DS Core Detect
Dentsply Sirona, Inc.DS Core Detect is an AI-powered software tool designed to help dentists identify permanent teeth that may have periapical radiolucencies (PARLs) using dental CBCT scans. It works alongside the dentist, highlighting areas of potential concern and providing visual maps to guide review, while leaving all final decisions to the clinician.
Intended Use
DS Core Detect is a concurrent read, computer assisted detection software intended to aid the dentist in the incidental detection of permanent teeth that may be associated with periapical radiolucencies in CBCT images. The device is not intended as a replacement for a complete dentist’s review or a replacement of their clinical judgment. The device is to be used by licensed dentists. The device is designed for patients who already have CBCT data obtained for other reasons. DS Core Detect does not generate X-ray images and does not provide an indication for taking such images. The device is intended for adults aged 22 years and older with permanent teeth.
Technology
DS Core Detect is a cloud-based, machine learning-enabled, computer-aided detection software accessed via a dental image viewer. It processes CBCT data, providing a list and visual map of teeth potentially associated with periapical radiolucency. The software allows dentists to confirm or reject flagged teeth. The only technological change from the predicate is the addition of a Predetermined Change Control Plan (PCCP) for structured modifications and compatibility expansion.
Performance
No additional performance testing was conducted for the subject device, as it is identical to the predicate device except for the inclusion of the PCCP. All validation and performance requirements remain aligned with the originally cleared device.
Predicate Devices
No predicate devices specified
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