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PAPAYA 3D & PAPAYA 3D Plus are digital panoramic, cephalometric and tomographic extra-oral X- ray systems, 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 (Only for PAPAYA 3D Plus);

(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 systems accomplish 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.

PAPAYA 3D & PAPAYA 3D Plus are diagnostic imaging system which consists of multiple image acquisition modes; panorama, cephalometric, and computed tomography. Also, PAPAYA 3D & PAPAYA 3D Plus are designed for dental radiography of the oral and craniofacial anatomy such as teeth, jaws and oral structures. The difference between PAPAYA 3D & PAPAYA 3D Plus is only optional of the cephalometric detector. Without cephalometric detector, we name model PAPAYA, and with cephalometric detector, we name model PAPAYA Plus. Due to this difference, the cephalometric image acquisition function applies only to PAPAYA 3D Plus, not to PAPAYA 3D.

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 360ºrotational image sequences of oral and craniofacial area.

The differences from predicate device (K150354) are change of power voltage, addition of image processing software (Theia, Triana).

The provided text does not contain detailed acceptance criteria and a study specifically proving the device meets those criteria for the PAPAYA 3D & PAPAYA 3D Plus, particularly with respect to its image processing software (Triana/Theia) beyond software validation. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (K150354) through a comparison of physical characteristics, intended use, and general performance specifications, along with adherence to various safety and regulatory standards.

Here's a breakdown of the available information from the provided text, addressing your questions to the extent possible:

1. A table of acceptance criteria and the reported device performance

The document presents performance specifications, but these are general technical specifications for the imaging hardware, not specific acceptance criteria for diagnostic performance outcomes. The comparison is between the proposed device and the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Non-Clinical Test results" referencing "each detector of PAPAYA 3D Plus" and "additional detector test results," but does not specify a sample size for any clinical test set or data provenance (country, retrospective/prospective). The evaluation appears to be based on technical specifications and laboratory testing of the detectors, rather than a clinical study with patient data.

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)

Not applicable. The document describes technical testing of components (detectors), and software validation (IEC 62304), not a clinical study involving experts establishing ground truth for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As no clinical study with a test set requiring adjudication 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

No MRMC comparative effectiveness study is mentioned. The device described (PAPAYA 3D & PAPAYA 3D Plus) is an imaging system (hardware) and associated image processing software (Triana/Theia). The software functions listed are for image viewing and manipulation (e.g., 3D visualization, 2D analysis, MPR, measurement, rotation), not AI assistance for diagnosis. Therefore, this question is not applicable to the information provided.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The software (Triana/Theia) is an image processing and viewing tool, not a standalone diagnostic algorithm. Its validation was done against IEC 62304:2006/AC: 2008 for software lifecycle processes, not for standalone diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the detector performance tests (MTF, DQE, Dynamic Range), the "ground truth" would be established by physical measurement standards and calibration, not clinical ground truth like pathology or expert consensus. For the software validation, the "ground truth" or reference for validation would be the functional and performance requirements defined during software development, ensuring it operates as intended according to IEC 62304.

8. The sample size for the training set

Not applicable. The document describes an imaging hardware system and image viewing software. There is no mention of an "AI" component or machine learning algorithm that would require a training set.

9. How the ground truth for the training set was established

Not applicable. As no training set for an AI algorithm is mentioned.

Summary of what the document does describe for proving acceptance:

The document focuses on demonstrating substantial equivalence to an existing predicate device (PAPAYA 3D Plus, K150354) by showing that the proposed devices (PAPAYA 3D & PAPAYA 3D Plus) have the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

The primary methods of "proving acceptance" appear to be:

• Comparison to Predicate Device: A detailed comparison table ([6]) highlights the similarities in indications for use, 3D technology, CT FOV, tube parameters, exposure times, and image receptors.
• Safety and EMC Testing: The device underwent testing to established international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-63) to verify electrical, mechanical, environmental safety, and electromagnetic compatibility ([8]).
• Performance Data for Detectors: Non-clinical tests were performed on the detectors, measuring MTF, DQE, and dynamic range, demonstrating "similar" diagnostic image quality to the predicate device ([8]).
• Software Validation: The image processing software (Theia) was validated according to IEC 62304:2006/AC: 2008, and its similarities to the already cleared Triana software (K103182) are highlighted. The software is classified as having a "Minor Level of Concern" ([8]).
• Compliance with Regulations: The device meets EPRC standards (21 CFR 1020.30.31.33) and NEMA PS 3.1-3.18 (DICOM Set). Relevant FDA guidance documents for submissions were also considered ([8]).

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The X-ray unit system is a diagnostic imaging system which consists of multiple image acquisition modes; panoramic, cephalometric, and CBCT (Cone Beam Computed Tomography). X-ray unit system is used for dental radiographic examination and diagnosis of teeth, jaw, oral structures and skull. The device is to be operated and used by dentists and other legally qualified professionals.

The proposed device PAPAYA 3D Premium Plus the computed tomography x-ray system which consists of image acquisition modes; panorana, cephalometric, and computed tomography. The difference between PAPAYA 3D Premium Plus is only optional of the cephalometric detector. It designed for dental radiography of the oral and cranionarial as teeth, jaws and oral structures. The device with cephalometric detector is named PAPAYA 3D Premium Plus and the device without cephalometric detector is named PAPAYA 3D Premium.

The proposed device are composed of flat panel x-ray detectors which are based on CMOS, and TFT detector types and divided in to CT, panoramic and cephalometric radiography, and x-ay tube. CMOS, and TFT detectors are used to capture scamed image for obtaining diagnostic information for craniofacial surgery or other treatments. And it also provides 3D the anatomic stuctures by acquiring 3609rotational image sequences of oral and craniofacial area.

The provided text describes a 510(k) premarket notification for a dental X-ray system, PAPAYA 3D Premium & PAPAYA 3D Premium Plus. The document focuses on demonstrating substantial equivalence to a predicate device (PAPAYA 3D Plus, K150354) rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for an AI algorithm.

Therefore, many of the requested details about acceptance criteria for an AI device, sample sizes, expert qualifications, and specific study designs (MRMC, standalone performance) are not present in the provided text. The device in question is a medical imaging hardware system, not an AI software.

However, I can extract information related to the performance validation of the newly added image receptors, which is the closest thing to "device meets acceptance criteria" in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance (as much as can be inferred for the imaging components):

Note: The document states these performance metrics were "tested," implying they met predefined acceptance criteria, but the specific numerical values or thresholds for "acceptance" are not provided.

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not explicitly stated for either clinical image evaluation or phantom testing. The document only mentions "clinical images" for evaluation.
• Data Provenance: The document does not specify the country of origin of the clinical images. It implies a retrospective review of existing clinical image sets.

3. Number of Experts and Qualifications:

• Number of Experts: "the clinical images were evaluated by the US board-certified oral surgeon." (Singular - implies one or an unspecified small number of US board-certified oral surgeons).
• Qualifications: "US board-certified oral surgeon." No specific years of experience are mentioned.

4. Adjudication Method:

• Adjudication Method: "Throughout the evaluation by oral surgeon..." This wording suggests a single expert's opinion, so there's no mention of a formal adjudication method (like 2+1 or 3+1).

5. MRMC Comparative Effectiveness Study:

• MRMC Study Done? No. This document describes a new imaging hardware device and its added detectors. There is no mention of an AI component requiring a comparison of human reader performance with and without AI assistance.

6. Standalone Performance (Algorithm Only):

• Standalone Performance Done? N/A. This is a hardware device. The closest related component is the "Theia" image processing software, which is described as having "only UI" differences from the predicate's software and being "developed for marketing purpose only." Its validation focused on standards compliance (EN 62304, NEMA PS 3.1-3.20 DICOM, FDA Guidance) rather than a standalone clinical performance study as one might expect for an AI algorithm.

7. Type of Ground Truth Used:

• For Clinical Image Evaluation: Expert consensus (from the US board-certified oral surgeon) on whether images were "diagnosable" and met indications for use.
• For Imaging Performance Tests: Phantom data (e.g., gantry positioning accuracy, spatial resolution, CNR, etc.).

8. Sample Size for Training Set:

• Training Set Sample Size: Not applicable. This is a hardware device, not an AI model that undergoes "training."

9. How Ground Truth for Training Set Was Established:

• Ground Truth Establishment for Training Set: Not applicable, as there's no AI training set described.

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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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