Formula for ArchiMed (model 4230) represents a multi-channel electrocardiograph machine equipped with an SVGA monitor, a PC keyboard and a trackball. It is intended to be used for acquisition, digitization, display and recording of conventional diagnostic twelve (12) simultaneous lead ECG waveforms. The 4230 is equipped with a resting interpretation program covering adult populations. This analysis program is offered to the physician on an advisory basis only and the physician is asked to overread and validate (or change) the ECG interpretation.

AI/ML Overview

The provided document (K974079) is a 510(k) Pre-Market Notification for the "Formula for ArchiMed" electrocardiograph and does not include detailed information about specific acceptance criteria or a dedicated study proving performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment for a performance study is not available in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided 510(k) summary. The document does not describe specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or report the device's performance against such criteria through a dedicated study. Instead, it highlights that the new system incorporates the same algorithms for key functions as the predicate device.

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

2. Sample size used for the test set and the data provenance

This information is not available. The document does not describe a performance study with a test set. It mentions "The new systems incorporate the same algorhythms for baseline stabilization, template and medians update, fiducial points (and ST measurements) and aberrant beat detection than the predicate device." This suggests reliance on the predicate device's established performance rather than a new, dedicated study with a specific test cohort for the Formula for ArchiMed.

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

This information is not available. As no specific test set or performance study is detailed, there's no mention of experts establishing ground truth. The device is intended to be used by a physician, and the analysis program is offered on an advisory basis, with the physician asked to "overread and validate (or change) the ECG interpretation." This implies that the physician is the ultimate arbiter of truth in clinical practice.

4. Adjudication method for the test set

This information is not available. No test set or adjudication method is described.

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. The document does not describe an MRMC study. The "Formula for ArchiMed" is an electrocardiograph with an interpretation program, not an "AI" in the modern sense of a machine learning-based diagnostic aid that would typically be evaluated in such a study for human reader improvement. The device provides an "advisory basis only" interpretation to the physician.

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

This information is not available. While the device has an "interpretation program," the document emphasizes it's an "advisory basis only" tool, and the physician is expected to "overread and validate (or change) the ECG interpretation." This means its performance is always considered in conjunction with a human, and a standalone algorithmic performance study is not detailed or implied.

7. The type of ground truth used

This information is not available for a specific validation study of the Formula for ArchiMed. However, since it's an electrocardiograph providing an "interpretation program," the implied "ground truth" in clinical practice would be a physician's expert diagnosis, potentially corroborated by other diagnostic tests or clinical outcomes. The document states "This analysis program is offered to the physician on an advisory basis only and the physician is asked to overread and validate (or change) the ECG interpretation." This implies expert consensus/overread by a physician is the ultimate ground truth in its intended use.

8. The sample size for the training set

This information is not available. The document makes no mention of a training set as would be relevant for machine learning algorithms. It states that the new system uses the "same algorhythms" as the predicate device (Esaote ACTA Formula K#922703). This suggests that the underlying algorithms were developed and validated prior to this submission, and their development details are not part of this 510(k).

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

This information is not available. As no training set or specific algorithm development for the Formula for ArchiMed is detailed, the method for establishing ground truth for any underlying algorithms used by the predicate device is not provided.

Summary

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

K974079

Safety and Effectiveness Summary Formula for ArchiMed Biosound Esaote

Safety and Effectiveness Summary

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR 807.92(a).

807.92(a)(1)

Submitter Information

Colleen Hittle, Official Correspondent8000 Castleway DriveIndianapolis, IN 46250Phone: (317) 849-1916Facsimile: (317) 577-9070
Contact Person:	Colleen Hittle
Date:	October 13, 1997
807.92(a)(2)
Trade Name:	Formula for ArchiMed
Common Name:	Electrocardiograph data analysis firmware
Classification Name(s):	Electrocardiograph 870.2340
Classification Number:	74DPS
807.92(a)(3)	Predicate Device(s)
Esaote	Formula	K922703

Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.

W
/
II

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

Safety and Effectiveness Summary Formula for ArchiMed Biosound Esaote

Comparison Chart for Substantial Equivalence

General Characteristics	ESAOTE 4230Formula for ArchiMed	ESAOTE ACTAFormula (K#922703)
Dimensions (l,w,h) in mm	78 x 66 x 144	75 x 68 x 145
Weight	80 kg	100 kg
Power Supply	100 - 115 / 200 - 230 V, 50 - 60 Hz	115 / 230 V, 50 - 60 Hz
Display	SVGA	SAME
ECG storage
• Digital device	Floppy, HardDisk	SAME
• Remote data storage	RS232, Network	No
• Digital storage resolution	500 Hz	250 Hz
Environmental Conditions
• Operating temperature	+10 / + 40°C	SAME
• Relative humidity	25 to 95% RH	SAME
Stress Testing Capabilities
Baseline Filter	Linear Interpolation, programmable	SAME
12 Leads Time Alignment (Medians)	Yes	SAME
Fiducial Points Identification	Yes	SAME
ST Measurements	ST level and ST slope	SAME
Aberrant Beats Detection	Yes	SAME
Arrhythmias classification	No	No
12 Leads Continuous Digital Recording and Storage	Yes (standard)	Yes (optional)
Stress Peripherals
• Treadmill	Trackmaster	SAME
• Bicycle	SECA	SAME
Other peripherals	Pressurometer	Pressurometer

The recommended pressurometer for Model 4230 is the Tango unit from SunTech Medical Instruments (USA).

Note: The new systems incorporate the same algorhythms for baseline stabilization, template and medians update, fiducial points (and ST measurements) and aberrant beat detection than the predicate device. A description of these algorhythms can be found in the User Manual.

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

Safety and Effectiveness Summary Formula for ArchiMed Biosound Esaote

807.92(a)(4)

Device Description

Formula for ArchiMed is also equipped with software that can be used for exercise stress testing. It incorporates a hard disk with 4 serial ports to add networking capabilities and to accommodate printing to a laser printer. Such laser recording abilities have been recently adopted by Schiller (Cardiovit CS-200), whose product literature is attached in Appendix E.

807.92(a)(5)

Intended Use(s)

The Formula for ArchiMed line of electrocardiograph products is intended to be used by a physician to analyze cardiac performance.

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

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three profiles facing right, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 1998

Ms. Colleen Hittle Biosound Esaote, Inc. 8000 Castleway Drive 46250 Indianapolis, IN

Re : K974079 Formula for ArchiMed (Model 4230) Regulatory Class: II (two) Product Code: 74 DPS Dated: January 9, 1998 Received: January 12, 1998

Dear Ms. Hittle:

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 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, qood 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 Requlations, 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 Regulation (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 In addition, FDA may publish further announcements regulatory action. 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.

{4}------------------------------------------------

Page 2 - Ms. Colleen Hittle

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 dev`ice 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/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

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

Enclosure

{5}------------------------------------------------

Indications For Use

510(k) Number (if known):

K974079

Device Name:

Formula for ArchiMed

Indications for Use:

The Formula for ArchiMed line of electrocardiograph products is intended to be used by a physician to analyze cardiac performance

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
OR
Over-The-Counter Use __

(Division Sign-Off)
Division of Cardiovascular, Respiratory.
and Neurological Devices
510(k) Number. K974079

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).