(85 days)
PHT-6500 (PHT-60CFO) is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional 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.
PHT-6500 (PHT-60CFO), a dental radiographic imaging system, consists of three different image acquisition modes; panoramic, cephalometirc and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PHT-6500 (PHT-60CFO) is a complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector for dental panoramic, cephalometric and cone beam computed tomographic radiography.
The dental CBCT system is based on CMOS digital X-ray detector. CMOS 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 CMOS X-ray detector.
This device submission is for a medical imaging device (X-ray system), not an AI/ML device. Therefore, the questions related to AI/ML specific criteria like "Multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "training set ground truth," and "sample size for training set" are not applicable. The document also does not provide specific acceptance criteria as quantitative metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device through performance and safety testing.
Here's the information extracted from the provided text, adapted for a medical imaging device:
1. Table of Acceptance Criteria (or Performance Parameters) and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" but rather describes the performance specifications and the testing conducted to show the device's acceptable performance and substantial equivalence to the predicate. The performance listed is primarily functional and technical comparability with the predicate device.
| Characteristic | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (PHT-6500) |
|---|---|---|
| Functional Modes | Panoramic, cephalometric, computed tomography | Panoramic, cephalometric, computed tomography |
| Input Voltage | AC 100-120/200-240 V | AC 100-120/200-240 V |
| Tube Voltage | 50-90 kV | 50-90 kV |
| Tube Current | 2-10 mA | 4-10 mA |
| Focal Spot Size | 0.5 mm | 0.5 mm |
| Exposure Time | 1.9-24 s | 0.7-24 s |
| Slice Width | 0.1 mm min. | 0.1 mm min. |
| Total Filtration | 2.8 mmAl | 2.8 mmAl |
| Chin Rest | Equipped Headrest | Equipped Headrest |
| Mechanical Design | Compact design | Compact design |
| Electrical Logic Circuit | LDCP logic circuit | LDCP logic circuit |
| Software Compatibility | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible |
| Anatomical Sites | Maxillofacial | Maxillofacial |
| Imaging Volume (CT) | 5x5 cm / 8x5 cm / 8x8 cm (for Xmaru0712CF) | Max. 8x8 cm (for Xmaru0712CF) |
| 5x5 cm / 8x5 cm / 8.5x8.5 cm / 12x8.5 cm | Max. 12x9 cm (for Xmaru1215CF Plus) | |
| (for Xmaru1215CF Plus) | Max. 12x9 cm (for Xmaru1215CF Master Plus) | |
| Pixel Resolution (CT) | 3.5 lp/mm (for Xmaru0712CF) | 3.5 lp/mm (for Xmaru0712CF) |
| 3.5 lp/mm (for Xmaru1215CF Plus) | 3.5 lp/mm (for Xmaru1215CF Plus) | |
| No equivalent listed | 10.1 lp/mm (full res), 5.0 lp/mm (2x2 binning), 2.5 lp/mm (4x4 binning) (Xmaru1215CF Master Plus) | |
| Pixel Resolution (Pano) | 5 lp/mm (Xmaru1501CF, Xmaru2301CF) | 5 lp/mm (Xmaru1501CF, Xmaru2301CF) |
| Pixel Resolution (Ceph) | 3.9 lp/mm (Xmaru2301CF) | 3.9 lp/mm (Xmaru2301CF) (This seems like a typo in the table, likely meant for 910SGA/1210SGA) |
| Pixel Size (CT) | 140x140 μm (Xmaru0712CF, Xmaru1215CF Plus) | 140x140 μm (Xmaru0712CF, Xmaru1215CF Plus) |
| No equivalent listed | 49.5 μm (full res), 99 μm (2x2 binning), 198 μm (4x4 binning) (Xmaru1215CF Master Plus) | |
| Pixel Size (Pano) | 100x100 μm (Xmaru1501CF, Xmaru2301CF) | 100x100 μm (Xmaru1501CF, Xmaru2301CF) |
| Pixel Size (Ceph) | No equivalent listed | 127x127 μm (910SGA, 1210SGA) |
2. Sample size used for the test set and the data provenance:
The document states: "Based on the non-clinical and clinical consideration and the outcome of a comparative review by a licensed dentist of images from both devices, PHT-6500 (PHT-60CFO) is substantially equivalent, in terms of safety and effectiveness, with PaX-Flex3D (PHT-7000), the predicate device."
- Sample Size for Test Set: Not specified. The submission refers to a "comparative review by a licensed dentist of images from both devices," but the number of images or cases reviewed is not mentioned.
- Data Provenance: Not explicitly stated. Given that Vatech Co., Ltd. is based in the Republic of Korea, the data likely originated from there. It is not specified if the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "a licensed dentist." So, at least one expert.
- Qualifications of Experts: "a licensed dentist." Further specific qualifications (e.g., years of experience, specialization) are not provided.
4. Adjudication method for the test set:
Not specified. Since only one "licensed dentist" is mentioned for the comparative review, it implies no formal adjudication process was used among multiple experts. The review was likely a direct comparison by this single expert.
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 was not done. This document pertains to an X-ray imaging device, not an AI/ML diagnostic software. The comparison was primarily for image quality and functional equivalence between the new device and a predicate device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is an X-ray imaging device. The performance relates to the hardware's ability to produce images, not a standalone algorithm.
7. The type of ground truth used:
The term "ground truth" usually refers to definitive factual data in the context of AI/ML performance. For this X-ray device, the "ground truth" relates to the performance characteristics of the images produced and the device's functionality. The clinical consideration and comparative review by a licensed dentist served as a form of "expert assessment" of the device's diagnostic utility and safety/effectiveness in comparison to the predicate. No pathology or outcomes data is explicitly mentioned as "ground truth."
8. The sample size for the training set:
- Not applicable. This is a hardware device. There is no mention of a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set."
§ 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.