Where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

The intended use of the STAR cardiotach is to monitor a neonatal, pediatric, or adult patient's heart rate and produce events/alarms for one of one of on paced and non-paced patients.

The intended use of the STAR arrhythmia analysis algorithm is to monitor a neonatal, pediatric, or adult patient's heart rate and ventricular and other arrhythmia events/alarms for one of two following both paced and non-paced patients.

The intended use of the ST/AR ST analysis algorithm is to monitor an adult patient of all possible ECG leads. The ST analysis produce events/alarms for ST segment elevation or depression and repatients.

Device Description

The modification is a software-based change that provides ST analysis for conventional 12-lead, MCL/V ST derivation, and single-lead QRS detection with adjustable QRS detection threshold capabilities.

AI/ML Overview

The provided text is a 510(k) summary for the Philips ST/AR ST and Arrhythmia Software, Release E.0. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data in the format requested.

Therefore, much of the specific information requested, such as a table of acceptance criteria with reported performance, sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, details of comparative effectiveness studies (MRMC), detailed standalone performance data, and detailed information about training set ground truth and size, is not explicitly available in the provided text.

However, I can extract and infer some information:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: "Pass/Fail criteria were based on the specifications cleared for the predicate device."
- Reported Device Performance: "Test results showed substantial equivalence. The results demonstrate that ST/AR Release E meets all reliability requirements and performance claims."
- Inference: The document does not provide a specific table of quantitative acceptance criteria or detailed performance metrics (e.g., sensitivity, specificity, accuracy for ST segment detection or arrhythmia). It only states that the device met the "specifications cleared for the predicate device" and passed testing.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified.
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)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Inference: The document does not mention the use of human experts to establish ground truth for testing. Testing involved "system level tests, performance tests, and safety testing from hazard analysis."
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified. (Likely "none" as no human adjudication is mentioned for establishing ground truth.)
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
- MRMC Study: Not mentioned.
- Effect Size: Not applicable as no such study is described.
- Inference: This device is software for monitoring, not described as an AI assistance tool for human readers in a diagnostic setting.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Implied. The document states "performance tests" were conducted and that the "ST/AR Release E meets all reliability requirements and performance claims." This refers to the software's inherent performance. However, specific performance metrics are not given.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not explicitly stated. Given the nature of cardiac arrhythmia and ST segment monitoring, ground truth would typically come from well-characterized ECG databases or expert-annotated ECG recordings, but the document does not specify this. "Pass/Fail criteria were based on the specifications cleared for the predicate device," suggesting the predicate's established performance served as a benchmark for what constituted acceptable behavior.
The sample size for the training set
- Not applicable/Not specified. This document pertains to a software release that is a modification of an existing device, and the focus is on verification and validation against predicate specifications, not on a new algorithm developed through machine learning training.
How the ground truth for the training set was established
- Not applicable/Not specified. This information is not relevant to the type of submission described (a software modification to an existing cleared device, primarily demonstrating substantial equivalence).

Summary of what is available from the text:

The provided 510(k) summary focuses on demonstrating that a new software release (Philips ST/AR ST and Arrhythmia Software, Release E.0) is substantially equivalent to a previously cleared predicate device. It states that "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate." The "Pass/Fail criteria were based on the specifications cleared for the predicate device," and the test results showed "substantial equivalence," indicating the device "meets all reliability requirements and performance claims." However, it does not provide detailed quantitative acceptance criteria, specific performance metrics (e.g., sensitivity, specificity), sample sizes for test data, details about data provenance, expert involvement, or adjudication methods. The study appears to be a validation against an existing cleared standard/predicate, rather than a de novo clinical study with new ground truth established by experts.

Summary

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FEB 1 2 2002

9.0 510(k) Summary

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 CFR §807.92.

1. The submitter of this premarket notification is: Dave Osborn Requlatory Affairs Engineer Cardiac & Monitoring Systems Group Philips Medical Systems
  3000 Minuteman Road Andover, MA 01810-1085 978 659 3178

Tel: 978 685 5624 Fax: Email: dosborn@hsgmed.com

This summary was prepared on 21 December, 2001

1. The name of this device is the Philips ST/AR ST and Arrhythmia Software, Release E.0. Classification names are as follows:

Classification	ProCode	Description
870.1025, III	74 MLD	Monitor, ST Alarm
870.1025, III	74 DSI	Arrhythmia Detector and Alarm
None	74 MHX	Physiological Monitor, Patient Monitor

The new device is substantially equivalent to the previously 3. cleared ST/AR ST and Arrhythmia Software device marketed pursuant to K964122, K991773, K001348, and K003621.
The modification is a software-based change that provides ST 4 . analysis for conventional 12-lead, MCL/V ST derivation, and single-lead QRS detection with adjustable QRS detection threshold capabilities.
The new device has the same Indications for Use as the legally 5. marketed predicate device. Where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
The new device has the same technological characteristics as the 6. legally marketed predicate device.
1. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of

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K014261
page 2 of 2

the new device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that ST/AR Release E meets all reliability requirements and performance claims.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 2002

Mr. Dave Osborne Quality Program Manager Philips Medical Systems Cardiac & Monitoring Systems Group 3000 Minuteman Road Andover, MA 01810-1099

Re: K014261

Trade Name: ST/AR and Arrhythmia Software, Model Release E.O. Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: January 31, 2002 Received: February 1, 2002

Dear Mr. Osborne:

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. Dave Osborne

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 or any is 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 orth 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 promoted 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,

Bram D. Zuckerman, M.D.

Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K014261

Page _ of _

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Philips Medical Systems ST/AR Software, Release E.O.

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arrhythmia of adult, pediatric, and neonatal for treatment, to arrily hill of adult, pediaerie, and information for treatment, to segment of addit pacients of girls in the exclude causes of symptoms.

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The intended use of the ST/AR ST analysis algorithm is to monitor Ine intended use of the Or ST segment elevation or depression and an addre patient of all possible ECG leads. The ST analysis produce evenes/arazme repatients.

The ST algorithm does not analyze ventricularly paced Note: or ventricular ectopic beats.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Use (Per 21 CFR 801.109) (Optional Format 1-2-96) OR

Over-The-Counter

Division of Cardiovascular & Respiratory Devices
510(k) Number 201426

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.