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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.

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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