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 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 text describes a 510(k) premarket notification for the Hitachi SCENARIA View computed tomography x-ray system (K200498). However, it focuses heavily on demonstrating substantial equivalence to a predicate device (SCENARIA View K190841) rather than detailing specific acceptance criteria and a study proving those criteria are met for this new iteration of the device, especially concerning any new AI features.

The document does mention two new features: "Volume Shuttle Scan" and "HiMAR Plus," and a "clinical image study to assess the image quality of the images reconstructed by using FBP and the two new features (HiMAR Plus, Intelli IPV)." It's unclear if "Intelli IPV" is a typo for "Volume Shuttle Scan" or another unmentioned feature.

Given the information provided, I cannot fully answer all aspects of your request as the document does not contain explicit acceptance criteria and detailed study results in the format you've requested for the new features. It primarily states that the overall device performance is "similar to the predicate device" and that "evaluation results confirm the performance characteristics of the SCENARIA View are comparable to the predicate device."

Here's an attempt to organize the available information based on your request, with significant gaps noted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative manner for new features or a direct comparison to specific performance metrics for the subject device (K200498) against pre-defined thresholds. Instead, it relies on demonstrating comparability to a predicate device (K190841) and general compliance with standards.

For the overall system, the document states:

"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."
"The evaluation results confirm the performance characteristics of the SCENARIA View are comparable to the predicate device."

For the new features (HiMAR Plus, Volume Shuttle Scan, and potentially Intelli IPV), specific acceptance criteria and their met performance are not detailed. The phrase "clinical image study to assess the image quality of the images reconstructed by using FBP and the two new features" implies an evaluation, but the results or acceptance criteria for this evaluation are not provided.

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

The document mentions a "clinical image study" for the new features. However, it does not provide any specific information on:

Sample size (number of images or patients) used for this test set.
Data provenance (e.g., country of origin, retrospective or prospective nature).

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

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. It briefly notes a "clinical evaluation comparison was conducted with the SCENARIA View system and the SCENARIA Phase 3 System (K150595) and found to be substantially equivalent," but this appears to be a general comparison of overall system performance rather than a specific MRMC study involving human readers with/without AI assistance.

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

The document does not specify if a standalone performance study was conducted. The mentioned "clinical image study" likely involves subjective evaluation of reconstructed images, which could imply a standalone assessment of image quality, but details are lacking.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used for the "clinical image study." Given the context of image quality assessment for new CT reconstruction features, the ground truth would likely be based on:

Expert Consensus: Radiologist interpretation of image quality parameters.
Physical Phantoms: Quantitative measurements using known phantom properties (though this tends to be more for technical performance aspects like noise and spatial resolution rather than a "clinical image study").

The document mentions evaluations for "dose profile, image noise, Modulation Transfer Function (MTF), slice thickness and sensitivity profile, slice plane location, and CT dose index," which would typically use physical phantoms. However, the "clinical image study" for "image quality of the images reconstructed by using FBP and the two new features" suggests a different type of assessment.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This is expected as the document describes a CT system (hardware and associated software features) rather than a deep learning AI model that typically requires extensive training data. The "new features" like HiMAR Plus (HItachi's Metal Artifact Reduction) are often based on algorithmic improvements rather than learned models from large datasets.

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

As no training set is mentioned in the context of typical AI/ML development, this information is not applicable/provided.

Summary of Gaps:

The FDA 510(k) summary provided is primarily focused on demonstrating substantial equivalence to a predicate device rather than detailing specific, quantitative acceptance criteria and the rigorous testing (especially for any AI components) that would fully answer your questions. While it mentions new features and a clinical image study, critical details such as sample sizes, expert qualifications, and specific results are absent in this public summary. These details would typically be found in the full submission to the FDA.

Summary

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July 17, 2020

Image /page/0/Picture/1 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.

Hitachi Healthcare Americas % Mr. Aaron Pierce Director, RA/QA 1959 Summit Commerce Park TWINSBURG OH 44087

Re: K200498

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: June 4, 2020 Received: June 8, 2020

Dear Mr. Pierce:

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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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,

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) K200498

Device Name SCENARIA View Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

Indications for Use (Describe)

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

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)

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.

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"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."

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Image /page/3/Picture/0 description: The image shows the logo for Hitachi. The word "HITACHI" is written in large, bold, black letters. Below it, the phrase "Inspire the Next" is written in a smaller, less bold font, also in black, with a small red accent mark above the letter "i" in "Inspire."

510(k) Summary

K200498

Submitter Information

Submitter:	Hitachi Healthcare Americas1959 Summit Commerce ParkTwinsburg, Ohio 44087-2371
Contact:	Aaron Pierce
Telephone number:	330-425-1313
Telephone number:	330-963-0749
E-mail:	piercea@hitachihealthcare.com
Date:	June 4, 2020

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 (K190841)
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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Image /page/4/Picture/0 description: The image shows the Hitachi logo. The word "HITACHI" is in bold, black letters on the top line. The words "Inspire the Next" are in a smaller font below the company name.

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 SCENARIA Phase 3 System (K150595) 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 (K190841)Predicate Device
Physical characteristics	Image: Subject Device	Image: Predicate Device
Gantry	There are not differences between the two systems.	There are not differences between the two systems.
Detector	There are not differences between the two systems.	There are not differences between the two systems.
X-ray Tube	There are not differences between the two systems.	There are not differences between the two systems.
X-ray Generator	There are not differences between the two systems.	There are not differences between the two systems.

1959 Summit Commerce Park, Twinsburg, OH 44087 Tel:800-800-3106 www.hitachimed.com

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Image /page/5/Picture/0 description: The image shows the logo for Hitachi. The word "HITACHI" is in large, bold, black letters on the top line. Below that, the words "Inspire the Next" are in a smaller, black font, with a small red accent mark above the letter "t" in "Next".

Systems	SCENARIA ViewSubject Device	SCENARIA View (K190841)Predicate Device
Patient Table	There are not differences between the two systems.
Display	There are not differences between the two systems.
Image Storage	There are not differences between the two systems.
Scanning, Reconstruction	There are not differences between the two systems.
Performance	There are not differences between the two systems.
Dose Controls	There are not differences between the two systems.
Dose Displays	There are not differences between the two systems.
Features	The new Volume Shuttle Scan and HiMAR Plus features have been added.

HiMAR Plus feature provides two strength levels as "standard" and "strong", which can adjust the correction strength in raw data space.

Volume Shuttle Scan is an optional feature for alternating the forward and backward directions of the table, in the same scan range, while at the same time taking scan images and moving the table quickly.

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 technoloqical characteristics.

ITEM	Overall Rationale Analysis
Gantry	There are no significant changes in the SCENARIA View from the predicate device which would affect safety or effectiveness.
Detector
X-ray Tube
X-ray Generator
Patient Table
Display
Image Storage
Scanning, Reconstruction
Performance
Dose Controls
Dose Displays
Features

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

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Image /page/6/Picture/0 description: The image shows the Hitachi logo. The word "HITACHI" is in large, bold, black letters. Below the company name is the slogan "Inspire the Next" in a smaller font, also in black. The letter "t" in "Next" has a small red accent mark above it.

currently marketed predicate device (SCENARIA View (K190841)) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.

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 3.1 ●

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 XR29 Standard Attributes on CT Equipment Related to Dose Optimization and . Management

Summary of Clinical Testing

Hitachi has conducted a clinical image study to assess the image quality of the images reconstructed by using FBP and the two new features. (HiMAR Plus, Intelli IPV).

Conclusions

Hitachi believes that, based on the information included in the submission, SCENARIA View Ph 2 is substantially equivalent with respect to hardware, base elements of the software, safety, effectiveness, and functionality to the SCENARIA View (K190841).

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.