(112 days)
Scanora 3Dx is a Cone Beam 3D x-ray system for imaging the head and neck areas, including the ENT and dentomaxillofacial areas, for use in diagnostic support. Dedicated panoramic imaging is an option. A flat panel detector is used to acquire 3D images and an optional CCD sensor to acquire panoramic images. The device is operated and used by qualified healthcare professionals.
Scanora 3Dx is a Cone Beam Computerized Tomography x-ray system for Dentomaxillofacial and Head & Neck (ENT) imaging. Dedicated panoramic imaging is an option. In CT mode it generates a conical x-ray beam during rotation around a patient's head and produces two dimensional projection images on a flat panel detector. Three dimensional images are then reconstructed and viewed with 3rd party software. In panoramic mode panoramic and TMJ images can be taken in the classical way on a separate CCD detector.
The provided text describes a 510(k) submission for the SCANORA 3Dx device, indicating that it is substantially equivalent to a predicate device (SCANORA 3D [K110839]). This type of submission relies on demonstrating similarity to an already approved device rather than presenting new clinical study data to establish effectiveness or meet novel acceptance criteria.
Therefore, the document does not contain a specific table of acceptance criteria and reported device performance based on a dedicated study proving these criteria. Instead, it focuses on comparative technological characteristics and a "preference study" for image quality.
Here's an breakdown of the information that can be extracted, and where information is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics for a clinical study. The primary "acceptance" is demonstrated through substantial equivalence to the predicate device.
- Reported Device Performance: The document highlights the technological characteristics of SCANORA 3Dx and compares them to the predicate device. The only "performance" comparison mentioned in a study context is a "preference study" for image quality, but specific metrics from this study are not provided.
| Characteristic | SCANORA 3Dx (New Device) | SCANORA 3D [K110839] (Predicate Device) |
|---|---|---|
| X-ray source | 3D mode: 90 kV, 4-10 mA, pulsed. Pan mode: 60-81 kV, 4-8 mA continuous. kV accuracy +/-5kV. Same x-ray source for 3D and Pan modes. | 3D mode: 90 kV, 4-12.5 mA, pulsed. Pan mode: 60-81 kV, 4-8 mA continuous. kV accuracy +/-5kV. Same x-ray source for 3D and Pan modes. |
| Focal spot | 0.5 mm | 0.5 mm |
| Image detector(s) | Amorphous Silicon Flat Panel + CCD for panoramic imaging | CMOS Flat Panel + CCD for panoramic imaging |
| 3D imaging technique | Reconstruction from 2D images | Reconstruction from 2D images |
| 3D's Field Of View | H50 x Ø50 mm, H50 x Ø100 mm, H80 x Ø100 mm, H140 x Ø100 mm, H80 x Ø165 mm, H140 x Ø165 mm, H180x Ø165 mm - Stitched, H240x Ø165 mm - Stitched | H60 x Ø60 mm, H75 x Ø100 mm, H75 x Ø145 mm, H130xØ145 mm - stitched |
| 3D's total viewing angle | 360 degrees | 360 degrees |
| Pixel size | Amorphous Silicon flat panel: 120 / 240 µm. CCD for panoramic imaging: 48 µm. | CMOS flat panel: 200 µm. CCD for panoramic imaging: 48 µm. |
| Voxel size | 100/150/200/250/300/350/400/500 µm | 133/200/250/300/350 µm |
| 3D scan time | 18 - 34 sec | 10 - 26 sec |
| 3D's effective exposure time | 2.4 - 6 sec | 2.25 - 6 sec |
| Indications for use | Scanora 3D is a Cone Beam 3D x-ray system for imaging the head and neck areas, including the ENT and dentomaxillofacial areas, for use in diagnostic support. Dedicated panoramic imaging is an option. A flat panel detector is used to acquire 3D images and an optional CCD sensor to acquire panoramic images. The device is operated and used by qualified healthcare professionals. | Scanora 3D is a Cone Beam 3D x-ray system for imaging the head and neck areas, including the ENT and dentomaxillofacial areas, for use in diagnostic support. Dedicated panoramic imaging is an option. A flat panel detector is used to acquire 3D images and an optional CCD sensor to acquire panoramic images. The device is operated and used by qualified healthcare professionals. |
| System footprint | H197cm x D140cm x W160cm | H197cm x D140cm x W160cm |
| Weight | 310 kg | 310 kg |
| Preference Study (Image Quality) | "Results were evaluated by internal reviewers." (No specific metrics or acceptance criteria reported for this study). | (Not applicable for this comparative preference study, as it was the comparison device) |
2. Sample sized used for the test set and the data provenance:
- Test Set Sample Size: "Same phantom" was used for the preference study. The number of images generated is not specified beyond this.
- Data Provenance: The study was conducted by the manufacturer, PaloDEx Group Oy (Finland). The provenance of the phantom data (e.g., country of origin, retrospective/prospective) is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "Internal reviewers" evaluated the results of the preference study. The exact number is not stated.
- Qualifications of Experts: Their qualifications are not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document only states "results were evaluated by internal reviewers." No specific adjudication method (like 2+1 or 3+1 where disagreements are resolved by a third party) is mentioned. It implies a qualitative "preference" rather than a quantitative ground truth establishment.
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 done. The described "preference study" was an image quality comparison between the new device and the predicate device using a phantom, judged by internal reviewers. This is not a comparative effectiveness study involving human readers with and without AI assistance.
- Effect Size: Not applicable as no such study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device is a hardware system (Cone Beam 3D X-ray system) that generates images. The document does not describe any specific algorithm or AI component that would have standalone performance measured without a human-in-the-loop. The mention of "FBP algorithm" refers to a standard image reconstruction technique, not a diagnostic AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "preference study," the ground truth was based on the qualitative "preference" of internal reviewers regarding image quality from a phantom. This is not expert consensus on diagnostic findings, pathology, or outcomes data. It's a subjective assessment of image quality.
8. The sample size for the training set:
- Not applicable. The document describes a medical imaging device (hardware) undergoing a 510(k) process based on substantial equivalence. It does not refer to a machine learning or AI algorithm that would require a "training set" in the context of diagnostic performance evaluation.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI algorithm is mentioned or implied.
§ 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.