(116 days)
CBCT, panoramic x-ray imaging system with cephalostat, is an extra oral 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 dental maxillofacial 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.
RCT700 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, and cephalometric scanning option for attaining cephalometric image are included.
Here's an analysis of the acceptance criteria and study details for the RCT700 device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list specific quantitative "acceptance criteria" in a table format with pass/fail thresholds. Instead, it compares the performance of the proposed device (RCT700) to its predicate devices (RAYSCAN α-Expert3D) based on established imaging quality metrics. The ultimate acceptance criterion communicated is "similar or better than the predicate device."
| Metric / Parameter | Acceptance Criteria (Implicit) | Reported Device Performance (RCT700) |
|---|---|---|
| Imaging Quality - CT | ||
| Pixel Size (SiX 650HD-E) | Similar to predicate (C10900D: 200um) | SiX 650HD-E: 150um (Smaller, indicating potentially higher resolution) |
| Limiting Resolution | Similar or better than predicate (C10900D: 2.5lp/mm) | SiX 650HD-E: 3.3lp/mm (Better) |
| MTF (650HD-E at 1LP/mm) | Similar or better than predicate (C10900D: 58%) | SiX 650HD-E: 60% (Better) |
| DQE (650HD-E at 1LP/mm) | Similar or better than predicate (C10900D: 0.22) | SiX 650HD-E: 0.45 (Better) |
| VOXEL | Similar to predicate (C10900D: 0.28mm) | 0.07~0.4mm (Range encompasses predicate, with smaller minimum, indicating potentially higher resolution) |
| Imaging Quality - PANO | ||
| MTF (XID-C15DP) | Similar to C10500D | XID-C15DP: 75% at 1LP/mm (Similar to C10500D's 70% at 1LP/mm, though the comparison specifically states "similar characteristics") |
| DQE (XID-C15DP) | Similar to C10500D | XID-C15DP: 0.88 at 1LP/mm (Better than C10500D's 0.5 at 1LP/mm, though the comparison specifically states "similar characteristics") |
| NPS (XID-C15DP) | Similar to C10500D | Demonstrated similar characteristics |
| Overall | Image quality equal or better than predicate | "the diagnostic image quality of the new sensor is equal or better than those of the predicate device and there is no significant in efficiency and safety." |
| Safety | Compliance with relevant IEC and FDA standards | Electrical, mechanical, environmental, and EMC safety testing conducted according to IEC 60601-1, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-63, IEC 60601-1-2. Complies with FDA standards 21 CFR 1020.30, 1020.31, 1020.33. All test results satisfactory. |
| Software Validation | Compliance with FDA guidance | Validated according to "Guidance for the Content and Premarket Submissions for Software Contained in Medical Devices." |
| Clinical Efficacy | Clinical diagnosis and structures are acceptable | Clinical images collected from the new detector deemed acceptable by licensed practitioners/clinicians. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a quantitative sample size (e.g., number of patients, number of images) for the clinical test set. It mentions "clinical imaging samples are collected from the new detector on propose device at the 2 offices" and "These images were gathered from the new detector installed with RCT700 on any protocols with random patient age, gender, and size." This suggests a qualitative, observational approach rather than a statistically powered clinical trial.
- Data Provenance: The document doesn't explicitly state the country of origin for the clinical data. It mentions the manufacturer is in Korea, but the location of the 2 offices where clinical images were collected is not specified. The data is prospective, as it states "clinical imaging samples are collected from the new detector on propose device."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: "two licensed practitioners/clinicians observed and verified" the images.
- Qualifications: "licensed practitioners/clinicians." Their specific specialties (e.g., dentist, radiologist) and years of experience are not mentioned.
4. 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 indicates that the "ground truth" or verification was established through expert review of the images, effectively serving as an expert consensus. There is no mention of a formal adjudication method like 2+1 or 3+1. It appears to be an agreement by the two practitioners.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an imaging system (CT, panoramic, cephalometric X-ray), not an AI-powered diagnostic aide designed to improve human reader performance with AI assistance. The performance comparison is between the new imaging hardware/system and older predicate imaging hardware/system, not between human readers with and without AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance evaluation was done, but it's for the imaging system's technical image quality (hardware and image reconstruction algorithm), not an AI algorithm for autonomous diagnosis. The bench testing and non-clinical considerations evaluated the inherent imaging capabilities of the device/sensor alone across various technical metrics (MTF, DQE, NPS, pixel size, limiting resolution). This is described as proving "the complete system works as intended" and ensuring "diagnostic image quality of the new sensor is equal or better than those of the predicate device."
7. The Type of Ground Truth Used
- For Technical Performance (Bench Testing/Non-Clinical): Established technical benchmarks and measurements against the predicate device using standardized phantom images and physical characterization methods (e.g., image quality phantoms, test patterns). This is a form of objective technical measurement against established metrics.
- For Clinical Efficacy: Expert consensus ("licensed practitioners/clinicians observed and verified that dental X ray system from RCT700" and their diagnoses determined "the clinical diagnosis and structures are acceptable"). There is no mention of pathology or outcomes data as ground truth.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning or AI. The RCT700 is a medical imaging device (hardware and associated reconstruction software), not an AI diagnostic algorithm that requires a separate training dataset.
9. How the Ground Truth for the Training Set Was Established
As no training set is described for an AI algorithm, this question is not applicable. The device's performance is established through technical benchmarks and clinical observation/verification.
§ 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.