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Dear fda medwatch, i am reporting a serious issue regarding planet dds's integration of pearl ai assist in denticon pms and xvweb imaging system, which led to an inaccurate treatment recommendation and inability to correct ai findings.What happened i recently visited a dental clinic that uses denticon pms with pearl ai assist.Before reviewing my dental images, the dentist recommended an endodontic procedure based on ai findings displayed in denticon.Ai suggested decay and a periapical radiolucency (parl), indicating a need for a root canal.I asked the dentist to open my x-rays.The ai's decay finding was incorrect, and the suggested root canal was unnecessary.In apteryx xvweb (planet dds's imaging system, also integrated with pearl ai), the ai findings were visible, but the dentist could not delete or modify them--only hide them.This means incorrect ai diagnoses remain in the system, which contradicts pearl ai's fda-cleared workflow, which allows findings to be modified.Concerns that need fda investigation why is planet dds recommending care when no fda clearance has been obtained for ai-driven treatment recommendations? denticon pms is a patient management system (pms), not a diagnostic tool, and does not have an fda 510(k) clearance.Pearl ai is fda-cleared for caries detection (k210365, k242522) but not for treatment recommendations.Ai-generated care opportunities mislead clinicians and risk unnecessary treatments.Why does xvweb prevent ai findings from being deleted or modified? the dentist could not remove the incorrect ai diagnosis in xvweb.Pearl ai's fda clearance states dentists should be able to modify findings, yet planet dds integrated it in a way that prevents this.This could lead to permanent documentation of incorrect diagnoses.Fdacleared 510(k) listings for reference planet dds (apteryx) fda-cleared imaging systems device name 510(k) number decision date xvweb k132342 12/20/2013 pearl inc.Ai fda-clearances (caries detection only) device name 510(k) number decision date second opinion cc k242522 01/16/2025 second opinion k210365 03/04/2022 none of these clearances cover ai-powered care recommendations.Patient safety risks ai-driven treatment recommendations without fda approval could lead to overtreatment.Clinicians may trust ai over proper clinical review.Locked ai findings in xvweb create inaccurate records, contradicting fda-approved ai workflows.Request for fda investigation i request an fda investigation into planet dds's ai integrations, ensuring: ? ai treatment recommendations are not misrepresented as fda-cleared.? ai findings in xvweb can be reviewed, modified, and deleted per fda-cleared workflows.? ai misuse does not risk patient safety.I am attaching photos showing the ai-generated care opportunity in denticon and the locked ai finding in xvweb.Thank you for your attention to this urgent matter.Sincerely, i also found an advertisement posted by planet dds on their official linkedin page, promoting ai-driven treatment recommendations within denticon pms.This advertisement reinforces the misleading claim that their ai assist tool is capable of identifying and recommending treatments, despite having no fda clearance for such use.I am attaching a screenshot of this advertisement as further evidence that planet dds is misrepresenting the intended use and regulatory status of its ai-powered tools.This misleading marketing could further contribute to patient safety risks by influencing dentists to rely on ai for treatment decisions without proper fda clearance.Https://www.Linkedin.Com/posts/planetdds_sayyestotreatment-aiassist-activity-7287839639074144256- b5pd? utm_source=social_share_send&utm_medium=member_desktop_web&rcm=acoaaajxrosbqrnr2spwqgrqpxvqdnv1bvbpct4.Ref report: mw5167619.
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