(203 days)
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):
| Acceptance Criteria (Inferred) | Reported Device Performance (for newly added detectors) |
|---|---|
| Clinical Considerations: Images are "diagnosable" and meet indications for use | "well enough to diagnosable and meet its indications for use" |
| Imaging Performance (for newly added CBCT image receptor FXDD-0909GA): | Tested for: |
| - Gantry positioning accuracy | - Gantry positioning accuracy |
| - In-plane uniformity | - In-plane uniformity |
| - Spatial resolution section thickness | - Spatial Resolution section thickness |
| - Noise | - Noise |
| - Contrast to Noise Ratio | - Contrast to Noise Ratio |
| - Geometric Distortion | - Geometric Distortion |
| - Metal Artifacts | - Metal Artifacts |
| Imaging Performance (for newly added Cephalometric image receptor FXDD-1012CA): | Tested for: |
| - Line pair resolution | - Line pair resolution |
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.
§ 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.