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510(k) Data Aggregation
(144 days)
Green X 12 SE (PHT-40CHS)
Green X 12 SE (Model : PHT-40CHS) is intended to produce panoramic, cephalometric, or 3D digital x-ray images. It provides diagnostic details of the dento-maxillofacial, 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 12 SE (Model : PHT-40CHS) 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 12 SE (Model : PHT-40CHS), a digital radiographic imaging system, acquires and processes multi-FOV diagnostic images for dentists. Designed explicitly for dental radiography. Green X 12 SE (Model : PHT-40CHS) 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. Green X 12 SE (Model : PHT-40CHS) can also acquire 2D diagnostic image data in conventional PANO and CEPH modes.
The provided document does not contain information regarding a study that proves the device meets specific acceptance criteria in the context of AI performance, clinical trials, or comparative effectiveness studies with human readers. The document describes a Computed Tomography X-Ray System named Green X 12 SE (PHT-40CHS) and its substantial equivalence to a predicate device (Green X 12 (PHT-75CHS)).
The performance data section primarily focuses on:
- Substantial Equivalence: Demonstrating that the new device is equivalent to the predicate device despite minor changes in detector technology and some feature deletions.
- Technical Performance Testing: Verification against international standards (IEC 61223-3-5) for general image quality indicators like Contrast, Noise, CNR, and MTF, and dosimetric performance (DAP).
- Safety and EMC: Compliance with relevant IEC standards for electrical, mechanical, environmental safety, and electromagnetic compatibility.
- Software Verification and Validation: Adherence to FDA guidance for device software functions.
Therefore, many of the requested categories for AI-related studies and acceptance criteria are not applicable based on the provided text.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in a table format for AI performance. Instead, it refers to equivalence to a predicate device and compliance with international performance standards for Computed Tomography X-ray systems.
| Criterion Type (Inferred from Text) | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Image Quality | Performed equivalently to the predicate device according to IEC 61223-3-5. | Contrast, Noise, CNR, and MTF were measured and demonstrated that the subject device performed equivalently to the predicate device in general image quality. |
| Dosimetric Performance | DAP measurements should be the same as the predicate device under identical exposure conditions. | DAP measurements in PANO, CEPH, and CBCT modes were the same as the predicate device under the same X-ray exposure conditions (exposure time, tube voltage, tube current). |
| Software Functionality | Compliance with FDA guidance for device software functions. Software criticality assessed as "basic documentation." | Software verification and validation were conducted and documented as recommended by FDA guidance. The Green X 12 SE provides EzDent-i (K241114) for 2D viewing and Ez3D-i (K231757) for 3D viewing, both previously cleared. |
| Safety and EMC | Compliance with IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-3:2008+AMD1:2013+AMD2:2021, IEC 60601-2-63:2012+AMD1:2017+AMD2:2021, and IEC 60601-1-2:2014+AMD1:2020. | Electrical, mechanical, environmental safety, and EMC testing were performed per specified IEC standards. All test results were satisfactory. The device also conforms to NEMA PS 3.1-3.18 (DICOM Set). |
| Manufacturing Standards | Conformance with 21 CFR Part 1020.30, 1020.31, 1020.33, and 21 CFR 820.30. | The manufacturing facility is in conformance with relevant EPRC standards. Adequate design and development controls (according to 21 CFR 820.30) were in place. |
2. Sample size used for the test set and the data provenance: Not applicable. The document discusses bench testing and comparison to a predicate device, not a test set of patient cases for AI evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This information is relevant for AI (CAD) performance studies, which are not described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 MRMC study was described. The device is an X-ray imaging system, not an AI-assisted diagnostic tool in the sense of a CADe/CADx system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical imaging system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI performance. For the technical performance aspects, the "ground truth" would be established by the specifications and measurements according to IEC standards.
8. The sample size for the training set: Not applicable. This device is an imaging system, not an AI algorithm requiring a training set in the conventional sense.
9. How the ground truth for the training set was established: Not applicable.
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