The Trinias is an angiographic X-ray system which is used for diagnostic imaging and interventional procedures. The Trinias is intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures

Device Description

Trinias is an interventional fluoroscopic x-ray system which uses digital x-ray receptor panels for image acquisition. The system has been modified to include new image enhancement software feature called "SCORE Opera." This new feature applies AI (deep learning technology) filter technology to enable efficient noise suppression and contrast enhancement, and to improve the visibility of devices that are generally difficult to achieve under low dose conditions, catheters for example.

AI/ML Overview

The provided FDA 510(k) clearance letter and its associated summary for the "Trinias X-Ray System" (K252099) offer some details about the device's enhanced features and the studies conducted. However, it does not contain enough specific information to fully describe the acceptance criteria and the study that proves the device meets those criteria in the comprehensive manner requested.

Specifically, the document states:

"The software was then subjected to non-clinical testing. Summary of non-clinical testing: We provided these detailed non-clinical test reports: The SCORE Opera Development process of leaning model AND a 2D Image Quality Evaluation Report."
"Clinical testing: A clinical image quality study was conducted. The objective of the study was to evaluate the clinical image quality of X-ray images processed by the Trinias system's AI algorithm. The study aims to confirm that the AI-enhanced images (AI-ON) maintain diagnostic quality compared to standard image processing (AI-OFF). This assessment is submitted to support the determination of substantial equivalence. The results confirm that the AI-ON processing frequently provides improved visibility of interventional devices and vessels."

While these passages indicate that studies were performed, they lack crucial quantitative and qualitative details required to answer the specific questions below. The FDA 510(k) summary is generally an abbreviated public document; more detailed information would typically be found in the full 510(k) submission itself (which is not provided here).

Therefore, I will extract and present what can be deduced from the provided text, and explicitly state when information is missing.

Acceptance Criteria and Device Performance Study (K252099 - Trinias X-Ray System)

1. Table of Acceptance Criteria and Reported Device Performance

Criterion Description (Inferred from Study Objective)	Acceptance Criteria (Not explicitly stated in the provided text, but inferred goal)	Reported Device Performance (From "Clinical Image Quality Study")
Clinical Image Quality: Diagnostic Quality	AI-enhanced images (AI-ON) must maintain diagnostic quality compared to standard image processing (AI-OFF).	"The results confirm that the AI-ON processing frequently provides improved visibility of interventional devices and vessels."
Clinical Image Quality: Visibility of Devices	Specific metric or threshold not stated. (Implied: Improve or at least not degrade visibility)	"Frequently provides improved visibility of interventional devices and vessels."
Noise Suppression & Contrast Enhancement	Specific metrics or thresholds not stated in document.	AI (deep learning technology) filter applied "to enable efficient noise suppression and contrast enhancement."
Safety and Effectiveness	Not to present any new issues of safety and effectiveness compared to predicate.	"Does not present any new issues of safety and effectiveness." "Performs as well as or better than our predicate."

Missing Information: The document does not provide specific, quantifiable acceptance criteria (e.g., "AI-ON images must achieve a minimum diagnostic rate of X%," or "visibility scores must improve by Y points on a Z-point scale"). The reported performance is qualitative and comparative.

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

Sample Size for Test Set: Not specified. The document mentions "A clinical image quality study was conducted" but provides no details on the number of images or cases included in this study.
Data Provenance: Not specified. The country of origin of the data (e.g., images) used in the clinical study is not mentioned. It is unclear if the data was retrospective or prospective.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. No information is given on how discrepancies among experts (if multiple were used) were resolved or how the final "ground truth" for diagnostic quality and visibility was established.

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

MRMC Study Done: Not explicitly stated as an MRMC study, but a "clinical image quality study" comparing AI-ON and AI-OFF was conducted. This type of study often involves human readers, which aligns with the spirit of an MRMC study, even if not formally named such. The document states, "The study aims to confirm that the AI-enhanced images (AI-ON) maintain diagnostic quality compared to standard image processing (AI-OFF)."
Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance: Not quantified or reported. The document only qualitatively states that "the AI-ON processing frequently provides improved visibility of interventional devices and vessels." It does not provide any statistical effect size or direct measure of how much human readers improved their diagnostic performance or speed with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study Done: Yes, implicitly. The AI algorithm's function is described as processing images ("AI (deep learning technology) filter technology to enable efficient noise suppression and contrast enhancement"). The "2D Image Quality Evaluation Report" mentioned under non-clinical testing likely includes standalone evaluations of the algorithm's output before human review, though specific metrics are not provided in this summary. The clinical study compared images from AI-ON vs. AI-OFF processing, implying these are the outputs of the standalone algorithm before human interpretation.

7. Type of Ground Truth Used

Type of Ground Truth: Inferred to be expert consensus or expert interpretation. For a "clinical image quality study" aiming to assess "diagnostic quality" and "visibility of interventional devices and vessels," the ground truth would most typically be established by experienced clinicians (e.g., interventional radiologists/cardiologists) who review and rate the images. The document does not mention pathology, outcomes data, or other objective measures for ground truth.

8. Sample Size for the Training Set

Sample Size for Training Set: Not specified. The document mentions "The SCORE Opera Development process of leaning model" (likely meaning "learning model"), indicating AI/deep learning training, but no details about the size or characteristics of the training data are provided.

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

How Ground Truth Was Established (Training Set): Not specified. For a deep learning model, the training set would require labeled data. The method for generating these labels (ground truth) is not described. This could involve manual annotation by experts, consensus, or other automated/semi-automated methods, but the document is silent on this point.

In summary, while the K252099 document confirms that a clinical image quality study and non-clinical evaluations were performed to support the new "SCORE Opera" AI feature, it lacks specific quantitative acceptance criteria, sample sizes for test and training data, details on expert qualifications, and the formal methodologies for ground truth establishment and adjudication. The reported performance is qualitative, stating "improved visibility" and maintenance of "diagnostic quality."

Summary

FDA 510(k) Clearance Letter - Trinias X-Ray System

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U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.08.03
Silver Spring, MD 20993
www.fda.gov

March 24, 2026

Shimadzu Corporation
℅ Daniel Kamm
Principal Engineer
Kamm & Associates
8870 Ravello Ct
NAPLES, FL 34114

Re: K252099
Trade/Device Name: Trinias
Regulation Number: 21 CFR 892.1650
Regulation Name: Image-Intensified Fluoroscopic X-Ray System
Regulatory Class: Class II
Product Code: OWB, QIH
Dated: February 10, 2026
Received: February 10, 2026

Dear Daniel Kamm:

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.

FDA U.S. FOOD & DRUG ADMINISTRATION

March 24, 2026

Shimadzu Corporation
℅ Daniel Kamm
Principal Engineer
Kamm & Associates
8870 Ravello Ct
NAPLES, FL 34114

Dear Daniel Kamm:

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K252099 - Daniel Kamm Page 2

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).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K252099 - Daniel Kamm Page 3

assistance/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,

Lu Jiang

Lu Jiang, Ph.D.
Assistant Director
Diagnostic X-Ray Systems 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

Enclosure

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Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. K252099

Please provide the device trade name(s).
Trinias

Please provide your Indications for Use below.

Please select the types of uses (select one or both, as applicable).

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

Trinias Page 8 of 43

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510(k) Summary

510(k)#: K252099 Prepared on: 2026-03-23

Contact Details

21 CFR 807.92(a)(1)

Field	Information
Applicant Name	Shimadzu Corporation
Applicant Address	1, Nishinokyo Kuwabara-cho, Nakagyo-ku, Kyoto 604-8511 Japan
Applicant Contact Telephone	+81-75-8231305
Applicant Contact	Mr. Koichi Kataoka
Applicant Contact Email	k_koichi@shimadzu.co.jp
Correspondent Name	Kamm & Associates
Correspondent Address	8870 Ravello Ct Naples FL 34114 United States
Correspondent Contact Telephone	847-374-1727
Correspondent Contact	Mr. Daniel Kamm, P.E.
Correspondent Contact Email	fda.help.now@gmail.com

Device Name

21 CFR 807.92(a)(2)

Field	Information
Device Trade Name	Trinias
Common Name	Interventional Fluoroscopic X-Ray System
Classification Name	Image-intensified fluoroscopic x-ray system
Regulation Number	892.1650
Product Code(s)	OWB, QIH

Legally Marketed Predicate Devices

21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K221922	Trinias	OWB

Device Description Summary

21 CFR 807.92(a)(4)

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

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Indications for Use Comparison

21 CFR 807.92(a)(5)

The indications for use are the same as the predicate. The modified device provides improved image processing. The enhancement is called SCORE Opera. SCORE Opera applies AI (deep learning technology) filter technology to enable efficient noise suppression and contrast enhancement, and to improve the visibility of devices that are generally difficult to achieve under low dose conditions. In addition to reducing radiation exposure, the burden of image diagnosis to physicians will be reduced, reducing treatment time. The system indications for use remains unchanged: The Trinias is an angiographic X-ray system which is used for diagnostic imaging and interventional procedures. The Trinias is intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures

Technological Comparison

21 CFR 807.92(a)(6)

Both the predicate and the proposed devices have the same technological characteristics (i.e., design, material, chemical composition, principle of operation, energy source, etc) except the modified device provides improved image enhancement capabilities.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

The software was developed and tested in accordance with these FDA Guidance Documents: Content of Premarket Submissions for Device Software Functions, Guidance for Industry and Food and Drug Administration Staff AND Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Guidance for Industry and Food and Drug Administration Staff. The software was then subjected to non-clinical testing. Summary of non-clinical testing: We provided these detailed non-clinical test reports: The SCORE Opera Development process of leaning model AND a 2D Image Quality Evaluation Report.

Clinical testing: A clinical image quality study was conducted. The objective of the study was to evaluate the clinical image quality of X-ray images processed by the Trinias system's AI algorithm. The study aims to confirm that the AI-enhanced images (AI-ON) maintain diagnostic quality compared to standard image processing (AI-OFF). This assessment is submitted to support the determination of substantial equivalence. The results confirm that the AI-ON processing frequently provides improved visibility of interventional devices and vessels.

After reviewing all of the nonclinical tests we conducted on our modified device, we have concluded that our device is as safe and effective as our predicate device and it does not present any new issues of safety and effectiveness. Our modified device performs as well as or better than our predicate. Clinical testing is not required for a finding of substantial equivalence.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.