For use only by a digital device to measure ST-segment shifts. Assessment of real time ST segment analysis in adult patients. The MIDA™ Algorithm Rev. B is intended for use in the hospital environment for the following patient population: Ages: 33-82 years Heights: 147 to 185cm (58 to 73 in.) Weights: 53 to 118kg (117 to 261 lbs.) Height to weight ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb) The use of EASI leads implies that the results may not be of diagnostic quality.

Device Description

The new device is a modification that allows the MIDA™ algorithm to use vectorcardiogram from the five leads system EASI.

AI/ML Overview

Acceptance Criteria and Device Performance Study for MIDA™ Algorithm Rev. B.

The Acceptance Criteria and the study proving the device meets these criteria for the MIDA™ Algorithm Rev. B are detailed below, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria in terms of metrics like sensitivity, specificity, or accuracy. Instead, the "acceptance criteria" appear to be met through a demonstration of "substantial equivalence" to a predicate device, specifically regarding the ability to measure ST-segment shifts using a 5-lead EASI system compared to a system using Frank electrode placement.

The "reported device performance" is framed as the ability of the MIDA™ Algorithm Rev. B to calculate ST-segment shifts when using the EASI lead system, and its comparability to the results obtained from Frank electrode placement.

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Substantial equivalence in	MIDA™ Algorithm Rev. B calculates ST-segment shifts using
ST-segment shift measurement	EASI electrode placement.
capability when using EASI	The calculated ST-segment shifts for both Frank and EASI
leads compared to Frank	electrode placements were compared, demonstrating sufficient
electrode placement.	similarity to establish substantial equivalence.
Functionality in a hospital	Intended for use in the hospital environment for adult patients
environment for specified	within specified age, height, and weight ranges.
adult patient population.
Ability to measure ST-segment	The device is described as allowing the MIDA™ algorithm to
shifts.	use vectorcardiogram from the five leads system EASI to
	measure ST-segment shifts.

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

Sample Size for Test Set: The text states, "Testing involved acquirement of data for patients that was undergoing PTCA." It does not specify the exact number of patients or the size of the test set.
Data Provenance: The patients were "undergoing PTCA" (Percutaneous Transluminal Coronary Angioplasty), indicating a medical procedure associated with cardiac conditions. The country of origin is not explicitly stated. The study appears to be prospective as it involved "acquirement of data for patients" during a procedure, suggesting real-time data collection or at least data collected specifically for this testing.

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications. The comparison was made between ST-segment shifts calculated by the MIDA algorithm using different lead placements, not against an expert-adjudicated ground truth for the presence of ischemia or ST-elevation.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method involving experts for establishing ground truth. The comparison was directly between the calculated ST-segment shifts from two different electrode placements (Frank vs. EASI) within the MIDA™ Algorithm, not against an external "ground truth" adjudicated by multiple experts.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. The study focused on the algorithm's performance in calculating ST-segment shifts with different lead systems, not on its impact on human reader performance or diagnostic accuracy.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The study involved comparing the ST-segment shifts calculated by the MIDA™ Algorithm Rev. B using EASI lead placement against the ST-segment shifts calculated by the same algorithm using Frank electrode placement. The conclusion is based on a "Software Test Report MIDA Algorithm Rev B. ID: P-593-062." This clearly indicates an assessment of the algorithm's output without direct human intervention in the interpretation or diagnostic process for the comparison.

7. Type of Ground Truth Used

The "ground truth" in this context was the ST-segment shifts calculated by the MIDA™ Algorithm using Frank electrode placement. The study aimed to demonstrate that using EASI leads with the MIDA™ Algorithm produced comparable results to the established Frank lead system within the same algorithm. It was not based on pathology, clinical outcomes, or expert consensus regarding the presence of a condition, but rather on the consistency of a measurement between two different input methods for the same algorithm.

8. Sample Size for the Training Set

The document does not provide information regarding a specific training set size. The description focuses on the verification and validation of the device, which typically involves a test set. It is possible that the MIDA™ Algorithm itself was developed using a separate dataset, but details are not provided in this 510(k) summary.

9. How Ground Truth for the Training Set Was Established

Since information on a training set is not provided, the method for establishing its ground truth is also not mentioned.

Summary

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DEC - 5 2003

023414

12

SECTION 2. GENERAL INFORMATION

A. 510(k) SUMMARY

Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes the Ortivus AB summary for the MIDA™ Algorithm Rev. B.

SUBMITTER'S NAME:	Ortivus AB
ADDRESS:	Enhagsslingan 5SE-187 40 Täby, Sweden
CONTACT PERSON:	Kenneth Eklund
PHONE NUMBER:	+46-8-446 45 35
FAX NUMBER:	+46-8-446 45 19
DATE OF SUBMISSION:	7 October, 2002

1. Identification of device: Proprietary Name: MIDA™ Algorithm Rev. B Common Name: Vectorcardiograph Classification Status: Class II per regulation 870.2400 Product Codes: 74DYC
1. Equivalent device:

The new device that allows the MIDA™ algorithm to use vectorcardiogram from the five leads system EASI is substantially equivalent to the MIDATM System, Models 1000/1100 manufactured by Medical Graphics Corporation (K896396) and the HP Viridia CMS (K992595).

1. Description of the Device:
  The new device is a modification that allows the MIDA™ algorithm to use vectorcardiogram from the five leads system EASI.
1. Indication for use:
  For use only by a digital device to measure ST-segment shifts. Assessment of real time ST segment analysis in adult patients. The MIDA™ Algorithm Rev. B is intended for use in the hospital environment for the following patient population: Ages: 33-82 years Heights: 147 to 185cm (58 to 73 in.) Weights: 53 to 118kg (117 to 261 lbs.) Height to weight ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb)

The use of EASI leads implies that the results may not be of diagnostic quality.

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1. Technological characteristics, comparison to predicate device The table below compares the MIDA B with the new predicate device (HP Viridia System) and the original MIDA.
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Characteristics	MIDA 1000/1100(K896396)	HP Viridia CMS(K992595)	MIDA Rev B(K023414)
Indications for Use	Monitor ischemia	Assessment of ST segment	Assessment of ST segment
Patient Population		Adults	Adults
Intended UseEnvironment	Hospital Environment	Hospital Environment	Hospital Environment
Technology	Digital	Digital	Digital
Number of Electrodes	8 Electrodes	5 Electrodes	5 Electrodes
Bandwidth	0.02 to 100 Hz	0.05 to 130 Hz	0.05 to 130 Hz
Input dynamic range	$\pm$ 320 mV	$\pm$ 500 mV	$\pm$ 328 mV
Storage	Store data	Doesn't store data	Doesn't store data
Calculated ST-VMparameter	Yes	No	Yes
Calculated STC-VMparameter	Yes	No	Yes

5. Verification, validation and testing

The activities to establish the performance, functionality and reliability characteristics of the new device with respect to the predicate device. Testing involved acquirement of data for patients that was undergoing PTCA. Simultaneous recordings were obtained from the patient using electrode placement according to Frank and EASI. ST-segment shifts were calculated for both lead placements and compared.

6. Conclusion

Based on the Software Test Report MIDA Algorithm Rev B. ID: P-593-062., MIDA™ calculated with both Frank electrode placement and EASI electrode placement and comparison with predicate devices, it is the conclusion of Ortivus AB that the MIDA™ algorithm Rev B is substantially equivalent with the predicate device and that there is no new concerns about safety and effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 5 2003

Ortivus AB c/o Mr. Kenneth Eklund Enhagsslingan 5 SE-183 25 Taby SWEDEN

Re: K023414

Trade Name: MIDA™ Algorithm Rev. B Regulation Number: 21 CFR 870.2400 Regulation Name: Vectorcardiograph Regulatory Class: Class II (two) Product Code: DYC Dated: September 9, 2003 Received: September 12, 2003

Dear Mr. Eklund:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your occurrent the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interscate for use stated in the encrosure) to regard to tegally and call be vice Americal Device Ameral Food. Drya commerce provision of May 20, 1970, the encordance with the provisions of the Federal Food. Drug, devices that have been reclaismed in accessful of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applicat and Costhelic Act (Act) that do not require approvince approvisions of the Act. The Act. The Act. The You may, merciole, market the devices, solo, exception of the samual registration, listing of general controls provisions of the free labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class II (PMA), it If your device is classified (soc above) ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional bontroller Entreasger of the 21, Parts 800 to 898. In addition, FDA may be found in the Code of Feach. It geteral stogething your device in the Federal Register.

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Page 2 – Mr. Kenneth Eklund

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 (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 yours,

Myra Mayer
Carolyn Coleman, MD

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

Enclosure

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INDICATIONS FOR USE

510(k) Number: K023414

Device Name: MIDA™ Algorithm Rev. B

Indication for use: For use only by a digital device to measure ST-segment shifts.

Assessment of real time ST segment analysis in adult patients.

The MIDA™ Algorithm Rev. B is intended for use in the hospital environment for the following patient population: Ages: 33-82 years Heights: 147 to 185cm (58 to 73 in.) Weights: 53 to 118kg (117 to 261 Ibs.) Height to weight ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb)

The use of EASI leads implies that the results may not be of diagnostic quality.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mesa Meis
(Division Sign-Off)

Page I of 1

rascular Devices 510(k) Number

Regulation Number and Section

§ 870.2400 Vectorcardiograph.

(a)
Identification. A vectorcardiograph is a device used to process the electrical signal transmitted through electrocardiograph electrodes and to produce a visual display of the magnitude and direction of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).