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The DENTIOIII series is intended for dental radiographic examination of the teeth and temporomandibular joints, specifically for panoramic and cephalometric examinations. It is to be used only by dental practitioners and/or radiologists

This equipment is a dental X-ray imaging device used for diagnostic purposes in dental examination. The operating principle of this device is obtaining the panoramic images by rotating the arm to get the recombination data, having the X-ray generator and detector rotate around the patient to irradiate the X-ray, and measuring the penetrated X-ray using the detector. When the X-ray irradiates the teeth area for instance, a large amount of X-ray is attenuated because objects such as bones are highly dense. By contrast, the X-ray permeates more through small molecules with low density such as skin or tissue measuring the X-ray is reconstructed by the software for display and analysis, the anatomical structure can be viewed for the diagnosis purposes. In addition, the Cephalo arm uses the scanning method.

This document is a 510(k) summary for the DENTIOIII series, an Extraoral Source X-Ray System. The summary focuses on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a standalone clinical study to prove new acceptance criteria for an AI/CADe device. Therefore, the information required to directly answer your request about acceptance criteria and study proving device meets those criteria (especially regarding AI performance, human reader improvement, and ground truth establishment methods for large datasets) is not present in this document.

The document primarily addresses the following for comparison with predicate devices:

• Technical characteristics: X-ray tube properties, detector types, pixel size, active area, MTF, DQE, geometry, software, and compliance with electrical safety and radiation protection standards.
• Intended use: Dental radiographic examination of teeth and temporomandibular joints for panoramic and cephalometric images.

However, based on the provided document, here's what can be extracted and inferred, along with explicit statements about missing information for your specific request related to AI/CADe systems:

No AI/CADe Performance Details:
This 510(k) application is for an "Extraoral Source X-Ray System," which is a device for acquiring X-ray images. It is not an AI/CADe device that performs analysis or assists human readers. Therefore, the concepts of "acceptance criteria" and "study proving the device meets acceptance criteria" as they relate to AI/CADe performance (e.g., sensitivity, specificity, human reader improvement, ground truth establishment by experts) are not applicable to this document's content. The "acceptance criteria" discussed implicitly refer to meeting technical specifications and safety standards for an imaging device.

1. A table of acceptance criteria and the reported device performance

The document does not present explicit "acceptance criteria" in the format of pass/fail metrics for a clinical study assessing diagnostic performance of an AI/CADe. Instead, it compares technical specifications of the proposed DENTIOIII series to predicate devices to establish substantial equivalence.

Implicit "Acceptance Criteria" (Technical Specifications for an Imaging Device):

The performance of the device is reported through its technical specifications, compared to predicate devices. These essentially serve as the "performance" data that needs to be "accepted" as substantially equivalent.

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