ShowCase is diagnostic quality radiological viewing software. ShowCase can be used to receive, store, display and manipulate medical images and associated clinical data. This device is not intended for diagnosis of lossy compressed images.

Device Description

AI/ML Overview

The provided text is a 510(k) summary for the Trillium Technology, Inc. ShowCase soft-copy reading system. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against specific acceptance criteria for a novel algorithm.

Therefore, many of the requested sections (acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable or not explicitly detailed in this type of submission.

The 510(k) summary for the ShowCase device emphasizes its functional equivalence to existing PACS and ultrasound workstations. The validation described is primarily related to software development and general safety, rather than a clinical performance study with statistical endpoints.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly defined in terms of quantitative performance metrics for a specific algorithm. The substantial equivalence claim is based on the device's ability to perform functions similar to predicate devices (eFilm Workstation, syngo Ultrasound Workplace, and Volcano s5i for a specific feature) and its adherence to software development and safety protocols.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence:
- Receive, store, display, and manipulate medical images and associated clinical data.	ShowCase performs these functions, similar to predicate devices.
- DICOM compliance.	ShowCase is DICOM compliant.
- Image and structured report viewing.	ShowCase includes these functions.
- Imaging measurements and manipulation tools.	ShowCase includes these tools.
- Stress echo displays (for ultrasound).	ShowCase includes stress echo displays.
- Doppler measurement tools (for ultrasound).	ShowCase includes Doppler measurement tools.
- In-line Digital Display (ILD) for intravascular ultrasound pullback.	ShowCase provides ILD image playback.
Safety and Effectiveness:
- Labeling with instructions, cautions, and warnings.	ShowCase labeling contains these.
- Use of "off the shelf" computer components.	Hardware components are "off the shelf".
- No direct patient contact or control of life-sustaining devices.	Confirmed, leading to a "minor" Level of Concern.
- Software designed, developed, tested, and validated according to written procedures.	Certification provided.
- Diagnostic quality images and associated information.	Claimed by the manufacturer.

2. Sample size used for the test set and the data provenance

Not applicable in the context of a clinical performance study for an AI algorithm.
The "testing" mentioned refers to software verification and validation, not a clinical test set with specific image data.

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

Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication is described.

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 applicable. ShowCase is a viewing system, not an AI-assisted diagnostic tool as understood in the context of MRMC studies for AI.

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

Not applicable. ShowCase is a software system for human interpretation, not a standalone diagnostic algorithm.

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

Not applicable. The validation described is for software functionality and safety, not for diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set

Not applicable. There is no mention of a machine learning or AI algorithm being "trained" in this submission. The "training set" concept is irrelevant to a soft-copy reading system.

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

Not applicable. As above, no training set or associated ground truth establishment is mentioned.

Summary of Device and Evidence:

The Trillium Technology ShowCase is a diagnostic quality radiological viewing software (PACS). Its 510(k) submission demonstrates substantial equivalence to predicate devices (eFilm Workstation, syngo Ultrasound Workplace, and the Volcano s5i for its ILD feature) primarily through functional comparison and adherence to software development and quality control processes. The "validation and effectiveness" section describes internal testing by programmers, non-programmers, and potential customers to ensure the software functions as intended and provides diagnostic quality images. This is a typical approach for software-only medical devices that are tools for clinicians, rather than algorithms performing independent diagnoses. The submission does not include a clinical performance study against specific diagnostic acceptance criteria, as it is not presenting a new diagnostic algorithm but rather a viewing system.

Summary

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K082135
Page 1 of 3

SECTION 2 -- SHOWCASE- Summary Information for 510k

1 -Submitted by:

Trillium Technology, Inc 448 Fifth Street Ann Arbor, MI 48103-4837

OCT 2 1 2008

Official Correspondent: Gary Allsebrook Regulatory Management Services regman10@comcast.net Email: 510-276-2648 Phone: Address: 16303 Panoramic Way San Leandro, CA USA 94578-1116

Company Contact Person:

Sandra Simon Operations Director Phone: 734-213-5975 FAX: 734-527-6198 Email: ssimon@trillech.com

SHOWCASE® 2-Proprietary Name:
Common/ Usual Name:

Soft-copy reading system

Classification: Classification Name

Device Class Classification Panel CRF Section Product Code

Picture Archiving and Communications System (PACS) Class II Radiology CFR 892.2050 LLZ

Substantial Equivalence Predicate Devices: 3-

Substantial Equivalence

ShowCase is substantially equivalent to the following devices:

Predicate Device Name andManufacturer	510(k)Number	ClearanceDate	ProductCode
eFilm™ Workstation with Modules,eFilm Medical Inc.(became Merge eMed, Inc.)	K020995	04/12/2002	LLZ

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K082135
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syngo® Ultrasound Workplace,Siemens Medical Systems USA, Inc.Ultrasound Division	K060992	04/28/2006	LLZ
Volcano s5i Family of Imaging Systems,Volcano Corporation	K061215	08/10/2006	LLZ

5- Device Description

6- Software Development

Trillium Technology certifies that ShowCase software is designed, developed, tested and validated according to written procedures. These procedures identify the individuals within the organization responsible for developing and approving products pecifications, codinq v erification and validation testing. The software developed for this product provides diagnostic quality images and associated information to the intended users.

7 - Summary of Technological Characteristics of the Principal Device as Compared with the Predicate Devices

ShowCase®, eFilm® Workstation and syngo® Ultrasound Workplace are all available as "software only" workplaces that run under Microsoft Windows® operating systems on readily available computer hardware. All applications indude image and structured report viewing and a seto f imaging measurements and manipulation tools. All three are DICOM compliant systems capable of receiving and storing images and moving imaging studies using DICOM Query/Retrieve.

ShowCase includes some of the ultrasound specific functionality of the syngo Ultrasound Workplace including stress echo displays and Doppler measurement tools.

ShowCase is a more basic level product than the predicate devices and has a smaller overall feature set. ShowCase has no advanced diagnostic modules.

The Volcano s5i family of products is a set of intravascular ultrasound acquisition products that have only one feature in common with ShowCase. The s5i acquisition device includes an interactive display of both the radial and longitudinal views of an IVUS image set, with a 360 degree cursor on the radial view that matches it to the

Section 2- 2

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K0821353 of 3
page

longitudinal view. This is referred to as the In-line Digital Display (ILD). ShowCase also provides the ILD image playback option for intravascular ultrasound pullback image sets.

8- Safety and Effectiveness

General Safety and Effectiveness Concerns:

ShowCase Workstation labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.

The hardware components specified (and optionally supplied) are all "off the shelf" computer components.

The device does not contact the patient, nor does it control any life sustaining devices. Thus, the "Level ofC oncern" for the ShowCase Workstation is "minor".

8- Validation and Effectiveness

Extensive testing of the software package has been performed by programmers, nonprogrammers and by potential customers.

9- Conclusion as to Substantial Equivalence

ShowCase Workstation has Indications for Use and a Target Population similar to the predicate devices, eFilm Workstation with Modules (K020995) and syngo Ultrasound Workplace (K060992). Any differences between the ShowCase Workstation software and the equivalent devices have no significant influence on safety or effectiveness. Therefore, ShowCase Workstation raises no new issues of safety or effectiveness from its predicate devices.

Andria B Simon

Sandra Simon Operations Director / Owner

14 - Oct - 2008 Date

Section 2- 3

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Image /page/3/Picture/0 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of an abstract human figure with three wavy lines extending from its arm. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Trillium Technology, Inc. % Mr. Gary Allsebrook Consultant Regulatoy Management Services 16303 Panoramic Way SAN LEANDRO CA 94578-1116

Re: K082135 Trade/Device Name: ShowCase® Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulation Name: Picture archiving and communications system
Regulation Cl Regulatory Class: II Product Code: LLZ Dated: July 27, 2008 Received: July 29, 2008

Dear Mr. Allsebrook:

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.

OCT 2 1 2008

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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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); 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.

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jaque M. Zhang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K082135

Device Name:Sh owCase®

Indications for Use:

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use(Part 21 CFR 801 Subpart D)	X
AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number	K082135

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).