Using the software listed to post-process images, various analysis and reconstruction can be initiated by the user to obtain clinically relevant information pertaining to cardiac and radiology. Additionally this information can be used in the detection of cardiovascular disease and radiology diagnosis and risk management. Support functions are:

URSE-001A: Stress Echo analysis of the ultrasound diagnostic images. .
URFR-001A: Three-dimensional image reconstruction from the ultrasound . diagnostic images for abdominal, small organs and peripheral vascular.
URTQ-001A : Following analysis from the TDI (Tissue Doppler Image) from the . ultrasound diagnostic images.
Gray scale (display of only black-and-white images)
Velocity display (display of the velocity after angle correction and smoothing)
Display of the velocity gradient based on the velocity image
Display of the degree of myocardial strain based on the velocity image
Display of the displacement based on the velocity image
Display of the dyssynchrony imaging based on the above imaging methods

Device Description

These software packages are to be applied to the imaging processing system Encompass from Agfa Corp. Using the software listed to post-process images, various analysis and reconstruction can be initiated by the user to obtain clinically relevant information pertaining to cardiac and radiology. Additionally this information can be used in the detection of cardiovascular disease and radiology diagnosis and risk management. Support functions are:

URSE-001A: Stress Echo analysis of the ultrasound diagnostic images. .
URFR-001A: Three-dimensional image reconstruction from the ultrasound . diagnostic images for abdominal, small organs and peripheral vascular.
URTQ-001A : Following analysis from the TDI (Tissue Doppler Image) from the . ultrasound diagnostic images.
Gray scale (display of only black-and-white images)
Velocity display (display of the velocity after angle correction and smoothing)
Display of the velocity gradient based on the velocity image
Display of the degree of myocardial strain based on the velocity image
Display of the displacement based on the velocity image
Display of the dyssynchrony imaging based on the above imaging methods

AI/ML Overview

The provided text is a 510(k) summary for the Toshiba America Medical Systems, Inc. Encompass Software Package (K053043). This document details the software's intended use, technological characteristics, and substantial equivalence to predicate devices. However, this specific document does not contain information about acceptance criteria, detailed study designs, performance metrics, sample sizes, or ground truth establishment that would typically be found in a performance study report.

The 510(k) process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance based on rigorous clinical trials and statistical acceptance criteria. The document explicitly states: "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... to legally marketed predicate devices."

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth, or MRMC studies, as this information is not present in the provided 510(k) summary. The summary focuses on comparing the new device's features and intended use to existing devices.

Below is a summary of what can be extracted from the provided text, while also noting the absence of the requested performance study details:

Summary of Device: Encompass Software Package (K053043)

1. Table of Acceptance Criteria and Reported Device Performance:

No specific acceptance criteria or quantified performance metrics are reported in this 510(k) summary. The document focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, rather than performance against defined criteria.

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

Not applicable / Not provided. The 510(k) summary does not describe any specific test set or data used for a performance study.
The comparison is made against predicate devices' known functionalities.

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 ground truth establishment process involving experts for a test set is described.

4. Adjudication method for the test set:

Not applicable / 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:

Not performed / Not described. This 510(k) summary does not mention an MRMC comparative effectiveness study. The device is software for post-processing images, not an AI for assisting human readers in diagnosis in the context of an MRMC study.

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

Not applicable / Not described as a standalone study. The software itself performs analysis and reconstruction, but its "performance" is assessed in terms of its functions being similar to predicate devices, not through a standalone quantitative performance study described here.

7. The type of ground truth used:

Not applicable / Not provided. No ground truth for a performance study is mentioned in this document. The basis for approval is substantial equivalence to legally marketed predicate devices and compliance with general controls.

8. The sample size for the training set:

Not applicable / Not provided. No training set for an algorithm is mentioned in this document.

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

Not applicable / Not provided. No training set or ground truth establishment for a training set is mentioned.

Explanation of Device and Substantial Equivalence (from the document):

This 510(k) submission is for software packages (URSE-001A, URFR-001A, URTQ-001A) designed to be applied to the Agfa Corp. Encompass imaging processing system. These software packages enable:

URSE-001A: Stress Echo analysis of ultrasound diagnostic images.
URFR-001A: Three-dimensional image reconstruction from ultrasound diagnostic images for abdominal, small organs, and peripheral vascular.
URTQ-001A: Analysis from Tissue Doppler Imaging (TDI) from ultrasound diagnostic images, including display of velocity, velocity gradient, myocardial strain, displacement, and dyssynchrony imaging.

The device's substantial equivalence is claimed based on its similarity in uses and applications to the predicate devices:

Agfa Corp. Encompass [K040896]
Toshiba SSA-770A [K041499]
General Electric Vivid 7 with TSI [K031663]

The FDA's determination of substantial equivalence (K053043) means the device can be legally marketed, as it has similar indications for use and technological characteristics to devices already on the market prior to May 28, 1976, or reclassified devices. This implies that the device is considered as safe and effective as the predicate devices, without requiring new clinical performance studies to prove novel performance or meet specific, quantifiable acceptance criteria.

Summary

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Kos 3043

510(k) Summary	NOV 1 8 2005
Date:	October 7, 2005
Submitter's Name:	Toshiba America Medical Systems, Inc.
Submitter's Address:	P.O. Box 2068, 2441 Michelle Drive,Tustin, CA 92781-2068
Submitter's Contact:	Paul Biggins, Regulatory Affairs Manager (714) 730-5000
Establishment RegistrationNumber:	2020563
Device Proprietary Name:	Software for EncompassURSE-001A, URFR-001A, URTQ-001A
Common Name:	Software
Regulatory Class:	Class II
Performance Standard:	none
Predicate Device(s):	Agfa Corp. Encompass [K040896], Toshiba SSA-770A [K041499], General Electric Vivid 7 with TSI[K031663]
Reason For Submission	new device (software)

Description of this Device:

URSE-001A: Stress Echo analysis of the ultrasound diagnostic images. .
URFR-001A: Three-dimensional image reconstruction from the ultrasound . diagnostic images for abdominal, small organs and peripheral vascular.
URTQ-001A : Following analysis from the TDI (Tissue Doppler Image) from the . ultrasound diagnostic images.
Gray scale (display of only black-and-white images)
Velocity display (display of the velocity after angle correction and smoothing)

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Display of the velocity gradient based on the velocity image
Display of the degree of myocardial strain based on the velocity image
Display of the displacement based on the velocity image
Display of the dyssynchrony imaging based on the above imaging methods

Summary of Intended Uses:

The software that can be used with the imaging processing system Encompass enables to provide images for the stress echo, to reconstruct three dimensional images for radiology examination and to provide images of TDI (Tissue Doppler Imaging) for cardiac diagnosis.

Technological Characteristics:

These software are similar in uses and applications as those of the predicate devices.

Safety and Effectiveness Concerns:

This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and the imaging processing system Encompass comply with Underwriters Laboratories (U.L.) Standard No.544 for Medical and Dental Equipment.

Substantial Equivalence:

The software URSE-001A, URFR-001A and URTQ-001A is substantially equivalent to the predicate devices, Agfa Corp. Encompass [K040896], Toshiba SSA-770A [K041499], General Electric Vivid 7 with TSI [K031663].

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

NOV 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re.: K053043

Trade/Device Name: Encompass Software Package Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system. Regulatory Class: II Product Code: LLZ Dated: October 26, 2005 Received: October 28, 2005

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 (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 (PMA), it may be subject to 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.

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

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.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 807.97). 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) 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

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

Indications for Use

510(k) Number (if known): __ K053043

Device Name: Software for Encompass (Model Numbers: URSE-001A, URFR-001A, URTQ-001A)

Indications for Use:

Using the software listed to post-process images, various analysis and reconstruction Osing the soltware librod to poor prostain clinically relevant information pertaining to cardiac and radiology. Additionally this information can be used in the detection of cardiovascular disease and radiology diagnosis and risk management. Support functions are:

URSE-001A: Stress Echo analysis of the ultrasound diagnostic images. .
URFR-001A: Three-dimensional image reconstruction from the ultrasound . diagnostic images for abdominal, small organs and peripheral vascular.
URTQ-001A : Following analysis from the TDI (Tissue Doppler Image) from the . ultrasound diagnostic images.
Gray scale (display of only black-and-white images)
Velocity display (display of the velocity after angle correction and smoothing)
Display of the velocity gradient based on the velocity image
Display of the degree of myocardial strain based on the velocity image
Display of the displacement based on the velocity image
Display of the dyssynchrony imaging based on the above imaging methods

Prescription Use × (Part 21 CFR 801 Subpart D) 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 Device Evaluation (ODE)

David A. Simpson

(Division Sign-Om)
Division of Reproductive, Abdominal,
and Radiological Devices K053042
510(k)

Page 1 of

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).