(262 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 CBCT 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-3D, SM3D, M3DS and M3DL are 3D computed tomography for scanning hard tissues like bone and teeth.
By rotating the c-arm which is embedded with high voltage generator all-in-one x-ray tube and a detector on each end, fault surface image of whole body is attained by recombining data from the same level that are scanned from different angle. Panoramic image scanning function for attaining image of whole teeth, and cephalometric scanning option for attaining cephalic image are included.
Detector Options:
Specific models according to the detector type; CT, Pano and Ceph mounted in the RAYSCAN α- Expert 3D system are classified as shown below.
RAYSCAN α-3D: CT(model-C10900D)+PANO(model-C10500D) RAYSCAN α-SM3D: CT(model-C10900D)+PANO(model-C10500D)+ Scan Ceph(model-XID-C24DS) RAYSCAN α-M3DL: CT(model-C10900D)+PANO(model-C10500D)+ One shot ceph(model-PaxScan 4336X) RAYSCAN α-M3DS: CT(model-C10900D)+PANO(model-C10500D) + One shot ceph(model-PaxScan 2530C)
The provided text describes the RAYSCAN a-Expert 3D, a dental X-ray system. Here's a breakdown of the acceptance criteria and study information:
Acceptance Criteria and Device Performance
The document does not explicitly state "acceptance criteria" for performance metrics in a pass/fail format. Instead, it compares the proposed device's detector specifications (mainly for the new one-shot cephalometric models, PaxScan 4336X and PaxScan 2530C) against those of the predicate devices. The implicit acceptance criterion is that the new detectors should have comparable or better imaging performance metrics (MTF, DQE, limiting resolution, pixel size) to the predicate devices, and that the overall system performs as intended.
Here's a table summarizing the relevant performance specifications for the new one-shot Ceph detectors and their closest predicate counterparts:
| Parameter | Acceptance Criteria (Predicate Device SDX-4336CP) | Reported Device Performance (Proposed Device PaxScan 4336X) | Reported Device Performance (Proposed Device PaxScan 2530C) |
|---|---|---|---|
| Ceph (One shot, Large Size) Detector | |||
| Manufacturer | Samsung Mobile Display | Varian | N/A (different size for this comparison) |
| Model | SDX-4336CP | PaxScan 4336X | N/A |
| Scintillator Material | CsI (Indirect type) | GADOX (Indirect type) | N/A (GADOX) |
| Total pixel area | 43.2 x 36.0 cm | 427(W)x356(H)mm (42.7 x 35.6 cm) | N/A (Smaller size, 30.2 x 24.9 cm for 2530C) |
| Total pixel | 2880 x 2400 | 3072x2560 | N/A (2176x1792 for 2530C) |
| Pixel size | 150 um | 139 um | N/A (139 um for 2530C) |
| Limiting resolution | 3.3 lp/mm | 3.6 lp/mm | N/A (3.6 lp/mm for 2530C) |
| MTF (at 1LP/mm) | 45% | 54% | N/A (54% for 2530C) |
| DQE (at 1P/mm) | 0.41 | 0.2 | N/A (0.2 for 2530C) |
Summary of Performance:
The proposed detectors (PaxScan 4336X and 2530C) show a higher limiting resolution (3.6 lp/mm vs 3.3 lp/mm) and a smaller pixel size (139 um vs 150 um) compared to the predicate's one-shot Ceph detector (SDX-4336CP). The MTF (Modulation Transfer Function) is also higher (54% vs 45%). However, the DQE (Detective Quantum Efficiency) is lower (0.2 vs 0.41), indicating less efficient X-ray photon utilization for image quality. The overall conclusion states that "the diagnostic image quality of the new detector is equal or better than those of the predicate device and there is no significant difference in efficiency and safety." This implies the lower DQE was deemed acceptable in the context of other improved metrics and overall system performance.
Study Details
-
Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document mentions "clinical imaging samples are collected from the new 2 one shot detector on propose device at the 2 offices." It also states "clinical test images were gathered from the new 2 one shot ceph detector installed with RAYSCAN α-M3DL and M3DS on any protocols with random patient age, gender, and size." However, a specific number of cases or images for the clinical test set is not provided.
- Data Provenance: Not explicitly stated, but implies real-world clinical data as the images were gathered from "2 offices" where the proposed devices were installed. It's likely prospective for these specific tests as it references "random patient age, gender, and size," suggesting real-time image acquisition for the test. However, the overarching context of a 510(k) submission might involve retrospective review of other data.
-
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: "two licensed practitioners/clinicians"
- Qualifications of Experts: "licensed practitioners/clinicians" - no further details provided (e.g., specialty, years of experience).
-
Adjudication Method for the Test Set:
- The document states, "As licensed practitioners or clinician diagnoses of the images, it might be proved that the clinical diagnosis and structures are acceptable in the region of interests." This suggests that the two practitioners independently reviewed the images and determined their diagnostic acceptability, likely reaching a consensus or individual affirmation of acceptability, rather than a formal adjudication process like 2+1 or 3+1 for conflicting interpretations. The method is not detailed beyond "observed and verified."
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a direct MRMC comparative effectiveness study is not explicitly mentioned. The study focuses on comparing technical specifications and verifying diagnostic acceptability of the proposed device's images. There's no mention of human readers' performance with and without AI assistance, as this is an imaging device, not an AI diagnostic tool.
-
Standalone (Algorithm Only) Performance Study:
- Yes, a standalone performance study was done for the detector components. Bench testing (IEC 61223-3-4, IEC 61223-3-5, FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State Xray Imaging Devices") was conducted to assess imaging performance metrics like MTF and DQE. This is a technical performance evaluation of the hardware, not an AI algorithm. The device itself is an X-ray imaging system, which inherently has "standalone" image generation capability without human interpretation during the image creation phase.
-
Type of Ground Truth Used:
- Clinical Diagnoses/Acceptability: For the clinical image evaluation, the ground truth was established by "licensed practitioners or clinician diagnoses of the images" determining if "the clinical diagnosis and structures are acceptable in the region of interests." This implies a form of expert consensus or clinical expert opinion on the diagnostic utility of the images. It's not explicitly stated as pathology or outcomes data.
-
Sample Size for the Training Set:
- Not Applicable / Not Provided. This device is an X-ray imaging system, not an AI algorithm that typically requires a large training set of labeled data for machine learning. The "software of RAYSCAN α-Expert3D has been validated" but no training set for the imaging capabilities of the X-ray system itself is mentioned, as its function is image acquisition, not autonomous interpretation.
-
How the Ground Truth for the Training Set Was Established:
- Not Applicable / Not Provided. As above, there is no mention of a "training set" in the context of an AI algorithm or diagnostic model here. The system's function is image acquisition based on physics and engineering principles, not learning from labeled data.
§ 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.