PAPA YA Plus is a digital extraoral source X-ray system intended to produce panoramic and Cephalometric images of the oral and craniofacial anatomy for a precise treating in adult and pediatric care. The system is used for dental & skull radiographic examination and diagnosis of teeth, jaw, oral skull by exposing an X-ray image receptor to ionizing radiation, with a digital imaging capability for taking both panoramic and cephalometric images.

Device Description

PAPAYA Plus is a diagnostic imaging system which consists of multiple image acquisition modes; panorama and cephalometric. PAPAYA Plus is designed for dental radiography of the oral and craniofacial anatomy. PAPAYA Plus is equipped with extra oral x ray detector based on CdTe digital X ray detector, panoramic & cephalometric radiography with an extra oral xray tube. CdTe digital X-ray detector is used to capture scanned image for obtaining diagnostic information for craniofacial surgery or other treatments. Cephalometric radiography is optional function. It can be choice to use the cephalo function as user's need.

AI/ML Overview

The provided 510(k) summary for the PAPAYA Plus Digital X-ray Imaging System seeks to demonstrate substantial equivalence to a predicate device (Vatech Co., Ltd.'s PCH-2500 (PaX-i)), rather than establishing novel safety and effectiveness criteria through a new clinical study with specific acceptance criteria that the device must meet.

Therefore, the information directly addressing sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a new clinical study to prove acceptance criteria is not present in this document.

Instead, the submission focuses on:

Bench Testing: Demonstrating compliance with various international standards for safety, EMC, and performance.
Comparison to Predicate Device: Arguing that the PAPAYA Plus has similar indications for use, performance specifications, and technical characteristics to the legally marketed predicate.
Performance Data for New Component: Providing "performance data for the CdTe sensor," which is the primary difference from the predicate device. However, the exact nature of this performance data, its acceptance criteria, and the study details are not elaborated upon in this summary.

Here's a breakdown of the available information and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define acceptance criteria as a table that the device was required to meet for a new clinical study. Instead, it relies on demonstrating compliance with recognized standards and substantial equivalence to a predicate device.

Category	Acceptance Criteria (Implied)	Reported Device Performance
Electrical, Mechanical, Environmental Safety & Performance	Compliance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, IEC 61223-3-4.	"All test results were satisfactory." "The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices."
EMC Testing	Compliance with IEC 60601-1-2.	"All test results were satisfactory."
Solid State X-ray Imaging Devices	Compliance with FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices."	"All test results were satisfactory."
EPRC Standards	Compliance with 21 CFR 1020.30, 31.	"PAPAYA Plus meets the EPRC standards (21 CFR 1020.30, 31)."
DICOM Standards	Compliance with NEMA PS 3.1-3.18.	"PAPAYA Plus also meets the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set."
Clinical Equivalence	Demonstrating comparable safety and effectiveness to the predicate device (PCH-2500 (PaX-i)).	"The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices." "PAPAYA Plus is deemd to be substantially equivalent to the predicate device, PCH-2500 (PaX-i) in safety and effectiveness."

Regarding the "Performance data for the CdTe sensor" mentioned: The summary states this data was provided in the submission, but it doesn't detail what specific performance metrics were measured, what the acceptance criteria for those metrics were, or the study design used to generate that data. This is a critical missing piece if one were to analyze the specific performance of the new sensor.

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

Sample Size: Not specified for any performance or clinical evaluation. The document mentions "performance data for the CdTe sensor" but does not quantify the sample size used to generate this data.
Data Provenance: Not specified. The summary only generally refers to "bench and clinical evaluation."

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Not specified.

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

No evidence of an MRMC study: The submission does not mention a comparative effectiveness study involving human readers with and without AI assistance (which is not applicable here as this is an X-ray imaging system, not an AI decision support tool). The focus is on the imaging system's inherent performance and its equivalence to an existing device.

6. Standalone (Algorithm Only) Performance

Not applicable in the context of this device: This device is an X-ray imaging system; its "standalone performance" is its ability to acquire and process images according to its technical specifications and safety standards, which is addressed by the compliance testing mentioned. There is no AI algorithm component for which standalone diagnostic performance would be measured in this context.

7. Type of Ground Truth Used

The document implies that the ground truth for "clinical evaluation" would be established through standard diagnostic practices (e.g., expert interpretation of images, comparison against clinical reports), but it does not explicitly state how ground truth was established for any specific performance assessment, particularly for the new CdTe sensor. Given that it's an imaging device for diagnosis, the "ground truth" would generally relate to the accuracy of the images for clinicians to make diagnoses.

8. Sample Size for the Training Set

Not applicable/Not specified: This is not an AI/machine learning device that requires a training set in the typical sense. Its "training" would be its design and calibration processes, which are verified through the various engineering and performance tests listed.

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

Not applicable/Not specified: As above, this is not an AI/machine learning device.

In summary:

This 510(k) submission for the PAPAYA Plus Digital X-ray Imaging System demonstrates substantial equivalence primarily through extensive bench testing against recognized standards and a comparison of technical specifications and indications for use with a predicate device. While it mentions general "clinical evaluation" and "performance data for the CdTe sensor," it lacks the detailed study methodology, sample sizes, expert involvement, and specific acceptance criteria typically found in clinical studies establishing novel diagnostic performance for algorithms or new indications. The regulatory pathway chosen (510(k) for substantial equivalence) often relies more heavily on non-clinical data and direct comparison to a predicate, especially for devices without novel clinical claims or significant technological changes that would warrant a full-scale prospective clinical trial with specific performance targets.

Summary

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KI30419

NOV - 6 2013

510(k) Summary Exhibit 5

ST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

.. ...

Date of Summary Preparation: January 18, 2013

Submitter and US Official Correspondent 1.

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): Jae Kim - Business Manager Correspondent : GENORAY America Inc. Address: 1073 N. Batavia St. Orange, CA 92867, USA

Telephone No.: 855-436-6729 714-786-8919 Fax: jae@genorayamerica.com Email:

2. Establishment Registration Number 3005843418

3. Device Information

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

Equivalent Legally Marketed Device 4.

< PCH-2500 (PaX-i)>
Manufacturer:	Vatech Co., Ltd.
Device Name:	PCH-2500 (PaX-i)
510(k) Number:	K122155 (Decision Date: Sep 04, 2012)
Classification:	System, X-ray, Extraoral Source, Digital: MUH,
	Class II per regulation 21 CFR 872.1800

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Description of the Device

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ProductItems	PAPAYA Plus
Performance Specification	Panoramic and cephalometric
X-ray Source	High Frequency. Stationary tube,60 ~ 90 kV, 4 ~ 12mA
Focal Spot	0.5mm
Image Detector	CdTe detector- Pixel size: 100um x 100um- Image field:Panoramic&Cephalometric sensor : 240mm x 4.8mmPanoramic sensor : 150mm x 4.8mm
Scan time /exposure time	Standard panorama program (Normal, Average): 12 secCephalo (Normal): 8 sec
Power Voltage /Input power	120 V~, 60 Hz, 2.2 kVA
Total filtration	CEJ Tube: 2.5mmAl (inherent:0.5mmAl, Added:2.0mmAl)Toshiba Tube: 2.8mmAl (inherent:0.8mmAl, Added:2.0mmAl)
Patient position	Standing
Main body weight	140 kg ± 5%
Dimension(W×H×D mm)	1775.4 × 2312 × 1010 mm

6. Indications for use

PAPAYA Plus is a digital extraoral source X ray system intended to produce panoramic and Cephalometric 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.

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Substantial equivalence chart 7.

500

Name	PAPAYA Plus	PCH-2500 (PaX-i)
Manufacturer	GENORAY Co., Ltd.	Vatech Co., Ltd.
510(k) No.	K130419	K122155
Classification	System, X-ray, Extraoral Source, Digital:MUH, Class II per regulation 21 CFR872.1800	System, X-ray, Extraoral Source, Digital:MUH, Class II per regulation 21 CFR872.1800
Figure
Indicationsfor use	PAPAYA Plus is a digital extraoralsource X-ray system intended to producepanoramic and Cephalometric images ofthe oral and craniofacial anatomy for aprecise treatment planning in adult andpediatric care. The system is used fordental & skull radiographic examinationand diagnosis of teeth, jaw, oral structure,and skull by exposing an X-ray imagereceptor to ionizing radiation, with adigital imaging capability for taking bothpanoramic and cephalometric images.	PCH-2500 (PaX-i) is a digital extraoralsource x-ray system intended to takepanoramic and cephalometric images ofthe oral and maxillofacial anatomy toprovide diagnostic information for adultand pediatric patients. The device shouldbe operated and used by dentists, x-raytechnicians and other professionalslicensed by the law of the state in whichthe device is used.
PerformanceSpecification	Panoramic and cephalometric	Panoramic and cephalometric
Input Voltage	120 V~	100-120 V~
Tube Voltage	60-90 kV	50-90 KV
Tube Current	4-12 mA	4-10 mA
Focal Spot Size	0.5 mm	0.5 mm
Exposure Time	Max. 17 sec	Max. 20.2 sec
Total Filtration	2.5 mmAl (CEI tube)2.8 mmAl (Toshiba tube)	2.8 mmAl
Pixel Size	Panoramic & cephalometric sensor: 100 x100 um	Panoramic & cephalometric sensor:100 x 100 umCephalometric (one shot type) sensor: 127x 127 um
Image Receptor	Panoramic & cephalometric sensor : CdTeSensor	Panoramic & Cephlometric sensor:CMOS Photodiode arrayCephalometric sensor(scan type):Amorphous silicon TFT with scintillator

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Indications for use, performance specification and technical characteristics of PAPAYA Plus and PCH-2500 (PaX-i) are similar. The primary difference is to offer a CdTe sensor for Panorama and Cephalometric mode of PAPAYA Plus. The Performance data for the CdTe sensor are provided in this submission.

Therefore, PAPAYA Plus is deemed to be substantially equivalent to the predicate device. PCH-2500 (PaX-i) in safety and effectiveness.

1. Safety, EMC and Performance data comparison to Predicate
- Electrical, mechanical, environmental safety and performance testing according to standard 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 were performed.
- 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 i Devices" was performed.
- . PAPAYA Plus meets the EPRC standards (21 CFR 1020.30. 31).
- PAPAYA Plus also meets the provisions of NEMA PS 3.1-3.18. Digital Imaging and . Communications in Medicine (DICOM) Set.

All test results were satisfactory.

The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices.

1. Conclusion
  In reference to the comparison information provided in substantial equivalence chart, most of function and electronic feature are similar in both products. We believe that the PAPAYA Plus is safe, effective and substantially equivalent in clinical & technical expect with the predicate devices. PCH-2500 (PaX-i),

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

November 6, 2013

Genoray Co., Ltd. % Mr. Jae Kim Business Development Manager 1073 N. Batavia Street ORANGE CA 92867

Re: K130419

Trade/Device Name: PAPAYA Plus, Digital X-ray Imaging System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: October 03, 2013 Received: October 07, 2013

Dear Mr. Kim:

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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Page 2-Mr. Kim

... ..........................................................................................................................................................................

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/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 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/Industry/default.htm.

Sincerely yours,

ரோ

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

510(k) Number (if known) K130419

Device Name

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

Indications for Use (Describe)

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)

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

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.