ELAN® is a digital 12 channel electrocardiograph designed for acquisition and digitization of conventional diagnostic 12-lead simultaneous ECG waveforms and ECG data and real-time visualization of 1 to 6 leads on its built-in LCD monitor. ELAN® can also record and store in its internal memory up to 100 ECG tests. Each ECG test can be analyzed, printed on the internal thermal printer and/or sent to a PC via serial cable, LAN or modem. ELAN® can perform automatic measurements of ECG waveform and preliminary interpretation of ECG test; measurements and diagnostic statements are offered to the physician on an advisory basis only; the physician is asked to review and validate or change the ECG interpretation.

Device Description

ELAN® is a digital 12 channel electrocardiograph for the simultaneous acquisition of the 12 ECG leads, featuring 6-lead LCD screen, alphanumeric keyboard and high resolution thermal printer on 210 mm paper. ELAN ® can record and store in its internal memory up to 100 ECG tests. Each ECG test can include patient data, ECG measurements, automatic interpretation, physician report. Stored ECG tests can be reviewed, printed on the internal thermal printer and/or sent to a local or remote PC via serial cable, LAN network or external standard modem.

AI/ML Overview

The provided text describes a 510(k) submission for the ELAN® Digital 12 Channel Electrocardiograph, aiming to establish substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, typically without requiring extensive new clinical studies. Therefore, the information provided focuses on technical specifications and functional comparisons rather than detailed performance studies with acceptance criteria in the same way one might find for a novel AI/ML device.

However, based on the document's content, we can infer acceptance criteria for "substantial equivalence" and report the device's characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission seeking substantial equivalence, the "acceptance criteria" are implied to be that the new device's specifications and performance are comparable to the predicate device. The following table directly compares the ELAN® device to its predicate, the M1770A Pagewriter 200i, for various technical specifications. The acceptance criterion for each specification is, therefore, that the ELAN® device's value is either the same as, or functionally equivalent or superior to, the predicate device.

Specification	Predicate Device (PAGEWRITER 200i, K954980) - Acceptance Criteria	ELAN® Digital 12 Channel Electrocardiograph - Reported Device Performance
CONFIGURATION	Tabletop / cart mount (optional)	Tabletop
LEADS
Lead switching	Automatic / manual	Automatic / manual
Sensitivity, mm/mV	5, 10, 20	5, 10, 20
Calibration signal	Manual	Manual
Frequency range, Hz Diagnostic	0.05 - 150	0.05 - 150
Filtered	Notch, EMG, baseline wander	Notch, EMG, baseline wander
Input impedance, Mohms	100	160 Mohms at 10 Hz
CMRR @ 60 Hz, dB	110	> 100
Leads-off indicator	Yes	Yes
RECORDER
Recording method	Digital thermal array	Digital thermal array
Paper size	A4	210 mm z-fold
Lead marker	Automatic	Automatic
Timing marker	No	No
Event marker	No	No
Chart speed, mm/sec	5, 10, 25, 50	6.25, 12.5, 25, 50
Channels acquired simultaneously	12	12
Channels printed simultaneously	3, 6, 12	3, 6, 12
PREVIEW SCREEN	LCD	LCD
NO. WAVEFORMS STORED	Optional 30, flash	Flash 25, optional 100
ECG TRANSMISSION	Optional	Yes
Type	Fax, Programmable modem, RS232	Programmable modem, RS232, LAN
INTERPRETATION	Yes	Yes
ECG MEASUREMENTS	Yes	Yes
DEFIBRILLATOR OVERLOAD PROTECTION	Yes	Yes
POWER REQUIREMENTS	110-220 VAC	115-230 VAC
DIMENSION, mm	102x432x381	340 x 400 x 110
WEIGHT, Kg	8.5	5.8
BATTERY OPERATION	Yes	Yes
Battery type	Lead acid	Built-in rechargeable NiMH
No. / Voltage	1/6	20 / 1.2 V
Operating time, hours	40 min	5 patient monitoring / 2 printing
ENVIRONMENTAL
Operating temperature	+10 to +40 °C	+10 to +40 °C
Operating humidity (non condensing)	25% to 75%	25% to 75%
Operating altitude	700-1060 mbar	700-1060 mbar
PLANNING & PURCHASE
Warranty	3 years in USA	2 years in USA

Study Information

The provided text describes a 510(k) submission, not a detailed clinical study demonstrating the performance of a novel AI/ML device against specific acceptance criteria. A 510(k) aims to establish "substantial equivalence" to a predicate device. The study that "proves the device meets the acceptance criteria" in this context is the comparison against the predicate device based on technical specifications and functional performance.

The document states: "The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices." and "After analyzing bench, electrical safety, EMC, and user testing data, it is the conclusion of Remco Italia S.p.A. that the ELAN® Digital 12 Channel Electrocardiograph is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device."

1. Sample size used for the test set and the data provenance:

Sample Size (Test Set): Not explicitly stated in terms of patient ECGs. The "test set" for this type of submission generally refers to the device itself undergoing various technical and functional evaluations (bench testing, electrical safety, EMC, user testing).
Data Provenance: Not specified as retrospectively or prospectively collected patient data. The "user testing" mentioned might involve evaluation by clinical users, but details on the data (e.g., origin, number of cases) are not provided.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable in the context of this 510(k) submission for an electrocardiograph. The "ground truth" for establishing substantial equivalence primarily relies on objective technical specifications and functional comparisons against the predicate device, rather than expert interpretation of a diagnostic output for a classification task. The device does perform "preliminary interpretation of ECG test" which is "offered to the physician on an advisory basis only; the physician is asked to review and validate or change the ECG interpretation," indicating that physician review (expert input) is part of its intended use but not the primary method for establishing ground truth for the 510(k) comparison.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This device is not being evaluated for a diagnostic accuracy task that would require expert adjudication of findings. Its performance is assessed against technical specifications and comparison with a predicate device.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device, while performing "automatic measurements of ECG waveform and preliminary interpretation," is explicitly stated as providing advisory statements that require physician review and validation. The submission does not claim to improve human reader performance but rather provides automated interpretation as an advisory tool.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

The device performs "automatic measurements of ECG waveform and preliminary interpretation of ECG test." This represents a form of standalone algorithmic performance. However, the regulatory submission does not detail the validation of this specific algorithmic performance against a ground truth, as it is presented as "advisory basis only" requiring physician validation. The "standalone" evaluation, in this context, is primarily against the performance characteristics of the predicate device's interpretation capabilities.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the purpose of substantial equivalence, the "ground truth" is typically the established technical and functional performance of the legally marketed predicate device. For the internal "preliminary interpretation," the document does not specify how the ground truth was established for the development of that algorithm, only that its outputs are advisory and subject to physician validation.

7. The sample size for the training set:

Not applicable/Not provided. The document does not describe the development of a novel machine learning algorithm that would have a distinct training set. The "interpretation" functionality would have been developed based on existing ECG knowledge and algorithms, but details of a specific training set size are not part of this 510(k) submission.

8. How the ground truth for the training set was established:

Not applicable/Not provided. As no specific training set for a novel AI/ML algorithm is described, the method for establishing its ground truth is not detailed in this document.

Summary

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EXHIBIT 2

510(k) Summary REMCO ITALIA S.p.A. 53, STRADA RIVOLTANA NUOVA SOUTH PEDRINO DI VIGNATE, MI., ITALY 20060 PHONE +39(0) 2 950518.1 Fax +39(0) 2 9566013 Contact: Carlo Depero, Director Date: July 1, 2003

OCT 03 2003

1 . Identification of the Device: Proprietary-Trade Name: ELAN® Digital 12 Channel Electrocardiograph. Classification Name: 74 DPS and LOS Common/Usual Name: Electrocardiograph, ECG Analysis
1. Equivalent legally marketed devices The legally marketed device to which equivalence is being claimed is the M1770A Pagewriter 200i manufactured by Hewlett-Packard, K954980, Brentwood "Telemed 12 Lead Resting ECG Analysis Library," K010505 and Telemed Omnigraph 6000, K880357
1. Indications for Use (intended use) ELAN® is a digital 12 channel electrocardiograph designed for acquisition and digitization of conventional diagnostic 12-lead simultaneous ECG waveforms and ECG data and real-time visualization of 1 to 6 leads on its built-in LCD monitor. ELAN® can also record and store in its internal memory up to 100 ECG tests. Each ECG test can be analyzed, printed on the internal thermal printer and/or sent to a PC via serial cable, LAN or modem. ELAN® can perform automatic measurements of ECG waveform and preliminary interpretation of ECG test; measurements and diagnostic statements are offered to the physician on an advisory basis only; the physician is asked to review and validate or change the ECG interpretation.
1. Description of the Device: ELAN® is a digital 12 channel electrocardiograph for the simultaneous acquisition of the 12 ECG leads, featuring 6-lead LCD screen, alphanumeric keyboard and high resolution thermal printer on 210 mm paper. ELAN ® can record and store in its internal memory up to 100 ECG tests. Each ECG test can include patient data, ECG measurements, automatic interpretation, physician report. Stored ECG tests can be reviewed, printed on the internal thermal printer and/or sent to a local or remote PC via serial cable, LAN network or external standard modem.
1. Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices.

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Substantial Equivalence Chart6.
SPECIFICATION	PAGEWRITER 200i, K954980	ELAN
CONFIGURATION	Tabletop / cart mount (optional)	Tabletop
LEADS
Lead switching	Automatic / manual	Automatic / manual
Sensitivity, mm/mV	5, 10, 20	5, 10, 20
Calibration signal	Manual	Manual
Frequency range, Hz Diagnostic	0.05 - 150	0.05 - 150
Filtered	Notch, EMG, baseline wander	Notch, EMG, baseline wander
Input impedance, Mohms	100	160 Mohms at 10 Hz
CMRR @ 60 Hz, dB	110	> 100
Leads-off indicator	Yes	Yes
RECORDER
Recording method	Digital thermal array	Digital thermal array
Paper size	A4	210 mm z-fold
Lead marker	Automatic	Automatic
Timing marker	No	No
Event marker	No	No
Chart speed, mm/sec	5, 10, 25, 50	6.25, 12.5, 25, 50
Channels acquiredsimultaneously	12	12
Channels printed simultaneously	3,6,12	3, 6, 12
PREVIEW SCREEN	LCD	LCD
NO. WAVEFORMS STORED	Optional 30, flash	Flash 25, optional 100
ECG TRANSMISSION	Optional	Yes
Type	Fax, Programmable modem, RS232	Programmable modem, RS232, LAN
INTERPRETATION	Yes	Yes
ECG MEASUREMENTS	Yes	Yes
DEFIBRILLATOR OVERLOADPROTECTION	Yes	Yes
POWER REQUIREMENTS	110-220 VAC	115-230 VAC
DIMENSION, mm	102x432x381	340 x 400 x 110
WEIGHT, Kg	8.5	5.8
BATTERY OPERATION	Yes	Yes
Battery type	Lead acid	Built-in rechargeable NiMH
No. / Voltage	1/6	20 / 1.2 V
Operating time, hours	40 min	5 patient monitoring2 printing
ENVIRONMENTAL
Operating temperature	+10 to +40 °C	+10 to +40 °C
Operating humidity
(non condensing)	25% to 75%	25% to 75%
Operating altitude	700-1060 mbar	700-1060 mbar
PLANNING & PURCHASE
Warranty	3 years in USA	2 years in USA

Conclusion 7.

After analyzing bench, electrical safety, EMC, and user testing data, it is the conclusion of Remco Italia S.p.A. that the ELAN® Digital 12 Channel Electrocardiograph is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 03 2003

REMCO ITALIA S.p.A. c/o Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, IL 60015

Re: K032200

Trade Name: ELAN® Digital 12 Channel Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph, ECG Analysis Regulatory Class: Class II (two) Product Code: DPS Dated: September 15, 2003 Received: September 16, 2003

Dear Mr. Kamm:

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. Daniel Kamm, P.E.

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 (OS) 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 (301) 594-4646. 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/dsma/dsmamain.html

Sincerely vours.

K. Oa. Ce. TM

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

Enclosure

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i) Indications for Use

510(k) Number Ko322000

Device Name: ELAN® Digital 12 Channel Electrocardiograph.

Indications for Use:

ELAN® can also record and store in its internal memory up to 100 ECG tests. Each ECG test can be analyzed, printed on the internal thermal printer and/or sent to a PC via serial cable, LAN or modem.

ELAN® can perform automatic measurements of ECG waveform and preliminary interpretation of ECG test; measurements and diagnostic statements are offered to the physician on an advisory basis only; the physician is asked to review and validate or change the ECG interpretation.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K032200

Prescription Use X OR Over the Counter Use __

(Per 21 CFR 801.109)

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).