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The X -- VIEW System is a device used to provide instant images of the human oral tissue and teeth without the use of conventional x-ray films. While an X-Ray machine is still utilized, the acquisition of an image requires up to 90% less radiation than a conventional system would require to produce the same image.

X View device consists of 3 components: the sensor and its cable, data box, and a PC with sensor adapter. The sensors outer body is made of hermitically sealed polymer shell which encapsulates a black and white CCD. The sensor attaches to the processing unit via a 3 m cable. The outer dimensions are approximately 40 x 25 x 5 mm with rounded edges.

The Data box relays the data to the computer for display. The data box is white 4 x 9 inch box with a 5 ft USB cable connection.

The X-View System is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional x-ray films. The sensor, upon radiation exposure, Captures the images into a computer for viewing, storage, and printing

The X-View System, along with the aforementioned other systems, consists of a sensor and its cable, a sensor adapter, and a personal computer. The sensor and cable are fully waterproof ( IXP 7 standard ) and may be sterilized by full immersion in a disinfectant solution. The sensor's outer body is made of hermetically sealed polymer shell, which encapsulates a black and white CCD. It has an active sensitive area of 600 mm2, an image matrix of 960,000 pixels and renders a minimum 15 lines / mm and a maximum 18 lines /mm.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific criteria. The document is primarily a 510(k) summary and FDA clearance letter, which focuses on device description, intended use, and substantial equivalence to predicate devices, rather than detailed performance study results against predefined acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about the study from the given input. The document mentions the device renders a minimum 15 lines/mm and a maximum 18 lines/mm, but this is presented as a characteristic, not an acceptance criterion with reported performance from a study.

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The EVA Digital Dental Imaging System is intended to be used with standard digital dental X-ray systems and computer stations for system operation, archive data storage, input capture and enhancement, and patient data and support.

The EVA System (previously named the Sens-A-Ray System) has been modified to incorporate a new sensor component and docking station. The proposed EVA System is essentially identical in intended use and fundamental technology to the parent Sens-A-Ray System described in K923067. The modifications are limited to changing the sensor from a CCD Sensor to a Complimentary Metal Oxide Semiconductor (CMOS) sensor and adding a docking station. As with the original Sens-A-Ray Sensor, the CMOS sensor when exposed to radiation captures the image in the form of a charge pattern on its surface. The resulting electronic output signals are digitized by a processor and sent to a computer screen for image presentation. The EVA System Sensor and supporting electronics are identical in intended use and fundamental technology to the parent Sens-A-Ray Sensor and supporting electronics.

The provided text is a 510(k) summary for the EVA Digital Dental Imaging System and a subsequent FDA clearance letter. It is a regulatory document focused on establishing substantial equivalence to a predicate device, not a study evaluating the device's performance against specific acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text.

The document primarily states:

• The EVA Digital Dental Imaging System is intended for use with standard digital dental X-ray systems for system operation, archive data storage, input capture and enhancement, and patient data and support.
• It is a modification of the predicate Sens-A-Ray System, changing the sensor from a CCD to a CMOS and adding a docking station.
• The CMOS sensor offers a larger image area, higher resolution, and lower power requirements.
• The computer interface changed from ISA to USB.

The FDA clearance letter confirms that the device is substantially equivalent to legally marketed predicate devices, which is the regulatory standard for 510(k) applications. It does not include an independent performance study against acceptance criteria as would be found in a clinical trial report or a detailed engineering verification and validation document.

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