(52 days)
The ScanX Intraoral View is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.
The ScanX Intraoral View is a dental device that scans photostimulable phosphor storage plates that have been exposed in place of dental X- Ray film and allows the resulting images to be displayed on a personal computer monitor and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose.
The provided document is a 510(k) premarket notification for a dental imaging device called ScanX Intraoral View. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving the device meets those criteria from an AI/algorithm performance perspective.
Therefore, the document does not contain the information requested regarding acceptance criteria for an AI/algorithm, a study proving device performance against such criteria, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment in the context of an AI/algorithm.
The document describes the device as a scanner that processes digital images from Phosphor Storage Plates (PSPs) and displays them on a computer monitor. It is not an AI/ML powered device, but rather a digital radiography system. The performance testing summarized focuses on:
- Safety testing: Electrical safety (IEC 61010-1), Electromagnetic Compatibility (EMC) (EN 61326-1), and Laser safety (IEC 60825-1).
- Imaging performance: Theoretical resolutions, MTF (Modulation Transfer Function), and DQE (Detective Quantum Efficiency) were measured with reference to IEC 62220-1:2003, as recommended by the FDA guidance for Solid State X-ray Imaging Devices.
- Software validation and risk analysis were performed.
- Cybersecurity was addressed per FDA guidance.
The document explicitly states: "Summary of clinical performance testing: Not required to establish substantial equivalence." This further confirms that no clinical study (which would typically assess performance against clinical acceptance criteria) was conducted or presented in this 510(k) submission.
In summary, the provided text does not describe an AI/ML-based device or a study proving its performance against acceptance criteria in the way your detailed questions imply for an AI/ML product.
§ 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.