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PaX-i3D Green Premium (Model: PCT-90LH) is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the maxillofacial areas for a dental and ENT treatment in adult and pediatric dentistry. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by physicians, dentists, ENT specialist and x-ray technicians.

PaX-i3D Green Premium (Model: PCT-90LH), a digital radiographic imaging system, acquires and processes multi FOV diagnostic images for a dentist and an ENT specifically designed for dental and ENT radiography, PaX-i3D Green Premium (Model: PCT-90LH) is a complete digital X-ray system equipped with imaging viewers, Xray 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 head, neck and craniofacial anatomy for ENT, oral surgery, implant and orthodontic treatment. PaX-i3D Green Premium (Model: PCT-90LH) can also acquire 2D diagnostic image data in panoramic and cephalometric mode.

The provided text describes the acceptance criteria and performance data for the PaX-i3D Green Premium (Model: PCT-90LH) digital X-ray system, comparing it to a predicate device, PaX-i3D Ortho (TON-95LH).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets. Instead, it describes acceptance as "performed similarly or better" than the predicate device and that "all test results were satisfactory." The key performance indicators evaluated are:

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of clinical images or specific patient data. The performance evaluations were conducted through non-clinical bench testing:

• Sample Size: Not explicitly stated as a number of images or cases. The tests were performed on the device's components (detector) and the finished X-ray equipment.
• Data Provenance: This was retrospective in the sense that the reference point for performance was the previously cleared predicate device. The tests themselves were conducted in a laboratory setting. The country of origin of the data is implied to be from the manufacturer (VATECH Co., Ltd., based in Korea) as it states "The sponsor tested the subject device in a laboratory and provided a non-clinical performance report."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

No explicit information is provided regarding the number or qualifications of experts used to establish ground truth for this non-clinical performance evaluation. The "ground truth" for the device's technical performance metrics (MTF, DQE, NNPS, Contrast, Noise, CNR) was established through objective physical measurements using established international standards (e.g., IEC 61223-3-5).

4. Adjudication Method for the Test Set

Not applicable. The performance evaluation was primarily objective, based on physical measurements of device characteristics against established standards and comparison to a predicate device's measured performance. There was no mention of human adjudication for the technical performance metrics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission focuses on the substantial equivalence of an X-ray imaging system, not on an AI-driven image analysis or diagnostic aid that would involve human reader performance improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Yes, aspects of a "standalone" performance were evaluated, particularly for the iterative reconstruction algorithm. The text states: "The safety and effectiveness of iterative reconstruction algorithm have been demonstrated and confirmed by the previous 510k submission of the reference device, PaX-i3D Smart (PHT-30LFO) (K152106)." This implies an evaluation of the algorithm's output (image quality parameters such as noise reduction) independent of a human reader's diagnostic performance. The document explicitly focuses on the "algorithm only" performance for noise reduction in CT images.

7. The Type of Ground Truth Used

The ground truth used for the technical performance metrics (MTF, DQE, NNPS, Contrast, Noise, CNR) was objective physical measurement based on established international standards (e.g., IEC 61223-3-5). For the iterative reconstruction algorithm, the "ground truth" for its effectiveness was implicitly defined by its ability to produce images with "noise levels less than or equal to images produced by standard filtered back projection reconstruction."

8. The Sample Size for the Training Set

Not applicable. This document describes the performance evaluation of an X-ray imaging system, not a machine learning or AI model that would require a dedicated training set. The "iterative reconstruction algorithm" mentioned is a signal processing algorithm, not a learning-based AI algorithm in the typical sense that would necessitate a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set in the context of machine learning.

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