The UltraExtend FX (TUW-U001S) is designed to allow the user to observe images and perform analysis using the examination data acquired with specified diagnostic ultrasound systems Aplio 500, Aplio 400 and Aplio 300.

Device Description

UltraExtend FX is a software package that can be installed in a general-purpose personal computer (PC) to enable data acquired from Aplio diagnostic ultrasound system (Aplio 300, Aplio 400 and Aplio 500), to be loaded onto the PC for image processing with other application software product. UltraExtend FX is a post-processing software that implements functionality and operability equivalent to that of the diagnostic ultrasound system, providing a seamless image reading environment from examination using the diagnostic ultrasound system to diagnosis using the PC.

AI/ML Overview

The provided document does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or quantitative performance metrics. It primarily focuses on the device description, regulatory information, and a substantial equivalence determination to a predicate device.

Therefore, many of the requested sections (Table of acceptance criteria and reported device performance, Sample size used for the test set, Number of experts used, Adjudication method, MRMC study details, Standalone performance, Type of ground truth, Training set sample size, and Ground truth establishment for training set) cannot be extracted from this document.

However, based on the provided text, here's what can be inferred or stated:

Device Name: UltraExtend FX, TUW-U001S
Device Type: Software package for post-processing ultrasound images.
Purpose: To enable observation and analysis of images acquired from specified diagnostic ultrasound systems (Aplio 300, Aplio 400, and Aplio 500).

Here's a response addressing the available information and noting the missing details for the requested categories:

Based on the provided K121076 510(k) summary for the Toshiba America Medical Systems UltraExtend FX, TUW-U001S:

This submission focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study with specific quantitative acceptance criteria and performance data for a novel algorithm or diagnostic aid. The device is a post-processing software for ultrasound images, and the validation activities appear to relate to ensuring the software functions as intended and is safe and effective in its role as an image viewer and analysis tool, in line with its predicate.

1. A table of acceptance criteria and the reported device performance:

Specific quantitative acceptance criteria and corresponding reported device performance metrics (e.g., sensitivity, specificity, accuracy, precision) for a diagnostic output are not provided in this document. The document primarily describes the functionality and comparative aspects for substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Details regarding the sample size, type, or provenance of any test sets (e.g., number of images, patient cases) used for formal performance evaluation are not explicitly mentioned in this document. The document states "Verification and validations tests were conducted on the subject device through bench testing to confirm device safety and effectiveness," which generally refers to software functionality testing, but not typically to clinical image-based performance studies in the way a diagnostic algorithm would be evaluated.

3. 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):

Information regarding experts, ground truth establishment, or their qualifications for any clinical test set is not present in the provided text.

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

No information on adjudication methods for a test set is available in this document.

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:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study and any reported effect sizes for human reader improvement are not mentioned in this document. This submission pertains to an image processing workstation, not a device providing diagnostic assistance via AI.

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

The document describes the UltraExtend FX as a "post-processing software that implements functionality and operability equivalent to that of the diagnostic ultrasound system, providing a seamless image reading environment from examination using the diagnostic ultrasound system to diagnosis using the PC." It's an analysis tool for images with human interpretation, not a standalone algorithm making diagnoses. Therefore, a standalone performance evaluation in the context of an autonomous AI algorithm is not applicable and not reported.

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

Given the nature of the device as an image processing workstation, the concept of "ground truth" for diagnostic accuracy (e.g., pathology) is not directly applicable to its evaluation in the manner typically seen for AI diagnostic algorithms. For functional validation, the "ground truth" would likely relate to the correct display and measurement capabilities compared to the original system or expected outputs. Specifics are not detailed.

8. The sample size for the training set:

As this is an image processing software and not an AI/machine learning model, the concept of a "training set" in that context is not applicable, and no information is provided.

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

Not applicable, as there is no mention of an AI/machine learning model or training set.

Summary

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K121076

Toshiba America Medical Syst Pre-Market Notification 510(k) UltraExtend FX, TUW-U001S

510(k) SUMMARY AND EFFECTIVENESS

OCT

1. DEVICE NAME:
  System, Image Processing, Radiological Generic Name: Ultrasound Workstation Package, UltraExtend FX Trade/ Proprietary Name: TUW-U001S Model Name:

2. ESTABLISHMENT REGISTRATION: 2020563

3. CONTACT PERSON AND U.S AGENT INFORMATION:

Charlemagne Chua Contact Person: Manager, Regulatory Affairs (714) 730-5000

U.S. Agent Name: Paul Biggins Director, Regulatory Affairs (714) 730-5000 Establishment Name and Address: Toshiba America Medical Systems, Inc. 2441 Michelle Drive Tustin, CA. 92780

Toshiba Medical Systems Corporation 4. MANUFACTURING SITE: 1385 Shimoishigami Otawara-shi, Tochigi 324-8550 Japan

DATE OF SUBMISSION: April 3, 2012 (revised August 3, 2012)

6. DEVICE DESCRIPTION:

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7. INDICATION FOR USE

The UltraExtend FX (TUW-U001S) is designed to allow the use to observe images and perform analysis using the examination data acquired with specified diagnostic ultrasound systems Aplio 300, Aplio 400 and Aplio 500.

DESIGN CHANGE 8.

The change allows the ability for the UltraExtend FX Workstation to process images from the Aplio Ultrasound System.

9. SUMMARY OF DESIGN CONTROL ACTIVITIES

PS Risk List for software is attached. Risk Analysis and Design Reviews were conducted. Verification and validations tests were conducted on the subject device through bench testing to confirm device safety and effectiveness. IEC 62304 processes was implemented in the development of the subject device. A declaration of conformity with design controls is included in this submission.

10. TRUTHFUL AND ACCURACY CERTIFICATION

A certification of the truthfulness and accuracy of the UltraExtend FX Workstation described in this submission is provided in this submission.

11. SUBSTANTIAL EQUIVALENCE

UltraExtend (Predicate) is a software that can be installed in a general-purpose personal computer (PC) to enable data acquired using diagnostic ultrasound systems (Aplio Artida SSH-880CV, Aplio XG SSA-790A, or Xario XG SSA-680A) to be loaded onto the PC for various application software programs. This software (UltraExtend) implements functions and operability of the basic measurement, cardiac application measurements using 2D, M and spectral Doppler, and report generation.

UltraExtend FX (Subiect) is designed to allow the user to observe images and perform analysis using the examination data acquired from an Aplio diagnostic ultrasound system (Aplio 300, Aplio 400 and Aplio 500), It has the application of basic measurement, cardiac measurement, vasicular measurement, stress echo, 4D review, Elastography, Auto-IMT and 2D wall motion tracking.

UltraExtend (Model USWS-900A) and UltraExtend FX (Model TUW-U001S) Ultrasound Workstation Package are capable of acquiring images from a specific ultrasound diagnostic systems and perform analysis. Their applications are not the same but the intended use of the software is the same. The UltraExtend FX has been found substantially equivalent to the previously cleared UltraExtend Workstation (Model USWS-900A) and Aplio 500/400/300 Diagnostic Ultrasound System (K110870) referenced in this submission.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

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

OCT

Toshiba Medical Systems Corporation, Japan % Ms. Charlemagne Chua Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K121076

Trade/Device Name: UltraExtend FX, TUW-U0001S, v2.02 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, IYN, and IYL Dated: September 28, 2012 Received: October 1, 2012

Dear Ms. Chua:

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 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 (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,

Janine M. Morris

Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K121076

Device Name:

UltraExtend FX, TUW-U001S, v2.02

Indications for Use:

Prescription Use × (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 IF NEEDED)

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

Signature

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K121076

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).