To analyze multi-channel ECG signals from adult and pediatric patients with algorithms that provide measurements, data presentations, graphical presentations and interpretations for review by the user.

The interpreted ECG with measurements and interpretive statements is offered to the clinician on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the patient, the results of the physical examination, the ECG tracings, and other clinical findings. A qualified physician is asked to over read and validate (or change) the computer generated ECG interpretation.

Where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule-out causes for symptoms.

Device Description

The name of this device is the Philips PageWriter Cardiograph. The modification provides the following additional capabilities: improved ease of use ( 3 step ECG), improved human factors engineering with patient interface module, 802.11 g wireless capability, compatibility with extended lead ECG interpretive algorithm.

AI/ML Overview

The provided 510(k) summary for the Philips PageWriter Cardiograph (K080999) does not contain detailed information regarding specific acceptance criteria, study methodologies, or the performance results of the device's interpretive algorithm.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

This information is not provided in the given text. The summary states that "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new algorithm with respect to the predicate," but it does not detail what specific acceptance criteria were used or what the measured performance metrics were.

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 text.

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 text.

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

This information is not provided in the given text.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The submission highlights that the interpretive ECG is "offered to the clinician on an advisory basis only" and "A qualified physician is asked to over read and validate (or change) the computer generated ECG interpretation," implying human-in-the-loop operation, but no study comparing human performance with and without AI assistance is described. The focus appears to be on the standalone performance of the algorithm and its equivalence to a predicate.

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

Yes, a standalone evaluation of the algorithm's performance can be inferred. The text states:

"Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new algorithm with respect to the predicate."
"The modification provides the following additional capabilities: compatibility with extended lead ECG interpretive algorithm."

While specific results are not presented, the testing of the "new algorithm" and its "interpretive algorithm" suggests a standalone evaluation to confirm its functionality and characteristics.

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

This information is not provided in the given text.

8. The sample size for the training set

This information is not provided in the given text. The document refers to "testing involved use of applicable consensus standards, system level tests, integration tests, and verification of risk mitigation identified in the hazard analysis," but it does not specify details about a training set.

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

This information is not provided in the given text.

Summary of what is known:

Device: Philips PageWriter Cardiograph (Model 860315)
Purpose: To analyze multi-channel ECG signals from adult and pediatric patients with algorithms that provide measurements, data presentations, graphical presentations, and interpretations for review by the user.
Intended Use: Advisory only; interpretations are to be used in conjunction with a clinician's knowledge, physical examination, ECG tracings, and other clinical findings. A qualified physician must over-read and validate or change the computer-generated interpretation.
Predicate Device: Philips cardiograph cleared under K020708.
Claim of Equivalence: The new device is substantially equivalent to the predicate.
Testing: Involved "applicable consensus standards, system level tests, integration tests, and verification of risk mitigation identified in the hazard analysis." The testing aimed to establish "performance, functionality, and reliability characteristics of the new algorithm with respect to the predicate."

Summary

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8.0 510(k) Summary

K080999

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.

1. The submitter of this pre-market notification is Philips Medical Systems
  This summary was prepared on 4 April 2008
1. The name of this device is the Philips PageWriter Cardiograph. Classification is as follows:

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870.2340. I	DPSবে ব	r 1Electrocardiograph

The new device is substantially equivalent to the previously cleared Philips 3. cardiograph cleared under K020708.
1. The modification provides the following additional capabilities: improved ease of use ( 3 step ECG), improved human factors engineering with patient interface module, 802.11 g wireless capability, compatibility with extended lead ECG interpretive algorithm.
1. The new device has the same Indications for Use as the legally marketed predicate device.
1. The new device has the same technological characteristics as the legally marketed predicate device.
1. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new algorithm with respect to the predicate. Testing involved use of applicable consensus standards, system level tests, integration tests, and verification of risk mitigation identified in the hazard analysis.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a symbol that resembles an abstract caduceus or a stylized representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 9 2008

Philips Medical Systems c/o Mr. Paul Schrader Senior Manager Regulatory Affairs Specialist Ultrasound and Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099

Re: K080999

PageWriter Cardiograph, Model 860315 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: April 4, 2008 Received: April 8, 2008

Dear Mr. Schrader:

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. Paul Schrader

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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

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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2.0 Indications for Use

510(k) Number (if known): K080999

Device Name: PageWriter Electrocardiograph (Model 860315)

Intended Use

Indications for Use

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

Over-The-Counter Use N/A (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	1680949

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).