(110 days)
The PaX-Uni3D is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
PaX-Uni3D (PHT-7500), a dental radiographic imaging system, consists of dual image acquisition modes; panoramic, cephalometirc and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PaX-Uni3D (PHT-7500) 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.
The provided text describes a 510(k) submission for a dental X-ray imaging system, PaX-Uni3D (PHT-7500). The submission aims to demonstrate substantial equivalence to a predicate device, PaX-Uni3D (K090467). The document focuses on non-clinical performance and safety data, rather than a clinical study evaluating the device's diagnostic performance compared to a baseline or human readers.
Here's a breakdown of the requested information based on the provided text, noting where specific details are not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, diagnostic performance sense (e.g., sensitivity, specificity, accuracy thresholds). Instead, it primarily focuses on demonstrating equivalence to the predicate device through technical specifications and adherence to international safety and performance standards.
| Characteristic / Standard | Acceptance Criteria (Implicit) | Reported Device Performance (PaX-Uni3D (PHT-7500)) |
|---|---|---|
| Indications for Use | Same as predicate device | Matches predicate device |
| Performance Specification (Modes) | Panoramic, cephalometric, computed tomography | Panoramic, cephalometric, computed tomography |
| Input Voltage | Within acceptable range | AC 100-120 / 200-240 V |
| Tube Voltage | Within acceptable range | 50-90 kV |
| Tube Current | Within acceptable range | 2-10 mA |
| Focal Spot Size | Matches predicate device | 0.5 mm |
| Exposure Time (Pano) | Within acceptable range | Max 20.2s |
| Exposure Time (CT) | Within acceptable range | 15s/24s selectable |
| Exposure Time (Ceph) | Within acceptable range | 0.9-1.2s |
| Total Filtration | Matches predicate device | 2.8 mmAl |
| Software | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible |
| Anatomical Sites | Maxillofacial | Maxillofacial |
| CT Resolution (Xmaru0712CF, Xmaru1215CF Plus) | Equivalent to or better than predicate | 3.5 lp/mm |
| Pano Resolution (Xmaru1501CF) | Equivalent to or better than predicate | 5 lp/mm |
| Ceph Resolution (1210SGA) | Equivalent to or better than predicate | 3.9 lp/mm |
| CT Pixel Size (Xmaru0712CF, Xmaru1215CF Plus) | Equivalent to or better than predicate | 140 x 140 μm |
| Pano Pixel Size (Xmaru1501CF) | Equivalent to or better than predicate | 100 x 100 μm |
| Ceph Pixel Size (1210SGA) | Equivalent to or better than predicate | 127 x 127 μm |
| Safety Standards | Compliance with IEC standards | Met IEC 60601-1, -1-1, -1-3, -2-7, -2-28, -2-32, -2-44, -1-2 (EMC) |
| DICOM Compliance | Compliance with NEMA PS 3.1-3.18 | Met NEMA PS 3.1-3.18 |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "an expert review of image comparisons for both devices" and "Non-clinical & Clinical considerations according to FDA Guidance 'Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices.'" However, it does not specify the sample size (number of images or patients) used for this "expert review" or "clinical consideration." The data provenance (e.g., country of origin, retrospective or prospective) is also not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document refers to "an expert review of image comparisons." It does not specify the number of experts or their precise qualifications (e.g., "radiologist with 10 years of experience").
4. Adjudication Method for the Test Set
The document mentions "an expert review of image comparisons" but does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used to establish ground truth or resolve discrepancies among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study is mentioned in the provided text. The submission focuses on demonstrating substantial equivalence through technical specifications and non-clinical performance, rather than evaluating the diagnostic improvement of human readers with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device itself is an X-ray imaging system, not an AI algorithm performing diagnostic tasks. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" as usually applied to AI models is not relevant in this context. The performance evaluation is related to the image quality and physical specifications of the imaging system.
7. The Type of Ground Truth Used
For the "expert review of image comparisons," the implicit "ground truth" would likely be the expert consensus or judgment on the diagnostic quality and clinical utility of the images produced by the new device compared to the predicate device. The specific criteria for this judgment are not detailed, but it would relate to image resolution, clarity, ability to visualize relevant anatomical structures, and potential for diagnosis. There is no mention of pathology or outcomes data being used as ground truth for this comparison.
8. The Sample Size for the Training Set
This document describes a 510(k) for an X-ray imaging system, not an AI-powered diagnostic algorithm that would typically have a "training set." Therefore, the concept of a training set sample size is not applicable to this submission.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for an AI algorithm in this context, this question is not applicable. The device is a hardware system for image acquisition.
§ 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.