Search Results

The OPTEO digital system is used to provide instant digital images of human oral tissue and teeth without the use of a conventional x-ray film. It is used for diagnosis purpose, by dental practitioners. This is achieved by using the conventional xray tube, and placing an electronic sensor in the patient's mouth instead of conventional film. The sensor, upon radiation exposure, automatically captures the images into a computer. The computer, which is not provided by OWNDY, controls all aspects of image acquisition and image display, storage and printing. Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zoom, contrasts controls, image inversion, and pseudo color renditions.

The Opteo digital system is designed to collect instant images of human oral tissue and teeth without the use of a conventional x-ray film. It is used with a conventional x-ray tube and a computer for dental radiographic imaging. The Opted is covered with a single use disposable sheath and positioned in the oral cavity opposite the tooth the dentist wishes to x-ray tube (which is not part of Opted) is pointed at the sensor and activated. The emitted radiation from the x-ray tube is detected by the sensor and transmitted as a data stream to the computer system that the device is connected to.

Intraoral detector for capturing x-ray images from an extraoral source generator. Captured images are automatically transmitted in digital form via USB connection for display, storage, and printing on the practitioner's computer using imaging software.

Intraoral detector for capturing x-ray images from an extraoral source generator. Captured images are automatically transmitted in digital form via USB connection for display, storage, and printing on the practitioner's computer using imaging software. The device is a modified version of the predicate and is similar in terms of basic component materials, overall design, and labeling ... Both the original predicate and the 510(k) device are covered with a single-use disposable hygienic sheath and positioned in the patient's mouth for radiographic examination of areas of the oral region. An external x-ray generator emits radiation that is partially absorbed by bone areas and soft tissue. Unabsorbed x-rays strike a scintillator in the device which converts the x-ray energy beam into light. An optical fiber filters this stream of photons. The light then hits an electron light sensor (CMOS) that in turn reemits it in the form of an electrical pulse. The resulting pixel matrix is sent to a connected computer and saved as a gray-scale image. Imaging software on the PC processes the image and enables nearly instant viewing and storage of the x-ray image ... The only significant modification to the original Visteo was integration of control box electronics with sensor board electronics in order to eliminate the control box, as more fully discussed in Section 12.

The provided 510(k) summary for the Owandy Opteo Intraoral Digital X-Ray Sensor (K133271) does not include information about acceptance criteria, a study proving the device meets those criteria, or details regarding AI/algorithm performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Visteo, K093105) based on:

• Similar intended use.
• Similar fundamental scientific technology.
• Technological features comparison.
• Risk analysis of modifications.
• Electromagnetic compatibility (EMC) and electrical safety tests (IEC 60601-1 and 60601-1-2).

Therefore, I cannot provide the requested information about acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or AI-related study details based solely on the provided text.

The document states:

• "A comparison of the subject and predicate, which shows the devices have the same performance characteristics and equivalent safety and efficacy profiles, is provided in Section 12." However, Section 12 is not included in the provided text.
• "EMC and Electrical Safety Testing: IEC 60601-1 and 6-0601-1-2 testing was performed to demonstrate continued conformance with recognized standards." These are safety and performance standards for medical electrical equipment, but they do not typically define clinical performance acceptance criteria in the way requested (e.g., sensitivity, specificity for a diagnostic task).

To answer your request thoroughly, I would need access to "Section 12" and potentially other parts of the original 510(k) submission that describe the performance characteristics and comparative studies in detail.

Ask a specific question about this device