(41 days)
The Cranex Novus dental panoramic equipment is indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures.
Cranex Novus is a panoramic extraoral source dental x-ray system, which produces digital images of dentition. Cranex Novus utilizes digital image receptor(CCD). The technique factor settings for panoramic examinations are: 60 kVp or 70 kVp, 7 mA DC and max. 9 s.
The provided text for CRANEX NOVUS does not contain sufficient information to fill out the acceptance criteria table or answer most of the detailed questions about the study that proves the device meets acceptance criteria. The document states:
"Verification and validation testing was successfully performed to confirm that Cranex Novus corresponds with the intended use."
However, it does not provide any specifics about this testing, such as:
- Specific acceptance criteria metrics (e.g., image quality measures, diagnostic accuracy).
- Reported device performance against any criteria.
- Sample size or provenance of data.
- Details about expert involvement or ground truth establishment.
- Whether MRMC or standalone performance studies were conducted.
- Description of the training set.
Therefore, most of the requested information cannot be extracted from the given text.
Here is what can be inferred or explicitly stated from the provided text:
Acceptance Criteria and Device Performance:
| Acceptance Criteria (Metric, Threshold) | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
| Device corresponds with intended use | Verification and validation testing was successfully performed to confirm that Cranex Novus corresponds with the intended use. |
Additional Information:
- Sample size used for the test set and the data provenance: Not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
- Adjudication method for the test set: Not specified.
- 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: Not specified.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not specified.
- The type of ground truth used: Not specified.
- The sample size for the training set: Not specified.
- How the ground truth for the training set was established: Not specified.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.