The Medstrat echoeSYSTEM™ is intended to enable the communication, storage, viewing and manipulation of diagnostic medical images and data. The echoeSYSTEM™ can show images on workstations locally and/or across computer networks at widely distributed locations. The echoeSYSTEM™ software is intended for assisting healthcare professionals in preoperative planning and postoperative evaluation of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and positioning the templates. The typical echoeSYSTEM™ users are trained professionals such as orthopedic surgeons, referring and collaborating physicians, and other authorized medical professionals.

It is the user's responsibility to bear in mind the display monitor's quality, ambient light conditions and the tradeoff between image compression ratio and clinical effectiveness for specific image study indications.

Device Description

ECHOES™ is a client-server software system designed to allow viewing access to medical images on a personal computer by authorized medical professionals. This product is designed to function with off-the-shelf hardware and software products including standard communications products. It does not require specialized, or nonstandard, devices of any type.

Image acquisition is via the industry standard DICOM 3.0 protocol allowing the images to be produced from the digital data originated by the imaging modality.

The software will run on standard off-the-shelf hardware and system configurations,

AI/ML Overview

The provided text is a 510(k) Summary for the Medstrat echoeSYSTEM™, a Picture Archiving and Communication System (PACS). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a performance study with quantitative results.

Therefore, many of the requested sections (e.g., specific acceptance criteria, sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not present in the provided text.

The summary describes the device's intended use and compares its features to two predicate devices to establish substantial equivalence. It does not contain information about a study designed to evaluate the statistical performance of the device against predefined acceptance criteria for clinical accuracy or efficacy.

Here's an analysis of what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

There are no explicit acceptance criteria or quantitative performance metrics reported in the provided document. The analysis focuses on substantial equivalence to predicate devices based on shared features and intended use.

Feature	Acceptance Criteria (Not Explicitly Stated/Quantitative)	Reported Device Performance (Comparison to Predicates)
Indications for Use	Implicit: Similar to predicate devices.	"Similar" to eFILM Workstation with Modules and Amicas Web/Intranet Server. Intended to enable communication, storage, viewing, and manipulation of diagnostic medical images and data, assisting healthcare professionals in preoperative planning and postoperative evaluation of orthopedic surgery, including overlaying prosthesis templates and measurements.
Target Population	Implicit: Competent health professionals.	"Health Professionals" (same as predicates).
Uses Off-the-Shelf Monitors	Implicit: Yes.	"yes" (same as predicates).
Lossy Image Compression	Implicit: Yes, adhering to standards.	"yes" (same as predicates), compression methods "believed to conform to the voluntary recognized consensus JPEG standard."
TCP/IP Communications	Implicit: Yes.	"yes" (same as predicates).
Software Only	Implicit: Yes.	"yes" (same as predicates).
Image Measurements	Implicit: Yes.	"yes" (same as predicates).
DICOM image data	Implicit: Yes.	"yes" (same as predicates), uses industry standard DICOM 3.0 protocol for image acquisition.
Pixel-for-Pixel Zoom	Implicit: Yes.	"yes" (same as predicates).
User Login/Authentication	Implicit: Yes.	"yes" (compared to Amicas, NA for eFilm), provides secure Internet and extranet interfaces through authentication mechanisms.
Digital templates	Implicit: Yes.	"yes" (compared to eFilm, no for Amicas), allows overlaying of prosthesis templates.
Editable state saves	Implicit: Yes.	"yes" (compared to both predicates which report "no"), provides functions for communicating, storing, and editing state save data of annotations, measurements, and image manipulation states.

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

Not provided. The document describes a comparison to predicate devices' features and intended use, not a clinical performance study with a test set.

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

Not provided. No test set or ground truth establishment process is described.

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

Not provided. No test set or adjudication method 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:

No, an MRMC study was not done/reported. The device is a PACS system for viewing and manipulation; it's not described as an AI-powered diagnostic aid that would typically undergo such a study for "human reader improvement."

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

Not applicable/Not provided. The echoeSYSTEM™ is described as a client-server software system and PACS for viewing and manipulation, not a standalone AI algorithm with independent diagnostic performance. Its primary function is displaying and managing images and providing tools for human professionals.

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

Not provided. No clinical ground truth is mentioned as a basis for validating the device's performance, as the submission focuses on substantial equivalence of functionality.

8. The sample size for the training set:

Not provided. There is no mention of a training set, as the device is not an AI/machine learning system in the sense of requiring a "training set."

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

Not provided/Not applicable. As no training set is mentioned, the method for establishing its ground truth is also not applicable.

Summary

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5/20/2005

B. ADMINISTRATIVE INFORMATION

JUL 1 4 2005

510(k) Summary of safety and effectiveness 1.

Manufacturer:

Address:	Medstrat, Inc.1901 Butterfield RoadSuite 600Downers Grove, IL 60515Phone: 630-960-8700Fax: 630-960-9787
Contact Person:	Robert J. Bishop
Summary Date:	April 25, 2005
Device Name:
Trade name:	echoeSYSTEM™
Common name:	Medstrat ECHOESTM PACS

Classification name: Picture archiving and communication system

Predicate Device:

eFILM Workstation with Modules, K020995, eFilm Medical Inc.

Amicas Web/Intranet Image Server, K970064, Autocyt Group, Inc.

Device Description:

Image acquisition is via the industry standard DICOM 3.0 protocol allowing the images to be produced from the digital data originated by the imaging modality.

The software will run on standard off-the-shelf hardware and system configurations,

Intended Use:

Medstrat. Inc.

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distributed locations. The echoeSYSTEM™ software is intended for assisting healthcare professionals in preoperative planning and postoperative evaluation of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and positioning the templates. The typical echoeSYSTEM™ users are trained professionals such as orthopedic surgeons, referring and collaborating physicians, and other authorized medical professionals.

Feature	EfilmWorkstationwith Modules	AmicasWeb/IntranetServer	EchoeSYSTEM
Indications for Use	Similar	Similar	Similar
Target Population	HealthProfessionals	HealthProfessionals	HealthProfessionals
Uses Off-the-ShelfMonitors	yes	yes	yes
Lossy Image Compression	yes	yes	yes
TCP/IP Communications	yes	yes	yes
Software Only	yes	yes	yes
Image Measurements	yes	yes	yes
DICOM image data	yes	yes	yes
Pixel-for-Pixel Zoom	yes	yes	yes
User Login/Authentication	NA	yes	yes
Digital templates	yes	no	yes
Editable state saves	no	no	yes

Substantial equivalence:

ECHOES™ has Indications for Use similar to other medical image devices such as to eFILM Workstation with Modules [K020995], eFilm Medical Inc. 510(k) Holder and Amicas Web/Intranet Image Server [K970064], Autocyt Group, Inc. 510(k) Holder. ECHOESTM also shares with these devices a Target Population that is competent health professionals. Also equivalent to these devices, the ECHOES™ design will operate with off-the-shelf hardware and systems.

Like the Amicas Web/Intranet Image Server [K970064], Autocyt Group, Inc. 510(k) Holder, ECHOES™ employs Image Compression to remove redundant or unimportant information in the original image data. The compression methods are believed to conform to the voluntary recognized consensus JPEG standard as declared in Section A.8 herein.

Like the eFILM Workstation with Modules [K020995], eFilm Medical Inc. 510(k) Holder, ECHOESTM provides image viewing and manipulation in a diagnostic setting affording users access to various image processing and measurement tools to assist them in viewing images. Users can overlay templates on medical images to aid in operative and non-operative treatment planning.

Medstrat, Inc.

Page 10

Image /page/1/Picture/11 description: The image shows a black and white photograph of what appears to be a cluster of trees or bushes. The image is somewhat grainy, and the contrast is high, making it difficult to discern fine details. The composition is focused on the right side of the image, where the cluster is most dense, while the left side is more sparse and faded.

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ECHOES™ provides secure Internet and extranet interfaces through authentication mechanisms, web accessible authentication servers and access for authorized users through secure protocols to web image servers. ECHOES™ provides functions for communicating, storing and editing state save data of annotations, measurements and image manipulation states intended to be used for supporting collaboration, clinical data collection and education among health professionals.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 2005

Dated: June 21, 2005 Received: June 29, 2005

4 2005

Medstrat, Inc. % Ms. Silvia Ankova Project Manager Underwriters Laboratories, Inc. 333 Pfingsten Rd. NORTHBROOK IL 60062

Re: K051745 Trade/Device Name: echoeSYSTEM™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ

Dear Ms. Ankova:

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 either class II (Special Controls) or class III (Premarket Approval), 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.

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Image /page/3/Picture/12 description: The image shows a black and white logo. The logo features a stylized depiction of an eagle or bird of prey with three distinct lines forming its body and wings. The bird is positioned within a circular border, with text partially visible around the top and left edges of the circle. The text appears to be part of the organization's name or motto.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This leter will anow you'to organ matters of substantial equivalence of your device to a legally prematice notification: "The PDF macinsing 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 If you desire specific active for a one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation on your responsibilities under the Act from the 807.77). I ou may oouall ourers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address

http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2. FDA Indication for Use Form

Indications for Use

K651745 510(k) Number (if known): __

・.

. .

Device Name: echoeSYSTEM™

Indications for Use:	The Medstrat echoeSYSTEM™ is intended to enable the communication, storage, viewing and manipulation of diagnostic medical images and data. The echoeSYSTEM™ can show images on workstations locally and/or across computer networks at widely distributed locations. The echoeSYSTEM™ software is intended for assisting healthcare professionals in preoperative planning and postoperative evaluation of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and positioning the templates. The typical echoeSYSTEM™ users are trained professionals such as orthopedic surgeons, referring and collaborating physicians, and other authorized medical professionals.
	It is the user's responsibility to bear in mind the display monitor's quality, ambient light conditions and the tradeoff between image compression ratio and clinical effectiveness for specific image study indications.

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K051745

Medstrat, Inc.

Page 12

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).