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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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PAPAYA & PAPAYA Plus are 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 crosssectional radiographic images provide dimensional information for dental implant planning and information about location of impacted teeth.

The proposed devices PAPAYA & PAPAYA Plus are diagnostic imaging system which consists of multiple image acquisition modes; panorama and cephalometric. The difference beteween PAPAYA & PAPA YA Plus is only optional of the cephalometric detector. (Without cephalometric detector, we model named PAPAYA, and with cephalometric detector, we model named PAPAYA Plus.)

The proposed devices have the CUST imaging option which is used to reconstruct tomographic images from a set of pre-acquired projection radiographic images of the object.

The differences from predicate device(K141700) are change of power voltage, addition of image processing software(Theia, Triana).

This FDA submission describes the PAPAYA & PAPAYA Plus digital extraoral source X-ray systems, which are intended to produce panoramic and cephalometric images for dental and craniofacial diagnosis and treatment planning. The submission asserts substantial equivalence to a previously cleared device, PAPAYA Plus (K141700).

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list acceptance criteria in the format of a separate table with target values. Instead, it presents a comparative table between the proposed device and the predicate device, highlighting performance specifications and software features. The "acceptance criteria" are implied to be that the proposed device performs at least equivalently to the predicate device, with any changes either being safety-verified or not impacting overall efficacy.

2. Sample Size Used for the Test Set and Data Provenance

The submission mentions "Clinical Evaluation Report and bench" testing for safety and effectiveness but does not provide specific details about the sample size used for any clinical test set or the provenance of any data (e.g., country of origin, retrospective/prospective). The primary focus of the performance data section is on adherence to regulatory standards and comparison to a predicate device's specifications.

3. Number of Experts Used to Establish Ground Truth and Qualifications

There is no mention of experts or ground truth establishment in the context of a diagnostic performance study for the proposed device in this submission. The submission centers on the physical device's specifications and software validation.

4. Adjudication Method

No adjudication method is mentioned, as there is no description of a study involving subjective assessment of diagnostic accuracy.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study comparing human readers with and without AI assistance is mentioned. The device described is an X-ray imaging system and associated image processing software, not an AI-assisted diagnostic tool in the sense of providing automated interpretations. While the software offers "3D visualization, 2D analysis, various MPR functions," which can assist human readers, it's not discussed in the context of an MRMC study for effect size improvement.

6. Standalone (Algorithm Only) Performance

A standalone performance study for the image processing software (Triana or Theia) beyond the validation against IEC 62304 for software lifecycle processes is not explicitly described in terms of diagnostic accuracy or a specific clinical task without human interaction. The software is described as a tool to "obtain, store, inquire, and process the acquired image," suggesting it's an enhancement for human interpretation, not a standalone diagnostic algorithm.

7. Type of Ground Truth Used

No specific "ground truth" (e.g., expert consensus, pathology, outcomes data) is mentioned as part of a diagnostic accuracy study. The safety and performance assessments are based on compliance with electrical, mechanical, and imaging standards, as well as software validation.

8. Sample Size for the Training Set

The submission does not mention a training set, as it does not describe the development or validation of a machine learning-based diagnostic algorithm. The software mentioned (Triana/Theia) performs image processing and visualization, not AI-driven diagnosis requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned, this information is not provided.

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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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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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