The device is a PC based diagnostic tool intended to acquire, process, and store ECG data of patients undergoing stress exercise testing. The software records ECG, heart rate, and ST data, creates summary tables, trends and a final report regarding a variety of cardiac data indices. The cardiac data provided by X-Scribe II is reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis of the electrocardiographic data reflecting the patient's physiological condition during stress exercise testing.

The device captures and presents electrocardiographic data reflecting a patient's physiological condition during physiologic stress testing that can be useful in determining a diagnosis when reviewed by a trained clinician or physician. The cardiac data provided by X-Scribe II is reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis of adult patients with various rhythm patterns.

The device is not intended to be the sole basis of diagnosis.

The device is indicated for use in a clinical setting by a physician, or trained personnel who are acting on the orders of a licensed physician.

The device is indicated for use on adult populations, typically symptomatic. The device is not intended to be used as a vital signs physiological monitor.

Device Description

The Mortara X-Scribe II is the latest evolution of the Mortara X-Scribe (K900720). It is a PC based diagnostic tool consisting of an ECG analysis software application running on a commercial PC using Windows operating system. Electrocardiographic data is obtained by means of a compatible device, such as the Mortara X-12 (K974149) or the Mortara direct connect patient cable, and sent to the CPU for processing. The user may generate reports for display or may opt to print results via a printer.

The device consists of a CPU, display, mouse, printer, keyboard, isolation power supply, and data collector. The device may interface with external devices, including a treadmill or erqometer for dynamic exercise evaluation, non-invasive blood pressure equipment, and computer communications equipment.

AI/ML Overview

The provided text describes the Mortara X-Scribe II Stress Exercise Testing System but does not contain specific acceptance criteria or details of a study proving the device meets particular performance metrics. The document is a 510(k) summary and approval letter, which focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than a detailed performance study with acceptance criteria.

Therefore, many of the requested details cannot be extracted from the provided input. However, based on the information that is present, I can provide the following:

1. A table of acceptance criteria and the reported device performance

This information is not available in the provided text. The document is a 510(k) summary, which typically focuses on describing the device and its intended use, and demonstrating substantial equivalence to a predicate device for regulatory clearance. It does not include a detailed performance study with specific acceptance criteria and reported device performance metrics in the way you might find in an academic paper or a more comprehensive validation report.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided text, as there is no description of a test set or ground truth establishment.

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

This information is not available in the provided text.

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

This information is not available in the provided text. The device is described as an "ECG analysis software application running on a commercial PC," and "The cardiac data provided by X-Scribe II is reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis." This suggests human-in-the-loop operation, but the text does not detail any comparative effectiveness study with or without AI assistance, or any specific AI components that would typically be evaluated in such a study.

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

This information is not available in the provided text. The "Indications for use" explicitly state, "The cardiac data provided by X-Scribe II is reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis," and "It is not intended as a sole means of diagnosis." This indicates the device is not intended for standalone use without human interpretation.

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

This information is not available in the provided text, as no performance study or ground truth establishment is described.

8. The sample size for the training set

This information is not available in the provided text.

9. How the ground truth for the training set was established

This information is not available in the provided text.

In summary, the provided document is a regulatory submission for a medical device (a stress exercise testing system), focusing on showing substantial equivalence to existing devices for market clearance rather than detailing performance studies with specific statistical acceptance criteria. Therefore, the majority of the information requested, which pertains to rigorous performance evaluation and validation, is not present in this type of document.

Summary

{0}------------------------------------------------

510(k) Summary

6 2002 SEP

Submitter:

Harlan Van Matre, Manager of Quality Assurance / Regulatory Affairs
Mortara Instrument, Inc.
7865 N. 86th Street
Milwaukee, WI 53224
Fax:	(414) 354-4760
Phone:	(414) 354-1600
Contact:	Harlan Van Matre (see above)
Trade Name:	X-Scribe II
Common Name:	Stress Exercise Testing System
Classification Name:	Programmable Diagnostic Computer (Class II Per 21 CFR § 870.1425)Electrocardiograph (Class II Per 21 CFR § 870.2340)
	Legally marketed devices to which S.E. is claimedMortara X-Scribe Stress Exercise System - 510(k) K900720Quinton Q-Stress – 510(k) K 001492

Description:

Intended use:

Indications for use:

The device is not intended to be the sole basis of diagnosis.

The device is indicated for use in a clinical setting by a physician, or trained personnel who are acting on the orders of a licensed physician.

The device is indicated for use on adult populations, typically symptomatic. The device is not intended to be used as a vital signs physiological monitor.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 2002

Mortara Instrument, Inc. c/o Mr. Harlan L. Van Matre Manager of Ouality Assurance and Regulatory Affairs 7865 North 86th Street Milwaukee, WI 53224-3431

Re: K022618

Trade Name: Mortara X-Scribe II Stress Exercise Testing System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: May 3, 2002 Received: August 7, 2002

Dear Mr. Van Matre:

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.

{2}------------------------------------------------

Page 2 - Mr. Harlan L. Van Matre

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

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

Enclosure

{3}------------------------------------------------

Device Name:

Mortara X-Scribe II Stress Exercise Testing System

The X-Scribe II is a PC based diagnostic tool intended to acquire, process, record. analyze, archive and output electrocardiographic data obtained during physiologic stress testing.

Intended use:

Indications for use:

The device is indicated for use to acquire, process, record, archive, analyze, and . output electrocardiographic data obtained during physiologic stress exercise testing.
. The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
The device is indicated for use on adult populations, typically symptomatic.
The device is not intended to be used as a vital signs physiological monitor. ●

(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE (F NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number	K022618

Prescription Use(Per 21CFR801.109)	OR	Over-The-Counter Use
----------------------------------------	----	----------------------

(Optional Format 1-2-96)

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).