(84 days)
The Suni Digital Radiography System is used to collect dental x-rays photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.
Not Found
This FDA letter, K021718, is a 510(k) premarket notification which indicates that the device, Suni Intraoral Imaging System, has been found substantially equivalent to a legally marketed predicate device. This type of FDA clearance does not typically include detailed studies proving specific performance acceptance criteria, as the primary goal of a 510(k) is to demonstrate equivalence to an already approved device, rather than novel efficacy.
Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods.
Here's why and what's missing:
- Acceptance Criteria & Reported Performance: The letter states the device is substantially equivalent to a predicate, meaning its performance is expected to be similar to that predicate. It does not define specific new performance metrics or report the Suni Intraoral Imaging System's performance against them.
- Sample Size, Data Provenance, Expert Numbers/Qualifications, Adjudication, MRMC, Standalone, Ground Truth (Test & Training), Training Sample Size, Training Ground Truth: These are all details of specific performance studies that are characteristic of a premarket approval (PMA) application or a de novo classification, where a device is novel and needs to prove its safety and effectiveness. A 510(k) relies on comparison to an existing device, and extensive new clinical studies with these details are often not required if substantial equivalence can be demonstrated through other means (e.g., technical specifications, non-clinical tests, existing clinical data on the predicate).
In summary, the provided document does not contain the specific information required to complete your request. It is a regulatory clearance letter, not a scientific study report.
§ 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.