ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O by PHILIPS MEDICAL SYSTEMS

Where the clinician decides to monitor cardiac arthythmia 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 ST/AR cardiotach is to monitor a neonatal, pediatic, or adult patient's ECG for heart rate and produce events/alarms for one or two ECG leads. The cardiotach function is capable of monitoring both paced and non-paced patients.

The intended use of the ST/AR arrhythmia analysis algorithm is to monitor a neonatal, pediation of adult patient ECG's for heart rate and ventricular arthythmias, and produce events/alarms for one or two ECG leads. The arrhythmia analysis algorithm is capable of monitoring both paced and non-paced patients.

The intended use of the ST/AR ST analysis algorithm is to monitor an adult patient's ECG for ST segment elevation or depression and produce events/alarms for all possible ECG leads. The ST analysis algorithm is capable of monitoring paced and non-paced adult patients.

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

The intended use of the ST/AR QT/QTc analysis is for use by the physician in the risk assessment process indicated for neonatal, pediatic and adult patients with and without symptoms of arrhythmia. OT measurement is intended to be used by qualified health professionals in hospital or clinical environments. Composite QT (single or multi-lead derived) measures the interval only and is not intended to produce any interpretation or diagnosis of those measurements.

EASI ECG is intended for monitoring multiple leads of ECG of adults, pediatrics and neonates. EASI ECG is indicated for use by health care professionals whenever there is a need to monitor ECG of adult, pediatric, or neonatal patients including arrhythmia monitoring or ST segment changes of adult patients, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

RLS ECG is intended for monitoring multiple leads of ECG of adults.

RLS ECG is indicated for use by health care professionals whenever there is a need to monitor ECG of adult patients including arrhythmia, ST segment changes, and QT/QTc, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

Device Description

The modification is a software-based change that adds the following features:
· Support derived 12-lead ECG (RLS ECG) from a 6-electrode lead set.
· Provide enhanced AF and Irregular HR alarms detection
· Provide enhanced QT and ST analysis and alarms.

AI/ML Overview

The provided text is a 510(k) summary for the Philips ST/AR ST and Arrhythmia Software, Release K.0. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or a study proving the device meets said criteria in the format requested.

Here's an analysis of what is and is not provided, based on your request:

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

Not provided. The document states: "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of 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 K.O meets all defined reliability requirements and performance claims."
This statement indicates that acceptance criteria (pass/fail criteria) were established and met, but it does not specify what those criteria were (e.g., sensitivity, specificity, accuracy targets) nor does it report the device's performance against those criteria with specific metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The document mentions "system level tests, performance tests, and safety testing from hazard analysis" but does not detail the sample sizes for these tests or the nature of the data (e.g., patient population, retrospective/prospective).

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)

Not provided. The document does not describe the establishment of a "ground truth" using experts for performance evaluation. The testing described focuses on functional equivalence to predicate devices and adherence to existing specifications.

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

Not provided. There is no mention of an adjudication process for the test set.

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

Not provided. This document describes a software update for a physiological monitor with expanded features (e.g., derived 12-lead ECG, enhanced AF/Irregular HR alarms, enhanced QT/ST analysis). It is not focused on an AI-assisted diagnostic tool that would typically involve a multi-reader multi-case study to assess human reader improvement. The focus appears to be on the algorithm's performance itself, rather than its impact on human interpretation.

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

Implied, but not explicitly detailed. The statement "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate" suggests that the algorithm itself was tested for performance against established specifications. However, specific metrics (like sensitivity, specificity, accuracy) are not provided in this summary. The testing appears to be focused on whether the new features function as intended and meet the specifications set for the predicate device.

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

Not explicitly stated how ground truth was established, if at all, for performance claims. The document uses the term "specifications cleared for the predicate device" as the basis for pass/fail criteria. This suggests that the ground truth for evaluation would be derived from comparisons to the expected outputs or performance of the cleared predicate devices, rather than an independent clinical ground truth like pathology or expert consensus on new data.

8. The sample size for the training set

Not provided. Training sets are typically associated with machine learning or AI development. While the device includes "algorithms" (e.g., ST/AR arrhythmia analysis algorithm, ST/AR ST analysis algorithm), this document does not provide details of their development processes that would include training sets. Given the submission date (2010), these algorithms likely rely on more traditional signal processing and rule-based methods rather than large-scale machine learning requiring explicit "training sets" in the modern sense.

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

Not applicable / Not provided. As no training set information is given, the method for establishing its ground truth is also not mentioned.

In summary, this 510(k) document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices. It confirms that testing was conducted and specifications were met, but it does not provide the detailed performance metrics, study designs, or ground truth establishment methods typically requested for a deeper understanding of a device's clinical performance and validation against specific acceptance criteria. The "study" mentioned is a general "Verification, validation, and testing" activity, not a specific clinical trial with reported outcomes.

Summary

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Philips Medical Systems

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PHILIPS

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 8807.92.

】. The submitter of this premarket notification is: Lois Giegerich RN Quality Specialist/Clinician Philips Medical Systems 3000 Minuteman Road. Andover, Massachusetts 01810-1099 Tel: 978-659-7809 Fax: 978-659-4481 e-mail: lois.giegerich@philips.com
JUL 2 9 2010

This summary was prepared on May 28, 2010.

1. The name of this device is the Philips ST/AR ST and Archythmia Software, Release K.O. Classification names are as follows:

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

1. The new device is substantially equivalent to the previously cleared ST/AR ST and Arrhythmia Software device marketed pursuant to K080461, K964122, K991773, K001348, K003621, K014261, K021251, K033513, K040357, K070260 and the Philips ECG Algorithm K073376, the Philips EASI ECG K033515, the GE 12RL Algorithm K060307, and the Siemens Infinity MultiView Workstation K030738.
1. The modification is a software-based change that adds the following features:
- · Support derived 12-lead ECG (RLS ECG) from a 6-electrode lead set.
- · Provide enhanced AF and Irregular HR alarms detection
- · Provide enhanced QT and ST analysis and alarms.
ನ್ನ The new device has the same Indications for Use and Intended Use as the legally marketed predicate devices.
1. The new device has the same technological characteristics as the legally marketed predicate devices.
1. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of 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

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test.results showed substantial equivalence. The results demonstrate that ST/AR Release K.O meets all defined reliability requirements and performance claims.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL 2 9 2010

Philips Medical Systems c/o Ms. Lois Giegerich Quality Specialist/Clinician 3000 Minuteman Road Andover, MA 01810-1099

Re: K101521

Device Name: Philips ST/AR ST and Arrhythmia Software, Release K.0 Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (With Arrhythmia Detection or Alarms) Regulatory Class: Class II (Two) Product Codes: MHX, MLD, DSI Dated: June 30, 2010 Received: July 8. 2010

Dear Ms. Giegerich:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Lois Giegerich

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1.1.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Prem D. Zuckerman, M.D.

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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1.1 ODE Indications Statement

Indications for Use

510(k) Number (if known): K101521

Device Name: ST/AR ST and Arrhythmia Software

Indications for Use:

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

RLS ECG is intended for monitoring multiple leads of ECG of adults.

Prescription Use (Part 21 CFR 801 Subpart D)	YES	AND/OR	Over-The-Counter Use NO (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED).

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number	K101521
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JUL 2 5 2010

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.