(87 days)
i-Scan Imaging Plate Scanner is intended to be used for scanning and processing digital images exposed on IP Imaging Plate in dental applications.
i-Scan Imaging Plate Scanner is a dental device that scans IP imaging plates that have been exposed in place of dental X-ray film and allows the resulting images to be displayed on a personal computer and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose. The device is an intraoral Plate Scanner, which is designed to read out intraoral Plates of the size 0, 1, 2 and 3. Intraoral plate scanners are state of the art since 2002 and are available in various designs from many companies around the world. The intraoral plates are put into the mouth of the patient, exposed to Xrays and then are read out with the device. The read-out-process is carried out with 651-665 nm laser. The laser beam is moved across the plate by an oscillating MEMS mirror. The laser beam stimulates the top coating of the plates, which consists of Xray sensitive material. Depending on the exposed dose, the coating emits different levels of light. These light particles are then requisitioned by an optical sensor (Photo Multiplier Tube/ PMT) and transferred into an electrical output signal is digitalized and is the data for the digital X-ray image. The data is transmitted via WIFI to a computer. Before the plate is discharged, the remaining data is erased by a LED-PCB. The user chooses which size of plate he must use and prepares the device by inserting the appropriate plate insert into the device. He then exposes the plate and then puts the plate directly into the insert by pushing it out of the light protection envelope. The user closes the light protection over and starts the read-out process. After the read out process the picture is transmitted to the connected computer, the picture can be viewed, and the IP is erased and ready to use for the next acquisition.
The provided document, a 510(k) summary for the i-Scan Imaging Plate Scanner, does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for an AI/ML medical device. This device is an X-ray imaging plate scanner, not an AI-powered diagnostic or assistive tool.
Therefore, many of the requested sections (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to the information provided in this document.
However, I can extract information related to performance testing and comparison with a predicate device, which are relevant to the device's substantial equivalence determination.
Here's a breakdown of the available information based on your request, with "Not Applicable (N/A)" for criteria not found or relevant to this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for clinical performance. Instead, it compares the subject device's technical specifications to those of a predicate device (Duerr Dental AG ScanX Intraoral View). The performance testing conducted was against international standards for X-ray imaging devices.
| Characteristic | Acceptance Criteria (from Predicate/Standard) | Reported Device Performance (i-Scan Imaging Plate Scanner) | Discussion/Compliance |
|---|---|---|---|
| Image Quality | |||
| Theoretical Resolutions | Predicate: 10, 20, 25 or 40 LP/mm | 10 or 33 LP/mm | The difference in theoretical resolutions does not affect the operating principle. Image quality distinctness is such that it does not affect the effectiveness of the device. |
| MTF | Predicate: More than 45% at 3 lp/mm | More than 45% at 3 lp/mm | Identical. |
| DQE | Predicate: More than 7.5% at 3 lp/mm | More than 21.0% at 3 lp/mm | Note 5 details that the subject device's DQE is higher. When spatial frequency is lower than 3lp/mm, DQE > 29% and MTF > 45%. When spatial frequency is higher than 7lp/mm, DQE |
§ 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.