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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.

• 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.

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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.

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.

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:

1. Bench Testing: Demonstrating compliance with various international standards for safety, EMC, and performance.
2. Comparison to Predicate Device: Arguing that the PAPAYA Plus has similar indications for use, performance specifications, and technical characteristics to the legally marketed predicate.
3. 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.

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.

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