(129 days)
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.
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.
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.
§ 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.