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rainbow CT is a computed tomography x-ray system intended to produce 3D, panoramic, and cephalometric diagnostic images of the maxillofacial areas for treatment planning for adult and pediatric patients. The device is operated and used by physicians, dentists, and x-ray technicians.

Rainbow 3D Image Viewer software functions for acquiring, saving, searching, displaying, diagnosing and sending digital X-ray image data in dental practices and clinics.

rainbow CT is a cone beam CT X-ray device for generating sectional images of dental images such as tooth, nasal cavity and temporomandibular joint. this is a medical diagnostic equipment designed to generate sectional images by placing X-ray source opposite to the imaging detector unit and rotating it around a patient. 2D images of the region of interest are reconstructed using a mathematical algorithm in 3 dimensional volumetric view and displayed on the computer monitor.

The system is composed of X-ray generator, X-ray detector, X-ray collimator, main frame, rotation unit, PC and Monitor, etc. in compliance with US performance standard and regulatory requirement.

The provided text is a 510(k) summary for the "rainbow CT" device. It describes the device, its indications for use, and a comparison to predicate and reference devices. However, this document does not contain the specific details required to answer your request about acceptance criteria and the study proving the device meets them.

The document states:

• "Performance testing was conducted for the subject device to access whether or not the parameter required for functionalities related to imaging properties of the dental X-ray device meets the designated acceptance criteria. The MTF, DQE and pixel resolution of the subject device performed similar to those of the predicate device. The pixel resolutions of the subject device in CBCT (2x2 binning) and pano mode are superior to that of the reference device. All test results were satisfactory." (Page 8)
• "Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed. Acceptance test according to IEC 61223-3-4 and IEC 61223-3-5 was performed. All test results were satisfactory." (Page 8)
• "Clinical Data: Not required for a finding of substantial equivalence." (Page 8)

This means the acceptance criteria and study details (like sample size, number of experts, adjudication methods, ground truth, effect sizes) for clinical performance are not present in this 510(k) summary because clinical data was explicitly stated as "Not required for a finding of substantial equivalence."

The performance testing mentioned (MTF, DQE, pixel resolution) refers to technical imaging performance characteristics of the CT system itself, not clinical diagnostic performance of an AI algorithm on patient images. The acceptance criteria for these technical parameters would likely be engineering specifications, and the "study" would be technical measurements in a lab setting, rather than a clinical trial with human readers and patient data.

Therefore, I cannot populate the table or answer the specific questions about clinical performance, human-in-the-loop studies, or ground truth derivation from the provided text. The document focuses on demonstrating substantial equivalence based on technical characteristics and safety standards, rather than a detailed clinical validation study for an AI component.

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