The ECG Holter evaluation software, MT-200, is an analysis software used for the analysis and evaluation of Holter ECG recordings. The Holter recordings are used for the diagnostics of symptomatic and asymptomatic arrhythmias, i.e. bradycardia, tachycardia, diagnostic of arrhythmias in patients with coronary artery disease, in patients after reanimation, in patients with different diseases such as cardiomyopathy, high blood pressure, long QT syndrome. A Holter ECG recording is also used for clarifying palpitations or syncopes and attacks of dizziness or for controlling medical therapies, or after operative treatments such as bypass operations or PTCA. The ST segment analysis of a Holter ECG is used for the detection of symptomatic or asymptomatic ischemias.

Device Description

The ECG Holter evoluation software, MT-200, is an analysis software used for the analysis and evaluation of Holter EOG recordings. The Holter iscoralings are used for the diagnostics of symptomatic and asymptomatic arrhythings, i.e. bradyeardia, tachycardia, diagnastic of arthythinias in pattents with coraniary artery disease, in cardiomopathy, high blood pressure, long QT syndrome, A Holter ECG recording is also used for clarifying palpitations or syncopes and attacks of aliziniess or for controlling medical theraples, or after operative treatments such as bypass operations or PTCA. The ST segment analysis of a Holter ECG is used for the detection of symptomatic or asymptomatic Ischemics. The software runs on Windows™ 95.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SCHILLER Microvit MT-200 Holter Analyzer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria	Reported Device Performance
Arrhythmia Detection	Based on the procedures and limits described in ANSI/AAMI EC 38-1994 when compared to annotated classifications of AHA and MIT databases.	"All tests are passed." (Implying compliance with ANSI/AAMI EC 38-1994 limits).
ST-T Segment Analysis	Absolute difference between paired values (reader MT-200) is less than 0.1 mV. The total number of differences greater than 0.1 mV is less than or equal to 2% of the total number of measurements.	"All tests are passed." (Implying compliance with the 0.1 mV and 2% difference criteria).
Software Quality	Conformity with "reviewer guidance for computer controlled medical devices undergoing 510(k) review".	"All tests are passed."

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

Arrhythmia Detection: The test set comprised "the AHA and MIT data bases." No specific number of records or patients is provided, but these are well-known, publicly available databases widely used for Holter ECG algorithm validation. The provenance is likely mixed, given the international nature of these databases, and typically retrospective, as they are pre-recorded and annotated datasets.
ST-T Segment Analysis: The test set used "the ESC ST.T. database." Similar to the arrhythmia detection, no specific number of records is provided. This is also a well-known, typically retrospective database.

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

Arrhythmia Detection: The ground truth for arrhythmia detection was established by "the annotations in the databases [AHA and MIT]." The number and qualifications of experts who created these annotations are not specified in this document. These databases are generally annotated by multiple expert cardiologists or electrophysiologists.
ST-T Segment Analysis: The ground truth for ST-T analysis was established by "two independent observers." Their specific qualifications (e.g., "cardiologist with X years of experience") are not provided, only that they were "independent observers."

4. Adjudication Method for the Test Set

Arrhythmia Detection & ST-T Segment Analysis: For arrhythmia detection, the MT-200's classifications were directly "compared with the annotated classifications of the data bases." For ST-T analysis, the MT-200's measurements were "compared to the deviations measured by two independent observers." This implies a direct comparison rather than an explicit arbitration or 2+1/3+1 adjudication method being used during the study. The ground truth itself, particularly for the well-established AHA/MIT/ESC databases, would have undergone rigorous expert consensus and adjudication during its creation.

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

No MRMC comparative effectiveness study is mentioned. The study focuses on evaluating the algorithm's performance against established ground truth rather than assessing human reader improvement with AI assistance.

6. Standalone Performance

Yes, a standalone performance study was conducted. The document explicitly states: "The classifications given by the MT-200 were then compared with the annotated classifications of the data bases," and for ST-T analysis, "The STsegment deviations measured by the MT-200 were compared to the deviations measured by two independent observers." This demonstrates the algorithm's performance without human intervention in the loop during the reported tests.

7. Type of Ground Truth Used

Arrhythmia Detection: Expert consensus, as represented by "the annotated classifications in the AHA and MIT databases."
ST-T Segment Analysis: Expert consensus, as determined by "two independent observers" measuring ST-segment deviations.

8. Sample Size for the Training Set

The document does not provide any information about the sample size used for the training set. The study focuses solely on the evaluation of the device's performance using established test databases.

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

Since no information on a training set is provided, there is no mention of how its ground truth would have been established. This K973751 focuses on the validation of the developed software using known benchmark databases.

Summary

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K973751

AUG 25 1998

510 K Summary

accordina to 21 CFR 807,92

A1 Address

SCHILLER America, Inc. 3002 Dow Avenue, #138 Tustin, CA 92780 Contact Name; Tel: Date:

Mr. Markus Martz 1619) 635 6023 22" September 1997

A2 Device Name

1. Trade Name:	Microvtt MT-200
2. Common Names:	Holter System, Holter Analyzer
3. Classification Name:	Computer, Diagnostic, Programmable

Panel Code: DEK ICV 74 Classification Class:

Computer Diagnostic Programmable Class 2

A3 Legally Marketed Device

Legally Marketed Device to which this submitted device is compared: Brentwood Rhythmscan Precision CS-6000 (K914577)

Description of Submitted Device A4

A Holter ECG recording is also used for clarifying palpitations or syncopes and attacks of aliziniess or for controlling medical theraples, or after operative treatments such as bypass operations or PTCA. The ST segment analysis of a Holter ECG is used for the detection of symptomatic or asymptomatic Ischemics.

The software runs on Windows™ 95.

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ITZEHL

A5 Intended Use

The ECG Holter Analyzer MT-200, Is a ECG analyzing software for the diagnostics of symptomatic and asymptomatic artnythmias and of Ischernic episodes.

hurnan beings without restrictions of age, sex or race. 1. Patient Population:

Difference to the Predicate Device: no differences.

Table of Comparison A6

Predicate device: Brentwood Rhytmsoan Precision CS-6000 (K914577)

	Precision CS-6000	MT-200
Recording Medium	Tape cassette and Solidstate recorder DL, 700	Solid state recorderMT-200
Channels	2 or 3	2
System requirements
CPU	IBM compatible PC386, 33 MHz8 Mbytes RAM80 Mbytes Hard-driveWindows™ 3.11 or 95	IBM compatible PC486, 66 MHz16 Mbytes RAM100 Mbytes Hard-driveWindows™ 95
Monitor	VGA Color Monitor	SAME
Printer	HP Laser Jet Series	SAME

Non-Clinical Tests B1

Data related to software quality

SCHILLER has reviewed the MT-200 Analyzer Software development process following the quideline "reviewer quidance for computer controlled medical devices undergoing 510 (k) review".

All tests are passed.

B2 Clinical Tests

To evaluate the performance of arthythmia detection of the MT-200 program, the AHA and MIT data bases were used and the annotations in the databases compared with the automatic analysis carried out by the MI-200 program.

Method

A normal analysis of the AHA and MIT records was carried out by the MT-200. The classifications given by the MT-200 were then compared with the annotated classifications of the data bases.

The results of the comparison were alven in tabular form. The procedure and limits described In ANSVAAMI EC 38-1994 were used.

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SCHILLER ITZERLAND

For the evaluation of the ST-T analysis the ESC ST.T. database was used. The STsegment deviations measured by the MT-200 were compared to the deviations measured by two independent observers.

The limits set up for test were not violated.

The absolute difference between paired values (reader MT-200) is less than 0.1 mV. The total number of differences greater than 0.1 mW Is less than or equal to 2% of the total number of measurements.

All tests are passed

ВЗ Conclusions from Tests

The fulfillment of the above standards ensures the safely and effectiveness of the submitted device. We consider the submitted device to be as safe and effective as the Predicate Brentwood Rhytmscan Precision CS-6000 (K914577) Device.

All tests are passed.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 25 1998

Mr. Markus Maritz Schiller America, Inc. 3002 Dow Avenue, Suite 138 Tustin, CA 92780

Re: K973751 Microvit MT-200 Requlatory Class: II (two) Product Code: 74 DQK Dated: May 29, 1998 Received: June 2, 1998

Dear Mr. Maritz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Markus Maritz

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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WELCH ALLYN 07 : 31 : 98 14:58 07/31/98 13:04 FAX

ID:619-621-6610 201 143 3101

AUG 04, 98 FD3-051 DECS

Page I of I

610(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:Holter Evaluation Software MT-200

Indications For Use:

A Holter ECG recording is also used for clarifying palpitations or syncopes and attacks of dizziness or for controlling medical therapies, or after operative treatments such as bypass operations or PTCA. The ST segment analysis of a Holter ECG is used for the detection of symptomatic or asymptomatic ischemias.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Dalla Tilla

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K97375/

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Pormat 1-2-90)

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).