To acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes and to record, display, analyze and store these ECG signals for review by the user. To be used in healthcare facilities by trained healthcare professionals. Analysis of the ECG signals is accomplished 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 overread 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.

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.

Device Description

The PageWriter Trim Series Cardiograph is Philips Medical Systems' cardiograph offering a full complement of features, for both adult and pediatric patients. The Cardiograph offers increased speed and ease-of-use for patient data entry. The device also consists of a digital patient acquisition module, LCD display and rechargeable battery, thermal printer, optional barcode scanner or magnetic card strip reader. The Cardiograph provides crisp, easy-to-read ECGs on a standard page. Records are clearly labeled with ECG data and patient information.

AI/ML Overview

This document primarily discusses the substantial equivalence of the Philips Medical Systems PageWriter Trim Series Cardiograph to a predicate device based on non-clinical testing. It does not provide detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria, particularly in the context of AI-driven performance metrics like sensitivity, specificity, or human-in-the-loop improvements.

Here's a breakdown of the information that can be extracted and where the document lacks detail regarding your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not contain a table of acceptance criteria or reported device performance in terms of specific diagnostic metrics (e.g., sensitivity, specificity, accuracy) for the analysis algorithms. It states that the device offers "measurements, data presentations, graphical presentations and interpretations."

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

The document does not specify a sample size for a test set related to the performance of the analysis algorithms. The testing mentioned is primarily for non-clinical aspects like electrical safety and software functionality.
Data provenance is not mentioned as no clinical test set for algorithmic performance is described.

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

Not applicable, as no clinical test set for algorithmic performance is described.

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

Not applicable, as no clinical test set for algorithmic performance is described.

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:

No MRMC study is mentioned. The document primarily focuses on demonstrating substantial equivalence through non-clinical testing and general device characteristics. It states the interpretations are "advisory" and "to be used in conjunction with the clinician's knowledge," implying a human-in-the-loop, but no comparative effectiveness study with AI assistance is described for the human reader.

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

While the device includes "algorithms that provide measurements... and interpretations," the document does not describe a standalone performance study for these algorithms. The interpretation is always presented as advisory and requiring physician overread.

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

Not applicable, as no clinical test set for algorithmic performance requiring ground truth is described in this document.

8. The sample size for the training set:

Not mentioned. The document describes the device, its intended use, and non-clinical testing for substantial equivalence, but it does not delve into the development or training of its algorithms.

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

Not mentioned. Similar to point 8, the document does not provide details on algorithm development.

Summary of available information related to acceptance criteria and performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (PageWriter Touch Cardiograph, K020708) through non-clinical testing. The "acceptance criteria" are implied by compliance with various applicable standards and established test procedures for performance, functionality, and reliability, rather than specific clinical performance metrics for the interpretive algorithm.

Acceptance Criteria (Implied from non-clinical testing):
- Compliance with AAMI EC11 (Performance Standard for Diagnostic Electrocardiographic Devices)
- Compliance with IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for safety)
- Compliance with UL 2601.1 (Safety Standard for Medical Electrical Equipment, Part 1: General Requirements)
- Compliance with IEC 60601-2-25 (Medical electrical equipment – Part 2-25: Particular requirements for the safety of electrocardiographs)
- Compliance with IEC 60601-1-2 (Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests)
- Performance, functionality, and reliability characteristics of the device and algorithm software testing follow established test procedures and quality system.
Reported Device Performance (from "Device Description" and "Comparison of Technological Characteristics"):
- Acquires multi-channel ECG signals from adult and pediatric patients.
- Records, displays, analyzes, and stores ECG signals.
- Provides measurements, data presentations, graphical presentations, and interpretations.
- Offers "increased speed and ease-of-use for patient data entry."
- Provides "crisp, easy-to-read ECGs."
- Has the "same ECG measurements, adult and pediatric analysis programs, software filtering algorithm, ECG basic controls" as the predicate device.
- Has similar standardization, DC offset sensitivity, time base and accuracy stability, bandwidth, input dynamic range as the predicate device.

The main takeaway is that this 510(k) submission confirms the device's substantial equivalence based on safety and non-clinical performance characteristics, not on a detailed clinical study demonstrating the diagnostic performance of its interpretive algorithms against a defined ground truth or improvement in human reader performance. The interpretive algorithm is explicitly stated to be "advisory" and requires a qualified physician to "overread and validate (or change)" the computer-generated interpretation.

Summary

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Philips Medical Systems

510(k) Summary of Safety and Effectiveness for Philips Medical Systems PageWriter Trim Series Cardiograph

March 27th, 2003 1. DATE SUMMARY PREPARED

2. SUBMITTER'S NAME AND ADDRESS

Philips Medical Systems Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099

Mr. Songhua Zhang 3. CONTACT PERSON Regulatory Affairs Engineer Email: songhua.zhang@philips.com Telephone: (978) 659-7319 Facsimile: (978) 659-3610
1. DEVICE NAME Proprietary (trade) Name: Page Writer Trim Series Cardiograph Common Name: Electrocardiograph Classification Name: Electrocardiograph, CFR 870.2340 Product Code: 74DPS Class: II Panel: Cardiovascular / Circulatory System Devices Panel (74)
1. PREDICATE DEVICE The legally marketed devices to which equivalence is being claimed is the PageWriter Touch Cardiograph manufactured by Philips Medical Systems - K020708

6. DEVICE DESCRIPTION

The PageWriter Trim Series Cardiograph is Philips Medical Systems' cardiograph offering a full complement of features, for both adult and pediatric patients.

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The Cardiograph offers increased speed and ease-of-use for patient data entry. The device also consists of a digital patient acquisition module, LCD display and rechargeable battery, thermal printer, optional barcode scanner or magnetic card strip reader.

The Cardiograph provides crisp, easy-to-read ECGs on a standard page. Records are clearly labeled with ECG data and patient information.

7. INTENDED USE

8. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The PageWriter Trim Series Cardiograph has the similar cardiograph characteristics as the predicate PageWriter Touch Cardiograph. For example, they both contain the same ECG measurements, adult and pediatric analysis programs, software filtering algorithm, ECG basic controls and both have the similar standardization, DC offset sensitivity, time base and accuracy stability, bandwidth, input dynamic range. The Page Writer Trim Series Cardiograph has similar hardware design as the predicate PageWriter Touch Cardiograph. They both have thermal ECG printer, digital patient acquisition module, rechargeable battery, and LCD display.

The technological differences do not affect the safety or effectiveness of the device. Any safety issues that may be raised by the new device are addressed in the device's risk analysis and the device verification and validation activities.

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Image /page/2/Picture/1 description: The image shows the Philips logo and brand name. The logo is on the left, and the brand name "PHILIPS" is in large, bold letters to the right of the logo. Below the brand name, there is a model number "K031422".

9. NON-CLINICAL TESTS USED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The substantial equivalence of the PageWriter Trim Series Cardiograph is demonstrated by the following non-clinical testing:

Testing to applicable standards: AAMI EC11, IEC 60601-1, UL 2601.1, IEC 60601-. 2-25, IEC 60601-1-2
s The performance, functionality, and reliability characteristics of the device and algorithm software testing follow established test procedures and quality system.

10. CONCLUSIONS FROM NON-CLINICAL TESTING

Prior to marketing in the US, PageWriter Trim Series Cardiograph will have completed the testing listed above with acceptable results, demonstrating substantial equivalence.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

3 2003 JUL

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medical Systems c/o Mr. Ned E. Devine Entela, Inc. Regulatory Affairs Engineer 3000 Minuteman Road Andover. MA 01810-1099

Re: K031422

Trade Name: Page Writer Trim Series Cardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: June 18, 2003 Received: June 20, 2003

Dear Mr. Zhang:

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. Ned E. Divine

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 (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.

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 Statement

510(k) Number (if known): Device Name: PageWriter Trim Series Cardiograph

PageWriter Trim Series Cardiograph

Intended Use

Indications for Use

12-Lead Interpretive Algorithm

Intended Use

Indications for Use

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off) Division of Cardiovascular Devices
Prescription Use(Per 21 CFR 801.109)	510(k) Number K031427OR Over-The-Counter Use

Indications for Use Statement

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).