(302 days)
PAPAYA 3D Plus is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in:
- (i) producing panoramic X-ray images of the maxillofacial area, for diagnostic examination of dentition (teeth), jaws and oral structures; and
- (ii) producing radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with the cephalometric arm;
- (iii) producing tomographic images of the oral and maxillofacial structure, for diagnostic examination of dentition(teeth), jaws ,oral structures and some cranial bones if equipped with CBCT option.
The system accomplishes tomographic exam by acquiring a 360-degree rotational X-ray sequence of images and reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two dimensional images and three-dimensional renderings.
PAPAYA 3D Plus is a diagnostic imaging system which consists of multiple image acquisition modes; panorama, cephalometric, and computed tomography. PAPAYA 3D Plus designed for dental radiography of the oral and craniofacial anatomy such as teeth, jaws and oral structures.
PAPAYA 3D Plus is equipped with extra-oral flat panel x-ray detectors which is based on CMOS digital X-ray detector and has CT, panoramic and cephalometric radiography with an extra-oral x-ray tube. CMOS Flat panel detectors are used to capture scanned image for obtaining diagnostic information for craniofacial surgery or other treatments. And it also provides 3D diagnostic images of the anatomic structures by acquiring 360°rotational image sequences of oral and craniofacial area.
The provided text describes the PAPAYA 3D Plus, a digital panoramic, cephalometric, and tomographic extra-oral X-ray system. The document is a 510(k) premarket notification, aiming to establish substantial equivalence to previously marketed devices. However, it does not contain a detailed study with specific acceptance criteria and performance metrics for the device's diagnostic capabilities.
The document primarily focuses on:
- Indications for Use: What the device is intended for (producing panoramic, cephalometric, and tomographic X-ray images of the maxillofacial area for diagnostic examination).
- Device Description: Technical specifications and features.
- Substantial Equivalence: Comparing the PAPAYA 3D Plus to predicate devices (Hyperion X9 and PAPAYA Plus) to demonstrate similar intended use and technological characteristics.
- Safety, EMC, and Performance Data: Compliance with industry standards (IEC, 21 CFR) and non-clinical testing results for image receptors and 3D performance using phantoms.
Based on the provided text, a detailed table of acceptance criteria and reported device performance for a diagnostic clinical study proving the device meets those criteria cannot be fully constructed for diagnostic accuracy in patient imaging. The performance data mentioned relates to technical aspects of the image receptors and phantom studies, not a clinical outcomes study with expert ground truth.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is missing for a full diagnostic study:
1. A table of acceptance criteria and the reported device performance
The document primarily discusses technical performance specifications and compliance with standards rather than diagnostic accuracy acceptance criteria from a clinical study. The "performance data" refers to technical characteristics of the imaging sensors and phantom tests.
| Acceptance Criteria Category | Specific Metric (as mentioned or inferred from technical tests) | Acceptance Value (N/A for clinical diagnostic accuracy as not provided) | Reported Device Performance (from non-clinical tests) |
|---|---|---|---|
| Image Receptor (New SSXI detectors: Extor-P, Extor-C, DualRay-S) | MTF (Resolution) - Panoramic | > 60% at 1 lp/mm (for similar diagnostic image quality to predicate) | > 60% at 1 lp/mm |
| MTF (Resolution) - Cephalometric | > 60% at 1 lp/mm (for similar diagnostic image quality to predicate) | > 60% at 1 lp/mm | |
| MTF (Resolution) - CT | > 60% at 1 lp/mm (for similar diagnostic image quality to predicate) | > 60% at 1 lp/mm | |
| DQE (Performance) - All new detectors | ~70% at 0.1 lp/mm (for similar efficiency to predicate) | ~70% at 0.1 lp/mm | |
| Dynamic Range - All new detectors | > 72dB (for similar efficiency to predicate) | > 72dB | |
| Image Receptor (Existing detectors) | MTF (Resolution) - Panoramic | > 80% at 2 lp/mm (for similar diagnostic image quality to predicate) | > 80% at 2 lp/mm |
| DQE (Performance) - Panoramic | ~80% at 0.1 lp/mm (for similar efficiency to predicate) | ~80% at 0.1 lp/mm | |
| Dynamic Range - Panoramic | > 72dB (for similar efficiency to predicate) | > 72dB | |
| 3D Performance (Phantoms) | Contrast scale | Within standard value range | Within standard value range |
| Noise | Within standard value range | Within standard value range | |
| Slice thickness | Within standard value range | Within standard value range | |
| Resolutions | Within standard value range | Within standard value range | |
| Safety and Compliance | Electrical, Mechanical, Environmental | Compliance with IEC 60601-1, -1-3, -2-63 | Complied |
| EMC | Compliance with IEC 60601-1-2 | Complied | |
| Acceptance Tests | Compliance with IEC 61223-3-4, -3-5 | Complied | |
| EPRC Standards | Compliance with 21 CFR 1020.30, .31, .33 | Met | |
| DICOM | Compliance with NEMA PS 3.1-3.18 | Met | |
| Software Validation | OTS Software, Triana | Validation per FDA Guidance for "Minor Level of Concern" | Validation report conducted |
Note: The reported performance for image receptors and 3D phantoms are from non-clinical tests. The document states: "Based on the Non-Clinical Test results, even though the pixel size and active area of the new SSXI detectors are different, the diagnostic image quality of new sensors is similar to that of the predicate device and there is no significant difference in efficiency and safety." This implies a comparison to predicate technical performance, not a clinical diagnostic accuracy study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Clinical Evaluation report" and "bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices." However, it does not provide details about the sample size, data provenance, or design (retrospective/prospective) of this clinical evaluation for the purpose of assessing diagnostic accuracy for the PAPAYA 3D Plus itself. The non-clinical tests were performed on the device's components (detectors) and with phantoms.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The text does not detail any specific clinical study involving human readers or expert ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document, as no detailed clinical study assessing diagnostic accuracy with human experts is described.
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
This information is not provided in the document. The PAPAYA 3D Plus is an X-ray imaging system, not an AI-powered diagnostic software. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to the device as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The device is an imaging system, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests related to technical image quality and 3D performance, phantoms were used as ground truth.
For any clinical evaluation that may have been performed (briefly mentioned but not detailed), the type of ground truth is not specified.
8. The sample size for the training set
This information is not applicable and not provided. The PAPAYA 3D Plus is an X-ray imaging system, not an AI or machine learning model that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
This information is not applicable and not provided, as the device is not an AI/ML model requiring a training set.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 10, 2015
GENORAY Co., Ltd. % Ms Kaitlynn Min Business Developer Manager GENORAY America, Inc. 3002 Dow Avenue, Suite 420 TUSTIN CA 92780
Re: K150354 Trade/Device Name: PAPAYA 3D Plus Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS, MUH Dated: November 17, 2015 Received: November 18, 2015
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,
Robert Ocklo
Robert Ochs. Ph.D. 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) K150354
Device Name PAPAYA 3D Plus
Indications for Use (Describe)
PAPAYA 3D Plus is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in:
- (i) producing panoramic X-ray images of the maxillofacial area, for diagnostic examination of dentition (teeth), jaws and oral structures; and
- (ii) producing radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with the cephalometric arm;
- (ii) producing tomographic images of the oral and maxillofacial structure, for diagnostic examination of dentition(teeth), jaws ,oral structures and some cranial bones if equipped with CBCT option.
The system accomplishes tomographic exam by acquiring a 360-degree rotational X-ray sequence of images and reconstructing a three-dimensional matrix of the examined volumensional views of this volume and displaying both two dimensional images and three-dimensional renderings.
| 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) | |||
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| information unless it displays a currently valid OMB number." | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of |
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
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Exhibit 5 510(k) Summary
Date of Summary Preparation: Feb 01, 2015
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- Submitter and US Official Correspondent Submitter: GENORAY Co., Ltd. Address: #512, Byucksan Technopia 434-6, Sangdaewon 1-dong, Jungwon-gu, Seongnam-city Gyeonggi-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
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- Establishment Registration Number 3005843418
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- Device Information Trade/Device Name: PAPAYA 3D Plus
Regulation Name: Computed tomography X-ray System
Classification Name/Product Code: X-ray, Tomography, Computed/OAS System, X-ray, Extraoral Source, Digital / MUH
Device Class: Class II per regulation 21 CFR 892.1750
- ર. Description of the Device
PAPAYA 3D Plus is a diagnostic imaging system which consists of multiple image acquisition modes; panorama, cephalometric, and computed tomography. PAPAYA 3D Plus designed for dental radiography of the oral and craniofacial anatomy such as teeth, jaws and oral structures.
PAPAYA 3D Plus is equipped with extra-oral flat panel x-ray detectors which is based on CMOS digital X-ray detector and has CT, panoramic and cephalometric radiography with an extra-oral x-ray tube. CMOS Flat panel detectors are used to capture scanned image for obtaining diagnostic information for craniofacial surgery or other treatments. And it also provides 3D diagnostic images of the anatomic structures by acquiring
360°rotational image sequences of oral and craniofacial area.
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Indications for use (intended use) 6.
PAPAYA 3D Plus is a digital panoramic, cephalometric and tomographic extra-oral Xray system, indicated for use in:
- (i) producing panoramic X-ray images of the maxillofacial area, for diagnostic examination of dentition (teeth), jaws and oral structures; and
- (ii) producing radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with the cephalometric arm;
- (iii) producing tomographic images of the oral and maxillofacial structure, for diagnostic examination of dentition(teeth), jaws ,oral structures and some cranial bones if equipped with CBCT option.
The system accomplishes tomographic exam by acquiring a 360-degree rotational Xray sequence of images and reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two dimensional images and three-dimensional renderings.
| Name | Proposed devicePAPAYA 3D Plus | Hyperion X9 | PAPAYA Plus |
|---|---|---|---|
| Manufacturer | GENORAY Co., Ltd. | CEFLA S.C. | GENORAY Co., Ltd. |
| 510(k) No. | - | K123381 | K141700 |
| Indicationsfor use | PAPAYA 3D Plus is a digitalpanoramic, cephalometric andtomographic extra-oral X-raysystem,indicated for use in:(i) producing panoramic X-rayimages of the maxillofacial area, fordiagnostic examination of dentition(teeth), jaws and oral structures; and(ii) producing radiographs of jaws,parts of the skull and carpus for thepurpose of cephalometricexamination, when equipped withthe cephalometric arm;(iii) producing tomographic imagesof the oral and maxillofacialstructure, for diagnostic examinationof dentition(teeth), jaws ,oralstructures and some cranial bones ifequipped with CBCT option.The system accomplishestomographic exam by acquiring a360-degree rotational X-raysequence of images andreconstructing a three-dimensionalmatrix of the examined volume,producing two-dimensional views ofthis volume and displaying both twodimensional images and three-dimensional renderings. | Hyperion X9 is a digital panoramic,cephalometric and tomographicextra-oral X-ray system,indicated for use in:(i) producing panoramic X-rayimages of the maxillofacial area, fordiagnostic examinationof dentition (teeth), jaws and oralstructures; and(ii) producing radiographs of jaws,parts of the skull and carpus for thepurpose of cephalometricexamination, when equipped withtele-radiographic arm (CEPH);(iii) producing tomographic imagesof the oral and maxillofacialstructure, for diagnostic examinationof dentition (teeth), jaws ,oralstructures and some cranial bones ifequipped with CBCT option.The system accomplishestomographic exam by acquiring a360-degree rotational X-raysequence of images andreconstructing a three-dimensionalmatrix of the examined volume,producing two-dimensional views ofthis volume and displaying both twodimensional images and three-dimensional renderings. | PAP A Y A Plus is a digitalextraoral source X-ray systemintended to produce panoramic andcephalometric(option) images of theoral and craniofacial anatomy for aprecise treatment planning in adultand pediatric care. The system isused for dental & skull radiographicexamination and diagnosisofteeth,jaw, oral structure, and skullby exposing an X-ray imagereceptor to ionizing radiation, with adigital imaging capability for takingboth panoramic and cephalometricimages. And this system can beequipped CUST(Tomographic)option, which is capable of takingcross-sectional radiographic images.These images provide dimensionalinformation for dental implantplanning and information aboutlocation ofimpacted teeth |
7. Substantial equivalence chart
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| Name | Proposed devicePAPAYA 3D Plus | Hyperion X9 | PAPAYA Plus |
|---|---|---|---|
| PerformanceSpecification | PanoramicCephalometricComputed tomography | PanoramicCephalometricComputed tomography | PanoramicCephalometricTomography |
| 3DTechnology | Cone beam Computed tomography | Cone beam Computed tomography | Volumetric tomography |
| CTFOV(D×H) | 14×14, 14×8, 8×8, 7×7, 4×4cm | 11×8, 11×5, 8×8, 8×5, 5×5cm | 4.8×10 |
| InputVoltage | 100-120V~ | 115 - 240 V~ | 100-120V~ |
| TubeVoltage | 60-90 kV | 60-90 kV | 60-90 kV |
| TubeCurrent | 4-12 mA | 1-10 mA | 4-12 mA |
| Focal SpotSize | 0.5 mm | 0.5 mm | 0.5 mm |
| ExposureTime | PANORAMA: max 17secCEPHALO: max 12secCT : max15sec | 160ms - 18 sec | Standard Panorama: 12 secCephalo(Normal): 8 sec |
| ImageReceptor | Panoramic: CMOS FPDCephalometric: CMOS FPDCBCT: CMOS FPD | Panoramic: CCDCephalometric: CCDCBCT: Amorphous Silicon FPD | Panoramic: CMOS FPDCephalometric: CMOS FPD |
The proposed PAPAYA 3D Plus was developed from the PAPAYA Plus(K141700) by adding Computed tomography function. Accordingly, the characteristics of the PAPAYA 3D Plus are identical or similar to those of the PAPAYA Plus(K141700) regarding X-ray generation device characteristics including tube voltage, tube current, focal spot size and X-ray image capturing device including type of detector.
The differences of the PAPAYA 3D Plus from the PAPAYA Plus(K141700) are the addition of detector options and Computed tomography function.
New SSXI detectors are Extor-P for Panorammic mode, Extor-C for Cephalo mode, and DualRay-S for CBCT mode. They are for the newly upgraded PAPAYA Plus(K141700). Remaining detectors are the same, the non-clinical considerations are also equivalent, and the report regarding non-clinical & clinical consideration for the added new detectors are provided separately.
The Computed tomography function of the PAPAYA 3D Plus is similar to Hyperion X9(K123381). The system accomplishes tomographic exam by acquiring a 360-degree rotational X-ray sequence of images and reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two dimensional images and three-dimensional renderings. It is known as CBCT.
The PAPAYA 3D Plus has the similar characteristics regarding intended use, X-ray generation device characteristics including tube voltage, tube current, and focal spot size as Hyperion X9(K123381). The PAPAYA 3D Plus has the same indication for use as the Hyperion X9(K123381).
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8. Safety, EMC and Performance data comparison to Predicate
PAPAYA 3D Plus complies with industry standards such as IEC 60601-1 Series and 21 CFR 1020.30 and 21 CFR 1020.31 and 21 CFR 1020.33 to minimize electrical, mechanical and radiation hazards.
- Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1, IEC 60601-1-3, and IEC 60601-2-63 were performed.
- EMC testing was conducted in accordance with standard IEC 60601-1-2.
- Acceptance test according to standard IEC 61223-3-4 and IEC 61223-3-5 were performed. ।
- FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging । Devices" was performed for each new detector of PAPAYA 3D Plus. The existing detector test results are as follows.
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.
And, the additional detector test results are as follows.
The tests include the MTF, DQE and the dynamic range of the panoramic sensor, the cephalometric sensor and the CT sensor. The MTF of the new detectors shows the resolution more than 60% at 11p / mm and the DQE of them shows the performance of about 70% at 01p / mm. The dynamic range of them shows more than 72dB.
Based on the Non-Clinical Test results, even though the pixel size and active area of the new SSXI detectors are different, the diagnostic image quality of new sensors is similar to that of the predicate device and there is no significant difference in efficiency and safety.
Please refer to Attachment X. Solid State X-ray imaging Device.
And 3D performance tests with phantoms were performed. Test items are contrast scale, noise, slice thickness, and resolutions. All test results were within standard value range.
- PAPAYA 3D Plus meets the EPRC standards (21 CFR 1020.30. 31. 33)
- PAPAYA 3D Plus also meets the provisions of NEMA PS 3.1-3.18. Digital Imaging and - Communications in Medicine (DICOM) Set.
- PAPAYA 3D Plus uses OTS software, Triana as an image viewer. Software validation report was conducted as recommended by FDA's Guidance document "Guidance for off-the-shelf Software Use in Medical Devices" The OTS Software, Triana in PAPAYA 3D Plus represents a Minor Level of Concern since failures or latent design flaws would not be expected to result in any injury to the patient or operator.
- PAPAYA 3D Plus was tested for safety and effectiveness related in Clinical Evaluation i report.
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.
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9. Conclusion
In reference to the comparison information provided in substantial equivalence chart, most of functions and electronic features are similar with predicate devices. We believe that the PAPAYA 3D Plus is safe and effective as predicate devices, and has no new indication for use. Thus PAPAYA 3D Plus is substantially equivalent to predicate devices.
§ 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.