The presence of Microvolt T-wave Alternans as measured by the Analytic Spectral Method of the Heartwave™ Alternans Processing System in patients with known, suspected or at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death).

The Heartwave™ Alternans Processing System should be used only as an adjunct to clinical history and the results of other non-invasive and/or invasive tests. The interpretive results of the Alternans Processing System should be reviewed by a qualified physician.

The predictive value of T-wave Alternans for cardiac events has not been established in patients with active, untreated ischemia.

*Microvolt T-wave Alternans is defined as T-wave alternans which (a) is measured from high-resolution multi-segment sensors, (b) is present in modour. The first fight two adjacent precordial leads, (c) is at the level of 1.9 microvolts after signal optimization and subtraction of the background noise level, (d) is at least three standard deviations greater than the background noise level, (e) has an onset heart rate at or below than the backgrounde, and (f) is sustained for all heart rates above the onset heart rate.

Device Description

The Heartwave™ Alternans Processing System is intended for the measurement The recording of T-Wave alternans. The modification which is the subject of this arra rooveraing of the inclusion of the Alternans Report Classifier software which was cleared for marketing on October 11, 2001 (K012206). Classification software provides the clinician with an indication of positive, negative, or indeterminate result for the Alternans Trend Reports. The results remain subject to the final review of a qualified medical practitioner. The Microvolt T-wave Alternans has been shown to be useful in predicting ventricular tachyarrhythmias and sudden cardiac death.

The Heartwave™ Alternans Processing System provides T-wave alternans diagnostic capabilities to standard stress labs. The Analytic Spectral Method of alternans Processing used in the Heartwave is intended for the measurement of Microvolt T-wave alternans at rest and during treadmill, ergometer and nharmacologic stress testing. The Alternans Report Classifier provides input to the physician on interpreting the Alternans trend reports.

The alternans test using the Analytic Spectral Method of Alternans Processing is performed with seven standard stress test electrodes and seven proprietary multi-segment Micro-V Alternans™ Sensors. The electrodes and sensors are attached through a leadwire set to the belt-worn patient module, which provides digitized data to the Alternans Processor.

AI/ML Overview

The provided 510(k) summary for the K013564 Heartwave™ Alternans Processing System does not contain the specific details about acceptance criteria, a standalone study, or a multi-reader multi-case (MRMC) comparative effectiveness study with effect sizes. It focuses more on the device's indications for use, description, and regulatory equivalence.

However, based on the information available, here's what can be extracted and what information is missing:

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

This information is not explicitly provided in the given 510(k) summary. The document describes the definition of Microvolt T-wave Alternans (e.g., "at the level of 1.9 microvolts," "at least three standard deviations greater than the background noise level") which might imply internal performance metrics, but it does not present a table of acceptance criteria with corresponding reported device performance values.

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 provided in the given 510(k) summary. The document mentions the device is used "in patients with known, suspected or at risk of ventricular tachyarrhythmia," but it doesn't describe any specific clinical study data (sample sizes, provenance, or study design) used for validation.

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 provided in the given 510(k) summary. The document states that "The interpretive results of the Alternans Processing System should be reviewed by a qualified physician," implying expert involvement in clinical practice, but it doesn't speak to expert involvement in a formal study setting for ground truth establishment.

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

This information is not provided in the given 510(k) summary.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done, or an effect size of human improvement with AI assistance, in the provided 510(k) summary. The device's "Alternans Report Classifier software which was cleared for marketing on October 11, 2001 (K012206)" provides "an indication of positive, negative, or indeterminate result for the Alternans Trend Reports," and states "The results remain subject to the final review of a qualified medical practitioner." This suggests that the software is an adjunct or aid, but not that a formal study of its impact on human reader performance was conducted and reported here.

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

The provided information does not explicitly state if a standalone performance study was done for the "Alternans Report Classifier software." While the device measures Microvolt T-wave Alternans, the summary focuses on its intended use as an adjunct tool.

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

This information is not explicitly provided in the given 510(k) summary regarding any specific study. The "Indications for Use" state that the presence of T-wave Alternans "predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death)." This suggests that outcomes data (actual cardiac events) would be the ultimate ground truth for validating predictive value, but the document doesn't detail how this was established in any specific study for the clearance.

8. The sample size for the training set

This information is not provided in the given 510(k) summary.

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

This information is not provided in the given 510(k) summary.

Summary

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K013564

510(k) Summary

October, 22, 2001

Submitter: Cambridge Heart, Inc 1 Oak Park Drive Bedford, Ma 01730 (781) 271-1200 (781) 275-8431 (Fax)

NOV 21 2001

Contact: David Chazanovitz

510(k) Numbers and Product Codes of equivalent devices.

Cambridge Heartwave™ Alternans Processing System

510K Number; #K010758 Product Code: 74 DPS CFR Section: 870.2340

Cambridge Heart Model CH 2000 Cardiac Diagnostic System

510K Number: #K010756 Product Code: 74 DPS CFR Section: 870.2340

Cambridge Heart Alternans Processing System

510K Number; #K012206 Product Code: 74 DPS CFR Section: 870.2340

Indications for Use and Intended Population

The Heartwave™ Alternans Processing System is intended for the measurement of Microvolt T-Wave Alternans* at rest and during ECG stress testing.

The Heartwave™ Alternans Processing System should be used only as an adjunct to clinical history and the results of other non-invasive and/or

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invasive tests. The interpretive results of the Alternans Processing System should be reviewed by a qualified physician.

The predictive value of T-wave Alternans for cardiac events has not been established in patients with active, untreated ischemia.

Device Description

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Standard Hardware Components

Alternans Processor:	Configured for English language and U.S. lead designations
Power Supply:	Modular medical-grade, in-line power supply with universal power input for Alternans Processor
PM-3 w/ Hi-Res™ Leads:	With U.S. lead designations
Printer, w/ data cable:	Inkjet Printer w/data cable & power cord
Line Cords:	IEC 320 line cord with NEMA 5-15P hospital grade plug for Alternans Processor; printer line cord supplied with printer.
Documentation:	Domestic Operator's Manual, Physicians Guide, and TWA Training Program
Shipping Containers:	Mobile pole, Processor unit and Display are shipped in a single container.

Standard Hardware Accessories

Patient Cable:	Set of 14 separately detachable lead wires whichmeet the requirements of 21CFR 898.12 and complywith IEC-601-1; 56.3c part 1.1, General Requirementsfor Safety
	Individual patient leads are either not detachable, oruser detachable with female socket connections suchthat no conductive surface is exposed whenunconnected.
User Manuals:	Operators manual supplied standard with everysystem. Training manual supplied in conjunction withtraining course.
Patient Electrodes:	Patient electrodes designed and approved specificallyfor use during exercise stress testing should be usedat all times with the Heartwave™ AlternansProcessing System.
	Measurement of alternating beat to beat T-waveamplitude (alternans) requires the use of theCambridge Heart Micro-V Alternans Sensor (Ref:#K002230) in conjunction with other patientelectrodes designed and approved specifically for useduring exercise stress testing.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 1 2001

Cambridge Heart, Inc. c/o Mr. John D. Greenbaum Generic Devices Consulting 20310 SW 48th Street Ft. Lauderdale, FL 33332

Re: K013564

Trade Name: HeartWave™ Alternans Processing System Regulation Number: 21 CFR 870.2340 and 870.1425 Regulation Name: Electrocardiograph and Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DPS and DQK Dated: October 22, 2001 Received: October 26, 2001

Dear Mr. Greenbaum:

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.

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Page 2 - Mr. John D. Greenbaum

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act tires - 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 Of It rat 0017, accems (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 promated 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 your 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,

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

Enclosure

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NOV 21 2001

Page 1 of 1

510(k) Number(if known):______________________________________________________________________________________________________________________________________________________

Device Name: Heartwave™ Alternans Processing System

Indications For Use:

The Heartwave™ Alternans Processing System is intended for the The Hourthave - " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " stress testing.

The presence of Microvolt T-wave Alternans as measured by the The prosented of Microrof the Heartwave™ Alternans Processing Amaryan in patients with known, suspected or at risk of ventricular Oystem in padonto will a increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death).

The Heartwave™ Alternans Processing System should be used only as The Heartwave - Anomans in the results of other non-invasive and/or an adjariot to cliffic interpretive results of the Alternans Processing System should be reviewed by a qualified physician.

The predictive value of T-wave Alternans for cardiac events has not been established in patients with active, untreated ischemia.

*Microvolt T-wave Alternans is defined as T-wave alternans which (a) is measured from high-resolution multi-segment sensors, (b) is (c) is modeleds X, Y, Z, VM or two adjacent precordial leads, (c) is at the level of 1.9 microvolts after signal optimization and subtraction of the background noise level, (d) is at least three standard deviations greater than the background noise level, (e) has an onset heart rate at or below 110 beats per minute, and (f) is sustained for all heart rates above the onset heart rate.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_X_ (Per 21 CRF 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number	K013564

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).