(94 days)
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.
| Criteria | Proposed device (PAPAYA & PAPAYA Plus) | Predicate Device (PAPAYA Plus - K141700) | Conclusion on Equivalence against Implicit Criteria |
|---|---|---|---|
| Indications for Use | Same as predicate | Digital extraoral source X-ray system for panoramic and cephalometric images of oral/craniofacial anatomy, dental/skull radiographic examination, and CUST (Tomographic) option for cross-sectional images for implant planning and impacted teeth. | Equivalent |
| Performance Specification | Panoramic (PAPAYA), Panoramic and Cephalometric (PAPAYA Plus) | Panoramic (PAPAYA), Panoramic and Cephalometric (PAPAYA Plus) | Equivalent |
| Input Voltage | 100-240 V~, 50/60Hz | 120 V~, 60Hz | Different, but safety/EMC verified |
| Tube Voltage | 60-90 kV | 60-90 kV | Equivalent |
| Tube Current | 4-12 mA | 4-12 mA | Equivalent |
| Focal Spot Size | 0.5 mm | 0.5 mm | Equivalent |
| Exposure Time | Panorama: max 17 sec, Cephalo: max 12 sec | Panorama: max 17 sec, Cephalo: max 12 sec | Equivalent |
| Exposure Mode | Panoramic, TMJ, SINUS, CUST, Cephalo | Panoramic, TMJ, SINUS, CUST, Cephalo | Equivalent |
| Image Receptor | CMOS (Panoramic and Cephalometric) | CMOS (Panoramic and Cephalometric) | Equivalent |
| Image Processing Software | Triana (K103182) or Theia | N/A (Predicate did not specify external image processing software in this comparison) | Different, but Theia validated against IEC 62304 and deemed functionally equivalent to Triana |
| Safety/EMC/Performance Data | Tested to IEC 60601-1, -1-2, -1-3, -1-6, -2-63,IEC 62366, IEC 62304, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance, Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software contained in Medical Devices, Pediatric Information for X-ray Imaging Device Premarket Notifications, Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices, NEMA PS 3.1-3.20 (DICOM Set) | Established in K141700 | Equivalent through compliance with relevant standards and guidelines |
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.
§ 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.