Under the supervision of a qualified physician trained in ECG interpretation, Atria can be used to record the electrical activity of the heart for the purpose of correlating the resultant waveforms with the health of the heart muscle tissue structures.

This equipment is not designed to produce a definitive interpretation nor exhaustive evaluation of the patient's heart but rather provide an effective beginning for evaluation of adult and pediatric patients with cardiac abnormalities.

Device Description

The Atria 3100 and 6100 are 12 lead electrocardiographs designed to record the electrical activity of the heart. They can display, print, electronically send and save ECG recordings. The Atria 6100 features a full alpha numeric keyboard and color display for data entry, waveform review and editing machine settings. The unit provides the ability to store 150 ECGs, print rhythm strips manually or automatically, and provides an optional interpretation. Advanced communications options allow the unit to fax, email and upload results to shared network drives via wired Ethernet, wireless 802.11 and modem.

The differences between the Atria 3100 and 6100 are as follows:

Screen Size:
Atria 3100 = 2 x 40 character display for data entry only (no waveform . viewing)
Atria 6100 = 640 x 480 color TFT VGA preview screen for waveform . viewing
Storage:
. Atria 3100 = 50 records
Atria 6100 = 150 records .
The Atria 6100 has a slightly different keyboard to accommodate navigation in the User Interface.

AI/ML Overview

Here's an analysis of the provided information regarding the Atria 3100 and Atria 6100 electrocardiographs, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary and the FDA's clearance letter. It primarily describes the device, its intended use, and argues for substantial equivalence to predicate devices. It does NOT contain detailed information on specific acceptance criteria or the studies that would typically prove a device meets those criteria in a rigorous fashion (e.g., performance metrics, sample sizes for test sets, ground truth establishment, MRMC studies, or standalone algorithm performance).

Therefore, I will extract relevant information where available and explicitly state when information is not present in the provided text.

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics. Its clearance is based on substantial equivalence to predicate devices. This means the FDA determined the new device is as safe and effective as a legally marketed device (predicate device) and does not raise new questions of safety and effectiveness.

The document states the "intended use, indication for use and principle of operation are substantially equivalent to the predicate devices, and do not raise any new types of safety and effectiveness questions." This is the core "acceptance criteria" from a regulatory perspective for a 510(k) submission, rather than specific performance numbers.

Predicate Devices:

PageWriter Trim Series Cardiograph - Phillips Medical Systems (K031422)
CP 100 and CP 200 - Welch Allyn, Inc. (K050074)

Detailed Study Information (Based on Available Text)

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics in the provided text. The primary "acceptance criterion" for 510(k) clearance is demonstrating substantial equivalence to existing predicate devices regarding safety and effectiveness, and not raising new safety/effectiveness questions.
- Reported Device Performance: No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity for ECG interpretation) are reported in this document. The device "can display, print, electronically send and save ECG recordings" and "provides an optional interpretation." The document repeatedly states it's "not designed to produce a definitive interpretation nor exhaustive evaluation" but rather "provide an effective beginning for evaluation."
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in the document. The 510(k) summary focuses on device description and substantial equivalence, not detailed clinical study results.
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)
- Not provided in the document. No information on ground truth establishment for any test set (since no test set is described).
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided in the document. No information on adjudication methods.
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 provided in the document. This type of study is not mentioned as part of the 510(k) submission, likely because the primary claim is not about improved human performance with AI assistance, but rather the device's basic functionality and equivalence. The "optional interpretation" is mentioned, but its performance or impact on human readers is not detailed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not provided in the document. While the device offers "optional interpretation," the document specifically states it's "not designed to produce a definitive interpretation nor exhaustive evaluation." This implies that a standalone, definitive diagnostic performance study was likely not part of this 510(k) given its intended use as an initial evaluation tool.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not provided in the document. No information on ground truth, as no specific performance study is detailed.
The sample size for the training set
- Not provided in the document. No information on any training set, as the document doesn't detail the development or validation of the "optional interpretation" algorithm.
How the ground truth for the training set was established
- Not provided in the document.

Summary

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K060167 Page 1

Cardiac Science Corporation Bothell, WA Abbreviated Premarket Notification January 20, 2006

APR 1 9 2006

II. 510(k) Summary

A. Name of Device

Trade name:	Atria 3100
	Atria 6100
Common name:	Electrocardiograph
Classification name:	Electrocardiograph

B. Predicate Devices

Device Name	PremarketNotification
PageWriter Trim Series Cardiograph - Phillips MedicalSystems	K031422
CP 100 and CP 200 - Welch Allyn, Inc.	K050074

C. Device description

The differences between the Atria 3100 and 6100 are as follows:

1. Screen Size:
- Atria 3100 = 2 x 40 character display for data entry only (no waveform . viewing)
- Atria 6100 = 640 x 480 color TFT VGA preview screen for waveform . viewing
1. Storage:
- . Atria 3100 = 50 records

Page 1 of 2
Page 4 of 39

Confidential

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zcbuiot Page 2

Cardiac Science Corporation Bothell, WA Abbreviated Premarket Notification January 20, 2006

Atria 6100 = 150 records .
1. The Atria 6100 has a slightly different keyboard to accommodate navigation in the User Interface.

D. Intended use

E. Summary

The intended use, indication for use and principle of operation are substantially equivalent to the predicate devices, and do not raise any new types of safety and effectiveness questions.

Page 2 of 2
Page 5 of 39

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 9 2006

Cardiac Science Corporation c/o Ms. Cheryl L. Shea Vice President. RA/QA 3303 Monte Villa Parkway Bothell, Washington 98021-8969

Re: K060167

Trade Name: Atria 3100 and Atria 6100 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: March 22, 2006 Received: March 24, 2005

Dear Ms. Shea:

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. Iisting 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). 11 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

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

Page 2 -- Ms. Cheryl L. Shea

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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), please contact the Office of Compliance at (240) 276-0120. 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/cdrl/industry/support/index.html.

Sincerely vours,

Bfumtemon for

Bram D. 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: KoloOlo 7

Device Name: Atria 3100 and Atria 6100

Indications for Use:

Prescription Use (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)

Bifumblona
Off

lovascular Devices
K060667

Page 1 of 1

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).