UNIWEB, VERSION 5.0 by ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM)

UniWeb™ is a device that receives digital images and data from various sources (including but not limited to digital mammography, MR scanners, ultrasound systems, CT Scanners, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across a computer network at distributed locations.

UniWeb™ will be used to display FFDM (Full Field Digital Mammography) postprocessed images in DICOM for presentation only formats.

UniWeb™ will NOT utilize digitized film images, only images from FFDM modalities.

UniWeb™ will be utilized for interpretation of mammography images in a primary diagnostic setting.

UniWeb™ will be utilized only on FDA approved monitors used for mammography.

Typical users of this device are trained professionals, including but not limited to physicians, nurses and technicians.

This product will only use lossless compression or no compression when displaying mammography images.

For image diagnosis, this device can only be used by trained professionals.

Device Description

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the UniWeb™ device:

This document is a marketing clearance letter for a Picture Archiving and Communications System (PACS) named UniWeb™, version 5.0. It is not a detailed study report or clinical trial summary. Therefore, much of the requested information regarding detailed acceptance criteria and a study proving performance against them is not present in this specific document.

The document primarily focuses on the device's substantial equivalence to a legally marketed predicate device, its intended use, and regulatory compliance. It does not contain primary data from performance studies.

However, based on the "Indications for Use Statement," we can infer some operational acceptance criteria for the device itself and constraints on its use, rather than strict performance metrics.

Acceptance Criteria and Device Performance (Inferred from "Indications for Use")

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred/Stated)
Image Handling:
Receives digital images from various sources	Stated capability: Receives images from digital mammography, MR, ultrasound, CT scanners, R/F Units, computed & direct radiographic devices, secondary capture, scanners, imaging gateways, or other imaging sources.
Stores, communicates, processes, and displays images and data within the system or across a network	Stated capability: Images and data can be stored, communicated, processed and displayed within the system and/or across a computer network at distributed locations.
Displays FFDM post-processed images in DICOM for presentation only formats	Stated capability.
Will NOT utilize digitized film images	Stated limitation.
Image Quality/Compression:
Uses lossless compression or no compression for mammography images	Stated as a requirement for displaying mammography images.
Clinical Use:
Utilized for interpretation of mammography images in a primary diagnostic setting	Stated intended use.
Utilized only on FDA approved monitors used for mammography	Stated requirement for use.
For image diagnosis, can only be used by trained professionals	Stated user requirement.
User Base:
Typical users are trained professionals (physicians, nurses, technicians)	Stated as the typical user base.

Missing Information and Explanation:

The provided document (an FDA 510(k) clearance letter) does not contain the following information:

Sample size used for the test set and the data provenance: This document does not describe a specific test set or clinical study data. The 510(k) pathway often relies on demonstrating substantial equivalence to a predicate device, which may involve engineering benchmarks rather than extensive clinical efficacy trials.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as detailed ground truth establishment for a specific test set is not described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as a test set and ground truth adjudication are not described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not described. PACS systems typically demonstrate equivalence for image display and handling rather than comparative diagnostic performance studies like those for AI algorithms.
If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a PACS for display and management of images. It is not an AI algorithm performing diagnosis independently.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as detailed ground truth is not described.
The sample size for the training set: Not applicable. This PACS is not an AI/ML device that requires a training set in the conventional sense. Its "training" would be more akin to software development and testing based on DICOM standards and image processing algorithms.
How the ground truth for the training set was established: Not applicable, as it's not an AI/ML device with a training set.

Summary regarding the "study that proves the device meets the acceptance criteria":

The provided text does not describe a specific study that proves the UniWeb™ device meets detailed performance acceptance criteria in the manner one would expect for a diagnostic AI algorithm. Instead, the FDA's 510(k) clearance process determined that the device is "substantially equivalent" to legally marketed predicate devices for its stated "Indications for Use." This equivalence typically relies on demonstrating that the device performs as intended and introduces no new safety or effectiveness concerns compared to existing devices. The "Indications for Use" statement implicitly defines the scope within which the device is deemed safe and effective based on this equivalence.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Electronic Business Machine Co., Ltd. c/o Mr. Andy Yew Engineer North America EBM Technologies, Inc. 1600 Kapiolani Blvd., Suite 1300 HONOLULU HI 96814

Re: K071166

Trade/Device Name: UniWeb", version 5.0 Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 26, 2007 Received: June 29, 2007

Dear Mr. Yew:

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.

JUL 2 3 2007

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.

Image /page/0/Picture/9 description: The image shows a circular seal with the text "FDA Certified" and the years "1906-2016". The seal has a star design around the perimeter. The letters "FDA" are prominently displayed in the center of the seal. There are three stars at the bottom of the seal.

Protecting and Promoting Public Health

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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 (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.

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 21 CFR 884.xxxx 21 CFR 892 xxxxx Other

(Gastroenterology/Renal/Urology) 240-276-0115 (Obstetrics/Gynecology) 240-276-0115 240-276-0120 (Radiology) 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. Brogdon

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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JUL 23 2007

INDICATIONS FOR USE STATEMENT

510(K) Number: UniWeb™ Device Name:

UniWeb™ will be used to display FFDM (Full Field Digital Mammography) postprocessed images in DICOM for presentation only formats.

UniWeb™ will NOT utilize digitized film images, only images from FFDM modalities.

UniWeb™ will be utilized for interpretation of mammography images in a primary diagnostic setting.

UniWeb™ will be utilized only on FDA approved monitors used for mammography.

Typical users of this device are trained professionals, including but not limited to physicians, nurses and technicians.

This product will only use lossless compression or no compression when displaying mammography images.

For image diagnosis, this device can only be used by trained professionals.

Prescription Use x

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AND/OR Over-the-Counter Use:

(Please do not write below this

(Concurrence of CDRH, Office of Device Evaluation)

Villas Reever

(Division Sign-Uff) Division of Reproductive, Abdominal an Radiological Devices 510(k) Number

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).