(97 days)
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.
| Criteria | Proposed Device (PAPAYA 3D & PAPAYA 3D Plus) | Predicate Device (PAPAYA 3D Plus - K150354) |
|---|---|---|
| 3D Technology | Cone beam Computed tomography | Cone beam Computed tomography |
| CT FOV (DXH) | 14x14, 14x8, 8x8, 7x7, 4x4 cm | 14x14, 14x8, 8x8, 7x7, 4x4 cm |
| Input Voltage | 100-240 V~, 50/60Hz | 100-120 V~, 50/60Hz |
| Tube Voltage | 60-90 kV | 60-90 kV |
| Tube Current | 4-12 mA | 4-12 mA |
| Focal Spot Size | 0.5 mm | 0.5 mm |
| Total Filtration | 2.8 mm Al (Canon tube) | 2.5 mm Al (CEI tube) |
| 2.8 mm Al (Canon tube) | ||
| Exposure Time | Panorama: max 17 sec | |
| Cephalo: max 15.5 sec (Plus only) | ||
| CT: max 15 sec | Panorama: max 17 sec | |
| Cephalo: max 15.5 sec | ||
| CT: max 15 sec | ||
| Image Receptor | Panoramic: CMOS FPD | |
| Cephalo: CMOS FPD | ||
| CT: CMOS FPD | Panoramic: CMOS FPD | |
| Cephalo: CMOS FPD | ||
| CT: CMOS FPD | ||
| Image processing S/W | Triana (K103182) / Theia | - (The predicate device itself likely had an image viewer, but it's not explicitly named as "Theia" or "Triana" in the predicate column of this table.) |
| Image Quality (from non-clinical tests) | MTF: >80% at 21lp/mm (panoramic/cephalometric sensors) | |
| DQE: ~80% at 01lp/mm (panoramic/cephalometric sensors) | ||
| Dynamic Range: >72dB (panoramic/cephalometric sensors) | ||
| MTF: >60% at 11lp/mm (all detectors) | ||
| DQE: ~70% at 01lp/mm (all detectors) | ||
| Dynamic Range: >72dB (all detectors) | (Implicitly similar or was the benchmark for the proposed device's "similar" image quality) |
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]).
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.