(97 days)
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 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Scanora 3D device:
Acceptance Criteria and Device Performance
The submission primarily focuses on establishing "substantial equivalence" to predicate devices rather than defining explicit performance acceptance criteria with numerical thresholds. The acceptance is based on demonstrating that the new Scanora 3D device is as safe and effective as existing legally marketed devices.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Characteristics (comparable to predicates) | - X-ray source: 3D mode: 90 kV, 4-12.5 mA, pulsed; Pan mode: 60-81 kV, 4-8 mA continuous; kV accuracy +/-5kV. |
- Focal spot: 0.5 mm.
- Image detector(s): CMOS Flat Panel + CCD for panoramic imaging.
- 3D imaging technique: Reconstruction from 2D images.
- 3D's Field Of View: H60 x Ø60 mm, H75 x Ø100 mm, H75 x Ø145 mm, H130xØ145 mm – stitched.
- 3D's total viewing angle: 360 degrees.
- Pixel size: CMOS Flat panel: 200 µm; CCD for panoramic imaging: 48 µm.
- Voxel size: 133/200/250/300/350 µm.
- 3D scan time: 10 - 26 sec.
- 3D's effective exposure time: 2.25 - 6 sec. |
| Indications for Use (similar to predicates) | - Scanora 3D: 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. Device operated by qualified healthcare professionals. |
| Safety and Effectiveness (demonstrated via substantial equivalence) | - "Based upon the similar technological/performance characteristics and image comparison as compared to the predicate devices and successful validation of the Scanora 3D software, the clinical performance of the Scanora 3D is deemed to be substantially equivalent to the predicate devices." |
| Image Quality (comparable to predicates) | - "Bench test image quality comparison between the Scanora 3D and the predicate devices was performed." (Specific metrics or quantitative comparisons are not provided in the summary.) |
| Software Validation (successful) | - "The Scanora 3D software has been successfully validated to confirm the performance of this device." |
Study Details
The provided document describes a non-clinical study to demonstrate substantial equivalence, rather than a clinical trial with specific performance metrics against an acceptance criterion.
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Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated as a number of images or cases. The study involved a "Bench test image quality comparison." This typically involves phantom images or controlled test objects, not patient data in the context of this submission.
- Data provenance: Not explicitly stated. Given it's a bench test, the data would originate from the testing environment (e.g., phantom images generated by the device). It is not specified as retrospective or prospective clinical data.
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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 summary. Since the study was a "bench test image quality comparison," it's unlikely that clinical experts were used to establish ground truth in the traditional sense for diagnostic accuracy. Ground truth for bench tests typically involves known physical properties of phantoms or objective measurements.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None specified. This type of adjudication is typically used in clinical studies involving interpretation of images by multiple readers, which was not described as part of this submission.
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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 was not done. The document explicitly states: "Clinical testing has not been conducted on this device." This device is an imaging system, not an AI-assisted diagnostic tool, so "human readers improve with AI vs without AI assistance" is not applicable to this submission. The focus is on the imaging system's inherent capabilities.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- A standalone performance evaluation was done. The "Bench test image quality comparison" evaluates the device itself (hardware and reconstruction software) without human diagnostic interpretation being the primary endpoint of the substantial equivalence claim. The "successful validation of the Scanora 3D software" also represents a standalone assessment of the software's functionality.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "Bench test image quality comparison," the ground truth would likely be based on known physical characteristics of test phantoms or objective measurements pertinent to image quality (e.g., resolution, contrast, noise, geometric accuracy). It is not expert consensus, pathology, or outcomes data, as these are related to clinical diagnostic accuracy, which was not assessed in this submission.
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The sample size for the training set:
- This information is not applicable/not provided in the context of this submission. This device is an imaging hardware system with reconstruction software. It does not describe an AI model that requires a "training set" in the machine learning sense. The "software validation" refers to confirming that the device's operational software (e.g., for image acquisition, reconstruction, and basic processing) functions as intended and meets specifications, not training a diagnostic algorithm.
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How the ground truth for the training set was established:
- This information is not applicable/not provided for the reasons stated above (not an AI training set).
§ 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.