(156 days)
ENCOMPASS Eagle 3D is intended to acquire two-dimensional digital panoramic and cephalometric radiographies, and multi-field of view 3D computed tomography images of dento-maxillo-facial region for the purpose of advanced diagnosis at the direction of qualified dental healthcare professionals
The ENCOMPASS Eagle 3D is a complete 3-in-1 system for dental imaging capable of make Tomography, Digital Panoramic Profiles and Digital Cephalometric Profiles. The machine uses a CCD sensor technology with the traditional scintillator technologies and auto image processing that speeds up the diagnostic and improves the clinic workflow. The equipment has three movement axes (two in orthogonal directions and one rotational) making it possible to execute elaborate imaging profiles. It features a complex profile movement around the dental arch and radiographic emission compensation in the spinal region, when necessary reconstructing the dental arch into a plane image. Each individual profile prioritizes a set of characteristics improving diagnostic capabilities. For example, the standard panoramic prioritizes image layer width, constant vertical magnification and homogeneous exposure along the whole image. Likewise, the low dosage profile prioritizes the reduction of dosage (time and anodic current).
The provided text describes the ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-ray device and its substantial equivalence to a predicate device (PREXION 3D ECLIPSE). However, it does not detail a study with specific acceptance criteria and reported device performance in the way a clinical performance study for an AI/ML SaMD would.
Instead, the document focuses on demonstrating substantial equivalence based on technical specifications and performance testing against the predicate device, a common approach for traditional medical devices like X-ray systems.
Here's a breakdown of the information that is available, formatted to address your request as much as possible, along with explanations of why some requested information is not present:
Acceptance Criteria and Device Performance for ENCOMPASS Eagle 3D
The device is an X-ray system, and its "performance" is primarily assessed by comparing its technical specifications and image quality characteristics (like MTF and DQE) to those of a legally marketed predicate device. The underlying acceptance criterion is that the new device should be substantially equivalent to the predicate device in terms of safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
For an X-ray device, "acceptance criteria" for demonstrating substantial equivalence are typically aligned with relevant electrical, mechanical, environmental, and radiation safety standards, as well as key imaging performance metrics (e.g., resolution, noise). The "reported device performance" is then how the new device measures up against these (often implicitly defined by the predicate's performance).
| Criterion/Metric (Implied Acceptance) | ENCOMPASS Eagle 3D (Reported Performance) | Predicate Device (PREXION 3D ECLIPSE) | Commentary on Equivalence |
|---|---|---|---|
| Indications for Use (Substantially Equivalent) | To acquire 2D digital pano/ceph and multi-FOV 3D CT images of dento-maxillo-facial for advanced diagnosis. | To produce 2D digital pano/ceph and 3D X-ray images of dento-maxillo-facial for diagnostic support. | Stated as "nearly identical" and "substantially equivalent." Minor wording differences do not impact equivalence. |
| X-Ray Tube Voltage Range | 60-85 kV | 50-90 kV | Within commonly accepted ranges for dental X-ray. The new device's range is narrower but falls within the predicate's capability. |
| X-Ray Tube Current Range | 4-8 mA | 1-4 mA | The new device has a higher maximum tube current, which could potentially improve image quality or reduce exposure time for some applications, but is still within safe and effective operating parameters for dental imaging. The submission implies these differences are acceptable. |
| Focal Spot Size | 0.5 mm | 0.2 mm | A larger focal spot size (0.5mm vs 0.2mm) generally implies slightly lower spatial resolution. However, other system parameters (like detector pixel size) contribute to overall image quality, and the device still met overall performance expectations as evidenced by MTF and DQE values considered acceptable for the intended use and compared to the predicate. |
| Detector Technology | CMOS (CT), CCD (Panoramic), CCD (Ceph) | FPD | Different detector technologies, but the crucial aspect is their resulting image quality, which is assessed via MTF and DQE. |
| Pixel Size (CT) | 100 µm | 200 µm | The new device has a smaller pixel size in CT, suggesting potentially higher intrinsic resolution. |
| MTF (Modulation Transfer Function) @ 40% | 2.2 lp/mm | 2.2 lp/mm | Identical performance, indicating similar resolution capabilities at this frequency. This is a direct measure of image quality. |
| MTF @ 70% | 1.05 lp/mm | 1.2 lp/mm | Slightly lower for the new device, but still deemed acceptable for substantial equivalence. Small differences in these objective metrics are expected given different components. |
| DQE (Detective Quantum Efficiency) @ 0 lp/mm | 46.9% | 51.7% | Slightly lower for the new device, but still deemed acceptable. DQE relates to how efficiently the system converts X-rays into image information, affecting signal-to-noise ratio. Small differences are expected. |
| Compliance with X-Ray Standards (IEC, CFR) | All applicable standards met and tests "satisfactory." | (Implied compliance as predicate) | Demonstrated compliance with safety and performance standards (e.g., IEC 60601 series, 21 CFR 1020.30, 31, 33). |
| Clinical Image Comparability | Comparable in diagnostic ability, sharpness, and quality to predicate images. | (Predicate images) | Assessed by a licensed dentist. This is a qualitative but important clinical confirmation of equivalence. |
2. Sample size used for the test set and the data provenance
The document states: "In accordance with the FDA guidance document on Solid State X-Ray Imaging Devices, clinical images were acquired with both the new device and the predicate device."
- Sample Size: The exact number of clinical images or cases used is not specified.
- Data Provenance: The country of origin and whether the data was retrospective or prospective are not specified. It is implied to be prospective data collection for the purpose of the submission since images were "acquired with both the new device and the predicate device" for comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: "a licensed dentist" assessed the clinical images. This implies one expert.
- Qualifications of Experts: "a licensed dentist." No further details on experience or specialization are provided in this summary.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Given that only "a licensed dentist" performed the comparison, there was no adjudication method (like 2+1 or 3+1 consensus) in the traditional sense, as there was only one reviewer.
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 comparative effectiveness study was done. This device is an X-ray imaging system, not an AI/ML-driven diagnostic software. The comparison was primarily on the physical and imaging characteristics of the hardware and the quality of the images produced, rather than reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No standalone algorithm performance study was done. This is a hardware device for image acquisition, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the clinical image comparison, the "ground truth" was implicitly established by the judgment of a single licensed dentist who compared images from the new device and the predicate device for diagnostic ability, sharpness, and quality. This is a form of expert assessment or expert-generated truth. There's no mention of pathology or outcomes data being used for this comparison.
- For the technical performance metrics (MTF, DQE), the "ground truth" comes from standard physical measurements using phantoms and calibrated equipment.
8. The sample size for the training set
- Not applicable / Not specified. This device is an X-ray imaging system, not an AI/ML algorithm that requires a "training set" in the context of machine learning. The device is trained/calibrated during manufacturing and installation processes, but this is distinct from an AI model's training data.
9. How the ground truth for the training set was established
- Not applicable / Not specified. As explained above, there isn't a "training set" in the AI/ML sense for this hardware device.
§ 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.