R.TEST EVOLUTION by NOVACOR DIV.

The R-Test Evolution is a miniature ambulatory ECG Event Recorder that is connected to the patient. This version (automatic mode) is capable of memorizing the most significant pathological events (symptomatic or silent) as well as the patient's continuous heart rate trend, and is capable of up to eight day ambulatory recording.

Device Description

The R-Test Evolution is a miniature ambulatory ECG Recorder, which is easy to connect to the patient. The most advanced version (automatic mode) is capable of memorizing the most significant pathological events (symptomatic or silent) as well as the patient's continuous heart rate, and is capable of up to eight days ambulatory recording. The system consists of a unit weighing about 40 grams and includes a lightweight neck cable which can be worn by the patient unobtrusively and without any discomfort. The R. Test Evolution is connected to the patient by a system of electrodes and the neck cable. Cardiac events are memorized by the R. Test evolution and then transferred by a decoder, the Decotest, to an electrocardiograph or a computer for interpretation: - either directly at the physician's surgery at the following visit, - or by being transmitted telephonically by the patient himself. The R. Test Evolution can also transmit real time ECG recordings by telephone. After making a telephonic or direct transfer, the R. Test Evolution can continue recording any further pathological events which may occur. Using a computer enables you to: - define the conditions and criteria of the recordings to be made by the R. Test Evolution, - to select, organize and store the results of a procedure, and to print them using specific report parameters.

AI/ML Overview

This document does not contain the information required to populate all sections of the requested table and study description. The provided text is a 510(k) summary for the Novacor R.Test Evolution, primarily focusing on general device description, intended use, and substantial equivalence to predicate devices, along with regulatory compliance. It does not detail specific performance studies with acceptance criteria, sample sizes, or ground truth establishment relevant to an AI/algorithm-based device in the way requested.

The device described is an ambulatory ECG recorder, which is a hardware device for recording physiological data, not an AI or software algorithm that interprets data. Therefore, many of the requested fields (like "AI vs without AI assistance," "standalone algorithm performance," "training set sample size," or "adjudication method") are not applicable to the information provided.

However, I can extract the general performance claims and what constitutes "performance standards" based on the provided text.

Here's the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Conformity to EN 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment)	Devices are manufactured according to EN-60-601-1. Testing for conformity to this standard will be completed, reviewed, and approved prior to release.
Conformity to EN 60601-1-1 (Collateral standard: Safety requirements for medical electrical systems)	Testing for conformity to this standard will be completed, reviewed, and approved prior to release.
Conformity to EN 55011 (Industrial, scientific and medical (ISM) radio-frequency equipment – Electromagnetic disturbance characteristics – Limits and methods of measurement)	Testing for conformity to this standard will be completed, reviewed, and approved prior to release.
Conformity to EN 55082-1 (Electromagnetic compatibility – Generic immunity standard – Part 1: Residential, commercial and light industry)	Testing for conformity to this standard will be completed, reviewed, and approved prior to release.
Conformity to IEC 801-2, 3 & 4 (Electromagnetic compatibility standards related to electrostatic discharge, radiated electromagnetic fields, and electrical fast transient/burst immunity)	Testing for conformity to these standards will be completed, reviewed, and approved prior to release.
Conformity to 93/42 EEC - European Medical Device Directive	Devices are manufactured according to 93/42 EEC. Testing for conformity to this directive will be completed, reviewed, and approved prior to release.
Conformity to EN 46002 / ISO 9002 (Quality assurance standards)	Devices are manufactured according to EN 46002 / ISO 9002. Testing for conformity to these standards will be completed, reviewed, and approved prior to release.
Ability to memorize significant pathological events (symptomatic or silent)	The R-Test Evolution is capable of memorizing the most significant pathological events (symptomatic or silent).
Ability to monitor continuous heart rate trend	The R-Test Evolution is capable of memorizing the patient's continuous heart rate trend.
Recording duration	Capable of up to eight days ambulatory recording.
Physical characteristics (weight, comfort)	Unit weighs about 40 grams, includes a lightweight neck cable worn unobtrusively and without discomfort.
Data transfer capability	Events can be transferred by a decoder (Decotest) to an electrocardiograph or computer; also capable of transmitting real-time ECG recordings by telephone.

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

Not applicable / Not provided. The document describes a medical device (hardware), not a software algorithm with a "test set" in the context of AI performance evaluation. The "testing" mentioned refers to compliance with safety and electrical standards, not clinical performance data on a specific dataset.

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

Not applicable / Not provided. Ground truth, in the context of algorithm performance, is not discussed. The device's function is to record events, not interpret them with an AI. Interpretation requires human experts (physicians) or an electrocardiograph/computer with specific software, which are external to the R-Test Evolution device itself.

4. Adjudication method for the test set

Not applicable / Not provided.

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

Not applicable / Not provided. This is not an AI-assisted interpretation device.

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

Not applicable / Not provided. This device is a recorder, not an analytical algorithm.

7. The type of ground truth used

Not applicable / Not provided. The device records ECG data. The "ground truth" for whether it records accurately would be comparison to a known accurate ECG source or standard, which is part of its regulatory testing for electrical and safety standards, but not in the context of an algorithm's diagnostic performance.

8. The sample size for the training set

Not applicable / Not provided. This is not an AI/machine learning device that would require a "training set."

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

Not applicable / Not provided.

Summary

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AFETY & EFFECTIVENESS DATA SUMMARY AUG

NOVACOR
K993788

Classification Name: Ambulatory ECG Recorder Common/Usual Name: Event Recorder Proprietary Name: R. Test Evolution

Establishment Registration Number:

Classification: Class II Reg. # 74IIDSH

Performance Standards: Devices are manufactured according EN-60-601-1, 93/42 EEC - European Medical Device Directive and EN 46002 / ISO 9002.

Substantial Equivalence: Event Recorders are currently being marketed and distributed by Instromedix who currently holds a 510(k) #K880620 for King of Hearts Recorder and Novacor's R.Test 60 & 160 ECG Recorders, K844391, Marketed by AMS Medical.

Material Composition

Ag/AgCl Electrodes

Testing conducted to assure safety and effectiveness include but is not limited to:

Testing conducted for conformity to these standards

EN 60601-1, EN 60601-1-1 EN 55011 EN 55082-1 IEC 801-2, 3 & 4

Note: This testing will be completed, reviewed and approved prior to release and distribution of this product.

Page 1 of 2

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SAFETY & EFFECTIVENESS DATA SUMMARY

Description of the new device:

The system consists of a unit weighing about 40 grams and includes a lightweight neck cable which can be worn by the patient unobtrusively and without any discomfort. The R. Test Evolution is connected to the patient by a system of electrodes and the neck cable.

Cardiac events are memorized by the R. Test evolution and then transferred by a decoder, the Decotest, to an electrocardiograph or a computer for interpretation:

either directly at the physician's surgery at the following visit,
or by being transmitted telephonically by the patient himself.

The R. Test Evolution can also transmit real time ECG recordings by telephone. After making a telephonic or direct transfer, the R. Test Evolution can continue recording any further pathological events which may occur.

Using a computer enables you to:

define the conditions and criteria of the recordings to be made by the R. Test Evolution,
to select, organize and store the results of a procedure, and to print them using specific report parameters.

Intended Use:

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around an emblem. The emblem is a stylized representation of an eagle or bird-like figure, with three curved lines suggesting wings or feathers. The overall design is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 2000 AUG

Novacor S.A C/O Ms. Lynette L. Howard Submission Correspondent International Medical Products · 203 Main Street, PMB 166 Flemington, NJ 08822-1610

Re: K993788 R.Test Evolution Event Recorder Requlatory Class: II (two) Product Code: 74 MLO Dated: June 20, 2000 Received: June 26, 2000

Dear Ms. Howard:

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 omendments, or to devices that have been reclassified in accordance with ruchancillor of to activederal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 A substantially equivalent determination assumes compliance with 895. 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the

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Page 2 - Ms. Howard

Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in Inis fecter will arrow you or work. The FDA finding of substantial your 510(k) premarket notifications in the marketed predicate device results equivalence of your device to a regulary permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation II you desire specific additionally 809.10 for in vitro diagnostic (ZI CFR Fall of and address.azi) of Compliance at (301) 594-4645. devices), prease concacions on the promotion and advertising of your Auditionally, for quebeiths on che promise at (301) 594-4639. Also, action please note the regulation entitled, "Misbranding by reference to Other general information on premarket notification" (21CFR 807.97). premarket nothlibation (Secthe Act may be obtained from the Division of your responsibilities ander che more in the foll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Mark N. Millhussen

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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STATEMENT OF INDICATIONS FOR USE

Mark N Milkerson
for
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on of Cardiovascular, Respiratory, veurological Devices 1993788 (k) Number _

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).