(14 days)
Green X 18 (Model : PHT-75CHS) is intended to produce panoramic, cephalometric or 3D digital x-ray images. It provides diagnostic details of the dento-maxillofacial, ENT, sinus and TMJ for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by healthcare professionals.
Green X 18 (Model : PHT-75CHS) is an advanced 4-in-1 digital X-ray imaging system that incorporates PANO, CEPH(optional), CBCT and MODEL Scan imaging capabilities into a single system. Green X 18 (Model : PHT-75CHS), a digital radiographic imaging system, acquires and processes multi-FOV diagnostic images for dentists. Designed explicitly for dental radiography. Green X 18 (Model : PHT-75CHS) is a complete digital X-ray system equipped with imaging viewers, an X-ray generator and a dedicated SSXI detector. The digital CBCT system is based on a CMOS digital X-ray detector. The CMOS CT detector is used to capture 3D radiographic images of the head, neck, oral surgery, implant and orthodontic treatment. The materials, safety characteristics, X-ray source, indications for use and image reconstruction/MAR(Metal Artifact Reduction) algorithm of the subject device are same to the predicate device (PHT-75CHS (K201627)). The difference from the predicate device is that it is equipped with a new CBCT/PANO detector to provide users with a larger CBCT FOV.
The medical device in question is the Green X 18 (Model: PHT-75CHS), a digital X-ray imaging system for panoramic, cephalometric, and 3D dental imaging. The study described focuses on demonstrating substantial equivalence to a predicate device, the Green X (Model: PHT-75CHS, K201627), particularly concerning a new detector, Xmaru1524CF Master Plus OP.
Based on the provided text, the acceptance criteria and study information can be summarized as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating equivalence to the predicate device rather than setting specific numeric acceptance criteria for unique features or diagnostic accuracy. Instead, the acceptance is based on the new detector performing "equivalently or better" than the predicate.
| Acceptance Criterion (Implicit) | Reported Device Performance (Subject Device vs. Predicate Device) |
|---|---|
| Technological Characteristics | The fundamental technological characteristics of the subject and predicate device are identical. Similar imaging modes (PANO, CEPH (Optional), CBCT, and 3D MODEL Scan). The materials, safety characteristics, X-ray source, indications for use, and image reconstruction/MAR (Metal Artifact Reduction) algorithm are the same as the predicate device. The difference is the new CBCT/PANO detector for a larger CBCT FOV. |
| Pixel Resolution (New Detector vs. Predicate Detector) | New Detector (Xmaru1524CF Master Plus OP): 5 lp/mm (2x2 binning), 2.5 lp/mm (4x4 binning) for CT&PANO. |
| Predicate Detector (Xmaru1314CF): 5 lp/mm (2x2 binning), 2.5 lp/mm (4x4 binning). Test patterns of the new sensor images show the test subjects without aliasing throughout the same spatial frequency as the predicate device. | |
| DQE Performance (New Detector vs. Predicate Detector) | New Detector (Xmaru1524CF Master Plus OP): Similarly or better overall DQE performance. At a low spatial frequency (~0.5 lp/mm), DQE of 41% (4x4 binning). |
| Predicate Detector (Xmaru1314CF): DQE of 36% (4x4 binning) at ~0.5 lp/mm. | |
| MTF and NPS Performance (New Detector vs. Predicate Detector) | The new sensor also exhibits similar performances in terms of MTF and NPS. |
| Image Quality (Contrast, Noise, CNR, MTF in CT mode) | The subject device performed equivalently or better than the predicate device in the general image quality, measured with FDK (back projection) and CS (iterative) reconstruction algorithm. |
| Dosimetric Performance (DAP) | PANO mode: DAP measurement was the same under identical FDD, exposure area, X-ray exposure time, tube voltage, and tube current. |
| CEPH mode: DAP measurement was the same under identical FDD, detector specifications, X-ray exposure conditions (exposure time, tube voltage, tube current). | |
| CBCT mode: DAP measurements compared at different FOV sizes (12x9/8x8/8x5/5x5 cm) were equivalent under identical FDD and exposure conditions. | |
| General Clinical Image Quality (PANO/CBCT mode) | The Clinical consideration and Image Quality Evaluation Report further demonstrated that the general image quality of the subject device is equivalent or better than the predicate device. |
| Compliance with Standards (Non-Clinical) | The acceptance test was performed according to the requirements of 21 CFR Part 1020.30, 1020.33 and IEC 61223-3-5. The device passed these tests. Non-clinical consideration report according to FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" was provided. Bench testing according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, Performance Testing – Bench" were performed. Acceptance test and Image evaluation report according to IEC 61223-3-4 and IEC 61223-3-5 were also performed. All test results were satisfactory. |
| Software Verification and Validation | Software verification and validation were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software was considered a "moderate" level of concern. The viewing programs EzDent-i (K202116) and Ez3D-i (K200178) were previously cleared. |
| Safety, EMC, and Performance Standards (Electrical, Mechanical, Environmental) | Electrical, mechanical, environmental safety and performance testing according to IEC 60601-1:2005+AMD1:2012(Edition 3.1), IEC 60601-1-3:2008+AMD1:2013 (Edition 2.1), IEC 60601-2-63:2012+AMD1:2017 (Edition 1.1) were performed. EMC testing was conducted in accordance with IEC 60601-1-2:2014 (Edition 4). Manufacturing facility conforms with relevant EPRC standards (21 CFR 1020.30, 31, and 33). Conforms to NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set. All test results were satisfactory. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of patient cases or images. The performance testing was conducted in a laboratory setting using test protocols and phantoms, not a clinical test set of patient images.
- Data Provenance: The testing was "non-clinical" and "in a laboratory." It compared the performance of the new detector and the subject device against the predicate device. This implies retrospective comparison against previously established performance data for the predicate, and possibly prospective bench testing on the new device itself. The data is likely from the manufacturer's internal testing facilities (presumably in Korea, given the manufacturer's address).
3. Number of Experts and Qualifications for Ground Truth of Test Set:
- There is no mention of human experts being used to establish ground truth for a test set of clinical images. The provided information describes non-clinical performance testing using quantitative metrics (DQE, MTF, NPS, Contrast, Noise, CNR) and comparison to the predicate device, as well as a "Clinical consideration and Image Quality Evaluation Report" which "demonstrated that the general image quality of the subject device is equivalent or better than the predicate device in PANO/CBCT mode." However, details on how this "Clinical consideration" was performed (e.g., blinded review by experts, number of experts, their qualifications, or what "ground truth" they used) are not provided in this summary.
4. Adjudication Method for the Test Set:
- Not applicable as the testing described is primarily non-clinical and does not involve human readers or a clinical test set requiring adjudication in the context of diagnostic accuracy.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study focuses on equivalence through non-clinical performance metrics and comparison to a predicate device, not on how human readers' performance improves with or without the device.
6. Standalone Performance:
- Yes, performance data for the standalone device/detector was done. The document outlines bench testing of the Xmaru1524CF Master Plus OP detector and the Green X 18 system itself, measuring metrics such as pixel size, DQE, MTF, NPS, Contrast, Noise, CNR, and DAP. These measurements represent the algorithm-only/device-only performance in a controlled environment.
7. Type of Ground Truth Used:
- For the non-clinical performance testing, the "ground truth" was established by physical standards and quantitative measurements in a laboratory setting, comparing the device's performance against industry standards (e.g., 21 CFR Part 1020.30, 1020.33, IEC 61223-3-5, IEC 61223-3-4) and the performance of the predicate device.
- For the "Clinical consideration and Image Quality Evaluation Report," the method for establishing ground truth is not detailed, but it would presumably involve expert review of images obtained from the device.
8. Sample Size for the Training Set:
- No training set information is provided, as the submission describes a medical imaging device (X-ray system), not an AI algorithm that requires a training set of images. The "image reconstruction/MAR(Metal Artifact Reduction) algorithm" is mentioned as being the same as the predicate device, implying it was developed prior and is not a new algorithm requiring a new training study for this submission.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as this is an imaging device and not an AI algorithm requiring a training set with established ground truth.
§ 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.