The SCENARIA View system is indicated to acquire axial volumes of the whole body including the head. Images can be acquired in axial, helical, or dynamic modes. The SCENARIA View system can also be used for interventional needle guidance.

Volume datasets acquired by a SCENARIA View system can be post-processed in the SCENARIA View system to provide additional information. Post-processing capabilities of the SCENARIA View software include, multi-planar reconstruction (MPR), and volume rendering.

Volume datasets acquired by a SCENARIA View system can be transferred to external devices via a DICOM standard interface.

The Low Dose CT Lung Cancer Screening Option for the SCENARIA View system is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body, a professional medical society, and/or Hitachi.

Device Description

The SCENARIA View is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles.

The SCENARIA View system uses 128-slice CT technology, where the X-ray tube and detector assemblies are mounted on a frame that rotates continuously around the patient using slip ring technology. The solid-state detector assembly design collects up to 64 slices of data simultaneously. The X-ray sub-system features a high frequency generator, X-ray tube, and collimation system that produces a fan beam X-ray output. The system can operate in a helical (spiral) scan mode where the patient table moves during scanning. As the X-ray tube/detector assembly rotates around the patient, data is collected at multiple angles.

The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system. The images are displayed on a Computer Workstation, stored, printed, and archived as required. The workstation is based on current PC technology using the Windows™ operating system.

The SCENARIA View system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories.

AI/ML Overview

The provided document is a 510(k) premarket notification for the FUJIFILM SCENARIA View Computed Tomography x-ray system. This submission primarily focuses on demonstrating substantial equivalence to a predicate device (SCENARIA View K200498) rather than presenting a performance study for a novel AI device with specific acceptance criteria.

The document states: "A clinical evaluation comparison was conducted with the SCENARIA View system and the predicate device (K200498) and found to be substantially equivalent as documented in Section 10 - Performance." However, Section 10 - Performance is not included in the provided document. Without this section, detailed acceptance criteria and reported performance metrics from a specific study are not available.

The only specific performance testing mentioned with some detail is related to a new feature: "FUJIFILM has conducted an evaluation to assess the effectiveness of the images reconstructed by using MCR and a summary of the results is contained in an explanatory document in the Specification section." Again, this "explanatory document in the Specification section" is not provided. Therefore, a complete answer regarding acceptance criteria and performance based on a study is not possible from the given text.

Based on the available information, here's what can be inferred and what is missing:

No Specific Acceptance Criteria or Performance Study for a Novel AI Device is Fully Described in the Provided Text.

The document is a 510(k) submission for a CT system, emphasizing substantial equivalence to a previous version of the same system (SCENARIA View K200498). The primary "study" mentioned is a clinical evaluation comparison to the predicate device and an evaluation of a new feature called Motion Compensate Reconstruction (MCR). While the document asserts these evaluations were conducted and support substantial equivalence, the details of the acceptance criteria and the results of these studies are not present.

The document indicates that comprehensive performance data for the CT system (Dose Profile, Noise, Mean CT number and Uniformity, Spatial Resolution, Tomographic Section Thickness and Sensitivity Profile, Tomographic Plane Location, and CT dose index) were evaluated and found to be unchanged or comparable to the predicate device. However, specific "acceptance criteria" and "reported device performance" in a tabular format are not provided for these metrics, nor are the studies detailing these.

Regarding the MCR feature: The document states that "FUJIFILM has conducted an evaluation to assess the effectiveness of the images reconstructed by using MCR and a summary of the results is contained in an explanatory document in the Specification section." This suggests a study was performed, but its details, acceptance criteria, and specific performance outcomes are not shared in the provided pages.

Based on what is explicitly stated or can be strongly inferred about the evaluation of the MCR feature (as this is the only new "feature" with an explicit "evaluation" mentioned), here's an attempt to answer the questions, highlighting the significant gaps in information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (for MCR, as inferred)	Reported Device Performance (for MCR, as stated)
Details not provided in the document. Would likely relate to reduction of motion artifacts or improvement in image quality.	"effectively reduces motion image" (implied from the purpose of MCR) "effectiveness of the images reconstructed by using MCR" was assessed.

(Note: Without "Section 10 - Performance" and the "explanatory document in the Specification section," the actual acceptance criteria and detailed performance metrics are unavailable.)

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

Sample Size (Test Set): Not specified in the provided document for the MCR evaluation or the clinical evaluation comparison.
Data Provenance: Not specified for any evaluation or data used. It's unclear if the data was retrospective or prospective, or the country of origin.

3. Number of Experts and Qualifications for Ground Truth:

Not specified. The document does not mention the use of experts to establish a ground truth for any evaluation, including the MCR feature.

4. Adjudication Method:

Not specified. No information is given about how findings or image quality assessments were adjudicated.

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

Not explicitly mentioned. The document primarily focuses on technical comparisons and the effectiveness of a new reconstruction algorithm (MCR) in image quality. It does not describe a study comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance:

The MCR feature is an "image reconstruction feature that reduces motion artifacts." This inherently implies an algorithm-only function. However, a formal "standalone performance" study with specific metrics (e.g., accuracy, sensitivity, specificity for identifying or correcting motion) is not described. The evaluation mentioned is about assessing the "effectiveness of the images reconstructed by using MCR," which could refer to qualitative or quantitative image quality assessment.

7. Type of Ground Truth Used:

Not specified. For the MCR evaluation, the ground truth would ideally involve images with known motion artifacts and/or comparison to a higher-fidelity scan if motion was absent. However, this is not detailed in the document. For the overall system, typical CT performance metrics are evaluated against industry standards and physical phantoms.

8. Sample Size for the Training Set:

Not applicable as this is a CT system with a new reconstruction algorithm (MCR), not a deep learning AI model requiring a distinct "training set" in the common sense for AI diagnostics. MCR is likely based on image processing and reconstruction physics, not machine learning that learns from a vast training dataset in the same way a diagnostic AI would.

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

Not applicable for the same reasons as #8.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a CT scanner. It mentions evaluations for new features (like MCR) and overall system performance compared to a predicate device. However, it does not contain the detailed reports, acceptance criteria, or quantitative results of these studies that would typically be expected for a comprehensive answer regarding acceptance criteria and device performance. The key missing pieces are "Section 10 - Performance" and the "explanatory document in the Specification section" that supposedly contain these details.

Summary

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May 23, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and consists of the FDA acronym and the words "U.S. Food & Drug Administration".

FUJIFILM Healthcare Corporation % Dennis Domoracki Senior Regulatory Affairs Specialist FUJIFILM Healthcare Americas Corporation 81 Hartwell Avenue, Suite 300 LEXINGTON MA 02421

Re: K213829

Trade/Device Name: SCENARIA View Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: April 26, 2022 Received: April 28, 2022

Dear Dennis Domoracki:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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.

Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT 8B: Division of Radiological Imaging 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

4-1

510(k) Number (if known)

K213829

Device Name SCENARIA View

Indications for Use (Describe)

Volume datasets acquired by a SCENARIA View system can be transferred to external devices via a DICOM standard interface.

The Low Dose CT Lung Cancer Screening Option for the SCENARIA View system is indicated for using low dose CT for lung cancer screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body, a professional medical society, and/or FUJIFILM Healthcare Americas Corporation.

Type of Use (Select one or both, as applicable)

☑ Research Use Only (RUO) Labeling	☐ For Further Manufacturing Use Only (FFMUO) Labeling
------------------------------------	-------------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Value from Innovation

K213829 510(k) Summary

Submitter Information

Submitter:	FUJIFILM Healthcare Corporation
	2-1, Shintoyofuta,
	Kashiwa-Shi, Chiba, JP 277-0804
Contact:	Dennis Domoracki, Senior Regulatory Affairs Specialist
Telephone number:	(330)-425-1313 Ext:2792
E-mail:	dennis.domoracki@fujifilm.com
Date:	December 3, 2021

Subject Device Name

Trade/Proprietary Name:	SCENARIA View
Regulation Number:	21 CFR 892.1750
Regulation Name:	Computed tomography x-ray system
Product Code	JAK, System, X-Ray, Tomography, Computed
Class	II
Panel	Radiology

Predicate Device Name

Predicate Device(s):	SCENARIA View (K200498)
Regulation Number:	21 CFR 892.1750
Regulation Name:	Computed tomography x-ray system
Product Code	JAK, System, X-Ray, Tomography, Computed
Class	II
Panel	Radiology

Indications for Use

Volume datasets acquired by a SCENARIA View system can be transferred to external devices via a DICOM standard interface.

Device Description

Function

The SCENARIA View is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles.

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Value from Innovation

Scientific Concepts

Physical and Performance Characteristics

The SCENARIA View system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories. The system performance is similar to the predicate device.

Performance Comparison

A clinical evaluation comparison was conducted with the SCENARIA View system and the predicate device (K200498) and found to be substantially equivalent as documented in Section 10 - Performance.

In addition, evaluations were conducted for dose profile, image noise, Modulation Transfer Function (MTF), slice thickness and sensitivity profile, slice plane location, and CT dose index as documented in Section 10 - Performance.

The evaluation results confirm the performance characteristics of the SCENARIA View are comparable to the predicate device and support our conclusion that the subject system is substantially equivalent.

Device Technological Characteristics

A summary of the differences is listed in the following table.

Systems	SCENARIA ViewSubject Device	SCENARIA View (K200498)Predicate Device
Physical characteristics	Image: SCENARIA View Subject Device	Image: SCENARIA View (K200498) Predicate Device
Gantry	The only difference is the Input Voltage has changed to 380/400/480 from 380/400.
Detector	There are no differences between the two systems.
X-ray Tube	There are no differences between the two systems.
X-ray Generator	There are no differences between the two systems.
Patient Table	There are no differences between the two systems.
Display	There are no differences between the two systems.

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Image /page/5/Picture/0 description: The image shows the Fujifilm logo. The logo is black with a red accent on the "i". Below the logo, the words "Value from Innovation" are written in a smaller font. The logo is simple and modern.

Value from Innovation

Systems	SCENARIA View	SCENARIA View (K200498)
	Subject Device	Predicate Device
Image Storage	The Hard Disk has changed to Image: 1 [TB], Raw Data CT-OC-22 : 3 [TB], andRaw Data CT-OC-23B : 2 [TB].
Scanning, Reconstruction	There are no differences between the two systems.
Performance	There are no differences between the two systems.
Dose Controls	There are no differences between the two systems.
Dose Displays	There are no differences between the two systems.
Features	The Image Analysis on External PC (Hyper Q-net V, Exam Split on Hyper Q-Net V), Intelli IPVImage Improvement, and Motion Compensate Reconstruction (MCR), features have beenadded or improved.

Therefore, based on a thorough analysis and comparison of subject device (SCENARIA View) and the predicate device, the technological characteristics do not impact safety and effectiveness.

Substantial Equivalence

A summary decision was based on a thorough analysis and comparison of the functions, scientific concepts, physical and performance characteristics, performance comparison and technological characteristics.

ITEM	OVERALL RATIONALE ANALYSIS
Gantry	Input Voltage 480V is added.
Detector	No changes
X-ray Tube	No changes
X-ray Generator	No changes
Patient Table	No changes
Display	No changes
Image Storage	Size of Raw Data Hard Disk (CT-OC-23B) is reduced. However, max numberof Raw Data (6000 scan) is not changed.
Scanning,Reconstruction	No changes
Performance	No changes
Dose Controls	No changes
Dose Displays	No changes
Features	Some of image analysis is allowed on external PC connected to the CT device.These analyzes are the same as those implemented in the predicate device.Low contrast enhancement for head is added. It is improvement of Intelli IPValready implemented on the predicate device.MCR is an image reconstruction feature that reduces motion artifacts.

Therefore, based on a thorough analysis and comparison of the functions, scientific concepts, physical and performance characteristics, performance comparison and technological characteristics, the proposed SCENARIA View is considered substantially equivalent to the currently marketed predicate device (SCENARIA View (K200498)) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.

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Value from Innovation

Summary of Non-Clinical Testing

This device complies with all applicable requirements for Dose Profile. Noise. Mean CT number and Uniformity, Spatial Resolution, Tomographic Section Thickness and Sensitivity Profile, Tomographic Plane Location, and CT dose index.

In addition, the SCENARIA View system is in conformance with the applicable parts of the following standards:

AAMI ANSI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and . A2:2010/(R)2012
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2 Edition 4.0 .
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
. IEC 60601-1-3 Edition 2.1
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
. IEC 60601-1-6 Edition 3.1
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-2-44 Edition 3.2
Medical electrical equipment Part 2-44: particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography.
. IEC 62304 Edition 1.1
Medical device software - Software life cycle processes
. IEC 62366 Edition 1.1
Medical devices - Application of usability engineering to medical devices
NEMA XR 25 Computed Tomography Dose Check
NEMA XR-26 Access Controls for Computed Tomography
. NEMA XR29 Standard Attributes on CT Equipment Related to Dose Optimization and Management

Summary of Performance Testing

Testing Type	Rationale Analysis
Performance Testing - Bench	There is no change is the following performance issues:Dose Profile, Noise, Mean CT number and Uniformity, Spatial Resolution, TomographicSection Thickness and Sensitivity Profile, Tomographic Plane Location, CT Dose Index.
Performance Testing - Clinical	FUJIFILM has conducted an evaluation to assess the effectiveness of the imagesreconstructed by using MCR and a summary of the results is contained in an explanatorydocument in the Specification section.

Conclusions

FUJIFILM believes that, based on the information included in the submission, SCENARIA View subject device is substantially equivalent with respect to hardware, base elements of the software, safety, effectiveness, and functionality to the SCENARIA View (K200498).

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.