(240 days)
Rotograph Prime 3D and I-MAX 3D are extra-oral dental panoramic and CBCT (aka CBVT) X-ray units to take either twc dimensional (panoramic, TMJ and sinus exams) or three dimensional radiographic exams of teeth, jaw and oral structures.
Two dimensional images are taken using the narrow beam technique. Three dimensional exams are taken using cone shaped x-ray beam technique; both of them are well known techniques.
The devices are operated and used by dentists, radiologists and other legally qualified health care professionals.
They can be used with both pediatric and adult patients.
Rotograph Prime 3D (and I-MAX 3D under trade mark Owandy Radiology) is a complete 3D and 2D panoramic X-ray system. It performs:
2D standard examination programs
- Standard Panoramic: adult/child panoramic exam
- TMJ open and closed mouth
- Sinus P/A projection
- Half Panoramic (left/right)
- Ortho Rad Panoramic
- Frontal Dentition
- Low Dose Panoramic
- Bitewing (Left/Right/Left and Right
3D standard examination programs
- 3D Full Dentition
- 3D Single Jaw (Maxillary, Mandibular)
- 3D Mandibular Teeth (Frontal, Premolars and Molars)
- 3D Maxillary Teeth (Frontal, Premolars and Molars)
- 3D TMJ (right/left)
- 3D Sinus
The images are acquired by a CMOS Flat Panel detector with CsI scintillator and are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer (not included in the device).
Here's a summary of the acceptance criteria and study information for the Rotograph Prime 3D (and I-MAX 3D) device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Metric | Predicate Device (I-MAX Touch 3D) Performance | Subject Device (Rotograph Prime 3D) Performance | Notes |
|---|---|---|---|---|
| 2D Panoramic Mode | Spatial resolution | 2.2 lp/mm | 3 lp/mm | Subject device shows improved spatial resolution. |
| Contrast resolution (visible holes in IEC 61223-3-4 phantom) | 4 | 4 | Equivalent contrast resolution. | |
| DAP (@80kV 9mA 13.8s) | 13.0 uGy·m² | 15.7 uGy·m² (@80kV 9mA 14.0s) | Slightly higher DAP for the subject device in panoramic mode, attributed to a larger field of view due to a higher detector. | |
| 3D Mode | Nyquist Frequency | 2.7 lp/mm | 2.85 lp/mm | Subject device shows improved Nyquist Frequency. |
| Contrast to Noise Ratio | 17.9 | 15.3 | Lower CNR for the subject device. This is explained as a choice to prioritize dose containment, with the option for users to increase radiological parameters for higher contrast. | |
| Homogeneity (Metrics defined in DIN6868-161) | 7.0 | 8.6 | Subject device shows improved homogeneity. | |
| MTF on axial slices (10% modulation) | 1.31 lp/mm | 1.37 lp/mm | Subject device shows improved MTF at 10% modulation. | |
| MTF on axial slices (50% modulation) | 0.57 lp/mm | 0.72 lp/mm | Subject device shows improved MTF at 50% modulation. | |
| Acceptance Index ((mGy·cm²)-1, defined in DIN6868-161) | 86 | 247 | Significantly higher Acceptance Index for the subject device, indicating overall better performance relative to the delivered dose. This parameter considers dose, resolution, and contrast. | |
| DAP (3D full dentition, @80kV 8mA 11.2s for predicate) | 196.7 uGy·m² | 108 uGy·m² (@84kV 5mA 7s) | Significantly lower DAP for the subject device in 3D mode, achieved by prioritizing dose containment with respect to the predicate device. | |
| Other Considerations | Electrical safety, EMC/EMI | Conformity with IEC 60601-1, IEC 60601-1-2 | Conformity with IEC 60601-1, IEC 60601-1-2 | Tested to established international standards. |
| Biocompatibility | Conformity with ISO 10993 series | Conformity with ISO 10993 series | Patient-contacting components assessed. | |
| Software Validation | Conformity with IEC 62304, FDA Guidance | Conformity with IEC 62304, FDA Guidance | Device software considered "Moderate Level of Concern". | |
| Usability | Conformity with IEC 60601-1-6, IEC 62366 | Conformity with IEC 60601-1-6, IEC 62366 | Confirmed through testing. | |
| Radiation Protection | Conformity with IEC 60601-1-3 | Conformity with IEC 60601-1-3 | Confirmed through testing. | |
| Dental Extra-oral X-ray Equipment | Conformity with IEC 60601-2-63 | Conformity with IEC 60601-2-63 | Confirmed through testing. | |
| Image Quality Equivalence (2D) | Equivalence assessed | Equivalence assessed | Equivalence of 2D image quality between proposed and primary predicate device assessed with image comparison tests. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size of real patient data or phantoms used for "image comparison tests" or "performance and image quality testing". It refers to "image comparison tests" and "specific technical data provided by the supplier of the detector." The evaluation appears to be based on physical measurements and comparisons against a phantom (e.g., IEC 61223-3-4, DIN6868-161) rather than a clinical trial with a population of patients. There's no mention of the country of origin or whether the data was retrospective or prospective in the context of image quality or performance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not specify the number of experts or their qualifications for establishing ground truth for the image quality and performance tests. The evaluation relies on standardized phantom measurements and objective metrics rather than human interpretation for ground truth.
4. Adjudication Method for the Test Set:
Not applicable, as the evaluation methods described involve objective measurements against phantoms and direct comparison of quantitative metrics, not expert adjudication of images.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document describes technical performance comparisons and image quality metrics, not studies evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the performance data presented is for the standalone device (algorithm only for image reconstruction and processing, but without a human-in-the-loop performance study for diagnostic efficacy). The table above provides various image quality metrics demonstrating the device's capabilities without human interaction.
7. The Type of Ground Truth Used:
The ground truth for the performance and image quality evaluations appears to be based on:
- Standardized Phantoms: Metrics like spatial resolution, contrast resolution, Nyquist Frequency, CNR, Homogeneity, MTF, and Acceptance Index are derived from measurements of these phantoms, which serve as objective ground truth.
- Physical Measurements: DAP values are direct physical measurements of radiation dose.
- Technical Specifications: Some comparisons relate to detector technology (CMOS vs. Amorphous Silicon), pixel size, and bit depth, which are inherent technical specifications.
8. The Sample Size for the Training Set:
The document does not describe any machine learning or AI components that would require a "training set" in the traditional sense. The device is an X-ray imaging system, and its software (firmware functions, reconstruction algorithms, image acquisition/correction) is a deterministic system, not an adaptive one that learns from data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no apparent training set for an AI/ML model for this device. The software functions are described as being designed by Villa/Owandy and implementing standard algorithms like Feldkamp for reconstruction.
§ 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.