(25 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.
Here's an analysis of the acceptance criteria and study information for the RCT800 device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria for the imaging performance, but rather indicates that the device's performance was compared to its predicate and found satisfactory. The performance specifications are primarily focused on the operational parameters of the X-ray system.
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functionality | Similar to predicate device (RCT800 - K182805) | RCT800 has PANO, CEPH (Optional), CBCT, Model Scan modes. Software (RAYSCAN) cleared with K182805. |
| X-ray Voltage Range (Patient) | Within acceptable dental X-ray system parameters | 60-100kVp (predicate: 60-90kVp) |
| X-ray Current Range (Patient) | Within acceptable dental X-ray system parameters | 4-17mA (same as predicate) |
| X-ray Voltage Range (Model Scan) | Within acceptable dental X-ray system parameters | 50-80kVp (same as predicate) |
| X-ray Current Range (Model Scan) | Within acceptable dental X-ray system parameters | 0.4-0.7mA (same as predicate) |
| Total Filtration | Min. 2.8 mm Al equivalent (same as predicate) | Min. 2.8 mm Al equivalent |
| Scan Time (CT - Patient) | Below 14 seconds (predicate: below 20 seconds) | Below 14 seconds |
| Scan Time (CT - Model Scan) | Below 180 seconds (same as predicate) | Below 180 seconds |
| Scan Time (Pano) | Below 14 seconds (same as predicate) | Below 14 seconds |
| Scan Time (Ceph Scan type) | Below 19 seconds (predicate: below 20 seconds) | Below 19 seconds |
| Scan Time (Ceph One shot) | Below 2 seconds (same as predicate) | Below 2 seconds |
| Safety Standards Compliance | Adherence to IEC 60601 series and IEC 61223 series | Complies with IEC 60601-1, -1-3, -1-6, -2-63, and IEC 60601-1-2. |
| Image Quality | Acceptable quality for intended use | Licensed practitioner reviewed sample clinical images and found them to be of acceptable quality for intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The text states, "Clinical images were provided these images were not necessary to establish substantial equivalence based on the modifications to the device but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended." It also mentions, "These images were gathered from the all detector installed with RCT800 on any protocols with random patient age, gender, and size." A specific numerical sample size (e.g., number of patients or images) is not provided.
- Data Provenance: The images were collected "at the 2 offices where the predicate device is installed." The text does not specify the country of origin but states the manufacturer (RAY Co., Ltd.) is from the Republic of Korea. It is implied to be prospective as the images were gathered for the purpose of this submission and involve "random patient age, gender, and size" on newly installed devices, rather than being pulled from existing archives.
3. 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 specific experience level (e.g., "10 years of experience") is provided, but being "licensed" implies a baseline qualification for medical interpretation.
4. Adjudication Method for the Test Set
The text states, "A licensed practitioner reviewed the sample clinical images and found them to be of acceptable quality for the intended use." It does not describe a formal adjudication method (like 2+1 or 3+1 consensus). It appears to be a single reviewer's assessment, which might suggest a less rigorous adjudication than a multi-reader consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described or presented in the provided text. The study focused on demonstrating substantial equivalence to a predicate device through technical specifications, bench testing, and a review of clinical images by a practitioner, rather than measuring reader performance with and without AI assistance. The device is an X-ray imaging system, not an AI diagnostic tool that assists human readers.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable in the context of an X-ray imaging device. The RCT800 is an imaging system, not an AI algorithm intended for standalone diagnosis. Its performance is evaluated on its ability to produce images of acceptable quality for human interpretation.
7. Type of Ground Truth Used
The ground truth for the clinical images was established by expert judgment/review by "licensed practitioners/clinicians." The practitioners assessed the "acceptable quality for the intended use" of the images. This is not pathology, or direct outcomes data, but rather an assessment of diagnostic utility from the images.
8. Sample Size for the Training Set
The provided text focuses on the performance of the imaging device itself and its comparison to a predicate, not on an AI algorithm that would require a distinct training set. Therefore, a training set sample size is not applicable or mentioned in this context. The "software" mentioned (RAYSCAN) is for viewing and managing images, not for AI-based analysis requiring a training dataset.
9. How Ground Truth for the Training Set Was Established
As no training set for an AI algorithm is mentioned, the method for establishing its ground truth is not applicable or 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.