-The SONIALVISION G4 is intended to be used for the fluoroscopy/radiography diagnosis in hospital.
The equipment must only be operated by qualified personnel, such as radiography technicians or those with equivalent qualifications.
The system is used for total patient population.
This system is NOT intended to be used for Mammography screening.
This system is NOT intended to be used for interventional procedure.
This system is used for radiographic, fluoroscopic, angiographic and pediatric examinations.
Stored images in this system can be used for re-monitoring, image processing, storing to optical media (CD/DVD), and sending to DICOM server.

Device Description

The Shimadzu SONIALVISION G4 is a universal X-ray RF system offering radiographic, fluoroscopic and angiographic techniques. The Shimadzu SONIALVISION G4 is floor mounted table, and the system can be configured with Digital Radiography System, X-ray High Voltage Generator, Collimator and X-ray Tube.

AI/ML Overview

The provided text describes a 510(k) submission for the SHIMADZU SONIALVISION G4, an X-ray TV system. The submission focuses on demonstrating substantial equivalence to a predicate device (DAR-8000F, K052500) rather than establishing novel acceptance criteria for a new device's performance against specific metrics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define distinct "acceptance criteria" in the format of specific numerical thresholds for diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Equivalence in ability to acquire X-ray images, demonstrated through linearity, MTF, DQE, and Density resolution, with performance comparable to the predicate device.	"both have enough performance to acquire X-ray images"
Overall clinical diagnostic capability equivalent to the predicate device.	"Result of overall clinical review confirmed that new device is substantially equivalent to the predicate device in aspect of its diagnostic capability."
Compliance with relevant electrical safety and performance standards.	Complies with AAMI/ANSI ES 60601-1:2005, IEC 60601-2-54 Edition 1.0:2009, and other involved standards.
Risk analysis completed and risk controls implemented.	Risk analysis completed and risk controls implemented to mitigate identified hazards.
All software specifications fulfilled acceptance criteria.	"The testing results support that all the software specifications have fulfilled the acceptance criteria."

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

Sample size for test set: The text mentions a "concurrence study of clinical images" but does not specify the number of clinical images or patients included in this study.
Data provenance: Not explicitly stated, however, the study was reviewed by a "U.S. radiologist," suggesting the clinical images might have been relevant to a U.S. clinical context, though their origin (country, etc.) is not specified. The study was conducted for the purpose of a 510(k) submission to the FDA.
Retrospective or prospective: Not explicitly stated. The description "concurrence study of clinical images" could imply either.

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

Number of experts: The text states the concurrence study "was reviewed by an U.S. radiologist." This implies one expert was primarily responsible for the review reported in the submission.
Qualifications of experts: "an U.S. radiologist." No further details on years of experience, subspecialty, Board Certification, etc., are provided.

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

Adjudication method: Not specified. Since only one radiologist is mentioned as reviewing the study, it suggests an adjudication method for multiple readers was likely none or not applicable in the way implied by "2+1" or "3+1". The review seemed to be a direct comparison by a single radiologist.

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

MRMC study: No, an MRMC comparative effectiveness study, especially one involving AI assistance, was not performed. The study was a "concurrence study of clinical images between subject device and its predicate device" reviewed by a single radiologist to confirm substantial equivalence in diagnostic capability, not to assess reader improvement with AI. This product is an X-ray system, not an AI-powered diagnostic tool.

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

Standalone algorithm performance: Not applicable. The SONIALVISION G4 is an X-ray imaging system, not an AI algorithm. Its performance is evaluated as an imaging device.

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

Type of ground truth: Not explicitly defined as a formal "ground truth" establishment process. The "concurrence study of clinical images" involved a U.S. radiologist reviewing the images from both the subject and predicate devices to determine diagnostic capability. This implies that the accepted clinical interpretation by that radiologist served as the basis for comparison, which could be considered a form of expert interpretation/clinical judgment in the context of demonstrating equivalence. It is not explicitly stated if this was compared against a separate, independent "ground truth" such as pathology or long-term outcomes.

8. The sample size for the training set

Sample size for training set: Not applicable/Not mentioned. This submission describes an X-ray imaging system, not an AI algorithm that undergoes a "training set" phase. Device development involved "verification and validation testing as well as phantom testing," but not a "training set" in the context of machine learning.

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

Ground truth for training set: Not applicable/Not mentioned. As this is not an AI device, there is no "training set" or corresponding "ground truth" to establish in that context.

Summary

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510(k) Notification Submission, SONIALVISION G4

MAR 2 8 2014

SECTION V:

510(k) Summary

The following information is submitted in accordance with the requirements of 21 CFR§807.92.

1) Date of Submission

April 2nd, 2013

2) Submitter

SHIMADZU CORPORATION

1, Nishinokyo-Kuwabaracho, Nakagyo-ku, Kyoto city, JAPAN 604-8511 Registration Number: 8030233 Phone: +81-75-823-1305 FAX: +81-75-823-1377

3) Primary Contact Person

Yoshihiro Mukuta Phone: +81-75-823-1305 E-mail: mukuta@shimadzu.co.jp

4) Secondary Contact Person

Don Karle SHIMADZU MEDICAL SYSTEMS 20101 South Vermont Ave., Torrance, CA 90502 Phone: 310-217-8855 ext 109 Email: karle@shimadzu-usa.com

5) The Device Name

Trade Name	X-RAY TV SYSTEM SONIALVISION G4
Common Name	X-RAY RF SYSTEM
Regulation Description	Image-intensified fluoroscopic x-ray system
Classification Panel	Radiology
CFR Section	21 CFR§892.1650
Device Class	Class II
Product Code	90 JAA

6) Legally Marketed Predicate Device

K052500	DAR-8000F
---------	-----------

KBI075
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510(k) Notification Submission, SONIALVISION G4

SECTION V:

510(k) Summary

7) Description of the Device

8) Intended Use

The SONIALVISION G4 is intended to be used for the fluoroscopy and radiography diagnosis. This system is operated and used by the physicians and X-ray technologist in a hospital. The system is used for total patient population. This system is used for radiographic, fluoroscopic, angiographic and pediatric examinations.

9) Indications for Use

The SONIALVISION G4 is intended to be used for the fluoroscopy/radiography diagnosis in hospital. The equipment must only be operated by qualified personnel, such as radiography technicians or those with equivalent qualifications.

The system is used for total patient population. This system is NOT intended to be used for Mammography screening. This system is NOT intended to be used for interventional procedure. This system is used for radiographic, fluoroscopic, angiographic and pediatric examinations. Stored images in this system can be used for re-monitoring, image processing, storing to optical media (CD/DVD), and sending to DICOM server.

Differences of indications are just additional information for usage, and those do not affect the safety and effectiveness of the device when used as labeled.

10) Technological Characteristics

The fundamental technologies of the SONIALVISION G4 are same as the predicate device. Modification was made in the material of Solid State Detector in the Digital Radiography System, which is similar to the predicate device regarding technical characteristic, performance and intended use. The safety and effectiveness is equivalent to the predicate device.

11) Non-clinical Performance Testing

Non-clinical performance testing was performed for the SONIALVISION G4 during product development, which includes verification and validation testing as well as phantom testing. The risk analysis was completed and risk controls implemented to mitigate identified hazards. The testing results support that all the software specifications have fulfilled the acceptance criteria.

The system complies to AAMI/ANSI ES 60601-1:2005, IEC 60601-2-54 Edition 1.0:2009 and other involved standards and applicable performance standards for radiation emitting products of this premarket submission.

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510(k) Notification Submission, SONIALVISION G4

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SECTION V:

510(k) Summary

We also conducted a performance bench test, comparing with image quality of both predicate device and modified device. Linearity, MTF, DQE and Density resolution of two detectors were measured and we estimated that both have enough performance to acquire X-ray images. ·

12) Clinical Testing

We performed concurrence study of clinical images between subject device and its predicate device, which was reviewed by an U.S. radiologist. The result of overall clinical review confirmed that new device is substantially equivalent to the predicate device in aspect of its diagnostic capability.

13) Conclusion

From the result of nonclinical and clinical testing discussed above, it is our conclusion that the SONIALVISION G4 is substantially equivalent to the commercially available predicate device DAR-8000f, which was cleared on Oct 17, 2005 with K052500.

This device is as safe, as effective, and performs as well as or better than the predicate device.

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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES USA

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 28, 2014

SHIMADZU CORPORATION % Mr. Don Karle. Manager. Customer Service Shimadzu Medical Systems 20101 South Vermont Avenue TORRANCE CA 90502-1328

Re: K131075

Trade/Device Name: X-RAY TV SYSTEM SONIALVISION G4 Regulation Number: 21 CFR 892.1650. Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: February 18, 2014 Received: February 21, 2014

Dear Mr. Karle:

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. 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 cither 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Мг. Karle

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/McdicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

Smh.7)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K131075

Device Name SONIALVISION G4

Indications for Use (Describe)

-The SONIALVISION G4 is intended to be used for the fluoroscopy/radiography diagnosis in hospital.
The equipment must only be operated by qualified personnel, such as radiography technicians or those with equivalent qualifications.
The system is used for total patient population.
This system is NOT intended to be used for Mammography screening.
This system is NOT intended to be used for interventional procedure.
This system is used for radiographic, fluoroscopic, angiographic and pediatric examinations.
Stored images in this system can be used for re-monitoring, image processing, storing to optical media (CD/DVD), and sending to DICOM server.

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

[x] Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)

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.