(239 days)
PaX-Zenith3D is a computed tomography x-ray system intended to take panoramic, cross-sectional images of the oral and craniofacial anatomy and provide diagnostic information for children and adults clinical care in dentistry. The device is operated and used by x-ray technicians and dentists including oral surgeons.
PaX-Zenith3D is a dual X-ray machine which combines cone beam CT and panoramic X-ray modality to offer high definition digital diagnostic images in multi FOV for dental practitioners. Separately embedded panorama and CT sensors capture 2D and 3D images based on digital and CT technology while the most advanced digital imaging process enables the capture S/W program to provide one of the most effective image analysis and diagnosis in real time.
The provided 510(k) summary (K102196) for the PaX-Zenith3D X-ray system does not detail specific acceptance criteria in the form of a numerical table or an explicit study proving numerical performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Picasso-Duo). This means the primary "acceptance criteria" were that the new device performs similarly enough to the legally marketed predicate device to be considered safe and effective for the stated indications for use.
Here's an analysis of the provided information based on your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, specific numerical acceptance criteria and a detailed table of device performance against these criteria are not provided in this 510(k) summary. The document emphasizes substantial equivalence based on similarity rather than on meeting specific quantitative thresholds for clinical performance.
The summary states:
- "The actual spatial resolution data for a digital panorama image for Xmarul 501CF for PaX-Zenith3D and S7199-01 for Picasso-Duo are almost identical after considering pixel binning of S7199-01. 5.0 lp/mm(Xmaru1501CF) and 5.2 lp/mm(S7199-01), respectively,"
- "The similar technical characteristics of both devices are further described in the SSXI Non Clinical Report (Tap 25, 26, and 27) in terms of MTF, DQE, and SNR comparison."
- "Finally, the sample clinical images for both devices have been included in the Clinical Report (Tab 28) to demonstrate the similar quality of images taken from both devices as well."
These statements indicate that the device's performance was compared to the predicate device's performance across metrics like spatial resolution, MTF (Modulation Transfer Function), DQE (Detective Quantum Efficiency), and SNR (Signal-to-Noise Ratio), and found to be "almost identical" or "similar." However, the exact acceptance thresholds for these similarities or the detailed numerical results are not included in this accessible summary.
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for a test set for a clinical performance study. The statement "sample clinical images for both devices have been included in the Clinical Report (Tab 28) to demonstrate the similar quality of images taken from both devices as well" suggests that a collection of images was used for comparison, but the number of cases or images is not quantified.
Data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned for any clinical data used for comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the summary. Since the submission relies on substantial equivalence and "similar quality of images" rather than a clinical trial with established ground truth diagnoses, details on expert panel review for ground truth are absent.
4. Adjudication method for the test set
This information is not provided. Given the nature of the submission (substantial equivalence based on technical and image quality similarity), a formal adjudication method for a clinical test set is not described.
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
An MRMC study was not performed according to the summary. This device is an X-ray imaging system, not an AI-powered diagnostic aid. The "performance" being evaluated is the image acquisition capability of the hardware, not the performance of human readers with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study for an algorithm was not done. This device is hardware (an X-ray system) that produces images for human interpretation, not an algorithm designed for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe the use of clinical ground truth (like pathology or outcomes data) in the context of demonstrating substantial equivalence. The comparison heavily relies on technical image quality metrics (spatial resolution, MTF, DQE, SNR) and a subjective assessment of "similar quality of images."
8. The sample size for the training set
This information is not applicable/not provided. This device is an X-ray imaging system and does not employ a machine learning algorithm that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established
This information is not applicable/not provided as there is no mention of a machine learning algorithm or a training set.
Summary of the Study that Proves Device Meets Acceptance Criteria:
The study proving the device meets its "acceptance criteria" (understood as demonstrating substantial equivalence) is primarily non-clinical technical testing and a comparison of sample clinical images.
The submission relies on:
- Technical performance data: Comparison of spatial resolution (5.0 lp/mm for PaX-Zenith3D vs. 5.2 lp/mm for Picasso-Duo, considering pixel binning), MTF, DQE, and SNR as detailed in the "SSXI Non Clinical Report" (Tabs 25, 26, and 27). The conclusion states these were "similar."
- Safety and EMC testing: Adherence to various IEC standards (IEC 60601 series) to ensure electrical, mechanical, and environmental safety, as well as electromagnetic compatibility. "All test results were satisfactory."
- DICOM compliance: Meeting NEMA PS 3.1-3.18 standards for Digital Imaging and Communications in Medicine.
- Clinical image comparison: "Sample clinical images for both devices have been included in the Clinical Report (Tab 28) to demonstrate the similar quality of images taken from both devices as well." This suggests a qualitative comparison of images.
The overall approach is to show that the PaX-Zenith3D performs as well as or comparably to the predicate device across key technical specifications and relevant safety standards, thereby establishing substantial equivalence. There is no mention of a formal clinical trial with defined endpoints, statistical analysis, or ground truth establishment for diagnostic accuracy.
§ 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.