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510(k) Data Aggregation
(144 days)
RAYSCAN a-Expert 3D, panoramic x-ray imaging system with cephalostat, is an extraoral source x-ray system, which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBVT technique, to generate dentomaxillofacial 3D images. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. 2D Image is obtained using the standard narrow beam technique.
RAYSCAN α-Expert 3D is a 3D computed tomography for scanning hard tissues such as bones and teeth. By rotating the c-arm that include the high voltage generator all-in-one xray tube and a detector on each end, a CBCT image of whole dentomaxillofacial is attained by recombining data from the same level that are scanned from different angles. Panoramic image scanning function for attaining images of the entire or segmental teeth and cephalometric scanning option (One shot type & Scan type) for attaining the cephalic images are included. It allows to choose from two different types of CEPH detectors: Base: RAYSCAN α-3D: CT+PANO Option: RAYSCAN α-Multi 3D: CT+PANO+One-shot CEPH Option: RAYSCAN a-SM3D: CT+PANO+SCAN CEPH SMARTDent software for processing and archiving is optional.
Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets them:
The document (K131695) describes the RAYSCAN α-Expert 3D, a dental panoramic/tomography and cephalometric x-ray system. This is a Special 510(k) submission, indicating a modification to a previously cleared device (K122981).
Emphasis: It's crucial to understand that this document is a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a predicate device. It does not typically involve detailed performance studies with acceptance criteria in the way one might expect for a novel device or a significantly modified one that requires extensive clinical validation. Instead, the "study" proving acceptance is largely based on demonstrating that the modified device's performance is equivalent to the predicate, particularly for the new feature (Scan type CEPH sensor).
Acceptance Criteria and Study Details:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a Special 510(k) for substantial equivalence to a predicate device, the "acceptance criteria" are essentially for demonstrating that the modified device's specifications and performance meet or are equivalent to the predicate device, especially for the new feature.
| Parameter | Acceptance Criteria (Predicate: RAYSCAN α-Expert 3D [K122981]) | Reported Device Performance (Modified: RAYSCAN α-Expert 3D) | Device Meets Criteria? |
|---|---|---|---|
| Common Name | Dental panoramic/tomography and cephalometric x-ray system | Dental panoramic/tomography and cephalometric x-ray system | Yes |
| Indications for Use | Intended for dental radiographic examination of teeth, jaw, oral structures; panoramic examinations, implantology, TMJ studies, cephalometry; capability for dento-maxillo-facial 3D images using CBVT technique; uses cone-shaped x-ray beam projection onto flat panel detector for 3D reconstruction; 2D images via standard narrow beam. | Intended for dental radiographic examination of teeth, jaw, oral structures; panoramic examinations, implantology, TMJ studies, cephalometry; capability for dento-maxillo-facial 3D images using CBVT technique; uses cone-shaped x-ray beam projection onto flat panel detector for 3D reconstruction; 2D images via standard narrow beam. | Yes |
| 3D Technology | CBCT Cone beam Computed Tomography | CBCT Cone beam Computed Tomography | Yes |
| Performance Specification | Panoramic, Cephalometric (optional: One_shot type) | Panoramic, Cephalometric (optional: One_shot type, Scan type) | Yes (with added Scan type) |
| Functional Option | Base: α -3D : CT+PANO; Option: a-Multi 3D: CT+PANO+One-shot CEPH | Base: α -3D : CT+PANO; Option: a-Multi 3D: CT+PANO+One-shot CEPH(option), a -SM3D: CT+PANO+SCAN CEPH(option) | Yes (with added Scan type option) |
| Detector Type (CT) | Flat panel X-ray sensor | Flat panel X-ray sensor | Yes |
| Detector Type (Pano) | Flat panel X-ray sensor | Flat panel X-ray sensor | Yes |
| Detector Type (Ceph, One-shot) | Flat panel X-ray sensor | Flat panel X-ray sensor(One-shot type) | Yes |
| Detector Type (Ceph, Scan type) | Not applicable (predicate did not have this) | CdTe Direct flat panel sensor [Scan type] | N/A (new feature, performance evaluated for equivalence) |
| Focal Size | 0.5mm | 0.5mm | Yes |
| Field of View (CT) | 90x90mm | 90x90mm | Yes |
| X-ray Voltage | 60-90kVp | 60~90kVp | Yes |
| X-ray Current | 4-17mA | 4~17mA | Yes |
| Total Filtration | 2.6 mm Al equivalent | 2.6 mm Al equivalent | Yes |
| Magnification (CT) | 1.39 | 1.39 | Yes |
| Magnification (Pano) | 1.31 | 1.31 | Yes |
| Magnification (Ceph One-shot) | 1.13 | 1.13 | Yes |
| Magnification (Ceph Scan type) | Not applicable | 1.11 | N/A (new feature, performance evaluated for equivalence) |
| Scan Time (CT) | 14sec | 14sec | Yes |
| Scan Time (Pano) | 14sec | below 14sec | Yes |
| Scan Time (Ceph One-shot) | 0.3sec~3.0sec | 0.3sec~3.0sec | Yes |
| Scan Time (Ceph Scan type) | Not applicable | below 18sec | N/A (new feature, performance evaluated for equivalence) |
| Safety and EMC (Applicable Standards) | IEC 60601-1, -1-1, -1-3, -2-7, -2-28, -2-32, -2-44, -1-2 | IEC 60601-1, -1-1, -1-3, -2-7, -2-28, -2-32, -2-44, -1-2 | Yes |
| Certificate Product | CE0120(MDD93/42/EEC) | CE0120(MDD93/42/EEC) | Yes |
| Non-clinical & Clinical Considerations (for added Scan CEPH sensor) | N/A | Report provided for equivalence | Yes |
Summary of "Acceptance": The device meets "acceptance criteria" by demonstrating that all parameters common with the predicate device are identical or within acceptable bounds, and the new "Scan type CEPH sensor" feature is evaluated and found to be substantially equivalent in terms of safety and effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" sample size or its provenance in terms of patient data. For a Special 510(k), the focus is often on engineering verification and validation (V&V) and comparing the new feature to the existing one.
- Test Set: Not explicitly defined in terms of patient images for a statistical study. The "test set" for demonstrating equivalence appears to be qualitative comparisons of imaging performance, particularly for the new "Scan type CEPH sensor."
- Data Provenance: Not specified. However, given that the manufacturer is based in South Korea, it's plausible any internal testing or "expert review of image comparisons" would involve data generated internally, possibly from phantoms or a limited set of patient images, likely retrospective if not specifically collected for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document mentions an "outcome of experts review of image comparisons."
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. It's reasonable to infer they would be qualified to review dental radiographic images, such as radiologists or oral and maxillofacial radiologists, but specific experience levels are not provided.
4. Adjudication Method for the Test Set
The document states "outcome of experts review of image comparisons," implying a qualitative assessment.
- Adjudication Method: Not explicitly stated (e.g., 2+1, 3+1). It was likely a consensus approach or individual expert assessment contributing to an overall finding of equivalence. There's no detail on how disagreements would be resolved.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This device is an imaging system, not an AI-assisted diagnostic tool. The submission is about physical device performance and substantial equivalence, not the improvement of human readers with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the context of an AI algorithm. This device is an X-ray imaging system. The "performance" assessment focuses on the image quality produced by the system and its technical specifications compared to the predicate device.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the "expert review of image comparisons," the "ground truth" would be the subjective assessment of image quality, diagnostic utility, and comparability between images from the modified device (especially the new CEPH scan type) and the predicate device. This is a form of expert consensus/assessment, rather than pathology or outcomes data. For the technical specifications, the ground truth is established through engineering measurements and adherence to international standards.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is an X-ray imaging machine, not a machine learning or AI algorithm that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
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