(60 days)
T2 is digital X-Ray imaging equipment for dental professionals that convert X-Ray signals into digital signals to acquire 2D images and reconstruct them into 3D images, using Panoramic (Pano), Cephalometric (Ceph), and Computed Tomography (CT) technology for the diagnosis of the anatomical structure of the oral and maxillofacial area.
T2 is a digital X-ray CT, panoramic, and Cephalo imaging system device composed of X-ray generator, X-ray controller, X-ray supporter, image processing unit (sensor), PC, and software. The apparatus attached to the equipment column is a structure that can be rotated 360 by the system control unit. This system control unit actuates the motor control, X-ray generator, and image processing unit (sensor). The height controlling unit controls the column and adjusts the height of the equipment. The X-ray generator and image processing unit (sensor) are attached to the rotating apparatus. When the rotating apparatus starts the rotation, X-ray is irradiated from the X-ray generator (generating unit). This X-ray irradiation penetrates the subject and reaches the image processing unit (sensor), and then is converted into electric signals to secure imagery information. Inside the imaging section of the image processing unit (sensor), real time X-ray input is converted into electric signals and consecutively combined, resulting in imagery information. The combined panoramic imagery information is then sent to the PC and saved in patient management software.
The provided document is a 510(k) summary for the T2 imaging device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with acceptance criteria.
Therefore, many of the requested details regarding acceptance criteria for clinical performance, sample sizes, expert qualifications, and ground truth establishment from a clinical trial perspective are not available in this document. The document explicitly states: "No clinical studies are submitted."
Here's a breakdown of the available information based on the prompt's questions:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific acceptance criteria or reported device performance in terms of clinical accuracy (e.g., sensitivity, specificity) against a clinical ground truth. Instead, the substantial equivalence hinges on non-clinical performance tests demonstrating compliance with relevant standards and technical specifications being similar to the predicate device.
The closest to "acceptance criteria" are the performance specifications listed in the "Substantial Equivalence Matrix" (pages 4-5) which compare the proposed device (T2) to the predicate device (T1-CS, T1-C). These are primarily technical specifications rather than diagnostic performance metrics.
| Feature | Acceptance Criteria (Predicate's Performance) | Reported Device Performance (T2) | Outcome |
|---|---|---|---|
| Device Name | T1-CS, T1-C | T2 | Different |
| 510(k) No. | K183475 | Proposed | Different |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Same |
| Indications for Use | Similar description for imaging oral anatomy | Similar description for imaging oral anatomy | Same |
| Performance Specification | Panoramic, cephalometric and computed tomography | Panoramic, cephalometric and computed tomography | Same |
| Input Voltage | 100-240 VAC | 100-240VAC | Same |
| Tube Voltage | 60-100 kV | 60-95KV | Similar (included within range of predicated product) |
| Tube Current | 5-16 mA | 5-11mA | Similar (included within range of predicated product) |
| Focal Spot Size | 0.5 mm | 0.5mm | Same |
| Exposure Time | Max. 22 s | Max. 22s | Same |
| 2D Image Viewing Program | Model Name: 2D01, 2D02 | Model Name: 2D02 | Similar (included within predicated product) |
| 3D Image Viewing Program | Model Name: 3D01, 3D02 | Model Name: 3D02 | Similar (included within predicated product) |
| Anatomical Sites | Maxillofacial | Maxillofacial | Same |
| Image Sensor (Computed Tomography) | 1515DXT, SEN1 | 1515DXT, SEN1 | Same |
| Image Sensor (Panoramic) | 1515DXT, SEN1 | 1515DXT, SEN1 | Same |
| Image Sensor (Cephalometric) | XID-C24DC | XID-C24DC | Same |
| Size of Imaging Volume (CT) | 1515DXT: Max. 15x9, SEN1: Max 15x10 (Stitching Mode: Max 15 X 15) | 1515DXT: Max. 15x9, SEN1: Max 15x10 | Similar (included within range of predicated product) |
| Pixel Resolution (CT) | 1515DXT: 3.94 lp/mm, SEN1: 4.0 lp/mm | 1515DXT: 3.94 lp/mm, SEN1: 4.0 lp/mm (-) | Same (The listed values for T2 are the high-resolution modes of predicate) |
| Pixel Resolution (Panoramic) | 1515DXT: 3.94 lp/mm, SEN1: 4.0 lp/mm | 1515DXT: 3.94 lp/mm, SEN1: 4.0 lp/mm | Same |
| Pixel Resolution (Cephalometric) | XID-C24DC: 5 lp/mm | XID-C24DC: 5 lp/mm | Same |
| Pixel Size (CT) | 1515DXT: 127 μm * 127 μm, SEN1: 125 μm * 125 μm | 1515DXT: 127 μm * 127 μm, SEN1: 125 μm * 125 μm | Similar (included within range of predicated product) |
| Pixel Size (Panoramic) | 1515DXT: 127 μm * 127 μm, SEN1: 125 μm * 125 μm | 1515DXT: 127 μm * 127 μm, SEN1: 125 μm * 125 μm | Same |
| Pixel Size (Cephalometric) | XID-C24DC: 100 μm * 100 μm | XID-C24DC: 100 μm * 100 μm | Same |
| Active Area (CT) | 1515DXT: 146 x 146 mm, SEN1: 160 x 128 mm | 1515DXT: 146 x 146 mm, SEN1: 160 x 128 mm | Same |
| Active Area (Pano) | 1515DXT: 146 x 8.13 mm, SEN1: 160 x 8 mm | 1515DXT: 146 x 8.13 mm, SEN1: 160 x 8 mm | Same |
| Active Area (Ceph) | 1.8 x 150 mm | 1.8 x 150 mm | Same |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no clinical studies were submitted. Non-clinical performance tests were conducted, but details on the "test set" for those are not provided in terms of origin or type (e.g., phantom data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical studies were submitted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies were submitted.
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
Not applicable. The T2 device is an X-ray imaging system, not an AI-assisted diagnostic tool. No clinical studies, let alone MRMC studies, were reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The T2 device is an X-ray imaging system, not an AI algorithm. Its performance is related to image acquisition and reconstruction, not autonomous diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical studies were submitted. For the non-clinical performance, the "ground truth" would be established by physical measurements and adherence to technical standards.
8. The sample size for the training set
Not applicable. This device is a hardware imaging system, not a machine learning algorithm that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable. This device is a hardware imaging system, not a machine learning algorithm.
§ 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.