(88 days)
The SIDEXIS Digital Radiography System consisting of digital sensor, image display is indicated to replace conventional radiographic film when used with extraoral source X-ray systems which are intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
SIDEXIS Digital Radiography System consisting of digital sensor, image display
The provided FDA 510(k) premarket notification does not contain information about acceptance criteria, device performance, or any clinical study details. The document is a clearance letter for the SIDEXIS Digital Radiography System, indicating its substantial equivalence to previously marketed devices for dental radiographic examination and diagnosis.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study details
- Standalone performance details
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document focuses on the regulatory clearance for the device based on substantial equivalence, rather than detailing a clinical performance study.
§ 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.