KONICAMINOLTA DI-X1 is a software device that receives digital x-ray images and data from various sources (i.e. R/F Units, digital radiographic devices or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and/or across computer networks at distributed locations. It is not intended for use in diagnostic review for mammography.

Device Description

KONICAMINOLTA DI-X1 is a software device that performs image processing and display using X-ray digital images (single-frame images, multi-frame images) generated by various diagnostic imaging modality consoles. It is a standalone software device intended to install onto off-the -shelf Servers and PCs. KONICAMINOLTA DI-X1 receives X-ray digital images, including serial images, processes the received images, as well as displays and sends the resulting images to PACS and other devices. In addition, KONICAMINOLTA DI-X1 can display images through the browser connection with the client that displays and process images, and instruct transmission of images. The personal computer used in KONICAMINOLTA DI-X1 stores the same data in two hard disks in real time using RAID1 mirroring function. Thus, even if one hard disk is defective, operations can be continued with the other hard disk which has the same data. The modifications are made on software to the identified predicate device to add the PC client to connect to the server using the browser on a personal computer to display images for a WEB reference. In addition, additional imaging processing MODES are implemented into the subject device. The subject device also modifies the graphical display to compare the past exam. graphs based on the measurement values in a chronological order.

AI/ML Overview

Let's break down the information about the acceptance criteria and performance study for the KONICAMINOLTA DI-X1 device based on the provided FDA 510(k) summary.

It's important to note that the provided document does not contain a detailed performance study with human readers, specific metrics for AI performance (like sensitivity/specificity), or the methodologies for establishing ground truth for a test set. The submission states that "No clinical studies were required to support the substantial equivalence." This implies that the device's modifications are considered minor enough that extensive clinical validation, as would be expected for a novel AI diagnostic device, was not necessary.

The focus of this submission is on demonstrating substantial equivalence to a predicate device (K182431) for a medical image management and processing system, not a new diagnostic AI algorithm. The "modifications are made on software... to add the PC client to connect to the server using the browser... and additional imaging processing MODES are implemented... The subject device also modifies the graphical display to compare the past exam. graphs based on the measurement values in a chronological order." This suggests the "performance data" refers to validation of these functional additions and software changes, rather than a diagnostic accuracy study.

Therefore, many of the requested points regarding AI performance and human reader studies cannot be precisely answered from this document.

Here's the breakdown based on the provided text, with clarifications where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Inferred from Device Description & Changes)	Reported Device Performance
Functional Equivalence to Predicate Device	The device has the same intended use, indications for use, technological characteristics, and principal operations as the predicate device (K182431).
Correct Operation of New Features:
* PC client connectivity via browser for WEB reference	Demonstrated to function as intended. (Implied by the statement: "Performance tests demonstrate that the KONICAMINOLTA DI-X1 performs according to specifications and functions as intended.")
* New Imaging Processing Modes (PH-MODE, PH2-MODE, LM-MODE)	Demonstrated to function as intended. (Implied by the statement: "Performance tests demonstrate that the KONICAMINOLTA DI-X1 performs according to specifications and functions as intended.")
* Modified graphical display for chronological comparison of past exam graphs based on measurement values	Demonstrated to function as intended. (Implied by the statement: "Performance tests demonstrate that the KONICAMINOLTA DI-X1 performs according to specifications and functions as intended.")
Data Integrity and Reliability (RAID1 mirroring)	"The personal computer used in KONICAMINOLTA DI-X1 stores the same data in two hard disks in real time using RAID1 mirroring function. Thus, even if one hard disk is defective, operations can be continued with the other hard disk which has the same data." (This is a design feature, its successful implementation and testing would be part of "performance tests.").
Meeting all specifications and risk analysis requirements	"All the verification activities required by the specification and the risk analysis for the KONICAMINOLTA DI-X1 were performed and the results demonstrated that the predetermined acceptance criteria were met."
No new issues of safety or effectiveness	"The technological differences raised no new issues of safety or effectiveness as compared to its predicate device (K182431)."

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

The document does not specify a distinct "test set" in the context of a clinical performance study for an AI algorithm. The performance data section states: "All the verification activities required by the specification and the risk analysis for the KONICAMINOLTA DI-X1 were performed and the results demonstrated that the predetermined acceptance criteria were met. No clinical studies were required to support the substantial equivalence."

This indicates that the "testing" was likely functional and verification testing of the software's new features and overall operation, rather than a diagnostic accuracy evaluation on a patient image dataset. Therefore, information regarding data provenance (country of origin, retrospective/prospective) and sample size for such a test set is not provided because such a clinical test set was not deemed necessary for this submission.

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

Not applicable. As noted above, no clinical study requiring expert-established ground truth on a test set for diagnostic accuracy was reported or required for this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. No clinical study requiring ground truth adjudication was reported.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "No clinical studies were required to support the substantial equivalence." Therefore, an MRMC study comparing human readers with and without AI assistance was not performed or reported.

6. Standalone (Algorithm Only) Performance

No. This device is described as a "medical image management and processing system" with enhancements, not a standalone AI diagnostic algorithm performing a specific diagnostic task (like detecting a disease). Its primary function is image handling, processing, and display. Therefore, a standalone performance metric (e.g., sensitivity/specificity for a disease) is not provided or applicable in the context of this submission.

7. Type of Ground Truth Used

Based on the lack of a clinical study, specific "ground truth" for diagnostic accuracy (e.g., pathology, outcomes data, expert consensus) was not established or used for performance evaluation in this 510(k). The "performance tests" focused on verifying the software's functional specifications.

8. Sample Size for the Training Set

Not applicable. This device is described as an image management and processing system, not a device incorporating a machine learning model that requires a "training set" in the typical sense of AI development for diagnostic tasks. The "modifications" were software developments, not AI model training.

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

Not applicable, as there was no AI model training set as described in typical AI/ML submissions.

Summary

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September 13, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Konica Minolta, Inc. % Jan Maniscalco Director of QA/RA Konica Minolta Healthcare Americas, Inc. 411 Newark-Pompton Turnpike WAYNE NJ 07470

Re: K212685

Trade/Device Name: KONICAMINOLTA DI-X1 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: August 16, 2021 Received: August 24, 2021

Dear Jan Maniscalco:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

, for

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212685

Device Name KONICAMINOLTA DI-X1

Indications for Use (Describe)

KONICAMINOLTA DI-X1 is a software device that receives digital x-ray images and data from various sources (i.e. RF Units, digital radiographic devices or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and/or across computer networks at distributed locations. It is not intended for use in diagnostic review for mammography.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K212685

Company:	KONICA MINOLTA, INC.1 Sakura-machi, Hino-shi, Tokyo, 191-8511 Japan
Contact:	Tsutomu FukuiSenior Manager of Regulatory & QMS Division1 Sakura-machi, Hino-shi, Tokyo, 191-8511 JapanTelephone: +81 42 589 8429Email : tsutomu.fukui1@konicaminolta.com
Date Prepared:	September 08, 2021
Device Name:
Trade Name:	KONICAMINOLTA DI-X1
Common Name:	Medical Image Management and Processing System
Regulation Number:	21 CFR 892.2050
Regulatory Class:	Class II
Product Code(s):	LLZ
Predicate Device:	K182431 - KONICAMINOLTA DI-X1KONICA MINOLTA, INC.Regulation Number: 21 CFR 892.2050Regulatory Class: Class IIProduct Codes: LLZ

Device Description

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Giving Shape to Ideas

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Image /page/4/Picture/0 description: The image shows the logo for Konica Minolta. The logo consists of a blue circle with several horizontal white lines across the middle. Below the circle is the text "KONICA MINOLTA" in a bold, sans-serif font.

KONICAMINOLTA DI-X1 receives X-ray digital images, including serial images, processes the received images, as well as displays and sends the resulting images to PACS and other devices. In addition, KONICAMINOLTA DI-X1 can display images through the browser connection with the client that displays and process images, and instruct transmission of images.

The personal computer used in KONICAMINOLTA DI-X1 stores the same data in two hard disks in real time using RAID1 mirroring function. Thus, even if one hard disk is defective, operations can be continued with the other hard disk which has the same data.

The modifications are made on software to the identified predicate device to add the PC client to connect to the server using the browser on a personal computer to display images for a WEB reference. In addition, additional imaging processing MODES are implemented into the subject device. The subject device also modifies the graphical display to compare the past exam. graphs based on the measurement values in a chronological order.

Indications for Use

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Comparison Table

The comparison to the predicate decides was summarized in the Table below.

	Subject Device	Predicate Device
	KONICAMINOLTA DI-X1	KONICAMINOLTA DI-X1
510(K) Number	This Submission	K182431
Indications forUse	KONICAMINOLTA DI-X1 is a softwaredevice that receives digital x-ray imagesand data from various sources (i.e. R/FUnits, digital radiographic devices orother imaging sources). Images and datacan be stored, communicated, processedand displayed within the system and/oracross computer networks at distributedlocations. It is not intended for use indiagnostic review for mammography.	KONICAMINOLTA DI-X1 is a softwaredevice that receives digital x-ray imagesand data from various sources (i.e. R/FUnits, digital radiographic devices or otherimaging sources). Images and data can bestored, communicated, processed anddisplayed within the system and/or acrosscomputer networks at distributedlocations. It is not intended for use indiagnostic review for mammography.
Input image	● DICOM 3.0● DICOM Modality (RF, DX, CR)	● DICOM 3.0● DICOM Modality (RF, DX, CR)
I/O Data	● DICOM Storage	● DICOM Storage
ImageProcessing	● REGIUS● FE-MODE● DM-MODE● BS-MODE● PL-MODE● Pk to Pk● PH-MODE● PH2-MODE● LM-MODE	● REGIUS● FE-MODE● DM-MODE● BS-MODE● PL-MODE● Pk to Pk
DisplayFunctions	● Adjustment of density andgradation, Rotation and reversal,Scaling, Panning● Screen display (listing, viewer)● Image display (Cine, Comparison,Annotation, Overlay)● Graph display (Time-seriescomparison)	● Adjustment of density and gradation,Rotation and reversal, Scaling,Panning● Screen display (listing, viewer)● Image display (Cine, Comparison,Annotation, Overlay)● Graph display
Measurement	● Distance● Angle● Area● CTR (Only the image of the front ofthe chest)	● Distance● Angle● Area● CTR
Client	● DI-X1 client● DI-X1 Server client● PC client (WEB reference)	● DI-X1 client● DI-X1 Server client

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Giving Shape to Ideas

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Image /page/6/Picture/0 description: The image contains the Konica Minolta logo. The logo features a blue globe-like shape at the top with several horizontal white lines running across it. Below the globe is the text "KONICA MINOLTA" in a simple, sans-serif font.

Performance Data

All the verification activities required by the specification and the risk analysis for the KONICAMINOLTA DI-X1 were performed and the results demonstrated that the predetermined acceptance criteria were met. No clinical studies were required to support the substantial equivalence.

Conclusion

KONICAMINOLTA DI-X1 has the same intended use and indications for use, technological characteristics, and principal operations. The technological differences raised no new issues of safety or effectiveness as compared to its predicate device (K182431). Performance tests demonstrate that the KONICAMINOLTA DI-X1 performs according to specifications and functions as intended. All the information to demonstrate assurance of our evaluation is attached to relevant sections of this submission.

Therefore, as for our conclusion, the KONICAMINOLTA DI-X1 is substantially equivalent to the predicate device and presents no new questions of safety or effectiveness.

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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).