Bone Suppression Software is an image processing technology to improve the visibility of soft tissues in the lung area by suppressing the signals of ribs and clavicles in chest x-ray images.

Device Description

The purpose of this software is to provide Bone Suppression images. The software receives the exposed frontal plain chest X-ray images as inputs, then starts processing each image from the Senciafinder Gateway application. After the software is started, it performs the extraction process of the lung field area and Bone Suppression process to attenuate the signals of bones, and outputs Bone Suppression images with attenuated signals of ribs and clavicles in the extracted lung field area.

In conjunction with the Senciafinder Gateway, images are received from diagnostic imaging equipment via network. Received images are applied Bone Suppression processing and output to image display system such as PACS / workstation via network.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Bone Suppression Software" (K240281) by Konica Minolta, Inc. The core information regarding acceptance criteria and performance studies is present in Section VII, "PERFORMANCE DATA."

However, the provided text explicitly states: "No clinical studies were required to support the substantial equivalence." This means that the 510(k) submission relied on non-clinical performance data and comparison to a predicate device, rather than new clinical trials with human subjects.

Therefore, many of the requested points in your prompt, such as data provenance for a test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance on a clinical test set, and detailed training set information, are not applicable or available from the provided text, because a clinical study (as typically understood in terms of human subjects and diagnostic performance analysis) was not performed or deemed necessary for this 510(k) clearance based on the provided document. The performance data relied on software verification and validation activities.

Here's a breakdown of what can be answered based on the provided text, and what cannot:

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

Acceptance Criteria: The text states, "All the verification and validation activities required by the specification and the risk analysis for the Bone Suppression Software were performed and the results showed that the predetermined acceptance criteria were met." However, the specific acceptance criteria (e.g., in terms of image quality metrics, bone suppression ratios, or processing speed) are not detailed in the provided document.
Reported Device Performance: Similarly, the specific quantitative performance metrics are not reported in the document. It only states that the device "performs as specified and functions as intended."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable for a clinical test set (as no clinical study was required for substantial equivalence). The performance data referred to "Software Verification and Validation Testing," which typically involves simulated data, historical non-clinical data, or controlled laboratory tests, not a clinical "test set" in the diagnostic performance sense. The text does not provide details on the nature or origin of the data used for V&V activities.

3. 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 was performed or required for the 510(k) substantial equivalence, no expert-established ground truth for a clinical test set is mentioned.

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

Not applicable. See point 3.

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

No. The document explicitly states, "No clinical studies were required to support the substantial equivalence." Therefore, no MRMC study evaluating human reader improvement with AI assistance was conducted or reported for this 510(k).

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

The document implies that standalone performance was assessed as part of "Software Verification and Validation Testing" to ensure it "performs as specified and functions as intended." However, the metrics of this standalone performance (e.g., objective image quality measurements, quantitative bone suppression metrics) are not provided in the text. It's a statement that V&V was successful, not a report of the results themselves.

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

Not explicitly stated for the V&V activities. For "Software Verification and Validation Testing," ground truth would typically be established based on the specifications and expected outputs of the software (e.g., if a bone is known to be in a certain location, can the software correctly identify and suppress it?). This is different from clinical ground truth based on expert reads, pathology, or outcomes. The document does not elaborate on how this "ground truth" for V&V was established.

8. The sample size for the training set

Not applicable/Not provided. The document does not mention details about the development (training) of the software. As it's a 510(k) submission, the focus is on verification and validation against a predicate, not detailing the original development process.

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

Not applicable/Not provided. See point 8.

Summary based on the provided text:

The acceptance criteria for the Bone Suppression Software were met through "Software Verification and Validation Activities." These activities confirmed that the device "performs as specified and functions as intended." However, the specific quantitative acceptance criteria and the detailed performance results are not disclosed in this 510(k) summary. Crucially, no clinical studies involving human subjects were required or conducted to support this substantial equivalence determination, meaning aspects like test set data, expert ground truth, adjudication, and MRMC studies are not part of this submission's evidence as described.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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 is 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 Executive Vice President QA/RA Konica Minolta Healthcare Americas, Inc. 411 Newark Pompton Turnpike Wayne, New Jersey 07470

Re: K240281

May 31, 2024

Trade/Device Name: Bone Suppression Software Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: May 1, 2024 Received: May 1, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

{1}------------------------------------------------

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K240281

Device Name Bone Suppression Software

Indications for Use (Describe)

Bone Suppression Software is an image processing technology to improve the visibility of soft tissues in the lung area by suppressing the signals of ribs and clavicles in chest x-ray images.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image contains the Konica Minolta logo. The logo consists of a blue circle with white horizontal lines inside. Below the circle, the words "KONICA MINOLTA" are written in a bold, sans-serif font.

510(k) Summary

K240281

Complying with 21 CFR R §807.92.

I. SUBMITTER

KONICA MINOLTA, INC. 1 Sakura-machi, Hino-shi, Tokyo, 191-8511, Japan

Contact Person: Tsutomu Fukui Phone: Email: Date Prepared: February 1st, 2024

II. DEVICE

Name of Device:	Bone Suppression Software
Common Name:	Radiological Image Processing Software
Classification Name:	Medical Image Management and Processing System(21 CFR 892.2050)
Regulatory Class:	Class II
Product Code:	LLZ

III. PREDICATE DEVICES

Predicate Device: ImagePilot, K210066 Reference Device: Bone Suppression Software, K133442

IV. DEVICE DESCRIPTION

Page 1 of 3 -

Giving Shape to Ideas

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the Konica Minolta logo. The logo consists of a blue circle with white horizontal lines inside, and the words "KONICA MINOLTA" are written in black below the circle. The blue circle is a gradient, with the top being a lighter blue and the bottom being a darker blue.

V. INDICATIONS FOR USE

Bone Suppression Software is an image processing technology to improve the visibility of soft tissues in the lung area by suppressing the signals of ribs and clavicles in chest x-ray images.

The Indications for Use statement for the Bone Suppression Software is similar to the reference device. The differences do not alter the intended use of the device, nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for the function of the bone suppression software, by suppressing the signals of the ribs and clavicles in chest x-ray images.

VI.COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The bone suppression function is available as an integrated optional function within the predicate device. The purpose of the subject device is to be available as a single image processing software device. The subject and predicate devices are based on the same technology to create bone suppression images by attenuating signals from ribs and clavicles in the extracted lung field area.

The following technological differences exist between the subject and predicate devices:

. The subject device must be used in conjunction with the Senciafinder Gateway whereas the predicate device has a bone suppression function incorporated into the system
Use of CR/DR images from own and other vendors.

VII. PERFORMANCE DATA

All the verification and validation activities required by the specification and the risk analysis for the Bone Suppression Software were performed and the results showed that the predetermined acceptance criteria were met. No clinical studies were required to support the substantial equivalence.

Page 2 of 3 -

Giving Shape to Ideas

{5}------------------------------------------------

Image /page/5/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.

Software Verification and Validation

Software Verification and Validation Testing Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions." The software for this device was considered as a "Basic Documentation Level" since a failure or latent flaw of the software function would not present a hazardous situation with a probable risk of death or serious injury to the patient or operator.

VIII. CONCLUSIONS

The technological differences do not raise different issues of safety and/or effectiveness as compared to its predicate device (K210066). Performance testing demonstrates that the Bone Suppression Software performs as specified and functions as intended. It is concluded that the subject device is as safe and effective as the predicate and is substantially equivalent to the predicate device.

Page 3 of 3 -

Giving Shape to Ideas

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).