PAPAYA Plus is a digital extraoral source X-ray system intended to produce panoramic and cephalometric(option) images of the oral and craniofacial anatomy for a precise treatment planning in adult and pediatric care. The system is used for dental & skull radiographic examination and diagnosis of teeth, jaw, oral structure, and skull by exposing an X-ray image receptor to ionizing radiation, with a digital imaging capability for taking both panoramic and cephalometric images. And this system can be equipped CUST (Tomographic) option, which is capable of taking cross-sectional radiographic images. These images provide dimensional information for dental implant planning and information about location of impacted teeth.

Device Description

PAPAYA Plus is a diagnostic imaging system which consists of multiple image acquisition modes; panorama and cephalometric. And proposed PAPAYA Plus has the CUST imaging option which is used to reconstruct tomographic images from a set of preacquired projection radiographic images of the object.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the GENORAY Co., Ltd. PAPAYA Plus Digital Extraoral Source X-ray System. The device is intended to produce panoramic and cephalometric images for dental and craniofacial anatomy. A key addition in this submission is the CUST (Tomographic) option, which generates cross-sectional radiographic images. The submission compares this new device to a previous version of PAPAYA Plus (K130419) and other related predicate devices.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for the CUST mode in a quantitative metric form (e.g., "sensitivity must be > X" or "resolution must be > Y"). Instead, the acceptance is based on demonstrating that the new CUST mode images have enough quality for diagnosis and that its performance and dosimetry satisfy safety and effectiveness requirements, as compared to predicate devices. The performance data presented are primarily technical specifications of the imaging system and general statements about image quality.

Acceptance Criterion (Implicit)	Reported Device Performance for CUST Mode / Overall Device
Image Quality for Diagnosis (CUST)	A licensed dentist reviewed panoramic, cephalometric, and CUST images and found them to "have enough quality for diagnosis."
Dosimetry (CUST)	Evaluation results of dosimetry for safe and effective use of PAPAYA Plus are "satisfied."
Safety and Effectiveness (CUST)	Evaluation results of images for safe and effective use of PAPAYA Plus are "satisfied." "PAPAYA Plus was tested for safety and effectiveness related of the CUST in Clinical Evaluation report." The addition of CUST option was evaluated through the performance data, and it is deemed substantially equivalent in safety and effectiveness.
Electrical, Mechanical, Environmental Safety & Performance	Testing performed according to IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, and IEC 61223-3-4. All test results were "satisfactory."
EMC Compliance	Testing conducted in accordance with IEC 60601-1-2. All test results were "satisfactory."
Solid State X-ray Imaging Devices Guidance (MTF, DQE, DR)	Performed according to FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices." - MTF: >80% at 2lp/mm for both panoramic and cephalometric sensors. - DQE: ~80% at 0.1lp/mm for both panoramic and cephalometric sensors. - Dynamic Range: >72dB for both panoramic and cephalometric sensors. (Note: These specifications appear to be for the overall system, not specifically the CUST mode).
EPRC Standards Compliance	Meets 21 CFR 1020.30, .31.
DICOM Compliance	Meets NEMA PS 3.1-3.18. Digital Imaging and Communications in Medicine (DICOM) Set.
Substantial Equivalence to Predicate Devices (Overall Device)	Functions and electronic features are similar to predicate devices. The CUST option is similar to Volumetric Tomography (K063773) in function (reconstructs tomographic images).

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

The document mentions "clinical evaluation report" for evaluating images and dosimetry of the CUST mode. However, the sample size for the test set is not specified. The document does not provide details on the country of origin of the data or whether it was retrospective or prospective.

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

A single licensed dentist was used to review images. The specific qualifications (e.g., years of experience, specialization) of this dentist are not thoroughly detailed beyond "licensed dentist."

4. Adjudication Method for the Test Set

The adjudication method is not explicitly described. Given that a single licensed dentist reviewed the images, it's implied that there was no formal multi-reader adjudication process mentioned for this specific aspect of the CUST image quality assessment.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed. Therefore, no effect size for human readers improving with or without AI assistance is provided.

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

The document focuses on the performance of the device as an imaging system, not an AI algorithm in the context of diagnostic assistance. While the CUST mode uses a reconstruction algorithm, its performance is assessed through the resulting images and reviewed by a human expert. There is no standalone ("algorithm only") performance study reported in the sense of an AI diagnostic aid.

7. Type of Ground Truth Used

The ground truth for the CUST image quality assessment was based on the expert opinion/consensus of a single licensed dentist who determined if the images had "enough quality for diagnosis." This is a form of expert consensus, though with only one expert mentioned.

8. Sample Size for the Training Set

This document describes a medical imaging device (X-ray system), not an AI algorithm that typically requires a training set in the current understanding of machine learning. The "CUST algorithm" mentioned is a reconstruction algorithm used to create tomographic images. There is no mention of a training set sample size in the context of machine learning for this device.

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

As there is no mention of a training set for a machine learning algorithm, the establishment of ground truth for a training set is not applicable or described in this document. The CUST algorithm itself reconstructs images based on physical principles, not through machine learning.

Summary

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

October 31, 2014

GENORAY Co., Ltd. % Ms. Kaitlynn Min Business Development Manager GENORAY America, Inc. 3002 Dow Avenue, Suite 420 TUSTIN CA 92780

Re: K141700

Trade/Device Name: PAPAYA Plus, Digital Extraoral Source X-ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: October 2, 2014 Received: October 6, 2014

Dear Ms. Min:

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

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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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Indications for Use

510(k) Number (if known) K141700

Device Name

Digital X-ray Imaging System (Model: PAPAYA Plus)

Indications for Use (Describe)

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

2 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)

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Exhibit 5 510(k) Summary

Date of Summary Preparation: July 25, 2014

1. Submitter and US Official Correspondent

Submitter:	GENORAY Co., Ltd.
Address:	#512, Byucksan Technopia434-6, Sangdaewon 1-dong,Jungwon-gu, Seongnam-cityGyeonggi-do, 462-716, Korea
Telephone No.:	+82-31-740-4100
Fax:	+82-31-737-8025

Official Correspondent (U.S): Kaitlynn Min - Business Manager Correspondent: GENORAY America Inc. Address: 3002 Dow Avenue, Suite 420, Tustin, CA 92780 Telephone No.: 714-289-8020 Fax: 714-786-8919 Email: kaitlynn@genorayamerica.com

Establishment Registration Number 2. 3005843418
1. Device Information

Proprietary/Trade Name:	PAPAYA Plus
Common/Usual Name:	Digital X-ray Imaging System
Classification Name:	Extraoral Source x-ray system
Product Code:	MUH
Device Class:	Class II per regulation 21 CFR 872.1800

1. Predicate Device (Equivalent Legally Marketed Device) PAPAYA Plus (K130419, GENORAY Co., Ltd) Volumetric Tomography (K063773, Instrumentarium Dental) Orthopantomograph OP 200 (K046312, Instrumentarium Dental)
ડ . Description of the Device

CUST algorithm has already been used for existing panoramic units as the predicate device OP200 (K046312) use the VT (K063773) imaging method. VT imaging method which is similar with CUST is described in the following scientific publication.

CEDERLUND, A; KALKE, M.; WELANDER, U. Volumetric tomography-a new tomographic technique for panoramic units. Dentomaxillofacial Radiology, 2009, 38: 104-111

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Indications for use (intended use) 6.

PAPAYA Plus is a digital extraoral source X-ray system intended to produce panoramic and cephalometric(option) images of the oral and craniofacial anatomy for a precise treatment planning in adult and pediatric care. The system is used for dental & skull radiographic examination and diagnosis of teeth, jaw, oral structure, and skull by exposing an X-ray image receptor to ionizing radiation, with a digital imaging capability for taking both panoramic and cephalometric images. And this system can be equipped CUST (Tomographic) option, which is capable of taking cross sectional radiographic images. These images provide dimensional information for dental implant planning and information about location of impacted teeth.

Name	Proposed devicePAPAYA Plus	Predicate devicePAPAYA Plus	Volumetric Tomography	Orthopantomograph®OP200, OP200D,Orthoceph®OC200,OC200D
Manufacturer	GENORAY Co., Ltd.	GENORAY Co., Ltd.	Instrumentarium Dental	Instrumentarium Dental
510(k)No.	K141700	K130419	K063773	K046312
Figure	Image: PAPAYA Plus	Image: PAPAYA Plus	*The VolumetricTomography imagingoption is used forOrthopantomograph®OP100 and OP200 productfamilies.	Image: Orthopantomograph
Indicationsfor use	PAPAYA Plus is a digitalextraoral source X-raysystem intended toproduce panoramic andcephalometric(option)images of the oral andcraniofacial anatomy for aprecise treatment planningin adult and pediatric care.The system is used fordental & skullradiographic examinationand diagnosis of teeth, jaw,oral structure, and skull byexposing an X-ray imagereceptor to ionizingradiation, with a digitalimaging capability fortaking both panoramic andcephalometric images.And This system can beequippedCust(Tomographic) option,which is capable of takingcross-sectional	PAPAYA Plus is a digitalextraoral source X-raysystem intended to producepanoramic andcephalometric(option)images of the oral andcraniofacial anatomy for aprecise treatment planningin adult and pediatric care.The system is used fordental & skull radiographicexamination and diagnosisof teeth, jaw, oralstructure, and skull byexposing an X-ray imagereceptor to ionizingradiation, with a digitalimaging capability fortaking both panoramic andcephalometric images.	Volumetric Tomography isintended to be used forproducing cross-sectional(tomographic)radiographic images fromthe edentulous or dentatearea of the jaws. Thecross-sectional imagesprovide dimensionalinformation for dentalimplant planning andinformation about locationof impacted teeth.	Orthopantomograph®OP200 (film unit) andOP200 D (digital unit)devices are intended to beused for producing X-rayradiographs of dentition,TM-joints and other oralstructures. The units arecapable of takingpanoramic, TM-joint andmaxillary sinusradiographs from patients.When the units areequipped withcephalometric optionOrthoceph® OC200 (filmunit) or OC200 D (digitalunit) units can be used forcephalometric radiographyand examinations relatedthereto. OP200 or OC200units can also beequipped with OrthoTrans (OT) option, whichis capable of taking both
	radiographicimages.These images providedimensional informationfor dental implant planningand information aboutlocation of impacted teeth.			cross and longitudinalslices of region of interest.Ortho Trans uses lineartomography imagingprinciple.
PerformanceSpecification	Panoramic andcephalometric	Panoramic andcephalometric	-	Panoramic andcephalometric
InputVoltage	120 V~	120 V~	-	110 V~, 50/60 Hz,1.65kVA
TubeVoltage	60-90 kV	60-90 kV	-	57 - 85 kV
TubeCurrent	4-12 mA	4-12 mA	-	2-16 mA
FocalSpotSize	0.5 mm	0.5 mm	-	0.5 mm
Exposure Time	Standard panorama: 12 secCephalo (Normal): 8 sec	Standard panorama: 12 secCephalo (Normal): 8 sec	-	Panorama: 2.7-16 secCephalo: 0.2-19 sec
Exposuremode	Panorama:Panoramic modeTMJ modeSINUS modeCUST modeCephalo: Cephalo mode	Panorama:Panoramic modeTMJ modeSINUS modeCephalo: Cephalo mode	Volumetric Tomography	Panorama:Panoramic modeTMJ modeSINUS modeLinear TomographyVolumetric TomographyCephalo: Cephalo mode
ImageReceptor	Panoramic &cephalometric sensor :CdTe Sensor	Panoramic &cephalometric sensor :CdTe Sensor	-	Panoramic, Cephalometricsensor: CCD Detector

7. Substantial equivalence chart

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The proposed PAPAYA Plus has the same specification for mechanism as predicate device, PAPAYA Plus (K130419). The primary difference is to add the CUST mode in exposure modes which shows the cross-sectional images through reconstruction. CUST mode is similar with Volumetric Tomography (K063773) which reconstructs tomographic images.

The image performances and dosimetry of CUST mode have evaluated through clinical evaluation report. Evaluation results of dosimetry and images for safe and effective use of PAPAYA Plus are satisfied. We also had a licensed dentist review of panoramic, cephalometric and CUST images. She found them to have enough quality for diagnosis.

Therefore, PAPAYA Plus is deemed to be substantially equivalent to the predicate devices in safety and effectiveness.

8. Safety, EMC and Performance data comparison to Predicate

Device Safety, EMC and Performance data is same to predicate device which has been established in 510(k) submission K130419 as below. All test results were satisfactory.

Electrical, mechanical, environmental safety and performance testing according to standard IEC i 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28 and IEC 60601-2-32, and IEC 61223-3-4 were performed.

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EMC testing was conducted in accordance with standard IEC 60601-1-2. i
FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed. The tests include the MTF, DQE and the dynamic range of the panoramic sensor and the cephalometric sensor. Both the MTF of the two detectors shows the resolution more than 80% at 21p / mm and the DQE of them shows the performance of about 80% at 01p / mm. The dynamic range of them shows more than 72dB.
PAPAYA Plus meets the EPRC standards (21 CFR 1020.30. 31) i
PAPAYA Plus also meets the provisions of NEMA PS 3.1-3.18. Digital Imaging and । Communications in Medicine (DICOM) Set.
i PAPAYA Plus was tested for safety and effectiveness related of the CUST in Clinical Evaluation report.

9. Conclusion

In reference to the comparison information provided in substantial equivalence chart, most of functions and electronic features are similar with predicate devices. The addition of CUST option was evaluated through the performance data. Thus PAPAYA Plus is substantially equivalent as compared with the predicate devices.

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.