The Stair Systems Constellation Suite Software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non- DICOM information and data management system. The STAIR System PACS & DICOM Viewer Software is comprised of modular software programs that run on standard "off-the-shelf" personal computers, business computers, and servers running standard operating systems. STAIR System & DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from any OEM modality which support DICOM standard imaging data: The system provides the capability to organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, and perform quantitative measurements.

The STAIR Systems Constellation Suite Software system should not be used for Diagnostic review of full-field digital mammograms.

Device Description

STAIR Constellation Suite is a collection of applications Coded in the Microsoft C# application language. A color scheme defined as a way to identify both highlighted or important information within the user interface and as a "not so grey" environment that could stand up to a user who was likely to work 10-12 hours a day in front of it. The layout and design of the layers of the UI evolved from the "old design" of having 3 separate computers. each with a single monitor copy of a single element of the system into a modern, multimonitor native design which incorporates large performance gains through the use of Microsoft's DirectX technologies.

The core of the Suite is the database, is an adaptive star relational design for Microsoft SQL Server 2008 Enterprise. The data server provides a dedicated, central place to provide disaster recovery servicing, and the large multi-terabyte storage required for PACS. Attaching to this are Northstar PACS clients, Cosmos Enterprise Managmenet Clients, Apex Servers, and Cascade Servers; all of which are STAIR produced software products.

The Northstar PACS client is intended to be a desktop replacement product, with the interface dominating the screen space on a workstation.computer. TThis design decision was made to accommodate non- technical doctors who, we found, typically prefer to have a simplified and unobtrusive environment to work in. Color based exam status listings were evolutionary, and grew from the initial 'field of green' into the more advanced dynamic tree view seen today in the client. It is a multi-monitor capable client, currently configurable in a 1, 2, or 3 monitor footprint.

Cosmos represents the nerve center of the STAIR Constellation Suite, providing services for securing the STAIR network, maintaining Paperless workflow, and other such critical day-today system maintenance tasks. Typically users will include hospital or practice administrators and functional personnel who may need to make modifications to STAIR database entries. It is an OLTP client, and requires port level access to the main STAIR database central server installation to function (we use DSN-less connections to the database usually requiring port 1433 to be excepted in the workstation's firewall rule set). The client performs many tasks, some of which are not relevant to every customer. though we encourage adoption of STAIR electronic processes by our clients in order to help them streamline their office efficiency. RIS integration is partially available (per vendor, STAIR offers no supported HL7 interface at this time), and can be incorporated in most cases to allow a RIS system to perform synchronization and workflow tasks in harmony with STAIR kept data records.

The Apex DICOM Storage Server provides the primary server capabilities of the STAIR system. It was built to be automatable such that it typically runs unattended, but a user interface is used to both help monitor and control the various DICOM storage processes necessary to import each study from an external source (modality, another PACS, etc). The Apex server incorporates a DICOM SCP service grouping that allows for DICOM ping response, client protocol negotiation, transfer syntax negotiation, and several other system-level DICOM negotiations. As each case is received; it is stored via a Service host to the local hard drive (into the STAIRIMAGE hierarchy), it is queued for storage at the top, and it is stored as data to the main database in one of 8 available simultaneous thread 'putaway' processes (shown as 'idle').

The STAIR Cascade is a DICOM SCU, and auxiliary compression Server product originally designed to allow the send and receive functions of DICOM to be split from the STAIR Apex product and balanced onto a separate physical server. This was to allow for load balancing within the STAIR Enterprise, and the product has evolved now into a secondary server role, handling transmission queues for all enterprise clients. To allow for DICOM transmissions to be seamless, we use a database table XMISSION QUES, and each client transmission request to the database are handled as a threaded process (8 simultaneous). Each process begins by downloading the Imageset for a requested case from the STAIR database to a local cache, where it is then added to a queue within the program for processing. As each queue slot opens, another case is promoted until the queue empties.

AI/ML Overview

Here's an analysis of the provided text regarding the Stair Systems Constellation Suite, focusing on the acceptance criteria and study information:

Based on the provided 510(k) Summary, there is no specific information detailing acceptance criteria for device performance or a study proving that the device meets such criteria.

The document primarily focuses on establishing "substantial equivalence" of the Stair Systems Constellation Suite to predicate devices, as required for a 510(k) premarket notification. This process typically relies on demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new issues of safety or effectiveness compared to legally marketed devices.

Let's address each point of your request based on the available text:

A table of acceptance criteria and the reported device performance
- Not available in the provided text. The document does not define specific performance metrics or acceptance criteria for the device (e.g., image display accuracy, processing speed, measurement precision etc.)
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available. The document does not describe any specific test set of data used for performance evaluation, nor does it mention data provenance. The "verification and validation testing" mentioned in the Conclusion is a general statement, without details on the scope, methodology, or data used.
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 available. Since no specific test set or performance evaluation study is described, there's no mention of experts or ground truth establishment.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available. No adjudication method is described.
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. There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This device is a PACS/DICOM viewer software, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a PACS system designed for human interaction and image management/display. It's not an AI algorithm performing standalone diagnostic tasks. The closest equivalent would be its performance in managing and displaying images according to DICOM standards, but specific standalone performance metrics are not detailed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not available. As no specific performance study is detailed, no ground truth type is mentioned. The "Conclusions" state: "A comparison of the labelling, substantial equivalence table, and verification and validation testing has established that the device meets its intended use and design specifications." This indicates that the validation focused on compliance with design specifications and intended use, likely through functional testing and adherence to standards (like DICOM), rather than clinical "ground truth" performance in a diagnostic sense.
The sample size for the training set
- Not applicable. The device described is a PACS and DICOM viewer software, which is an infrastructure and display system, not a machine learning or AI model that requires a training set.
How the ground truth for the training set was established
- Not applicable. As it's not an AI/ML device, there's no training set or ground truth in that context.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a logo for a company called "Efficient Radiology AIRSYSTEMS Inc." The logo features a stylized sunburst design above the company name. The sunburst is made up of several triangular shapes that radiate outwards from a central point. The text is in a simple, sans-serif font.

STAIR Systems, Inc. 3801 (V. Market St.)
E-mail: sales alstairs vsterrss ner Hittp://w

ട. 510(k) Summary (21 CFR 807.92(c))

100256

2 6 21 11

ADMINISTRATIVE INFORMATION

Manufacturer Name:

Contact Person:

Official Correspondent:

Stair Systems, Inc 3801 West Market St. Greensboro, NC 27407

Ray Eveland, Vice President, Tel: (336) 413-6967 Fax: (336) 852-0651 E-mail: jimowen@stairsytems.net

CALISO Consulting, LLC James W. Monroe, Regulatory Manager 1516 Oak Street, Suite 312 Alameda, CA 94501 (484) 894-4921

Establishment Registration Number:

Date prepared:

Name of Device:

Trade Name:

Suite

Common Name:

Medical Image Workstation

Stair Systems Constellation

January 11, 2010

Systems, PACS Classification Name: 21 CFR 892.2050

Product Code: LLZ

Identification of Predicate Device(s):

Manufacturer	Device	510(k)
Number
Mercury computer Systems, Inc.	Visage PACS/CS	K062490
Ramsoft Inc.	Ramsoft PACS	K031562
Advance Imaging Solutions, LLC	EZPACS	K062878
CALGARY SCIENTIFIC, INC	ResolutionMD	K062164
Fuji Medical System USA	Fuji Synapse WorkstationSoftware	K051553

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a logo for Stair Systems, Inc. The logo includes a stylized image of stairs or steps radiating outward from a central point. The text "Efficient Radiology STAIRSYSTEMS, Inc." is present, along with the website address "HTTP://WWW.STAIRSYSTEMS.NET".

alor@crairossoms.com pot. Horniturems.com

Intended Use Statement

The STAIR Systems PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The STAIR System PACS & DICOM Viewer Software is comprised of modular software programs that run on standard "off-the-shelf"

personal computers, business computers, and servers running standard operating systems, STAIR System & DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from any OEM modality which support DICOM standard imaging data; The system provides the capability to organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, and perform quantitative measurements. The STAIR PACS & DICOM Viewer Software system should not be used for Diagnostic review of full-field digital mammograms.

DEVICE DESCRIPTION

The core of the Suite is the database, is an adaptive star relational design for Microsoft SQL Server 2008

Enterprise. The data server provides a dedicated, central place to provide disaster recovery servicing, and the large multi-terabyte storage required for PACS. Attaching to this are Northstar PACS clients, Cosmos Enterprise Managmenet Clients, Apex Servers, and Cascade Servers; all of which are STAIR produced software products.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows a logo for Tair Systems, Inc. The logo features a stylized sunburst design above the company name. The text "Efficient Radiology" is above the company name, and the website address is below the company name. The sunburst design is made up of several shapes that are arranged in a semi-circle.

database usually requiring port 1433 to be excepted in the workstation's firewall rule

STAIR Systems, Inc. 3801 W. Market St., Greensboro, NC 27407 1-336-856-857.

set). The client performs many tasks, some of which are not relevant to every customer. though we encourage adoption of STAIR electronic processes by our clients in order to help them streamline their office efficiency. RIS integration is partially available (per vendor, STAIR offers no supported HL7 interface at this time), and can be incorporated in most cases to allow a RIS system to perform synchronization and workflow tasks in harmony with STAIR kept data records.

Predicate Device Comparison

The Stair Systems Constellation Suite has similar intended use and technical features of the predicate devices listed above. The subject device is not indicated for Mammography use where as some of the predicate devices are indicated. This difference in the subject device does not raise any questions with respect to the safety and effectiveness of the device. substantially equivalent to similar features to the predicate devices. The Stair Systems Constellation Suite differs from the Fuji Medical Synapse in that it is not intended for Mammography use. The features of the subject device do not raise or affective the safety or effectiveness of the device.

The subject device does comply with the following voluntary Standards:

. ACR/NEMA Digital Imaging and Communication in Medicine (DICOM) Standard.

Conclusions

A comparison of the labelling, substantial equivalence table, and verification and validation testing has established that the device meets its intended use and design specifications.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bars representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

MAR 2 9 2010

STAIRS Systems, Inc. % Mr. James W. Monroe Regulatory Affairs CALISO Consulting, LLC 3801 W. Market St. GREENSBORO NC 27407

・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

Re: K100236

Trade/Device Name: Stair Systems Constellation Suite Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 11, 2010 Received: February 2, 2010

Dear Mr. Monroe:

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 vour 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

{4}------------------------------------------------

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) 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,

Amiel Jaffe

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows a logo for Efficient Radiology. The logo has a graphic of a sun with rays emanating from it. The text "Efficient Radiology" is below the graphic.

Indications for Use

510(k) Number (if known): K100236

Device Name: Stair Systems Constellation Suite

Indications for Use:

The STAIR Systems Constellation Suite Software system should not be used for Diagnostic review of full-field digital mammograms.

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 IF NEEDED)

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

DML

Division of Radiological Dev

510K K100236

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).