Q-Station software is a software application package. It is designed to manage, view and report image data acquired by Ultrasound systems and cardiac waveform data from Philips Stress Vue ECG systems. Q-Station offers support for QLAB plug-ins for analysis, quantification and reporting of data from ultrasound systems.

Device Description

O-Station is workstation software designed for managing, viewing and reporting qualitative and quantitative image data from ultrasound exams. It includes advanced analysis via QLAB integration (QLAB 8.0) and provides integrated tools that allow users to manually assess and score cardiac wall motion and export images and/or exams and reports. It supports connectivity to ultrasound systems, PACS, other DICOM storage repositories, and Philips Stress Vue ECG systems to aid clinicians in diagnostic activity. Q-Station supports QLAB Plug-ins.

AI/ML Overview

The provided 510(k) summary for Q-Station 1.0 focuses on demonstrating substantial equivalence to a predicate device (Xcelera K061995) rather than on specific clinical performance metrics with pre-defined acceptance criteria.

The submission states that:

"No performance standards for PACS systems or components have been issued under the authority of Section 514."
"The Q-Station software has been designed to comply with the following voluntary standards: NEMA PS 3.1 - 3.18 (2008), Digital Imaging and Communications in Medicine (DICOM) Set and IEC/ISO 10918-1:1994 Technical Corrigendum 1:2005, Information technology - Digital compression and coding of continuous-tone still images."
"Software development for the Q-Station software follows documented processes for software design, verification and validation testing. A risk assessment has been completed to identify potential design hazards that could cause an error or injury based on the use of the quantification results. Appropriate steps have been taken to control all identified risks for this type of image display and quantification product."

Therefore, the submission does not include a study that defines explicit acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) and then provides data to prove the device meets these criteria in the way new AI/CADe devices typically do. Instead, the focus is on compliance with standards and internal software development processes to mitigate risks and achieve substantial equivalence.

Given the information provided, it is not possible to complete the requested table and details for acceptance criteria and a study proving those criteria were met. The document describes a regulatory submission process based on demonstrating substantial equivalence and compliance with general software/DICOM standards, not a specific clinical performance study with predefined metrics.

Here's a breakdown of what can be inferred or what is explicitly not available based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Not explicit (device is compared to predicate based on functionality and compliance with standards rather than specific performance metrics)	Not provided in a quantitative, performance-based manner within the document for diagnostic accuracy, sensitivity, specificity, etc.
Compliance with NEMA PS 3.1 - 3.18 (DICOM)	Stated compliance with this standard.
Compliance with IEC/ISO 10918-1:1994 (JPEG compression)	Stated compliance with this standard.
Functionality similar to predicate device (Xcelera K061995) for managing, viewing, reporting, and QLAB integration.	Device description outlines these functionalities, implying they function similarly to the predicate.
Risk assessment indicating identified risks are controlled.	Stated that "Appropriate steps have been taken to control all identified risks."
No new issues of safety or effectiveness are raised.	Stated as a conclusion.

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

Not provided. The document does not describe a clinical performance test set. The validation mentioned refers to software verification and validation, not clinical data evaluation for diagnostic performance.

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

Not applicable / Not provided. No specific test set with ground truth established by experts is mentioned for assessing diagnostic performance.

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

Not applicable / Not provided. No specific test set with adjudication is mentioned.

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. The document does not mention any MRMC study. Q-Station is described as a workstation software for managing, viewing, and reporting image data, including advanced analysis via QLAB integration and tools for manual assessment and scoring. It's not presented as an AI/CADe assistance tool in the context of improving human reader performance.

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

No. The document describes a workstation for human interaction with imaging data, including manual assessment. It does not present a standalone algorithm for diagnostic tasks.

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

Not applicable / Not provided. No specific ground truth for diagnostic performance assessment is mentioned.

8. The sample size for the training set

Not applicable / Not provided. The device is described as software for managing, viewing, and reporting image data, not explicitly as a machine learning/AI device requiring a "training set" in the conventional sense of AI model development for diagnostic tasks.

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

Not applicable / Not provided. (See point 8).

In summary, this 510(k) submission details a software workstation that functions as a tool for clinicians to view, manage, and analyze ultrasound and ECG data. Its regulatory pathway relies on demonstrating substantial equivalence to existing predicate devices and compliance with relevant industry standards (DICOM, JPEG), alongside internal software verification and validation processes. It does not present data from clinical performance studies against specific diagnostic acceptance criteria.

Summary

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510(k) Premarket Notification

... ... ...

Q-Station 1.0

5. 510(k) Summary

K103815

This summary of safety and effectiveness is provided as part of the Premarket JAN 2 2011
Notification in compliance with 21CER Part 807 Submat E Section 807 92 Notification in compliance with 21CFR. Part 807, Subpart E. Section 807.92

Submitter's name, address, telephone number, contact person

Philips Ultrasound. Inc. P.O. Box 3003 Bothell, WA 98021-3003 Nancy Burke, Regulatory Affairs Specialist Telephone: (425) 487-7371 Facsimile: (425) 487-8666 E-mail: Nancy. Burke@philips.com

Date prepared: December 15, 2010

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

3) Substantially Equivalent Devices

Philips Ultrasound believes that the Q-Station 1.0 software is substantially equivalent to other commercially available products, specifically Xcelera (K061995).

3) Device Description

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4) Intended Use

Q-Station software is a software application package. It is designed to manage; view and report image data acquired by ultrasound systems and cardiac waveform data from Philips StressVue ECG systems.

5) Technological comparison to predicate devices

Both Philips Q-Station and Philips Xcelera are software applications for medical image and data review and patient report preparation. Both are DICOM compatible and allow for the storage and save/retrieve of image data and reports. Both are workstation software applications intended to be used with medical DICOM images and waveforms acquired from other modalities.

6) Non-clinical performance data

No performance standards for PACS systems or components have been issued under the authority of Section 514. The Q-Station software has been designed to comply with the following voluntary standards:

NEMA PS 3.1 - 3.18 (2008), Digital Imaging and Communications in Medicine (DICOM) Set
t IEC/ISO 10918-1:1994 Technical Corrigendum 1:2005, Information technology - Digital compression and coding of continuous-tone still images

Software development for the Q-Station software follows documented processes for software design, verification and validation testing. A risk assessment has been completed to identify potential design hazards that could cause an error or injury based on the use of the quantification results. Appropriate steps have been taken to control all identified risks for this type of image display and quantification product.

7) General Safety and Effectiveness Concerns

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

8) Conclusions

The O-Station software is designed and manufactured to meet United States and international standards for the display and quantification of images acquired on 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/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three lines representing the head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Philips Medical Systems Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

JAN 2 5 2011

Re: K103815

Trade/Device Name: Q-Station Software 1.0 Regulation Number: 21 CFR 892,2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 28, 2010 Received: December 29, 2010

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.

Sincerely Yours.

Mary S Postel

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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1. Indications for Use Statement

510(k) Number (if known):

ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺎﺑﻘﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ

Device Name: Q-Station software 1.0

Indication for Use:

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

Over-the-counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Richard O'Brien

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K103815

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).