Gem Heart One/One+ is a standard 12 leads electrocardiograph designed to register. analyze and display electrocardiograms at rest. It is capable of displaying up to 12 leads at a time on the screen and print 3/6 channels by means of its thermal printer of 112mm width.

It incorporates the Hannover Electrocardiogram System (HES) automatic interpretation program for cardiac signal analysis and has the possibility of introducing the patient's data, store the records and send them to a PC by serial communication (RS-232, USB and LAN). The interpretation by the Gem Heart One/One+ is only significant if it is considered and analysed by a qualified physician and used for patients over 16 years old. No therapy or drugs can be administered based solely on the interpretations statements obtained from the HES interpretation program.

For non-interpretative applications, the Gem Heart One/One+ can be used for patients with no limitations with respect to age, sex and race of the patient. It is intended for use in routine ECG recording by trained physicians in hospital environment.

The Gem Heart One/One+ is a standard portable electrocardiograph that measures and records 12 channel electrocardiographic waveforms, measures ST segment level changes and gives real time heart rate measurements.
Intended use is equivalent to the intended use of the predicate Cardioline AR . 1200 and CorScreen electrocardiograph.

Device Description

The Gem Heart One/One+ is a portable electrocardiograph of 12 channels with simultaneous leads recording, with a high quality thermal printing of 112 mm, a lithium ion battery, high resolution screen, and connectivity through serial port (RS-232), local network LAN (10/100 Base T) and USB 2.0.

The device includes protection against defibrillation integrated. Provides the automatic interpretation based on the program Hannover Ecg System HES® developed by Biosigna GmbH under the standards IEC 60601-2-51:2003. Uses the format SCP (Standard Communications Protocol) to import and export the ECG records in the framework of the CSE (Common Standards for Quantitative Electrocardiography) of the European Union.

The Gem Heart One/One+ can operate in Spanish, Catalan and English and other languages can be implemented. It includes downloading and ECG viewing PC software gem heart viewer.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Gem Heart One/One+" electrocardiograph. It claims substantial equivalence to predicate devices based on meeting safety and effectiveness standards. However, it does not contain a separate study or detailed performance data to establish specific acceptance criteria and prove the device meets them, especially in the context of an AI-powered interpretation component.

The document mainly focuses on:

Comparing technical specifications with predicate devices (Cardioline AR1200 and CorScreen).
Stating compliance with general electrical and medical device safety standards (EN 60601-1, IEC 60601-2-25, EN60601-1-2).
Mentioning the integration of the "Hannover Ecg System HES®" for automatic interpretation but explicitly states that interpretation is only significant if considered and analyzed by a qualified physician and no therapy or drugs can be administered based solely on these interpretations.

Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. Specifically, there is no:

Table of explicit acceptance criteria and reported device performance for the interpretive function.
Sample size used for a test set, data provenance, or details about the ground truth relevant to the interpretive function.
Information on the number or qualifications of experts, or adjudication methods for an interpretive test set.
Multi-reader multi-case (MRMC) comparative effectiveness study for the AI component.
Standalone algorithm performance study.
Sample size, ground truth establishment for a training set.

Below is a summary of what can be extracted or inferred based on the document's content, with strong limitations noted where information is absent.

Acceptance Criteria and Study Details for Gem Heart One/One+

The provided document, a 510(k) summary for the "Gem Heart One/One+" electrocardiograph, indicates that the device's acceptance criteria primarily relate to its technical specifications and compliance with general medical device safety and performance standards, establishing substantial equivalence to its predicate devices.

Critical Note: The document explicitly clarifies that the automated interpretation program (Hannover ECG System HES®) is not intended for standalone diagnostic use. Its output must be considered and analyzed by a qualified physician, and no therapy or drugs should be administered solely based on its interpretations. This indicates that the regulatory approval in this document does not hinge on the standalone diagnostic performance of the AI interpretation, but rather on the device as a safe and effective ECG recording and display system, with the interpretation as an assistive tool under physician oversight. Therefore, detailed performance metrics for the interpretive algorithm, as one would expect for an AI-diagnostic device, are not provided.

1. Table of Acceptance Criteria & Reported Device Performance

Based on the provided text, the acceptance criteria are implicitly tied to the technical specifications being comparable or superior to the predicate devices and the device's compliance with safety and effectiveness standards. No explicit "acceptance criteria" for the interpretive function (e.g., sensitivity, specificity, or F1 score) are given, nor are specific performance results for such criteria reported in this document.

Parameter	Predicate Device (Cardioline AR 1200 / CorScreen) Acceptance Range (Implicit)	Gem Heat One (Reported Performance)	Notes
Technical Specifications:
Input dynamic range	+/-300mV @ DC; +/-10.0mV within bandpass	+/-300mV @ DC; +/-18.0mV within band pass	Gem Heart One exceeds the predicate in bandpass dynamic range, indicating potentially better signal capture.
Frequency response	0.05-150Hz (-3dB)	0.05-150Hz	Matches predicate device.
A/D conversion	12 bits (AR1200) / 24 bits (CorScreen)	16 bits	Falls between the two predicates, but is an improvement over AR1200.
Leads	12 Standard / 12 Cabrera (AR1200) / 3+3 / 12 Standard (CorScreen)	12 Cabrera / Orthogonal	Offers Cabrera and Orthogonal leads, comparable lead capabilities to predicates.
Sensitivity	2.5, 5, 10, 20 mm/mV +/-5%	2.5, 5, 10, 20 mm/mV	Matches predicate device sensitivity options. The +/-5% tolerance for predicate implies this is also expected for the new device.
Writing system	Thermal head 108mm, 8 dots/mm (AR1200) / Ink Printer (CorScreen)	Thermal head, 110mm, 16dots/mm - 8dots/mm	Improved resolution (16 dots/mm) over AR1200, broader paper width, and thermal head like AR1200.
Printed channels	3/4/6 (AR1200) / 1/2/6/12 (CorScreen)	1/3/6	Channel output options are within the range provided by predicate devices.
Paper speed	5mm/s +/-10% & 50mm/s +/-5% (AR1200) / 25 50 mm/s (CorScreen)	10, 25, 50 mm/s	Offers speeds comparable to or broader than predicates.
Mode of operation	Manual and Automatic recording	Manual and Automatic recording	Matches predicate device.
Input/output	Infrared digital interface (AR1200) / SD Memory card (CorScreen)	RS 232, Ethernet, USB	Offers modern connectivity options exceeding predicates.
Display Size	120x32 pixels / 240x320 pixels (AR1200)	240X320 pixels	Matches the higher resolution predicate display.
Number of displayed channels	3/6 (AR1200) / 1/3/6/12 (CorScreen)	1/3/6/12	Matches or exceeds predicate display channel options.
Traces speed	12.5 25.50 mm/s (AR1200) / 5 10 25 50 mm/s (CorScreen)	10, 25, 50 mm/s	Comparable trace speed options.
Safety and Effectiveness:	Compliance with EN 60601-1, IEC 60601-2-25, EN60601-1-2 standards	Passed EN 60601-1, IEC 60601-2-25, EN60601-1-2 standards and showed full compliance.	This is the core "acceptance criteria" presented regarding safety and effectiveness, confirming the device operates safely and as intended when measured against established medical device standards. The "study" proving this is stated as "The device has completely passed the tests and has shown full compliance to the standards."
Interpretive Function:	N/A (Predicate devices may or may not have had integrated interpretation)	Integrates Hannover Ecg System HES®; interpretation requires physician analysis and oversight.	No specific acceptance criteria or performance metrics for the interpretive function are provided. The document states its interpretation "is only significant if it is considered and analysed by a qualified physician" and "No therapy or drugs can be administered based solely on the interpretations statements." This indicates that the interpretive function is considered an aid, not a standalone diagnostic.

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

Test Set Sample Size: Not specified for the interpretive function. The document mentions "The Gem Heart One/One+ has been tested under the same standards to its predicate device... in accordance with the EN 60601-1 and IEC 60601-2-25, as well as for EMC tests EN60601-1-2 standards." This refers to hardware and electrical safety testing, not a clinical performance test of the interpretation algorithm.
Data Provenance: Not specified for any algorithm performance testing. For the general device testing, no specific "dataset" or "provenance" is discussed beyond compliance with international standards.

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

Not Applicable / Not Provided. Since no specific "test set" for the interpretive algorithm's performance is described in terms of a clinical study, there is no mention of experts to establish its ground truth.

4. Adjudication Method for the Test Set

Not Applicable / Not Provided.

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

No. The document does not describe any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated.

6. Standalone (Algorithm Only) Performance Study

No. The document does not provide details of a standalone performance study for the Hannover ECG System HES® algorithm. Furthermore, it explicitly states that the interpretation is not for standalone use, requiring physician oversight.

7. Type of Ground Truth Used (for the interpretation program)

Not Provided. Since no specific performance study of the interpretive algorithm is detailed, the type of ground truth used for its development or validation is not mentioned in this document.

8. Sample Size for the Training Set (for the interpretation program)

Not Provided. The document mentions the Hannover ECG System HES® is "developed by Biosigna GmbH," implying it's an existing, established program, but does not give details about its training data.

9. How the Ground Truth for the Training Set Was Established (for the interpretation program)

Not Provided.

Summary

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SEP 04 2009

6. 510(k) Summary

Date of application:

Applicant's name and address: Gem-Med S.L. Calle Cartagena 245, 5é, of. 5-6 08025, Barcelona (Spain)

Contact Person:

Mr. Wilson Tseng Tel. (+34) 935 309 650 Fax. (+34) 934 366 144 E-mail: wtseng@gem-med.com

Date of submission: December, 15th 2008

Device Trade Name: Gem Heart One/One+

Device Common Name: Electrocardiograph

Device Classification Name: CFR 870.2340 Electrocardiograph

Product Code: DPS Class II

Predicate Device	Premarket Notification
CARDIOLINE AR1200	K051534
CORSCREEN	K070614

Summary of Safety and Effectiveness

Parameter	Cardioline AR 1200	Gem Heat One	CorScreen
Input dynamic range	+/-300mV @ DC +/-10.0mV within the bandpass	+/-300mV @ DC +/-18.0mV within the band pass	+/-300mV @ DC
Frequency response	0.05-150Hz (-3dB)	0.05-150Hz	0.05-150Hz
A/D conversion	12 bits	16 bits	24 bits
Leads	12 Standard / 12 Cabrera	12 Cabrera / Orthogonal	3+3 / 12 Standard

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SEP 0 4 2009

	Sensitivity
	2.5.5.10.20 mm/mV+/-5%	2.5 5.10 20 mm/mV	5, 10, 20 mm/mV
Writing system	Thermal head 108mm8 dots/mm	Thermal head110mm 16dots/mm- 8dots/mm	Ink Printer US letterand DIN-A4 size
Printed channels	3/4/6	1/3/6	1/2/6/12
Paper speed	5mm/s +/-10%50mm/s +/-5%	2510 25 50 mm/s	25 50 mm/s
Thermal paper	DOTCARD 120mm	DOTCARD 120mm	US letter and DIN-A4
Mode of operation	Manual and Automatic recording	Manual andAutomatic recording	Manual
Input/output	Infrared digital interface	RS 232, Ethernet,USB	SD Memory card
DISPLAY	AR 1200	Gem Heat One	CorScreen
Size	120x32 pixels / 240x320 pixels	240X320 pixels	240X320 pixels
N° of displayed channels	3/6	1/3/6/12	1/3/6/12
Traces speed	12.5 25.50 mm/s	10.25 50 mm/s	5 10 25 50 mm/s

Device description

The Gem Heart One/One+ is a portable electrocardiograph of 12 channels with simultaneous leads recording, with a high quality thermal printing of 112 mm, a lithium ion battery, high `resolution screen, and connectivity through serial port (RS-232), local network LAN (10/100 Base T) and USB 2.0.

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The Gem Heart One/One+ can operate in Spanish, Catalan and English and other languages can be implemented. It includes downloading and ECG viewing PC software gem heart viewer.

Intended use

Gem Heart One/One+ is a standard 12 leads electrocardiograph designed to register, analyze and display electrocardiograms at rest. It is capable of displaying up to 12 leads at a time on the screen and print 3/6 channels by means of its thermal printer of 112mm width.

The Gem Heart One/One+ is a standard portable electrocardiograph that measures and records 12 channel electrocardiographic waveforms, measures ST segment level changes and gives real time heart rate measurements.
Intended use is equivalent to the intended use of the predicate Cardioline AR 1200 � and CorScreen electrocardiograph.

Summary of Device Testing

The Gem Heart One/One+ has been tested under the same standards to its predicate device the Cardioline AR1200 and CorScreen, in accordance with the EN 60601-1 and IEC 60601-2-25, as well as for EMC tests EN60601-1-2 standards. The device has completely passed the tests and has shown full compliance to the standards.

34 -

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SEP 0 4 2009

Conclusions

The intended use, indication for use and principle of operation are similar to the predicate devices with some distinct features that have been previously cleared which do not raise any new types of safety and effectiveness questions. Furthermore it has been demonstrated that the Gem Heart One/One+ has shown to have passed the same safety and effectiveness standards to its predicate device, Cardioline AR1200 and the CorScreen.

Based on the performance and characteristics of the Gem Heart One/One+ described above, it is demonstrated that it is substantially equivalent to the predicate device Cardioline AR 1200 and CorScreen electrocardiographs.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

SEP - 4 2009

Gem-Med S. L. c/o Mr. Casey Conry Underwriters Laboratories, Inc. 1285 Walt Whitman Road Melville, NY 11747

K092576 Re:

Trade/Device Name: Gem Heart One/One+ Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (Two) Product Code: DPS Dated: August 19, 2009 Received: August 21, 2009

Dear Mr. Conry:

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.

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. Casey Conry

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.htm 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/ResourcesforYou/Industry/default.htm.

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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Indication for Use

510(k) Number (if known):

Device Name: Gem Heart One/One+

Indications for Use:

The Gem Heart One/One+ is a standard portable electrocardiograph that � measures and records 12 channel electrocardiographic waveforms, measures ST segment level changes and gives real time heart rate measurements.
Intended use is equivalent to the intended use of the predicate Cardioline AR . 1200 and CorScreen electrocardiograph.

Prescription Use × (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 CDRA Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

W.M.

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K092576

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).