(256 days)
T1-C, T1-CS are a computed tomography x-ray system intended to produce panoramic, cephalometric or crossectional images of the oral anatomy on a real time basis by computer reconstruction of X-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360° rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentistry. The device is operated and used by physicians, dentists, and X-ray technicians.
"T1-C, T1-CS", a dental radiographic imaging system, consists of three image acquisition modes; panoramic, cephalometric and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, "T1-C, T1-CS" are a complete dental X-ray system equipped with X-ray tube, generator and dedicated detector for dental panoramic, cephalometric and cone beam computed tomographic radiography. The dental CBCT system is based on digital X-ray detector. CT detector is used to capture radiographic diagnostic images of oral anatomy in 3D for dental treatment such as oral surgery or implant. The device can also be operated as the panoramic and cephalometric dental X-ray system based on X-ray detector. T1-CS provides three modes, Whereas, T1-C provides only panoramic and cone beam computed tomography mode.
The provided text describes a 510(k) premarket notification for the T1-C and T1-CS computed tomography x-ray systems. The document states that the devices are substantially equivalent to a predicate device (PHT-30LFO, K152106), but it does not provide specific acceptance criteria or details of a study proving the device meets those criteria.
Here's an breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
No specific acceptance criteria (numerical thresholds for performance metrics) are explicitly stated in the document. The document generally asserts substantial equivalence based on technical characteristics and clinical image quality.
The performance specifications of the subject device (T1-CS, T1-C) and the predicate device (PHT-30LFO) are listed as follows:
| Characteristic | Subject Device (T1-CS, T1-C) | Predicate Device (PHT-30LFO) |
|---|---|---|
510(k) number | K183475 | K152106 |
Indications for Use | Similar | Similar |
Performance Specification | Panoramic, cephalometric and computed tomography | Panoramic, cephalometric and computed tomography |
Input Voltage | AC 100-240 V | AC 100-240 V |
Tube Voltage | 60-100 kV | 50-99 kV |
Tube Current | 5~16 mA | 4~16 mA |
Focal Spot Size | 0.5 mm | 0.5 mm |
Exposure Time | Max. 22 s | Max. 18 s |
Slice Width | 0.2-1.0mm | 0.1 mm min |
Chin Rest | Equipped Headrest | Equipped Headrest |
Mechanical | Compact design | Compact design |
2D Image Viewing Program | Model Name: 2D01, 2D02 | EasyDent |
3D Image Viewing Program | Model Name: 3D01, 3D02 | Ez3D Plus |
Anatomical Sites | Maxillofacial | Maxillofacial |
Image Receptor/Resolution/Pixel Size Comparison:
| Image Receptor/Metric | Subject Device (T1-CS, T1-C) | Predicate Device (PHT-30LFO) |
|---|---|---|
| Computed Tomography | ||
| Image Receptor | 1515DXT, SEN1 | Xmaru1404CF |
| Size of Imaging Volume (cm) | 1515DXT: Max. 15x9; SEN1: Max 15x10 | Xmaru1404CF: Max. 10x8.5 |
| Pixel Resolution | 1515DXT: 3.94 lp/mm (1x1), 1.97 lp/mm (2x2); SEN1: 4.0 lp/mm (1x1), 2.0 lp/mm (2x2) | Xmaru1404CF: 5.0 lp/mm (2x2), 2.5 lp/mm (4x4) |
| Pixel Size | 1515DXT: 127 µm (1x1), 254 µm (2x2); SEN1: 125 µm (1x1), 250 µm (2x2) | Xmaru1404CF: 99 µm (2x2), 198 µm (4x4) |
| Active Area | 1515DXT: 146 x 146 mm; SEN1: 160 x 128 mm (CT) | Xmaru1404CF: 135.8 x 36.4 mm (CT) |
| Panoramic | ||
| Image Receptor | 1515DXT, SEN1 | Xmaru1404CF |
| Pixel Resolution | 1515DXT: 3.94 lp/mm; SEN1: 4.0 lp/mm | Xmaru1404CF: 5.0 lp/mm (2x2), 2.5 lp/mm (4x4) |
| Pixel Size | 1515DXT: 127 µm; SEN1: 125 µm | Xmaru1404CF: 99 µm (2x2), 198 µm (4x4) |
| Active Area | 1515DXT: 146 x 8.13 mm; SEN1: 160 x 8 mm (Pano) | Xmaru1404CF: 135.8 x 5.94 mm (Pano) |
| Cephalometric | ||
| Image Receptor | XID-C24DC | Xmaru2301CF, 1210SGA, 910SGA, Xmaru2301CF-O |
| Pixel Resolution | XID-C24DC: 5 lp/mm | Xmaru2301CF: 5 lp/mm; 1210SGA/910SGA: 3.9 lp/mm; Xmaru2301CF-O: 5 lp/mm |
| Pixel Size | XID-C24DC: 100 µm | Xmaru2301CF: 100x100 µm; 1210SGA/910SGA: 127x127 µm; Xmaru2301CF-O: 100x100 |
| Active Area | (Ceph) | Xmaru2301CF: 5.9 x 230.4 mm; 1210SGA: 260.1 x 325.1 mm (Ceph) |
The document notes: "Although the detector sizes of our device and the predicate device are different, this difference does not affect the substantially equivalent performance of our device to the predicate, and it does not affect the scope of intended use compared to the predicate device."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A "clinical study was completed to evaluate the image quality of T1-C, T1-CS's maxillofacial area." However, no specific sample size (number of patients or images) for this clinical study is provided.
- Data Provenance: The document states, "The clinical images of patients are presented as the clinical data..." The country of origin of the data is not explicitly mentioned, nor is it specified whether the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: "The images acquired using T1-C. T1-CS were reviewed by qualified clinicians..." The specific number of qualified clinicians is not provided.
- Qualifications of Experts: The experts are described as "qualified clinicians" and "licensed professional(s)". No further details regarding their specific specialty (e.g., radiologists, dentists), years of experience, or board certifications are mentioned.
4. Adjudication Method for the Test Set
The document states that images were "reviewed by qualified clinicians to be of acceptable clinical effectiveness." No specific adjudication method (e.g., 2+1, 3+1, none) is provided. It simply indicates a review process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being conducted or its results. The study described focuses on the image quality of the subject device itself, not a comparison of human readers with and without AI assistance.
6. Standalone Performance (Algorithm Only)
The T1-C and T1-CS are computed tomography x-ray systems that produce images. They are not explicitly described as AI algorithms where standalone (algorithm-only) performance would be a primary metric for an AI device. The "imaging software" components (2D Viewer: Xvision, One vision; 3D Viewer: OneClinic, One 3D) are for viewing and reconstruction, not explicitly AI for diagnostic interpretation. Therefore, this question is not applicable in the context of an AI device's standalone performance as the primary focus seems to be on the imaging system itself.
7. Type of Ground Truth Used
The "clinical study" evaluated "image quality" and clinicians confirmed "acceptable clinical effectiveness." This suggests a qualitative assessment of clinical image quality based on expert opinion/review, rather than a quantitative ground truth established by pathology, specific outcomes data, or a strict expert consensus on specific abnormalities.
8. Sample Size for the Training Set
The document mentions "Software was designed and developed according to a software development process." However, no specific sample size for a training set is provided. Given that the "imaging software" listed are viewers/reconstructors rather than AI diagnostic tools, the concept of a "training set" in the context of machine learning may not strictly apply here.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of an AI algorithm, this information is not provided/applicable.
§ 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.