A nuclear medicine image display and processing application suite that provides software applications used to process, analyze, and display medical images/data. The results obtained may be used as a tool, by a nuclear physician, in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structure. The data processed may be derived from any nuclear medicine camera. EBW NM 2.0 should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.

Device Description

EBW NM 2.0 is a Windows®-based Nuclear Medicine suite of image display and processing applications for the Nuclear Medicine market segment. The software package is deployable on hardware platforms, which meet the minimum requirements needed to run the software. The comprehensive tools and features provided with this product, will allow the technologist and/or physician to perform image review, processing of source data, post processing, hardcopy production, interpretation, report generation and contains the utilities necessary to support the workflow and data management between those activities.

AI/ML Overview

The provided document is a 510(k) summary for the Philips EBW NM 2.0 Image Processing System. It states that the device is "substantially equivalent" to predicate devices based on similar intended use, technological comparison, and system performance. However, it does not contain the specific details of performance studies, acceptance criteria, or ground truth establishment that you are requesting.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance data against specific acceptance criteria. This document describes the device, its intended use, and its equivalence to two predicate devices (NM Application Suite K080961 and AutoSPECT K090403).

Therefore, based solely on the provided text:

A table of acceptance criteria and the reported device performance: Not provided. The document states "system performance" but does not detail how this was measured against specific criteria.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided.
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.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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 indicated or described. The device is an "Image Processing System" and while it may assist human readers, a formal MRMC study is not mentioned as part of this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not indicated or described.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not provided.
The sample size for the training set: Not provided.
How the ground truth for the training set was established: Not provided.

In summary, this 510(k) summary confirms the regulatory clearance of the device but does not include the detailed study information or performance metrics you've asked for. Such information, if generated, would typically be found in detailed internal validation reports or potentially in a more comprehensive clinical study report, neither of which is part of this 510(k) "summary of safety and effectiveness."

Summary

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ア

MAY 2 4 2011

ADMINISTRATIVE INFORMATION

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS I.

A. Submitted By:

Philips Medical Systems (Cleveland), Inc. 3860 N. First Street, San Jose California 95134

Tel: (408) 468-3042 Fax: (408) 468-3050

Contact Person:

Lori R. Peterson At address above

February 3, 2011

Date Prepared:

B. Device Trade Name: Common Name: Classification Name:
EBW NM 2.0 Image Processing System Picture Archive and Communication Systems (PACS)

C. Predicate Device(s):

Manufacturer	Product Name	510(k)
Philips Medical Systems(Cleveland), Inc.	NM Application Suite	No.K080961
Philips Medical Systems(Cleveland), Inc.	AutoSPECT	K090403

D. Device Description:

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E. Intended Use:

F. Technological Comparison:

The predicate, NM Application Suite (K080961) and EBW NM 2.0 have similar indications for use and overall function and perform in a similar manner with respect to, display, review and processing applications. AutoSPECT (K090403) and the Philips reconstruction applications (AutoSPECT Pro), that are a subset of the EBW NM base package, have similar indications for use and overall function and perform in a similar manner with respect to reconstruction processing, which includes resolution recovery, scatter correction, noise control, and attenuation correction.

II. CONCLUSION

The EBW NM 2.0 is substantially equivalent to the NM Application Suite (K080961) a predicate device based on similar intended use, technological comparison, and system performance. The subset of applications, AutoSPECT Pro, is substantially equivalent to the AutoSPECT predicate device (K090403) based on similar intended use and technological comparison.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol with three lines forming a shape resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the 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 (Cleveland), Inc. % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062

MAY 2 4 2011

Re: K111336 Trade/Device Name: EBW NM 2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 10, 2011 Received: May 12, 2011

Dear Mr. Devine:

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 (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 (OS) regulation (21 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 Patel

Mary S. Pastel, Sc.D. 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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Indications for Use Form

510(k) Number (if known): < // / 336

Device Name: EBW NM 2.0

Indications for Use:

A nuclear medicine image display and processing application suite that provides software applications used to process, analyze and display medical images/data. The results obtained may be used as a tool, by a nuclear physician, in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical The data processed may be derived from any nuclear structure. medicine camera. EBW NM 2.0 should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.

Prescription 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)

Mury S. Patil

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K///33C

Page 1 of 1

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).