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X-MIND prime 3D (and I-MAX 3D under trademark Owandy Radiology) is an extra-oral dental panoramic and CBCT (aka CBVT) X-ray unit to take either two dimensional (panoramic, TMJ and sinus exams) or three dimensional radiographic exams of teeth, jaw and oral structures. The models with cephalometric arm will be able to take two dimensional cranial cephalometric exams in different projections and the wrist exam (Carpus) dedicated to the evaluation of the bone growth.

Two dimensional images are taken using the narrow beam technique. Three dimensional exams are taken using cone shaped X-ray beam technique; both of them are well known techniques.

The device is operated and used by dentists, radiologists and other legally qualified health care professionals, i.e. Prescription Use (Part 21 CFR 801 Subpart D).

The target patient population includes adults and pediatric patients from 7 years old [~27 kg (59.5 lb); 125 cm (49.2 in) standing height].

Anyway, the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians.

X-MIND prime 3D is an X-ray device for the radiographic analysis of the maxillo-facial complex. X-MIND prime 3D performs 2D Panoramic, Half-panoramic, Low dose Panoramic, Frontal dentition, Ortho Rad Panoramic, Bitewing Bilateral, Bitewing Right, 2D Sinus and 2D TMJ, 3D Dentition with multiple available FOV centered in different areas of the maxillo-facial complex (Full Dentition, Maxillary Jaw, Mandibular Jaw, Maxillary Teeth, Mandibular Teeth), 3D Sinus, 3D TMJ, AP and LL cephalometric exams, Carpus exam.

X-MIND prime 3D system can be used with the following type of patient:

• . Patient population: the target patient population includes adults and pediatric patients from 7 years old [~25 kq (55 lb); 125 cm (49.2 in) standing height]. Anyway, the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians
• Patient status: .
  • self-sufficient patient (the patient can autonomously place himself as requested by · the physician)
  • . non self-sufficient patient (the patient is assisted by medical personnel)
  • in any case the patient must be conscious, not anaesthetized and not incapacitated
• . Nationality: multiple.

The reason of the present submission is the introduction of a significative change on X-MIND prime 3D device (listing number D342123 and FDA clearance K180601).

This significant change mostly consists in the addition of the cephalometric arm to X-MIND prime 3D.

This document is a 510(k) summary for the X-MIND prime 3D dental X-ray system. It primarily focuses on demonstrating substantial equivalence to predicate devices, particularly K180601 (X-MIND prime 3D) and K181297 (DENTIOIII Series).

The document does not contain information related to acceptance criteria for an AI-powered device, nor does it detail a study proving such a device meets acceptance criteria. The device described is a medical imaging hardware system, not an AI or software-only diagnostic aid.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert establishing ground truth, adjudication methods, MRMC studies, standalone performance, or how ground truth was established, as this information is not present within the provided text for an AI-powered device.

The document primarily focuses on:

• Device Description: X-MIND prime 3D (and I-MAX 3D) is an extra-oral dental panoramic and CBCT X-ray unit, with a new version including a cephalometric arm. It performs 2D panoramic, TMJ, sinus exams, and 3D radiographic exams of teeth, jaw, and oral structures. The cephalometric arm adds 2D cranial cephalometric exams and wrist exams for bone growth evaluation.
• Intended Use: Used by dentists, radiologists, and other legally qualified healthcare professionals for prescription use, targeting adults and pediatric patients from 7 years old.
• Comparison to Predicate Devices: Detailed tables comparing the proposed device to its primary predicate (X-MIND prime 3D, K180601, manufactured by de Götzen S.r.l. – ACTEON Group) and an additional predicate (DENTIOIII Series, K181297, manufactured by HDX WILL CORP.) regarding features, examination programs, technical characteristics, and software functions.
• Performance Data and Testing Evidence: This section mentions only Electrical safety and EMC testing conducted by an NRTL to verify compliance with general requirements for medical electrical equipment, usability, and electromagnetic compatibility. It lists various IEC, ANSI/AAMI, and ISO standards to which the device complies. It also states compliance with 21 CFR §1020.30, §1020.31, and §1020.33 related to performance standards for ionizing radiation emitting products.

In summary, none of the requested information pertains to an AI component or a study evaluating AI performance within this 510(k) summary.

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