(318 days)
PaX i3D Ortho (TON-95LH) is a computed tomography x-ray system intended to produce cross-sectional images of the oral anatomy by reconstructing a three dimensional radiographic images from the same axial plane taken at different angles. It provides diagnostic details of the maxillofacial areas for a dental treatment in adult and pediatric dentistry. The system also acquires carpal images for orthodontic treatment. The device is operated and used by physicians, dentists, and x-ray technicians.
PaX-i3D Ortho (TON-95LH) is a dental radiographic imaging system with cone beam computed tomography (CBCT) to offer high definition digital diagnostic images in multi FOV for dental practitioners. Specifically designed for dental radiography of the teeth or jaws, TON-95LH is a complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector for dental CBCT radiography.
The PaX-i3D Ortho (TON-95LH) dental CBCT system is equipped with a CMOS digital Xray detector which is used to capture radiographic diagnostic image data of oral and maxillofacial anatomy and reconstruct a three dimensional (3D) image for dental treatments such as oral surgery, implant and orthodontic. The PaX-i3D Ortho (TON-95LH) dental CBCT system also can reconstruct 2D panoramic and cephalometric images from the same diagnostic image data which the system originally obtained.
The provided text describes a 510(k) premarket notification for the "PaX-i3D Ortho (TON-95LH)" dental computed tomography x-ray system. The submission aims to demonstrate substantial equivalence to a predicate device, the "PaX-Zenith3D." The information focuses on technical similarities and performance testing to support this claim, rather than defining specific acceptance criteria and a detailed study proving the device meets them in the context of clinical accuracy or diagnostic efficacy for specific conditions.
Therefore, many of the requested details about acceptance criteria, sample sizes, expert ground truth establishment, and comparative effectiveness studies are not explicitly present in the provided document. The document primarily discusses device-level performance benchmarks related to image quality and safety standards.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state numerical acceptance criteria. Instead, it focuses on demonstrating that the new device's performance is "equal or better" than the predicate device in specific technical aspects.
| Acceptance Criteria (Implied) | Reported Device Performance (PaX-i3D Ortho (TON-95LH)) |
|---|---|
| Modulation Transfer Function (MTF) performance equivalent or better than predicate | "equal or better than those of the predicate device" |
| Detective Quantum Efficiency (DQE) performance equivalent or better than predicate | "equal or better than those of the predicate device" |
| Noise to Power Spectrum (NPS) performance equivalent or better than predicate | "equal or better than those of the predicate device" |
| Compliance with IEC 60601 series standards (electrical, mechanical, environmental safety) | Compliant |
| Compliance with NEMA PS 3.1-3.18 (DICOM) | Meets provisions |
| Compliance with FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" | Performed |
| Acceptance and CT image evaluation according to IEC 61223-3-4 and IEC 61223-3-5 | Performed, results satisfactory |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for specific tests. The document refers to "laboratory and clinical performance testing" and "Non-clinical test and clinical consideration test." It does not provide the number of cases or images used in these tests.
- Data Provenance: Not specified. The testing was conducted by "qualified individuals employed by the sponsor." Given the manufacturer's address in Gyeonggi-Do, Republic of Korea, it's likely the testing was conducted there, but this is not explicitly stated. The nature (retrospective/prospective) is also not specified.
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 document. The testing described focuses on technical image quality metrics (MTF, DQE, NPS) rather than diagnostic accuracy requiring expert interpretation and ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document, as the testing described does not involve expert adjudication for diagnostic outcomes.
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 mentioned.
- This device is a dental CBCT system, a hardware device for image acquisition, not an AI-assisted diagnostic tool. Therefore, a study on human reader improvement with AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a hardware imaging system, not a standalone algorithm. The "standalone" performance here would refer to the image acquisition capabilities, which are assessed through technical metrics like MTF, DQE, and NPS.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The concept of a "ground truth" for diagnostic accuracy (e.g., pathology, outcomes data) is not applicable to the performance testing described. The "ground truth" for the technical image quality tests would be physical phantoms and established measurement techniques for MTF, DQE, and NPS.
8. The sample size for the training set:
This is not applicable as the device is a hardware imaging system, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as above.
§ 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.