UltraExtend USWS-900A v2.1 and v3.1 is a software package that can be installed in a general-purpose personal computer (PC) to enable data acquired from Aplio diagnostic ultrasound systems (Aplio XG, Aplio MX, Aplio Artida, Aplio 300, Aplio 400 and Aplio 500), to be loaded onto a PC for image processing with other application software product. UltraExtend USWS-900A v2.1 and v3.1 is a postprocessing software that implements functionality and operability equivalent to that of the diagnostic ultrasound system the data was acquired from, providing a seamless image reading environment from examination using the diagnostic ultrasound system to diagnosis using the PC.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification for a software product called "UltraExtend USWS-900A v2.1 and v3.1." This submission is for a modification of an already cleared device and does not include a study proving device performance against acceptance criteria in the typical sense of a clinical trial for a novel device.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This means that the device is shown to function similarly and be intended for the same use as legally marketed devices.

Therefore, many of the requested categories for a study proving device performance are not directly applicable or are addressed differently in this type of submission.

Here's a breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

The document states that "Risk Analysis, Verification/Validation testing conducted through bench testing, as well as software validation documentation... demonstrate that the device meets established performance and safety requirements and is therefore deemed safe and effective." However, it does not provide a table of specific acceptance criteria or quantitative performance metrics for those criteria. The "performance" being evaluated is primarily the functional equivalence and safety of the software modifications.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Functional Equivalence: The software should perform key functionalities (displaying, analyzing ultrasound images, accessing data from specific ultrasound systems, running applications like CHI-Q and TDI-Q, 2D wall motion tracking) in a manner equivalent to the predicate devices and the diagnostic ultrasound systems from which the data is acquired.	"UltraExtend USWS-900A v2.1 and v3.1 is a post-processing software that implements functionality and operability equivalent to that of the diagnostic ultrasound system the data was acquired from, providing a seamless image reading environment..." Modifications allow data from Aplio 300, 400, 500 systems to be accessible, and new applications (CHI-Q, TDI-Q) and features (2D wall motion tracking) were added.
Safety: The modifications should not introduce new safety concerns and the device should comply with relevant regulations and standards.	"Risk Analysis, Verification/Validation testing conducted through bench testing... demonstrate that the device meets established performance and safety requirements and is therefore deemed safe and effective." Device designed and manufactured under Quality System Regulations (21 CFR §820 and ISO 13485 Standards) and IEC 62304 processes were implemented.
Compatibility: The software should be compatible with specified operating systems (Windows XP for v2.1, Windows 7 for v3.1) and able to access data from the listed Aplio diagnostic ultrasound systems.	UltraExtend USWS-900A v2.1 runs under Windows XP and v3.1 runs under Windows 7. Allows data acquired by Aplio 300, Aplio 400 and Aplio 500 Diagnostic Ultrasound Systems to be accessible.

Study Details (Based on the document, many are not applicable for a 510(k) modification without clinical studies)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of a clinical study. The validation involved "bench testing" and "software validation documentation." This typically means testing against a variety of use cases and scenarios, but the number of cases or the specific data used for this internal validation is not provided.
- Data Provenance: Not specified. As no clinical studies were performed, there's no mention of country of origin or retrospective/prospective data for a clinical test set. The data would likely be internally generated or from existing Aplio systems.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical study with expert-established ground truth was conducted. The "ground truth" for software validation would be adherence to functional specifications and absence of bugs, verified by software engineers and quality assurance personnel.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no clinical study with adjudicated results was conducted.
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 MRMC study was done. The document explicitly states: "UltraExtend USWS-900A v2.1 and v3.1 did not require clinical studies to support substantial equivalence." This is a software for displaying and analyzing images, not an AI diagnostic tool requiring MRMC evaluation for reader improvement.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not directly applicable in the sense of an algorithmic diagnostic performance study. The "standalone" performance here refers to the software's ability to correctly process and display images, and run its embedded applications. This was assessed through "Risk Analysis, Verification/Validation testing conducted through bench testing, as well as software validation documentation."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For software validation, the "ground truth" would be the software requirements and specifications. The validation process verifies that the software functions as designed and meets these predefined requirements, rather than clinical ground truth (like pathology or expert consensus).
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a separate "training set" in the context of developing a diagnostic algorithm. It's a software package for image post-processing and display.
How the ground truth for the training set was established:
- Not applicable, as no training set (in the ML context) was used.

Summary

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ТОЯНІВА АМЕRICA MEDICAL БУБТЕМБ, INC. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-5000

510(k)-SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with 21 CFR 807.92, the following summary of the information is provided.

1. Submitter's Name: Toshiba America Medical Systems, Inc.
1. Submitter's Address: 2441 Michelle Drive Tustin, CA 92781-2068
1. Establishment Registration Number: 2020563
1. Contact Person: Charlemagne Chua Manager Regulatory Affairs (714) 730-5000
1. Date Prepared: February 25, 2013
1. Device Proprietary Name: UltraExtend USWS-900A, v2.1 UltraExtend USWS-900A, v3.1

7. Common Name: System, Picture Archiving and Communications

1. Classification: 21 CFR §892.2050 Class II
  Product Code: LLZ
1. Predicate Devices:

Product	Marketed by	510(k) Number	Clearance Date
UltraExtend	Toshiba America	K082596	September 23, 2008
USWS-900A	Medical Systems
UltraExtend FX	Toshiba America	K121076	October 9. 2012
TUW-U001S v2.02	Medical Systems

JUL 2 3 2013

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10. Reason for Submission:

Modification of the cleared device UltraExtend USWS-900A, K082596

11. Device Description:

12. Indications for Use:

This software is intended for displaying and analyzing ultrasound images for medical diagnosis in cardiac and general examinations.

13. Determination of Substantial Equivalence:

UltraExtend USWS-900A v2.1 and v3.1 functions in a manner similar to and is intended for the same use as the predicate devices UltraExtend, USWS-900A (K082596) and UltraExtend FX (K121076), marketed by Toshiba America Medical Systems.

UltraExtend USWS-900A v2.1 and v3.1 include modifications to the previously cleared device, UltraExtend USWS-900A, which allows data acquired by Aplio 300, Aplio 400 and Aplio 500 Diagnostic Ultrasound Systems (K121422) to be accessible on a PC running UltraExtend USWS-900A v2.1 and v3.1. Additionally, two applications, CHI-Q and TDI-Q, as well as the new feature, 2D wall motion tracking for the images acquired by the Aplio 300, Aplio 400 and Aplio 500 were added. UltraExtend USWS-900A v2.1 runs under Windows XP and v3.1 runs under Windows 7.

UltraExtend USWS-900A v2.1 and v3.1 employs the same fundamental scientific technology as the predicate devices.

A complete comparison of the subject device versus the predicate devices is available in TAB 3 of this submission.

14. Safety:

This device is designed and manufactured under the Ouality System Regulations as outlined under 21 CFR§820 and ISO 13485 Standards.

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15. Summary of Testing:

Software Documentation a.

Risk Analysis, Verification/Validation testing conducted through bench testing, as well as software validation documentation as required by the FDA Guidance Document titled, "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices," are presented in TABS 5 and 7. This documentation demonstrates that the device meets established performance and safety requirements and is therefore deemed safe and effective. Additionally, IEC 62304 processes were implemented in the development of the subject device.

b. Clinical Test

UltraExtend USWS-900A v2.1 and v3.1 did not require clinical studies to support substantial equivalence.

16. Conclusion:

The modifications implemented in the subject device do not change the the intended use of the device. Based upon the safety and effectiveness data/information provided, the clinical performance of UltraExtend USWS-900A v2.1 and v3.1 are deemed to be substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 23, 2013

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

Re: K131822

Trade/Device Name: UltraExtend USWS-900A v2.1 and v3.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ and IYN Dated: June 19, 2013 Received: June 20, 2013

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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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Page 2 - Mr. Job

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.ltm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

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): K131822

Device Name: UltraExtend, USWS-900A, v2.1 and v3.1

Indications for Use:

This software is intended for displaying and analyzing ultrasound images for medical diagnosis in cardiac and general examinations.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (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 Diagnostics and Radiological Health (OIR)

Sm(i,j)

(Division Sign-Off) Division of Radiological Health Office of In Viro Diagnostics and Radiological Health

510(k) K131822 ___________

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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).