The REGIUS Unitea software is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications. The REGIUS Unitea software primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The REGIUS Unitea software can process and display medical images from the following modality types: Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and other DICOM compliant modalities. The REGIUS Unitea must not be used for primary image diagnosis in mammography.

Device Description

REGIUS Unitea is a software which is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications. REGIUS unitea software controls and manages the cassette type CR (Computed Radiography) such as REGIUS MODEL 170,190 and 110 that is connected via the network. REGIUS Unitea receives and displays images from other DICOM compliant modalities connected via the network and whole use digital media such as DVD/CD-R, DSC and USB memory cards connected as disk drives.

REGIUS Unitea software has the following set of features.

Feature to automatically obtain patient demographic information (Name, Age, Sex, Date of Birth, etc) from Hospital Information Systems.
Feature to specify the reading condition (Sampling Sensitivity of the sensor and so on) of the connected CR device.
Receive and store image data from REGIUS MODEL 170, 190 and 100 CR, other DICOM compliant modalities and digital media (such as DVD/CD-R, DSC and USB memory cards).
Display image data received from the REGIUS MODEL 170, 190 and 100 CR, other DICOM compliant modalities and digital media (such as DVD/CD-R, DSC and USB memory cards).
Feature to apply image processing to images received from REGIUS MODEL 170. 190 and 100 CR.

AI/ML Overview

This 510(k) summary (K071436) describes a medical image processing workstation called REGIUS Unitea. The submission primarily focuses on establishing substantial equivalence to a predicate device (REGIUS CS-2000 and CS-3000, K051523) and details the device's features and intended use.

Crucially, this 510(k) summary does NOT contain information about specific acceptance criteria or an analytical study proving the device meets those criteria, as it relates to performance metrics like accuracy, sensitivity, or specificity for a specific medical task.

Instead, the submission for REGIUS Unitea, being a "Picture archiving and communications system" (PACS) product (21 CFR 892.2050), falls under a general controls regulatory pathway. For such devices, the primary "acceptance criteria" revolve around demonstrating that the device functions as intended, handles various image modalities, complies with DICOM standards, and does not introduce new safety or efficacy concerns compared to a legally marketed predicate device.

The study described is largely a comparative analysis for substantial equivalence, not a performance study measuring clinical accuracy or effectiveness in a typical sense for an AI/CAD product.

Given the information provided, here's a breakdown of the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided K071436 summary, there are no explicit quantitative acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, AUC) for a specific diagnostic task. The acceptance is primarily based on:

Acceptance Criteria Category	Reported Device Performance/Compliance
Functional Equivalence	"REGIUS Unitea is substantially equivalent to our REGIUS CS-2000 and CS-3000, 510(k) number: K051523. Comparison of the principal characteristics of these devices is shown in the Section 3." (Section 3 is not fully provided here, but it would detail feature-by-feature comparison). The new device offers similar image processing, display, and management capabilities to the predicate.
Safety and Efficacy (New Issues)	"REGIUS Unitea introduces no new safety and efficacy issues other than those already identified with the predicate device. The results of a hazard analysis, combined with the appropriate preventive measure taken indicate that the device is of minor level of concern as per the May 11, 2005 issue of the "Guidance for the Content of Premark Submissions for Software Contained in Medical Devices"."
Intended Use Compliance	Intended for installation on off-the-shelf PC, processing and presentation of medical images on display monitors suitable for the medical task. Supports various modalities (Plain X-ray Radiography, CT, MRI, Ultrasound, Nuclear Medicine, other DICOM compliant). Explicitly not for primary image diagnosis in mammography. This matches the scope of a PACS device.
DICOM Compliance	Implicitly stated throughout in relation to receiving/displaying images from "DICOM compliant modalities" and outputting to "other DICOM devices."
Connectivity/Compatibility	Controls/manages cassette-type CR (REGIUS MODEL 170, 190, 110), receives/displays images from other DICOM modalities, utilizes digital media (DVD/CD-R, DSC, USB).
Image Processing Features	The device successfully implements a range of image processing features as described (Contrast/Density adjustments, F-processing, E-processing, H-processing, I-processing, Masking, Rotating/Flipping, Re-sampling/Resizing, Stitching, Grid Suppression, Digital marker/Annotation). The "acceptance" here is that these features are present and function as specified, presumably verified through internal testing.

2. Sample Size Used for the Test Set and Data Provenance

Given this is a PACS device submission for substantial equivalence, there is no mention of a specific "test set" in the context of diagnostic performance (e.g., a set of patient cases to evaluate diagnostic accuracy).

The evaluation typically involves:

Verification and Validation (V&V) testing: This would involve testing the software's functionalities (e.g., image loading, display, processing, storage, network communication) using various types of DICOM images and system configurations.
Hazard Analysis: To identify and mitigate risks.

The K071436 does not specify the sample size of images or the origin of data used for these V&V activities. Since it's a software device interacting with CR systems, the "data" would consist of DICOM images (potentially synthetic, proprietary, or from various sites) to confirm proper handling. It's likely a mix of internal, proprietary data, and potentially public DICOM conformance test images. The provenance is not specified (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This submission doesn't describe a study requiring diagnostic "ground truth" established by medical experts. A PACS workstation stores, retrieves, processes, and displays images; it doesn't make diagnostic interpretations itself requiring ground truth for AI performance evaluation. The "ground truth" for its functions would be whether it accurately performs the specified operations (e.g., does it correctly adjust contrast, does it store the image without corruption, does it display it correctly according to the DICOM header). These are typically verified by engineers and quality assurance personnel, not medical experts establishing diagnostic ground truth.

4. Adjudication Method for the Test Set

Not applicable. As no diagnostic performance test set is described, there is no adjudication method mentioned.

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 applicable. This device is a PACS workstation, not an AI or CAD system intended to assist readers in diagnostic interpretation. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The REGIUS Unitea is an image management and processing system, entirely human-in-the-loop, as it's a tool for medical professionals to view and manipulate images. It does not perform any standalone diagnostic analysis or algorithmic interpretation where "algorithm only" performance would be relevant.

7. The Type of Ground Truth Used

Not applicable in the diagnostic sense. The "ground truth" for a PACS system would pertain to its functional performance and adherence to standards:

Functional correctness: Does the software perform its operations (e.g., image processing, storage, display) as specified? (Verified by testing against software requirements and design specifications).
DICOM conformance: Does it correctly interpret and generate DICOM objects? (Verified using DICOM conformance tools and test images).
Image integrity: Are images stored and displayed without degradation or loss of information? (Verified by comparing processed/stored images with their originals, often using objective quality metrics or visual inspection).

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI models that require a "training set." It is a software application developed using traditional programming paradigms.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI model, there is no corresponding ground truth establishment process.

Summary

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K071436

510(k) Summary

1. Company Identification

JUN 2 7 2007

Konica Minolta Medical & Graphic, Inc. 2970 Ishikawa-machi, Hachioji-shi, Tokyo 192-8505, Japan Phone: 81-42-660-9607 Fax: 81-42-660-9588

2. Official Correspondent

Koji Matsushima (Mr.) Manager Standards & Regulations Department Quality Assurance Center

3. Date of Submission

May 21, 2007

4. Establishment Registration No. 3003769120

1. Device Trade Name REGIUS Unitea

6. Common Name

Medical Image Processing Work Station

7. Classification

Class LI, 90 LLZ, 21 CFR 892. 2050, Picture archiving and communications system

8. Predicate Device

REGIUS CS-2000 and CS-3000, 510(k) number: K051523 cleared on Jul.20,2005

9. Description of Device

REGIUS Unitea software has the following set of features.

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1. Feature to automatically obtain patient demographic information (Name, Age, Sex, Date of Birth, etc) from Hospital Information Systems.
1. Feature to specify the reading condition (Sampling Sensitivity of the sensor and so on) of the connected CR device.
1. Receive and store image data from REGIUS MODEL 170, 190 and 100 CR, other DICOM compliant modalities and digital media (such as DVD/CD-R, DSC and USB memory cards).
1. Display image data received from the REGIUS MODEL 170, 190 and 100 CR, other DICOM compliant modalities and digital media (such as DVD/CD-R, DSC and USB memory cards).
1. Feature to apply image processing to images received from REGIUS MODEL 170. 190 and 100 CR.

Image processing applied includes:

1. Contrast and Density Adiustments.
1. F-processing: Frequency processing that highlights fine details in the image, or enhances detail that has been blurred, without affecting density.
1. E-processing: Equalization processing that improves the image quality that cannot be fully expressed by the film latitude due to wide distribution of the subject.
- 1. H-processing: Hybrid processing which combines frequency enhancement processing and equalization processing based on multi-resolution analysis.
1. 1- processing: Integral processing that automatically adjusts luminance (film density) and contrast of an image.
1. Masking: Filis black on the area of the frame where X-ray is not irradiated.
1. Rotating/Flipping: Rotate/Reverse an image.
1. Re-sampling and Resizing: Function that re-samples and resizes the image data.
1. Stitching: Function that manually or automatically recognizes long body part and stitch multiple images to create a composite image. The stitched image can be divided into several small images before outputting to a storage device or film printer.
1. Grid Suppression Function to suppress the grid and moire patterns within the image exposed with the grid
1. Function to add digital marker for patient information and to add annotations to the image data
1. Function that outputs image data to a printer, other DICOM devices and digital media.

10. Intended Use

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software can process and display images from the following modality types: Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and other DICOM compliant modalities. The REGIUS Unitea must not be used for primary image diagnosis in mammography.

11. Substantial Equivalence to Predicate Device

REGIUS Unitea is substantially equivalent to our REGIUS CS-2000 and CS-3000, 510(k) number: K051523. Comparison of the principal characteristics of these devices is shown in the Section 3.

12. Safety Information

REGIUS Unitea introduces no new safety and efficacy issues other than those already identified with the predicate device. The results of a hazard analysis, combined with the appropriate preventive measure taken indicate that the device is of minor level of concern as per the May 11, 2005 issue of the "Guidance for the Content of Premark Submissions for Software Contained in Medical Devices".

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

UN 2 7 2007

Konica Minolta Medical & Graphic, Inc. % Mr. Russell Munves US Agent and Attorney Storch, Amini, & Munves, P.C. 140 East 45th St., 25th Floor Two Grand Central Tower NEW YORK NY 10017

Re: K071436

Trade/Device Name: REGIUS Unitea Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 21, 2007 Received: May 23, 2007

Dear Mr. Munves:

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.

Image /page/3/Picture/9 description: The image is a circular logo for the FDA Centennial, celebrating 1906-2006. The letters "FDA" are prominently displayed in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line beneath the word "Centennial".

roloting and Promoting Public Stoa

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Page 2 -

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 (2) 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.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C Hodgon

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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Indications for Use

510(k) Number (if known)

Device Name REGIUS Unitea

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert Lewis

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K071436

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).