(56 days)
RCT800 is CBCT and panoramic x-ray imaging system with cephalometric. Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway for diagnostic support for adult and pediatric patients. And a model scan is included as an option. Cephalometric image is also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment. The device is to be operated and used by dentists or other legally qualified heath care professionals.
RCT800 is 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, CBCT images of dental maxillofacial 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, cephalometric scanning option for attaining cephalic image, and Model Scan option for attaining dental model CBCT image are included.
The provided text describes the regulatory clearance of a medical device (RCT800), focusing on its substantial equivalence to predicate devices rather than a detailed study proving it meets specific acceptance criteria in the context of AI performance. Therefore, the information needed to fully answer the request, particularly regarding AI performance, ground truth establishment, expert qualifications, and sample sizes for training/test sets in an AI context, is largely absent.
It appears the RCT800 is a dental X-ray system (CBCT, panoramic, cephalometric) and not explicitly an AI-powered diagnostic device from the provided documentation. The "software" mentioned is for image generation, patient data management, and inquiry, with a moderate level of concern, suggesting it functions as control and viewing software rather than an AI-driven interpretation system.
However, I can extract and infer some information based on the request and the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission focused on substantial equivalence for an imaging device, the "acceptance criteria" are generally aligned with demonstrating that the new device performs as safely and effectively as legally marketed predicate devices, and meets relevant performance standards.
| Feature/Metric/Test | Acceptance Criteria (Implied by Substantial Equivalence and Standards) | Reported Device Performance (RCT800) |
|---|---|---|
| Safety Testing | Conformance to IEC 60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-63, IEC 60601-1-2 (EMC) | All test results were satisfactory. |
| Imaging Performance Testing | Conformance to IEC 61223-3-4 and IEC 61223-3-5 | All test results were satisfactory. |
| Non-Clinical Performance | Performance (e.g., image quality, dose) similar to predicate devices | Similar to predicate device FXDD-0606CA (for PANO, CBCT, Model Scan) and 1717SCC (for Cephalometric) detectors. |
| Software Validation | Adherence to FDA Guidance for Software Contained in Medical Devices and Cybersecurity Guidance (moderate level of concern) | Validated and documented. Risk analysis indicates no effect on safety/effectiveness. |
| Clinical Operation | System works as intended for dental X-ray. Clinical diagnosis and structures are acceptable in regions of interest. | Observed and verified by two licensed practitioners/clinicians. Clinical images gathered from new detector on random patients. |
| Image Parameters | Matching parameters with predicate devices (see tables) for: Focal size, Field of View (CT), X-ray Voltage/Current, Total Filtration, Detector Pixel size, Magnification, Scan time. | Comparison tables show very close matching or "Same as predicate device." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size:
- Clinical Images: "random patient age, gender, and size" were used to gather clinical images from the new detector installed with RCT800. The number of patients or images is not specified.
- Non-Clinical Performance: Test results for the new detectors (FXDD-0606CA, 1717SCC) were compared to predicates. This likely involved quantitative testing on phantoms or test objects, not patient data in the same sense as clinical images. The sample size for these non-clinical tests is not specified, but typically involves a defined set of measurements.
- Data Provenance: The new detector was installed at "2 offices where the predicate device is installed." This suggests prospective data collection (images gathered from newly installed RCT800 units in a clinical setting). The country of origin is not explicitly stated for the clinical data, but the manufacturer is in the Republic of Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: "two licensed practitioners/clinicians."
- Qualifications of Experts: "licensed practitioners/clinicians." No specific specialization (e.g., radiologist, dentist) or years of experience are provided, but the context of "dental X-ray system" strongly implies dental professionals.
4. Adjudication method for the test set
- The text 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 an assessment of diagnostic acceptability by the two practitioners. An explicit "adjudication method" (like 2+1 or 3+1) is not detailed; it's more of a verification of intended function rather than a formal ground truth consensus process for diagnostic accuracy.
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, an MRMC comparative effectiveness study involving AI assistance was not described. The submission is for an imaging device itself, not an AI-powered diagnostic aid. The device helps acquire images; it does not independently interpret them or assist human readers in interpretation beyond providing the images.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone algorithm performance study was not described. This device is an X-ray system; it requires a human operator to acquire images and human practitioners to interpret them. The "software" mentioned supports device operation and image viewing, not autonomous diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the clinical observations, the "clinical diagnosis and structures are acceptable in the region of interests" by "licensed practitioners or clinician diagnoses." This suggests expert diagnostic opinion as the basis for evaluating image acceptability. It does not refer to pathology or outcomes data.
- For non-clinical performance (e.g., image quality, dose), the ground truth would be physical measurements against established standards (IEC norms) or direct comparison to the physical properties/output of the predicate devices.
8. The sample size for the training set
- Not applicable / Not provided. The RCT800 is an X-ray imaging system, not an AI model requiring a training set in the conventional sense. The software mentioned is for control, patient data management, and image generation, not for learning from a training set to make diagnoses.
9. How the ground truth for the training set was established
- Not applicable. As a non-AI imaging device, there is no "training set" or "ground truth for the training set" in the context of machine learning model development.
§ 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.