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.

Device Description

KONICAMINOLTA DI-X1 is a software device that performs image processing and display using Xray 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.

Modifications are made to add the TD-MODE, Position Tracking and Signal Value Change. The TD-MODE is designed to extract the initial contour of the tracheal wall. The TD-MODE also displays the minimum and maximum tracheal diameter in the frame. The subject device also incorporates Position Tracking and Signal Value Change. Position Tracking is used to track the reference point specified in a frame and display a graph of the position change data. Signal Value Change graphically displays the signal value change within the ROI specified in a frame.

AI/ML Overview

The provided document is a 510(k) summary for the KONICAMINOLTA DI-X1 device. It describes the device, its intended use, and compares it to a predicate device. However, it explicitly states that "No clinical studies were required to support the substantial equivalence" and that "Performance tests demonstrate that the KONICAMINOLTA DI-X1 performs according to specifications and functions as intended."

This indicates that the submission relies on non-clinical performance data and comparison to a predicate device rather than a comprehensive clinical study involving human readers and AI assistance. Therefore, many of the requested details, such as specific acceptance criteria for AI performance, sample sizes for test sets in a clinical AI study, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and ground truth establishment for a training set in an AI context, are not available in this document.

The document discusses modifications to the device (TD-MODE, Position Tracking, and Signal Value Change) which are new features. While these new features clearly have specific functions (e.g., "TD-MODE is designed to extract the initial contour of the tracheal wall" and "displays the minimum and maximum tracheal diameter"), the document does not provide quantitative acceptance criteria or detailed study results for the performance of these specific new features. Instead, it broadly states that "All the verification activities required by the specification and the risk analysis for the KONICAMINOLTA DI-X1 were performed and the results showed that the predetermined acceptance criteria were met."

Given this, I can only provide information based on what is stated in the document.

Based on the provided FDA 510(k) summary for KONICAMINOLTA DI-X1:

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

The document states that "All the verification activities required by the specification and the risk analysis for the KONICAMINOLTA DI-X1 were performed and the results showed that the predetermined acceptance criteria were met." However, the document does not detail these specific acceptance criteria in a table or quantify the reported device performance against them. It only provides a general statement of compliance.

The new features added are:

TD-MODE: Designed to extract the initial contour of the tracheal wall and display minimum and maximum tracheal diameter in the frame.
Position Tracking: Used to track a specified reference point and display a graph of position change data.
Signal Value Change: Graphically displays signal value change within a specified ROI.

No quantitative performance metrics or specific acceptance criteria for these features are provided in the summarized text.

2. Sample size used for the test set and the data provenance:

The document explicitly states: "No clinical studies were required to support the substantial equivalence." This means there was no clinical test set of patient data used in the typical sense for evaluating AI performance on diagnostic tasks. The evaluation was based on non-clinical performance tests and comparison to a predicate device. Therefore, no information on data provenance (country of origin, retrospective/prospective) for a clinical test set is available.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Since no clinical study with a test set for diagnostic performance was conducted or reported in this summary, there is no information provided on the number or qualifications of experts used to establish ground truth.

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

As no clinical test set for diagnostic performance was utilized, no adjudication method is 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:

The document states: "No clinical studies were required to support the substantial equivalence." Thus, an MRMC comparative effectiveness study was not performed or, if it was, the results are not included in this 510(k) summary. Therefore, no effect size for human reader improvement with AI assistance is available.

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

The document describes the device as a "software device that performs image processing and display" and includes features like TD-MODE, Position Tracking, and Signal Value Change. While these are algorithmic functions, the document only states that "Performance tests demonstrate that the KONICAMINOLTA DI-X1 performs according to specifications and functions as intended." It does not provide specific standalone quantitative performance metrics or a detailed study of the algorithm's performance independent of human interaction for diagnostic purposes.

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

Given the lack of a clinical study assessing diagnostic performance, no type of ground truth (expert consensus, pathology, outcomes data) for such a study is mentioned. The "ground truth" for the device's functionality would likely be derived from the software's specified outputs for given inputs based on engineering verification tests, rather than clinical diagnostic ground truth.

8. The sample size for the training set:

The document does not describe the use of machine learning or AI models that would require a "training set" in the context of diagnostic image analysis. Instead, it describes a software device with image processing and display functions. Therefore, no information on the sample size of a training set is provided.

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

As no training set for machine learning or AI diagnostic models is mentioned, this information is not applicable and not provided.

In summary, the provided 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device based on common intended use, technological characteristics, and principle operations, supported by non-clinical performance verification. It does not contain the details of a clinical study for AI performance as typically seen for devices that provide diagnostic interpretations or assistance.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.

Konica Minolta, Inc. % Jan Maniscalco Executive Vice President QA/RA Konica Minolta Healthcare Americas, Inc. 411 Newark Pompton Turnpike Wayne, New Jersey 07470

Re: K230906

April 25, 2023

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: March 31, 2023 Received: March 31, 2023

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 medical devices and radiation-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.

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of 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) K230906

Device Name KONICAMINOLTA DI-X1

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image shows the Konica Minolta logo along with the text "150 YEARS". The Konica Minolta logo consists of a blue sphere with white lines inside and the company name in black letters. The "150 YEARS" text is in black, with the "150" above a blue line and the word "YEARS" below the line.

510(k) Summary

K23xxxx (will be assigned)

Company:	KONICA MINOLTA, INC.1 Sakura-machi, Hino-shi, 191-8511 Japan
Contact:	Tsutomu FukuiSenior Manager of Regulatory & QMS Division1 Sakura-machi, Hino-shi, 191-8511 JapanTelephone: +81 42 589 8429Email : tsutomu.fukui1@konicaminolta.com
Date Prepared:	March 31, 2023
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:	K212685 - KONICAMINOLTA DI-X1KONICA MINOLTA, INC.Regulation Number: 21 CFR 892.2050Product Codes: LLZ

Device Description

Giving Shape to Ideas

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Image /page/4/Picture/0 description: The image shows the Konica Minolta logo and the text "150 YEARS". The Konica Minolta logo is a blue circle with white horizontal lines inside. The text "KONICA MINOLTA" is written in black letters below the logo. To the right of the logo is the number 150 in large black font with the word "YEARS" written below it.

Indications for Use

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 in diagnostic review for mammography.

Comparison Table

	Subject Device	Predicate Device
Device name	KONICAMINOLTA DI-X1	KONICAMINOLTA DI-X1
Version	1.30	1.20
510(K) Number	This Submission	K212685
Indications forUse	KONICAMINOLTA DI-X1 is a software devicethat receives digital x-ray images and datafrom various sources (i.e. R/F Units, digitalradiographic devices or other imagingsources). Images and data can be stored,communicated, processed and displayedwithin the system and/or across computernetworks at distributed locations. It is notintended for use in diagnostic review formammography.	KONICAMINOLTA DI-X1 is a software devicethat receives digital x-ray images and datafrom various sources (i.e. R/F Units, digitalradiographic devices or other imagingsources). Images and data can be stored,communicated, processed and displayedwithin the system and/or across computernetworks at distributed locations. It is notintended for use in diagnostic review formammography.
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
Image	● REGIUS	● REGIUS

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

Giving Shape to Ideas

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Image /page/5/Picture/0 description: The image shows the Konica Minolta logo. The logo consists of a blue globe with white lines on the left and the text "KONICA MINOLTA" below it. To the right of the logo is the number "150" above a line and the word "YEARS" below the line.

	Subject Device	Predicate Device
Device name	KONICAMINOLTA DI-X1	KONICAMINOLTA DI-X1
Version	1.30	1.20
510(K) Number	This Submission	K212685
Processing	FE-MODE DM-MODE BS-MODE PL-MODE PH-MODE PH2-MODE LM-MODE TD-MODE	FE-MODE DM-MODE BS-MODE PL-MODE Pk to Pk PH-MODE PH2-MODE LM-MODE
DisplayFunctions	Adjustment of density and gradation,Rotation and reversal, Scaling, Panning Screen display (listing, viewer) Image display (Cine, Comparison,Annotation, Overlay) Graph display (Time-series comparison) Graph display the max/min of thetracheal diameter including past images	Adjustment of density and gradation,Rotation and reversal, Scaling, Panning Screen display (listing, viewer) Image display (Cine, Comparison,Annotation, Overlay) Graph display (Time-series comparison)
Measurement	Distance Angle Area CTR (Only the image of the front of thechest) Position Tracking, Signal Value Change	Distance Angle Area CTR (Only the image of the front of thechest)
Client	DI-X1 client DI-X1 Server client PC client (WEB reference)	DI-X1 client DI-X1 Server client PC client (WEB reference)

Performance Data

All the verification activities required by the specification and the risk analysis for the KONICAMINOLTA DI-X1 were performed and the results showed 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 principle operations. The technological differences do not raise new issues of safety or effectiveness as compared to its predicate device (K212685). Performance tests demonstrate that the KONICAMINOLTA DI-X1 performs according to specifications and functions

Giving Shape to Ideas

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Image /page/6/Picture/0 description: The image shows the Konica Minolta logo along with the text "150 YEARS". The Konica Minolta logo consists of a blue globe with white horizontal lines and the text "KONICA MINOLTA" in black. The text "150" is in large black font, with a blue line underneath, and the text "YEARS" is in smaller black font below the line. The logo is likely celebrating the 150th anniversary of Konica Minolta.

as intended. All information supporting our assessment is included in the relevant sections of this submission.

Therefore, it is our conclusion that the KONICAMINOLTA DI-X1 is substantially equivalent to the predicate device and does not raise new issues 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).