(46 days)
the wireless digital RX sensor is intended to capture an intraoral digital RX image, when exposed to X-Rays, for diagnostic purposes. The process is automatic and continues transmitting to a Personal Computer the digital image by wireless Bluetooth connection.
WDS is a wireless digital X-ray sensor for intraoral radiography.
The provided text is a 510(k) summary for the WDS Wireless Digital X-ray Sensor, indicating its intended use and establishing substantial equivalence to predicate devices. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert involvement, or ground truth establishment.
Therefore, I cannot provide the requested table or detailed answers to the specific questions regarding acceptance criteria and study particulars, as this information is not present in the provided document.
The document primarily focuses on:
- Device Description: WDS is a wireless digital X-ray sensor for intraoral radiography.
- Intended Use: To capture intraoral digital X-ray images for diagnostic purposes and transmit them wirelessly to a PC.
- Substantial Equivalence Comparison: Claiming substantial equivalence to predicate devices (K031448 RSV VISIODENT, K050693 ACCENT, K990002 QUICKRAY DSX730) based on similar components, design, technical characteristics, and mode of operation.
To answer your request, information regarding performance studies and acceptance criteria would need to be in a different section of a full 510(k) submission, typically in a "Performance Data" or "Clinical Data" section, which is not included here.
§ 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.