870.2340)
	Classification Name:
3.0	Classification:	Class II
4.0	Predicate Device:	This predicate device is ReadMyHeart (K042814) marketed by DailyCare BioMedical Inc.

Intended Use: 5.0

ReadMyHeart OTC version is intended to record, store and transfer Lead I ECG signals, Readwyrealt OTC version is interest for home health care use. The intended users are and display three LOC paramoters for not intended to substitute for a hospital adults above 20 years old. "This device is also not intended for recording and transmission of user's ECG signal simultaneously. Users with implanted pacemaker are not
user's ECG signal simultaneously. Users with and many in has eimple software users ECG Signal Simultanously
recommended to use this device. The ReadMyHeart OTC version has simple software user interface without ECG trace viewing function.

Device Description: 6.0

ReadMyHeart is a handheld, personalized use, dry electrode and affordable ECG

Page 1 of 2

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Premarket Notification: Modification to ReadMyHeart

recording device that records user's cardiac functions for daily health check. It takes ECG recording device that rooms signals of asero with the are and automatically stores the last 15 seconds signals into the build-in memory, while three parameters measured, mainly, Heart Rate Signals Into the build in RRS interval of cardiac ECG signal, displays on LCD of the device.

User may also record ECG signals optionally through auxiliary external electrode osci "Thay "also "over" and "over" will be " provided soparatery, in the engineer via USB. ReadMyHeart is In the momery burnery source. Users may activate the device to acquire ECG Lead I information voluntarily and mutually.

Performance Summary: 7.0

In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards include

All Safety test according to IEC 60601-2-25 & IEC 60601-1,

- EMC tests according to IEC 60601-1-2
- Performance tests according to IEC 60601-2-47 and IEC 60601-2-51 voluntarily.
- Environment tests are tested to comply with the safety requirements.
*The performance is also tested with MIT-IBH database and simulators and meets the requirements.

Discussion of Clinical Test performed: 8.0

Since the ECG parameters algorithm and hardware design in this device is exactly the same as in the original cleared device, ReadMyHeart, no clinical validation for ECG parameters is required.

Conclusions: 9.0

In order to benefit the public health, the ReadMyHeart OTC version has simple software user interface without ECG trace viewing function. It has generally the same technological characteristics (e.g. circuit design and signal detection algorithm...) as original cleared ReadMyHeart. The OTC version demonstrates essential safety and effective to the common users.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three parallel lines that curve upwards. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. The text is written in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 16 2005

Dailycare Biomedical, Inc. c/o Mr. Daniel J. H. Chang Senior Engineer 8F, 25-3, Ji-Lin Road Chungli 320 TAIWAN

Re: K052303

Trade Name: ReadMyHeart model RMH 2.0 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: November 18, 2005 Received: November 21, 2005

Dear Mr. Chang:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(8) premained institutially equivalent (for the indications referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predical Device Amendments for use stated in the enclosure) to regally manced produced Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chaculters with the provisions of the Federal Food, Drug, devices that have been reciassified in accordance with as proval application (PMA).
and Cosmetic Act (Act) that do not require approval as treations of the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The
You may, therefore, market the device, subject to the generation, listin You may, therefore, market the device, subject to the gents for annual registration, listing of
general controls provisions of the Act include requirements michrending and general controls provisions of the rict merade required.
devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (SCC above) this. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such adultional controls. Entrological on 898. In addition, FDA may be found in the Code of Peacharterganing your device in the Federal Register.

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Page 2 -- Mr. Daniel J. H. Chang

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualitat of a substanted only requirements of the Act
that FDA has made a determination that your device also also also must that FDA has made a determination and your as reason agencies. You must
or any Federal statutes and regulations administered to: registration and listing or any Federal statures and regulations administered or registration and listing (21)
comply with all the Act's requirements, including, but not reastion sequirements as set comply with all the Act s requirements, mename, variasturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electroni CFR Part 807); labeling (21 CFR Fatl on ); good manatin 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000-1850 forth in the quality systems (QS) regulation (21-542 of the Act); 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section 5 product radiation control provisions (occions 511 312 012 41 11 11 11 11 This letter will allow you to begin harketing your antile equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivaliae and thus, premarket notification. The FDA Inding of substantial equive and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rst led If you desire specific advice for your de 0.0 %. Also, please note the regulation entitled,
contact the Office of Compliance at (240) 276-0120. Also, please note the regulati contact the Urice of Compliance at (240) 270 - 1200 (210) Part 807.97). You may obtain
"Misbranding by reference to premarket notification (21) of first from the Division of "Misbranding by reference to prematics notifieddon (c) be Act from the Division of Small)
other general information on your responsibilities under the Act from the 1900 638-0 other general information on your responsionner Assistance at its toll-fire number (800) 638-2041 or Manufacturers, International and Consumer 71ssiblance arrest of to over corport/index.html.

Sincerely yours,

B.H. Nimmons for

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): K052303

ReadMyHeart Device Name: _

(DailyCare BioMedical Inc.)

Indications for Use:

fuloutions for our and intended to record, store and transfer Lead I ECG.
ReadMyHeart OTC version is intended to record, same hoolth, care, use . The Readwyneart OTO version is interest for home health care use.
signals, and display three ECG parameters for the device is not intend The signals, and display three 200 pears old. This device is not intended to intended users' are 'addits' above' 20' years' simily in also not intended for substitute for a nospital diagnostio ECG signal simultaneously. Users with recording and transmission of assist of assessment of the ReadMyHeart
implanted pacemaker are not recommended to use this devices viowing function implanted pacemaker are not roominents.
OTC version has simple software user interface without ECG trace viewing function.

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

| Over-The-Counter Use (21 CFR 801 Subpart C)

PAT 21 CPN 801 Babbar 27
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Blummena
(Sign-Off)

Buislon of Cardlov 10(k) Number

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).