CARDIOLINE AR 600 and AR 1200 and AR 2100 are a family of electrocardiograph recorders provided with a program for automated ecg analysis and with a graphic LCD display.

The equipments are intended for use in routine ecg recording in physician practice and/or hospital. The electrical heart activity is detected by means of two or more electrocardiograph electrodes and is recorded on thermal paper.

Intended use for non interpretive applications covers the full range of patient population with no limitations with respect to age, sex and race of the patient.

The interpretation program is intended to provide a diagnostic support to the physician for the ecg evaluation on rhythm and morphology.

Interpretation Statements must be overviewed and approved by trained Physician's. Interpretation statements just represent a partial qualitative and quantitative information of the general patient cardiovascular condition: no therapy or drugs can be subministrated based solely on Interpretation statements.

The equipments are intended to be used by trained medical personnel or physician's.

Device Description

CARDIOLINE AR 600, AR 1200 and AR 2100 is a family of electrocardiographs providing the following characteristics:

Mains and internal battery operation
Manual acquisition of the 12 Standard Leads
Simultaneous acquisition of the 12 Standard Leads
Storage of 10 seconds of acquired ecg signal
Storage of up to 40 ecg recordings (optional)
Multichannel Ecg printout on thermal paper
Copy function of the stored ecg
High resolution digital thermal printer
Digital filters for AC interference suppression and base-line drift
Time and date printout
Possibility to send acquisition data to a Personal Computer or Workstation via Infrared serial interface
Interpretation Program Hannover Ecg System (HES) providing the following additional informations (optional):
- Representatives Templates of each lead including markers on fiducial A points
- Summary of mean measurements A
- Summary of measurements performed on each lead A
- A Rythm Analysys Statements
- Rythm graphical representation A
- Signal noise detection and information A
- A Specific findings on QRS complex
- A Conduction statements
- QRS T Diagnostic Statements A
- Summary of measurements performed on each lead
- Arrhythmia monitoring detection
- A Heart Rate Variability
graphic LCD display for user interface and ECG visualisation
Patient input data for Interpretation, identification and filing purposes

More specifically, the equipments family is based on 3 model variants characterized by different print and display capabilities.

AI/ML Overview

The CARDIOLINE AR 600, AR 1200, and AR 2100 electrocardiographs incorporate the Hannover ECG System (HES) interpretation program. The submission states that this program has not been changed and its performance is established through prior validation and publication.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative format for the interpretive program to be met by the new device. Instead, it relies on the established performance of the unchanged HES program within the predicate device. The comparison table (Table 5.7.1) primarily focuses on technical specifications of the recorder and display components, demonstrating similarities and some differences between the new devices and the predicate.

For the interpretive program (HES), the study cited serves as the evidence of its quality and accuracy. The "reported device performance" for the interpretive program is qualitative, implying it meets the standards of a high-quality, accurate ECG interpretation system as demonstrated in the cited study.

Acceptance Criteria (Implied for the HES interpretive program): The interpretive program's quality and accuracy are considered acceptable, as demonstrated by the published study "The Diagnostic Performance of Computer Programs for the Interpretation of Electrocardiograms" in the New England Journal of Medicine.

Reported Device Performance (for HES interpretive program): "The results shown in this study have demonstrated the quality and accuracy of the HES program with respect to other commercially available programs."

Parameter	Acceptance Criteria (Implied for HES program)	Reported Device Performance (HES program)
Interpretive Program Quality	Demonstrated quality and accuracy via peer-reviewed study against commercially available programs.	"demonstrated the quality and accuracy of the HES program with respect to other commercially availabe programs"
Interpretive Program Accuracy	Demonstrated quality and accuracy via peer-reviewed study against commercially available programs.	"demonstrated the quality and accuracy of the HES program with respect to other commercially availabe programs"

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

Sample Size for Test Set: The document does not explicitly state the sample size for the test set used in the cited "The Diagnostic Performance of Computer Programs for the Interpretation of Electrocardiograms" study. It merely refers to the study as evidence of the program's performance.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states that the study was published in "New England Journal of Medicine."

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

The document does not provide details about the number of experts, their qualifications, or how the ground truth was established within the cited study. It focuses on the study's overall conclusion regarding the HES program's quality and accuracy.

4. Adjudication Method for the Test Set

The document does not describe the adjudication method used in the cited study.

5. 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

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study regarding how much human readers improve with AI vs without AI assistance for the CARDIOLINE AR devices. The study cited is focused on the standalone diagnostic performance of computer programs, including HES.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone study was done. The entire premise of citing "The Diagnostic Performance of Computer Programs for the Interpretation of Electrocardiograms" is to establish the standalone performance (algorithm only) of the Hannover ECG System (HES) interpretation program. The document states: "The measurements and interpretation program has not been changed. It has been intensively tested and validated by the developer Medizinische Hochschule Hannover. Test results have been published on the New England Journal of Medecine..."

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not specify the type of ground truth used in the cited study.

8. The Sample Size for the Training Set

The document does not provide the sample size for the training set used for the HES program. The focus is on the validation of the already developed program.

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

The document does not provide details on how the ground truth for the training set was established for the HES program.

Summary

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OCT 5 - 2005

et medical devices spa

FDA DOCUMENT NUMBER: k (515-34

1/5

Summary of Safety and Effectiveness 5.

CARDIOLINE AR 600, AR 1200, AR 2100

5.1 Date of application: 06/07/2005
5.2 Applicant's name and address: et medical devices spa Via De Zinis 6 38011 Cavareno (Trento) ITALY

5.3 Contact person:	Mr. Attilio Castelli
Tel:	(+39) 0463850125
Fax:	(+39) 0463850088
E-mail:	a.castelli@etmed.biz

5.4 Device Trade Name CARDIOLINE AR 600, AR 1200, AR 2100

5.5 Device Common Name ECG Interpretive Electrocardiograph

5.6 Device Classification Name CFR 870.2340 Electrocardiograph Class II 74 DPS

5.7 Unmodified (Predicate) Device

The legally marketed device which has been modified is:

Manufacturer Name	Applicant Name	Predicate Device	510(k) Number
Elettronica Trentinaspa (*)	H&C MedicalDevices spa (*)	AB CARDIETTEDaedalus Viewbase and Hes	K002074

(*) name changed into et medical devices spa in year 2003.

(°) merged into et medical devices spa in year 2003.

The safety features of the CARDIOLINE AR 600, AR 1200 and AR 2100 are identical to those of the predicate Daedalus View. The performances of CARDIOLINE AR 600, AR 1200 and AR 2100 are basically similar to the predicate Daedalus View and are summarized in table 5.7.1. The Parameters computation and Interpretation Program implemented in CARDIOLINE AR 600 and AR 1200 and AR 2100 is equivalent to the one implemented in the predicate Daedalus View Hes.

CARDIOLINE AR 600, AR 1200, AR 2100 special 510(K) SUBMISSION DOCUMENT Page 8 of 32

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FDA DOCUMENT NUMBER:

Summary of Safety and Effectiveness (con't)

Intended use of CARDIOLINE AR 600 and AR 1200 and AR 2100 is identical to that of AB CARDIETTE Daedalus View base and Hes.

Parameter	AR 600	AR 1200	AR 2100	AB CARDIETTEDAEDALUS VIEWBase and Hes
RECORDER
Input dynamicrange	+/-300mV @ DC+/- 5.0 mV withinthe bandpass	+/-300mV @ DC+/- 10.0 mV withinthe bandpass	+/-300mV @ DC+/- 10.0 mV withinthe bandpass	+/-300mV @ DC+/- 25 mV within thebandpass
Frequencyresponse	0.05 – 150 Hz (-3dB)	0.05 – 150 Hz (-3dB)	0.05 – 150 Hz (-3dB)	0.05 – 150 Hz (-3dB)
A/Dconversion	11 bits	12 bits	12 bits	14 bits
Leads	12 Standard / 12Cabrera	12 Standard / 12Cabrera	12 Standard / 12Cabrera	12 Standard / 12Cabrera
Sensitivity	2.5 5 10 20mm/mV +/-5%	2.5 5 10 20 mm/mV+/-5%	2.5 5 10 20 mm/mV+/-5%	1.25 2.5 5 10 20 40mm/mV +/-5%
Writingsystem	Thermal head 48mm 8 dots/mm	Thermal head 108mm 8 dots/mm	Thermal head 210mm 8 dots/mm	Thermal head 210mm 8 dots/mm
Printedchannels	1/2/3	3/4/6	3/4/6/12	3/4/6/12
Paper speed	25 50mm/s +/-5%	5 mm/s +/-10% 2550mm/s +/-5%	5 mm/s +/-10% 2550mm/s +/-5%	1.25 2.5 5 10 12.5mm/s +/-10% 2550mm/s +/-5%
Thermalpaper	DOTCARD 65 mm	DOTCARD 120 mm	DOTCARD 210 mm	DOTCARD 210 mm
Mode ofoperation	Manual andAutomaticrecording	Manual andAutomatic recording	Manual andAutomatic recording	Manual, Manualdelayed andAutomatic recording
Input/output	Infrared digitalinterface	Infrared digitalinterface	Infrared digitalinterface	RS 232 standarddigital port
DISPLAY
Size	120 x 32 pixels	120 x 32 pixels / 240x 320 pixels	120 x 32 pixels / 240x 320 pixels	VGA 640 x 480pixels
Nº ofdisplayedchannels	none	3/6	3/6/12	3/6
Traces speed	N/a	12.5 25 50 mm/s	12.5 25 50 mm/s	1.25 2.5 5 10 12.525 50 mm/s
Sensitivity	N/a	5 10 20 mm/mV	5 10 20 mm/mV	1.25 2.5 5 10 20 40mm/mV

Table 5.7.1

CARDIOLINE AR 600, AR 1200, AR 2100 special 510(K) SUBMISSION DOCUMENT Page 9 of 32

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FDA DOCUMENT NUMBER:

Summary of Safety and Effectiveness (con't)

5.8 Device description

CARDIOLINE AR 600, AR 1200 and AR 2100 is a family of electrocardiographs providing the following characteristics:

· Mains and internal battery operation
· Manual acquisition of the 12 Standard Leads
· Simultaneous acquisition of the 12 Standard Leads
· Storage of 10 seconds of acquired ecg signal
· Storage of up to 40 ecg recordings (optional)
· Multichannel Ecg printout on thermal paper
· Copy function of the stored ecg
· High resolution digital thermal printer
· Digital filters for AC interference suppression and base-line drift
· Time and date printout
Possibility to send acquisition data to a Personal Computer or Workstation via Infrared serial interface
Interpretation Program Hannover Ecg System (HES) providing the following additional informations (optional):
- Representatives Templates of each lead including markers on fiducial A points
- Summary of mean measurements A
- Summary of measurements performed on each lead A
- A Rythm Analysys Statements
- Rythm graphical representation A
- Signal noise detection and information A
- A Specific findings on QRS complex
- A Conduction statements
- QRS T Diagnostic Statements A
- Summary of measurements performed on each lead
- Arrhythmia monitoring detection
- A Heart Rate Variability
· graphic LCD display for user interface and ECG visualisation
· Patient input data for Interpretation, identification and filing purposes

More specifically, the equipments family is based on 3 model variants characterized by different print and display capabilities. Table 5.8.1 summarizes all model variants.

CARDIOLINE AR 600, AR 1200, AR 2100 special 510(K) SUBMISSION DOCUMENT Page 10 of 32

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4/5-

FDA DOCUMENT NUMBER:

Summary of Safety and Effectiveness (con't)

Table 5.8.1

Model variant	Thermal head	LCD display	Interpretation
AR 600	50 mm	YES (alpha-num.)	YES
AR 1200	108 mm	YES (graphic)	YES
AR 2100	210 mm	YES (graphic)	YES

5.9 Intended use

CARDIOLINE AR 600, AR 1200 and AR 2100 is a family of electrocardiographs characterized as basic standard electrocardiographs with program for automated ecq analysis.

Intended use is equivalent to the intended use of the predicate Daedalus View. More specifically:

The equipment are intended for use in routine ecg recording in physician practice and/or hospital. The electrical heart activity is detected by means of two or more electrocardiograph electrodes and can be visualized on a digital display and recorded on thermal paper.

Intended use for non interpretive applications covers the full range of patient population with no limitiations with respect to age, sex and race of the patient.

The interpretation program is intended to provide a diagnostic support to the physician for the ecg evaluation on rythm and morphology.

5.10 Comparison of technological characteristics

CARDIOLINE AR 600 and AR 1200 and AR 2100 electrocardiographs are based on the same technological characteristics of the predicate device AB CARDIETTE Daedalus View base and Hes.

5.11 Non clinical tests used for Substantial Equivalence Determination

Full safety tests according to EN60601-1 and IEC 601-2 25 have been performed on all model variants. Tests have shown full compliance with these standards. The equipments have been subject to Electromagnetic Compatibility testing procedures according to EN60601-1-2 standard. Tests have shown full compliance with this standard.

The correct implementation of the measurements and interpretation program has also been tested and validated.

The measurements and interpretation program has not been changed. It has been intensively tested and validated by the developer Medizinische Hochschule

CARDIOLINE AR 600, AR 1200, AR 2100 special 510(K) SUBMISSION DOCUMENT Page 11 of 32

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FDA DOCUMENT NUMBER:

Hannover. Test results have been published on the New England Journal of Medecine 325:1767-1773 December 19, 1991 under the title:

The Diagnostic Performance of Computer Programs for the Interpretation of Electrocardiograms.

The results shown in this study have demonstrated the quality and accuracy of the HES program with respect to other commercially availabe programs.

Moreover, the equipments are marketed worldwide since 2001 under the name CARDIETTE AR 600, AR 600 ADV, and AR 1200 ADV, AR 1200 VIEW, AR 2100, AR 2100 VIEW.

No adverse working conditions have been claimed and filed up to date. All equipments are CE marked according to 93/42/CEE Medical Device Directive.

5.12 Risk Analysis

Comparative risk analysis has been performed with respect to the umodified (predicate) device (see Att. A) demonstrating that all means adopted for risk reduction were identical to those adopted for the umodified equipment. The safety and the risk related to the use of the modified equipment are identical to the unmodified equipment.

5.13 Conclusions

Based on the above, et medicale devices belives that CARDIOLINE AR 600, AR1200 and AR 2100 electrocardiographs are substantially equivalent to AB CARDIETTE Daedalus View base and Hes.

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Image /page/5/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 curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 5 - 2005

et medical devices SpA c/o Mr. Attilio Castelli Via De Zinis, 6 38011 Cavareno (TN) ITALY

Re: K051534

Trade Name: Cardioline AR 600, AR 1200 and AR 2100 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: August 31, 2005 Received: September 6, 2005

Dear Mr. Castelli:

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 such 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. Attilio Castelli

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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 contact the Office of Compliance at (240) 276-0295. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bhimima 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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K051534

et medical devices spa

Indications for Use:

CARDIOLINE AR 600 and AR 1200 and AR 2100 are a family of electrocardiograph recorders provided with a program for automated ecg analysis and with a graphic LCD display.

Intended use for non interpretive applications covers the full range of patient population with no limitations with respect to age, sex and race of the patient.

The interpretation program is intended to provide a diagnostic support to the physician for the ecg evaluation on rhythm and morphology.

The equipments are intended to be used by trained medical personnel or physician's.

Indication for use of the modified device has not been changed with respect to the predicate device AB CARDIETTE DAEDALUS VIEW base and Hes K002074.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Simmon

of Cardlovascular Devices 510(k) Number ರಿ.

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).