(260 days)
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:
- Bench Testing: Demonstrating compliance with various international standards for safety, EMC, and performance.
- Comparison to Predicate Device: Arguing that the PAPAYA Plus has similar indications for use, performance specifications, and technical characteristics to the legally marketed predicate.
- 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.
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Electrical, Mechanical, Environmental Safety & Performance | Compliance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, IEC 61223-3-4. | "All test results were satisfactory." "The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices." |
| EMC Testing | Compliance with IEC 60601-1-2. | "All test results were satisfactory." |
| Solid State X-ray Imaging Devices | Compliance with FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices." | "All test results were satisfactory." |
| EPRC Standards | Compliance with 21 CFR 1020.30, 31. | "PAPAYA Plus meets the EPRC standards (21 CFR 1020.30, 31)." |
| DICOM Standards | Compliance with NEMA PS 3.1-3.18. | "PAPAYA Plus also meets the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set." |
| Clinical Equivalence | Demonstrating comparable safety and effectiveness to the predicate device (PCH-2500 (PaX-i)). | "The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices." "PAPAYA Plus is deemd to be substantially equivalent to the predicate device, PCH-2500 (PaX-i) in safety and effectiveness." |
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.
§ 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.