Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is designed to host optional advanced analysis applications via QLAB integration and provides integrated tools that allow users to manually assess and score cardiac wall motion and export images and/or exams and reports. Q-Station can view DICOM images of non-ultrasound images such as CT, MR, NM, CR, MG, XA, PET, RT, and X-Ray modalities for reference viewing. It supports connectivity to ultrasound systems, PACS and other DICOM storage repositories.

Device Description

Q-Station is designed to manage post-acquisition ultrasound images and other data, for the purposes of diagnosing the patient's condition. This includes using Q-Station on a PC to review images and measurements sent from an ultrasound acquisition device, analyze 3D and other data with QLAB. Q-Station is used to review various ultrasound exam types, including Adult echo, General Imaging, Stress echo, Vascular, and TEE. In addition, Q-Station can be used for reference viewing of non-ultrasound DICOM images. Q-Station can be used to add interpretive findings, key images, measurements and calculations and other comments that create reports that can be shared with other clinicians. During this review, users may also use Q-Station to import and export exams, print reports, and anonymize images for export. Q-Station supports QLAB Q-Apps for advanced analysis (K132165).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Philips Q-Station (K140808) based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria in a traditional efficacy study. As such, the information you requested regarding numerical performance metrics, sample sizes for test sets, expert involvement for ground truth, and comparative effectiveness studies (MRMC) is not present in this type of regulatory submission. The submission explicitly states "The subject of this premarket submission, Q-Station 3.0 software did not require clinical studies to support substantial equivalence."

Therefore, many of the requested fields will state "Not Applicable" or "Not Provided" in the table below, as the submission relies on verification and validation activities rather than formal clinical studies with statistical acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (as implied or stated)	Reported Device Performance
Functional Equivalence	Functionality for managing post-acquisition ultrasound images and other data.	Q-Station is designed to manage post-acquisition ultrasound images and other data, for the purposes of diagnosing the patient's condition.
Analysis Packages	Inclusion of Adult Echo, Pediatric Echo, and Vascular analysis packages.	Includes Adult Echo, Pediatric Echo, Vascular analysis packages, stated as "essentially the same as those included with the EPIQ ultrasound system (K132304)".
Multi-modality Viewing	Ability to view non-ultrasound DICOM images (CT, MR, NM, CR, MG, XA, PET, RT, X-Ray) for reference.	Can view CT, MR, NM, CR, MG, XA, PET, RT, and X-Ray images for reference viewing in 1-up or n-up formats.
Measurement Tools	Ability to view, copy, edit system-defined measurement labels/groups/collections; create, edit, delete customized measurement labels/groups/collections.	Device descriptions indicate these capabilities are present, similar to predicate devices.
Connectivity	Supports connectivity to ultrasound systems, PACS, and other DICOM storage repositories.	Device description explicitly states this support.
Reliability Requirements	Meets all defined reliability requirements.	"Testing performed demonstrated that the Q-Station 3.0 meets all defined reliability requirements and performance claims."
Performance Claims	Meets all defined performance claims.	"Testing performed demonstrated that the Q-Station 3.0 meets all defined reliability requirements and performance claims."
Safety Testing	Compliance with safety testing from risk analysis.	Included in verification and validation processes.
System Level Tests	Successful completion of system level tests.	Included in verification and validation processes.
Performance Tests	Successful completion of performance tests.	Included in verification and validation processes.

2. Sample Sizes Used for the Test Set and Data Provenance

Sample Size for Test Set: Not provided. The submission states that "The subject of this premarket submission, Q-Station 3.0 software did not require clinical studies to support substantial equivalence." Testing involved "system level tests, performance tests, and safety testing from risk analysis," implying internal validation rather than a formal test set of patient data.
Data Provenance: Not provided (not applicable as clinical studies were not performed).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable/Not provided. Clinical studies with expert-established ground truth were not conducted.

4. Adjudication Method for the Test Set

Not applicable/Not provided. Clinical studies with adjudication were not conducted.

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. An MRMC comparative effectiveness study was not done. The device is a Picture Archiving and Communications Systems Workstation, and this type of study is not relevant to demonstrating its substantial equivalence for its stated functions of viewing, analysis, and reporting.

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

Not explicitly described as a standalone algorithm performance study. The device itself is software for managing, viewing, and analyzing images, implicitly involving human interaction. The validation focused on the software's functionality, reliability, and safety when used with a human.

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

Not applicable/Not provided. For the internal verification and validation, ground truth would likely refer to expected software behavior based on product specifications and design requirements, rather than a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable/Not provided. This device is described as software for managing, viewing, and analyzing existing image data, rather than an AI/ML algorithm that requires a "training set" in the conventional sense. Its "analysis packages" are "essentially the same as those included with the EPIQ ultrasound system," suggesting pre-existing modules rather than newly trained AI.

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

Not applicable/Not provided, as there is no mention of a training set for an AI/ML algorithm.

Summary

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K140808 APR 1 7 2014

5. 510(k) Summary

This summary of safety and effectiveness is provided as part of the Premarket Notification in compliance with 21CFR. Part 807, Subpart E, Section 807.92

Submitter's name, address, telephone number, contact person Penny Greco, Regulatory Affairs Specialist Philips Healthcare, Ultrasound 3000 Minuteman Road Andover, MA Telephone: (978) 659-4615 Facsimile: (978) 975-7324 E-mail: penny.greco@philips.com

Date prepared: March 14, 2014

Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

Common/Usual Name: Picture Archiving and Communications Systems Workstation

Proprietary Name: Q-Station

CFR 892.2050, system, image processing, radiological, Product Classification Name: code LLZ, Class II

3) Substantially Equivalent Devices

Philips Ultrasound believes that modifications introduced with Q-Station 3.0 are substantially equivalent to other commercially available devices including Philips Xcelera (K061995) and Philips EPIQ (K132304). The Q-Station analysis packages and multi-modality viewing are the same as those found on Philips ultrasound systems, including EPIQ.

4) Device Description

Q-Station is designed to manage post-acquisition ultrasound images and other data, for the purposes of diagnosing the patient's condition. This includes using Q-Station on a PC to review

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images and measurements sent from an ultrasound acquisition device, analyze 3D and other data with QLAB. Q-Station is used to review various ultrasound exam types, including Adult echo, General Imaging, Stress echo, Vascular, and TEE. In addition, Q-Station can be used for reference viewing of non-ultrasound DICOM images. Q-Station can be used to add interpretive findings, key images, measurements and calculations and other comments that create reports that can be shared with other clinicians. During this review, users may also use Q-Station to import and export exams, print reports, and anonymize images for export. Q-Station supports QLAB Q-Apps for advanced analysis (K132165).

5) Intended Use

O-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is designed to host optional advanced analysis applications via QLAB integration and provides integrated tools that allow users to manually assess and score cardiac wall motion and export images and/or exams and reports. Q-Station can view DICOM images of non-ultrasound images such as CT, MR, NM, CR, MG, XA, PET, RT, and X-Ray modalities for reference viewing. It supports connectivity to ultrasound systems, PACS and other DICOM storage repositories.

6) Technological comparison to predicate devices

Philips Q-Station 3.0 is application software similar to Q-Station as submitted in K103815. It is designed to manage, view and report image data acquired by Ultrasound systems, but with Q-Station 3.0 now includes analysis packages and multi-modality viewing similar to Philips Xcelera and Philips EPIQ.

Both Q-Station and Xcelera are software applications for off-cart image analysis and patient report preparation. Both are DICOM compatible.

The integrated analysis packages included in Q-Station 3.0 are essentially the same as those included with the EPIQ ultrasound system (K132304), except that the Q-Station analysis packages are limited to Adult Echo, Pediatric Echo and Vascular applications. The Analysis packages are also similar to Philips Xcelera analysis packages (K061995).

The Q-Station 3.0 multi-modality viewing allows users to view non ultrasound images such as CT, MR, NM, CR, MG, XA, PET, RT, and X-Ray modalities for reference viewing. These images can be viewed in 1-up or in n-up for comparison. In cases where the images are present in stack format, O-Station viewer will allow the user to navigate the frames/slices of these stacks and analyze them one by one. No modification is allowed on multi-modality images/studies, nor is reporting allowed on such studies. The Q-Station Multi-modality viewing is similar to that of both EPIQ and Xcelera.

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Model	PhilipsQ-Station	PhilipsQ-Station 3.0	PhilipsXcelera	PhilipsEPIQUltrasound System
510(k)Reference	K103815	Subject submission	K061995	K132304
Product Code	LLZ	LLZ	LLZ	IYN, IYO, ITX
Intended Use	Q-Station software isa softwareapplication package.It is designed tomanage, view andreport image dataacquired byUltrasound systemsand cardiacwaveformn datafrom PhilipsStressVueEGG systems. Q-Station offerssupport for QLABplug-ins for analysis,quantification andreporting of datafrom ultrasoundsystems.	Q-Station is applicationsoftware intended to manage,view, analyze, and reportqualitative and quantitativeimage data from ultrasoundexams. It is designed to hostoptional advanced analysisapplications via QLABintegration and providesintegrated tools that allowusers to manually assess andscore cardiac wall motionand export images and/orexams and reports. Q-Station can view DICOMimages of non-ultrasoundimages such as CT, MR, NM,CR, MG, XA, PET, RT, andX-Ray modalities forreference viewing. It supportsconnectivity to ultrasoundsystems, PACS and otherDICOM storage repositories.	An integratedmultimodality image andinformation system,designed to perform thenecessary functionsrequired forimport/export/storage/archiving/review/analysis/quantification/reporting and databasemanagement of digitalcardiovascular images.waveforms and data relatedto cardiology.	The EPIQ DiagnosticUltrasound System is ageneral purpose,software controlleddiagnostic ultrasoundsystem. Its function isto acquire ultrasounddata and to display thedata in a various modesof operation.
AnalysisPackages	No	Adult EchoPediatric EchoVascular	Xcelera packages include:Adult EchoPediatric EchoVascular	EPIQ packages include:Adult EchoPediatric EchoVascular
MeasurementTool	No	View, copy, and edit system-defined measurement labels,groups, and collections.Create, edit, and deletecustomized measurementlabels, groups, andcollections.	Create, edit, deletemeasurements &calculations and re-labelexisting measurements &calculations	Same as Q-Station 3.0
Viewer forotherModalities	No	CT, MR, NM, CR, MG, XA,PET, RT, and X-Ray images	Same + US	Same as Q-Station 3.0

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7) Non-clinical performance data

No performance standards for PACS systems or components have been issued under the authority of Section 514. O-Station 3.0 was tested in accordance with Philips verification and validation processes. Quality assurance measures were applied to the system design and development, including:

. Risk Analysis
. Product Specifications
Design Reviews .
. Verification & Validation

Summary of Clinical Tests:

The subject of this premarket submission, Q-Station 3.0 software did not require clinical studies to support substantial equivalence.

Conclusion:

Verification and Validation activities required to establish the performance, functionality, and reliability characteristics of Q-Station 3.0 were performed. Testing involved system level tests, performance tests, and safety testing from risk analysis. Testing performed demonstrated that the O-Station 3.0 meets all defined reliability requirements and performance claims.

8) General Safety and Effectiveness Concerns

The device labeling contains operating instructions for the safe and effective use of the Q-Station 3.0 software.

9) Conclusions

The Q-Station software is designed and manufactured to meet United States and international standards for the display and reporting of qualitative and quantitative image data acquired on Phillips Ultrasound devices. The system is designed to incorporate components common to all image viewing systems for the display, manipulation and quantification tasks within a clinical setting. The Q-Station software incorporates features of predicate devices cleared through premarket notification and no new issues of safety or effectiveness are raised.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that represents the department's mission related to health and human services. The symbol is composed of three curved lines that form a stylized human figure.

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

April 17, 2014

Philips Ultrasound, Inc. % Mr. Mark Job Responsible Third Party Official 1394 25th Street NW Buffalo, MN 55313

Re: K140808

Trade/Device Name: Q-station Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 31, 2014 Received: April 1, 2014

Dear Mr. Job:

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.

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.

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Page 2-Mr. Job

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sm.h.D

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

K140808

Device Name

Q-Station

Indications for Use (Describe)

Q-Station is application software intended to manage, view, and report qualitative and quantitative image data from ultrasound < rans. It is designed to host optional advanced analysis applications via QLAB integration and provides integrated tools that allow users to manually assess and score cardiae wall motion and export images and/or exams and reports. Q-Station can view DICOM images of nonwhansound images such as CT, MR, NM, XA, PET, RT, and X-Ray modalities for reference viewing. It supports connectivity to ultrasound systems, PACS and other DICOM storage repositories.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

Page 1 of 1

EF PSC Publishing Services (301) 443-6740

Regulation Number and Section

N/A