(169 days)
RAYSCAN α - 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 a-Expert 3D is a 3D computed tomography for scanning hard tissues such as bones and teeth. By rotating the c-arm which includes the high voltage generator all-in-one x-ray tube and a detector on each end, 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 teeth and cephalometric scanning option for attaining the cephalic images are included. The system includes processing, and archiving "SMARTDent "software(Optional)
The provided text is a 510(k) submission for the RAYSCAN α-Expert 3D device. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in terms of diagnostic accuracy or clinical effectiveness involving human subjects or AI performance metrics.
The document focuses on demonstrating substantial equivalence to a predicate device (Rotagraph EVO 3D, K111152) primarily through a comparison of technical specifications and intended use.
Here's a breakdown of the information that is present and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not provided. The document includes a table comparing technical specifications of the RAYSCAN α-Expert 3D with the predicate device. This table lists parameters like detector pixel size, scan time, X-ray voltage, etc., but it does not present specific acceptance criteria (e.g., minimum spatial resolution, contrast-to-noise ratio) nor does it provide a direct "reported device performance" against such criteria. The comparison simply shows the values for both devices.
| Parameter | RAYSCAN α-Expert 3D (New Device) | Rotagraph EVO 3D (Predicate Device) |
|---|---|---|
| Focal size | 0.5mm | 0.5mm |
| Field of View (CT) | 90x90mm | 85x85mm |
| X-ray Voltage | 60~90kVp | 60~86kVp |
| X-ray Current | 4~17mA | 6~12 mA |
| Total Filtration | 2.6 mm Al equivalent | 2.5 mm Al equivalent |
| CT Detector Pixel size | 100 μm | 127 μm |
| Pano Detector Pixel size | 100 μm | 127 μm |
| Ceph Detector Pixel size | 150 μm | 48 μm |
| CT Magnification | 1.39 | 1.25 (Open/close mouth TMJ) |
| Pano Magnification | 1.31 | 1.28 |
| Ceph Magnification | 1.13 | 1.10 |
| CT Scan time | 14sec | Max 20sec |
| Pano Scan time | 14sec | Max 13.8sec |
| Ceph Scan time | 0.3sec~3.0sec | 15sec |
| CT Grey level | 14bit | 14bit |
| Pano Grey level | 14bit | 14bit |
| Ceph Grey level | 14bit | 12bit |
| Rotation angle | 360° | 200° |
2. Sample Size Used for the Test Set and Data Provenance:
- Not provided. The document mentions "Non-clinical & Clinical considerations according to FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed, but no details about participants, data provenance (country of origin, retrospective/prospective), or a specific test set for evaluation are given. The submission focuses on technical and safety equivalence, not clinical performance data from a specific study population.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
- Not applicable/Not provided. Since there's no clinical performance study involving a test set described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication Method:
- Not applicable/Not provided. As no clinical performance study is detailed, no adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document does not describe an MRMC study or any comparison of human readers with vs. without AI assistance. The device as described is an imaging system, not an AI-powered diagnostic tool in the sense of providing automated interpretations.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable/Not provided. This is an imaging device, and its approval is based on its ability to produce images comparable to a predicate device, not on the performance of a standalone algorithm for diagnosis.
7. Type of Ground Truth Used:
- Not applicable/Not provided. Without a described performance study, there's no mention of ground truth (e.g., pathology, expert consensus). The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness of the predicate device, to which the new device is being compared for "substantial equivalence."
8. Sample Size for the Training Set:
- Not applicable/Not provided. The device is an X-ray imaging system, not an AI model that requires a training set in the typical sense.
9. How the Ground Truth for the Training Set was Established:
- Not applicable/Not provided. As above, this is an imaging device, not an AI model requiring a training set and corresponding ground truth.
Summary of the Study Mentioned:
The document states: "Electrical, mechanical, environmental safety and performance testing according to standards IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32 and IEC 60601-2-44 was performed, and EMC testing was conducted in accordance with the standard IEC 60601-1-2. Non-clinical & Clinical considerations according to FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed. All test results were satisfactory."
This indicates that the device underwent bench testing and compliance testing with recognized international safety and performance standards for medical electrical equipment and specific X-ray equipment. These tests are designed to ensure the device functions as intended from an engineering and safety perspective, and meets regulatory requirements for radiation safety and electrical safety. The "Non-clinical & Clinical considerations" refer to review against FDA guidance, which might involve analysis of image quality metrics typically reviewed for X-ray devices (e.g., spatial resolution, contrast, noise, dose efficiency), but specific details of such studies (sample size, methodology, acceptance criteria) are not included in this summary.
Conclusion from the document:
The conclusion drawn by the manufacturer is that "Based on a comparison of intended use, indications, constructions, construction materials, principal of Operation, features and technical data, the RAYSCAN α-Expert 3D system are safe and effective to perform its intended use as well as substantially equivalent to the predicate device."
Therefore, the "study" that proves the device meets (implicitly, safety and effectiveness) criteria is essentially the technical comparison and independent testing against recognized standards to establish substantial equivalence to the predicate device, rather than a clinical performance study with specific diagnostic accuracy metrics.
§ 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.