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The NewTom 5G XL is cone beam computed tomography x-ray imaging system that acquires sequences of images of the head, including ear, nose and throat (ENT), of dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandbular joint (TMI), other areas of the human skull and neck with sections of upper cervical spine and lower extremities for use in diagnostic support.

The NewTom 5G XL is a volumetric Cone Beam Computed Tomography (CBCT) system intended for diagnostic use. It obtains geometrical and x-ray information through digital 2D and 3D images of the objects in the area being examined.

The NewTom 5G XL is able to analyze the regions of the head, including the dental and maxillofacial and the otorhinolaryngology areas, the cervical spinal column and upper and lower limbs.

Particularly, the NewTom 5G XL can be used in the following fields:

• maxillofacial surgery, orthodontics, implants, endodontics, otorhinolaryngology, prosthetics, and orthopedics.
  The NewTom 5G XL CBCT device acquires a sequence of x-ray images by performing a rotation around the patient's head then, starting from these images, reconstructs a 3D matrix of the examined volume and produces 2D views of it.

From these views it is possible to reconstruct other 2D images on which 3D images, angle and distance measurements can be taken. Each image can be printed and/or stored in a magnetic/optical media (CD, hard disk, network, USB pen or other mass storage device).

NewTom 5G XL consists of three main components: the scanner unit, the motorized patient support and the main workstation (secondary workstations could be also available as optional) that supports the dedicated software, enabling data acquisition.

The software requires a Microsoft Windows OS (version 7 or later).

I am sorry, but the provided text does not contain the detailed information needed to construct the complete table of acceptance criteria and reported device performance, nor does it provide a full study description as requested.

The document discusses the substantial equivalence of the NewTom 5G XL device to predicate devices (NewTom 5G and NewTom VGi Evo) based on safety, non-clinical performance, and clinical performance tests. However, it does not explicitly state acceptance criteria as specific numerical thresholds that the device was required to meet for each performance metric. It generally states that the device's performance is "comparable" or "able to fulfill the main standard reference."

Here's a breakdown of what can be extracted and what is missing:

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

Missing information for a complete study description:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   • The document mentions "clinical evaluation" and "different anatomical sites and different patient population" but does not specify the number of cases/patients, the origin of the data, or if it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   • The document mentions "clinical evaluation" and "clinical experience" but does not specify the number of experts or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   • No information provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   • This device is a CBCT imaging system, not an AI-powered diagnostic algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable in this context (and not mentioned). The studies described are assessing the performance of the imaging device itself rather than a CAD/AI component for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   • Not applicable as it's an imaging device, not a standalone algorithm. The "clinical evaluation" mentioned is of the images generated by the device, not an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   • For the clinical evaluation, the ground truth seems to be based on "clinical experience" and the ability of the images to show "diagnostic reliability and utility." It's not explicitly stated as expert consensus, pathology, or outcomes data. For the non-clinical tests, physical phantoms were used as the reference.
8. The sample size for the training set:
   • Not applicable; this is an imaging device, not an algorithm that requires a training set in the typical machine learning sense. The software updates and functionalities are compared to previous versions, but no "training set" for an AI algorithm is referenced.
9. How the ground truth for the training set was established:
   • Not applicable.

In summary: The provided text focuses on demonstrating the substantial equivalence of a new CBCT imaging device (NewTom 5G XL) to existing predicate devices by comparing technical specifications and performance metrics using phantoms and general clinical evaluation. It does not describe an AI/CAD algorithm validation study with specific acceptance criteria, sample sizes, and expert adjudication details typical for such submissions.

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