(153 days)
The OP300 dental panoramic, cephalometric and cone beam computed tomography x-ray device is intended for dental radiographic examination of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.
The Orthopantomograph OP300 is an extraoral source, software-controlled dental x-rav device which produces conventional digital 2D panoramic, cephalometric and TMJ x-ray images as well as digital x-ray projection images taken during cone beam rotations around a patient's head. The projection images are reconstructed to be viewed in 3D by a 3D viewing software.
The provided text does not contain detailed information about specific acceptance criteria (performance metrics with thresholds) for the OP300 device, nor does it detail a comprehensive study designed to prove the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Here's an analysis based on the available text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in terms of performance metrics with specific thresholds (e.g., accuracy > 90%, sensitivity > 85%). Instead, it establishes "substantial equivalence" based on similar technological characteristics. The table provided focuses on comparing the design and function of the modified OP300 to its predicate (OP300 [K093683]).
| Concept | OP300 (Modified) Performance | Acceptance Criteria (Implicit: Substantial Equivalence to Predicate) |
|---|---|---|
| Indications for Use | Dental radiographic examination of teeth, jaw, and TMJ areas; produces conventional 2D x-ray images and x-ray projection images for 3D reconstruction. | Same as predicate |
| Imaging modes | Panoramic, Cephalometric, TMJ, 3D | Same as predicate |
| X-ray source | 3D: 90kV; Pan: 57-90 kV; Ceph: 60-90 kV; kV accuracy: +/-5kV; mA range: 3.2-16 mA; 3D power: pulsed | Close match to predicate (mA range for predicate is 2-16 mA, modified is 3.2-16 mA, which is within the predicate's range) |
| Focal spot | 0.5mm | Same as predicate |
| Image detector(s) | CMOS Flat Panel + CMOS for pan/ceph imaging | Same as predicate |
| 3D imaging technique | Reconstruction from 2D images | Same as predicate |
| 3D's Field Of View | 61 x 41 mm, 61 x 78 mm | Same as predicate |
| 3D's total viewing angle | 200 degrees | Same as predicate |
| Pixel size | CMOS flat panel for 3D: 200 um; CMOS for panoramic imaging: 100 um | Same as predicate |
| Voxel size | 80-350 µm | Same as predicate |
| Reconstruction Software | Filtered Back Projection (FBP) or Algebraic Reconstruction Technique (ART) | Predicate used Algebraic Reconstruction Technique (ART). The modified device includes FBP as an additional option, which is noted in the non-clinical data as widely used. |
| 3D's effective exposure time | 2.3 - 12.5 sec | Predicate: 2 - 20 sec (modified device falls within this range) |
| 3D Reconstruction Time | 1-3 min | Same as predicate |
| Patient's Position | Standing and wheelchair | Same as predicate |
| System footprint | H161-241cm x D1390cm x W97-193 cm | Same as predicate |
| Weight | Pan/3D 205 kg; Ceph 250 kg | Same as predicate |
The "acceptance criteria" here are largely based on the new device having "Same" or "similar" (within a specified range) technological and performance characteristics as the predicate device, which is a common approach for 510(k) submissions.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: The document mentions a "Preference study as an image quality comparison." It states that "Same patient data was used for the reconstructions." It does not specify the number of patients or images used in this preference study.
- Data provenance: Not explicitly stated. The manufacturer is based in Finland. The study is referred to as a "preference study" implying image review, but the source of the patient data (country, retrospective/prospective) is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of experts: The preference study involved "internal reviewers and external dental professionals." The exact number of these professionals is not specified.
- Qualifications of experts: The document only refers to them as "external dental professionals" and "internal reviewers." No specific qualifications (e.g., years of experience, specialization) are provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe the adjudication method for the preference study. It simply states that images were "evaluated by internal reviewers and external dental professionals."
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, an MRMC comparative effectiveness study, particularly one measuring the improvement of human readers with AI assistance, was not conducted. This device is a pure imaging system, not an AI diagnostic tool.
- The "preference study" compares images from the new OP300 with its predicate. It's a reader study, but not an MRMC for AI assistance. It aims to show equivalent image quality between the devices, not human performance improvement with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is less relevant to the OP300, as it is an imaging device, not an AI algorithm intended for standalone diagnostic performance.
- The "standalone" performance in this context would refer to the image quality produced by the system itself. The preference study was designed to compare the image quality of the modified OP300 to the predicate, effectively assessing its standalone imaging performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the preference study, the "ground truth" was subjective expert preference/evaluation of image quality. It was not based on objective clinical ground truth like pathology or outcomes data. This is appropriate for an image quality comparison study rather than a diagnostic accuracy study.
8. The sample size for the training set
This device does not involve a "training set" in the context of machine learning. It's an X-ray imaging device. Its algorithms (Filtered Back Projection or Algebraic Reconstruction Technique) are established methods, not 'trained' in the same way an AI model is.
9. How the ground truth for the training set was established
Not applicable, as no machine learning training set is mentioned or implied for this 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.