The FDR SE Lite flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The FDR SE Lite is not intended for mammography, fluoroscopy, and angiography applications, as well as pediatric and neonatal exams.

Device Description

Fujifilm's FDR SE Lite (DR-ID 330), is a portable digital detector system that interfaces with, and acquires and digitizes X-ray exposures from, standard radiographic systems. DR-ID 330 is designed to be used in any environment that would typically use a radiographic cassette for examinations of adults, not for pediatrics and neonates. The detector models support only wireless data communication between the detector and the console. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams.

AI/ML Overview

The provided text is a 510(k) summary for the Fujifilm FDR SE Lite Flat Panel Detector System (DR-ID 330). It is a regulatory filing for a medical device and thus focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria for AI or diagnostic performance in the way clinical trials typically would.

Based on the provided document, the FDR SE Lite Flat Panel Detector System is a hardware device (a digital X-ray detector), not an AI-powered diagnostic tool. Therefore, the questions related to AI-specific acceptance criteria, ground truth, expert readers, MRMC studies, and training sets are not applicable to this device's submission.

The document explicitly states: "Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies." This means the device's performance was evaluated through technical tests and comparisons to the predicate device's specifications, not through studies involving human readers or AI algorithms.

Here's a breakdown of what can be answered based on the provided text, and where the information is not present or not applicable:

Acceptance Criteria and Device Performance:

Since this is a hardware device (FDR SE Lite Flat Panel Detector System) and not an AI algorithm, the acceptance criteria relate to technical performance, safety standards, and equivalence to a predicate device. The document does not provide a table of quantitative acceptance criteria and specific reported performance values in the way one would expect for an AI algorithm's diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, it states that the device conforms to voluntary standards and that image quality was confirmed to be substantially equivalent.

Acceptance Criteria Category	Description (Based on Document)	Reported Device Performance (Based on Document)
Safety & Effectiveness	Device is as safe and effective as the legally marketed predicate device (K142003). Does not raise different questions of safety and effectiveness.	Concluded to be as safe and effective as the predicate based on non-clinical studies.
Voluntary Standards Compliance	Conformance to AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366, DICOM.	Device "conforms to the voluntary standards."
FDA Guidance Document Compliance	Followed FDA's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices (September 1, 2016) and Radio Frequency Wireless Technology in Medical Devices (August 14, 2013).	Described detector characteristics as per guidance. Tested wireless features as per guidance.
Risk Analysis & Verification	Necessary verification activities performed, including software testing, as required by risk analysis.	Results were satisfactory.
Image Quality Equivalency	Image quality of the subject device (FDR SE Lite) using MarsXF detectors is substantially equivalent to that of the predicate device.	"Image quality evaluation confirmed that the image quality of the FDR SE Lite system using MarsXF detectors is substantially equivalent to that of the predicate device."

Study Details (as applicable to a hardware device 510(k) submission):

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of patient images. The "test set" here refers to the non-clinical performance evaluations of the device hardware.
- Data Provenance: Not applicable in the context of patient data. The non-clinical tests would have been performed in a laboratory or engineering setting. The document only mentions "Fujifilm Corporation" (Japan) as the submitter and "Fujifilm Medical Systems U.S.A., Inc." as the US representative.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth established by experts in a diagnostic sense, as no clinical study was performed. The "ground truth" for hardware performance would be defined by engineering specifications and objective measurements against validated reference standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No expert readers or adjudication for diagnostic performance. Adjudication methods are relevant for clinical studies involving reader interpretations of images.
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 study has been performed." Therefore, no MRMC study, and no human reader improvement (as this is a hardware device, not an AI algorithm assisting human readers).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a flat panel detector, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For a hardware device, "ground truth" for performance would relate to physical measurements (e.g., DQE, MTF, SNR, dose efficiency), adherence to engineering specifications, and compliance with national/international standards. It's not diagnostic "ground truth" in the clinical sense.
The sample size for the training set:
- Not applicable. This is a hardware device, not an AI algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable. As above, no training set for an algorithm.

In summary: The provided document is a regulatory filing for a medical imaging hardware device (an X-ray detector). It demonstrates substantial equivalence for market clearance based on non-clinical performance and adherence to standards, not complex clinical studies, AI performance metrics, or human reader studies. The questions posed are primarily relevant to AI/CADe/CADx devices, which is not what the FDR SE Lite Flat Panel Detector System is.

Summary

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November 1, 2019

Fujifilm Corporation % Kamila Sak Specialist. Regulatory Affairs FuiiFilm Medical Systems U.S.A., Inc. 81 Hartwell Avenue, Suite 300 LEXINGTON MA 02421

Re: K192440

Trade/Device Name: FDR SE Lite Flat Panel Detector System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: September 5, 2019 Received: September 6, 2019

Dear Kamila Sak:

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

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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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,

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)

K192440

Device Name FDR SE Lite Flat Panel Detector System

Indications for Use (Describe)

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)

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510(k) Summary

FDR SE-Lite Flat Panel Detector System (DR-ID 330)

Date: September 5, 2019

Submitter's Information:

FUJIFILM Corporation

798 Miyanodai Kaisei-Machi

Ashigarakami-Gun, Kanagawa, 258-8538, Japan

FDA Establishment Registration Number: 3001722928

Contact Person:

Name:	Kamila Sak
Title:	Specialist, Regulatory Affairs
Telephone:	(347) 577-2309

ldentification of the Device:

Proprietary:

Model Number: DR-ID330 Classification Name: Stationary X-ray system CFR Section: 21 CFR 892.1680 Product Codes: 90 MQB Device Class: Class II Review Panel: Radiologv Common Name: Flat Panel Digital Detector System

ldentification of the Legally Marketed Device:

FDR D-EVO II Flat Panel Detector System (DR-ID 1200), K142003 cleared 10/21/2014

FDR SE Lite Flat Panel Detector System

l. DEVICE DESCRIPTION

II. INDICATIONS FOR USE

The FDR SE Lite flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The FDR SE Lite is not intended for mammography, fluoroscopy, tomography, and angiography applications, as well as pediatric and neonatal exams.

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Image /page/4/Picture/0 description: The image shows the logo for Fujifilm Medical Systems, USA. The word "FUJIFILM" is written in large, bold, black letters. There is a red square on top of the letter "I". Below the word "FUJIFILM" is the text "Fujifilm Medical Systems, USA".

SUBSTANTIAL EQUIVALENCE ..............................................................................................................................................................................

Fujifilm FDR SE Lite FPD System (DR-ID 330) is substantially equivalent to the following legally marketed device.

Legally Marketed Device	510(k) #	Clearance Date
FDR D-EVO II Flat Panel Detector System (DR-ID1200)	K142003	10/21/2014

Both the subject device FDR SE Lite (DR-ID 330) and predicate device FDR D-EVO II (DR-ID 1200) in K142003 are portable digital detector systems that are intended to be used for the same purposes except for pediatric and neonatal use and wired communication. The most detector characteristics remain unchanged for FDR SE Lite, and the image quality is substantially equivalent to the predicate device. The design made for the FDR SE Lite have been successfully tested and validated as summarized below.

IV. SUMMARY OF STUDIES

Non-clinical Performance Data: FDR SE Lite FPD System (DR-ID330) conforms to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366 and DICOM. In addition, the FDA's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices (September 1, 2016) was followed to describe the detector characteristics, and Radio Frequency Wireless Technology in Medical Devices (August 14, 2013) was followed to test wireless features. As required by the risk analysis, necessary verification activities were performed including software testing, and the results were satisfactory. Furthermore, the image quality evaluation confirmed that the image quality of the FDR SE Lite system using MarsXF detectors is substantially equivalent to that of the predicate device.

Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies.

> CONCLUSION

Based upon the supporting data summarized above, we concluded FDR SE Lite Flat Panel Detector System (DR-ID 330) is as safe and effective as the legally marketed device DR-ID 1200 (K142003), and do not raise different questions of safety and effectiveness than K142003.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.