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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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The NewTom 5G is a cone beam computed tomography x-ray imaging system that acquires of the head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibularjoint (TMJ), other areas of human skull and neck with sections of upper cervical spine, and lower extremities for use in diagnostic support. The device accomplishes this task by reconstructing a three dimensional matrix of the examined volume and producing two dimensional views of this volume, displaying both two and three dimensional images.

The NewTom 5G is a cone beam computed tomography x-ray imaging system that acquires of the head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibularjoint (TMJ), other areas of human skull and neck with sections of upper cervical spine, and lower extremities for use in diagnostic support. The device accomplishes this task by reconstructing a three dimensional matrix of the examined volume and producing two dimensional views of this volume, displaying both two and three dimensional images.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the "NewTom 5G" device. The document is primarily a 510(k) clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices, and outlining regulatory requirements. It specifies the "Indications for Use" for the device but does not detail any performance studies, data provenance, expert qualifications, or ground truth methodologies.

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NewTom VGi is a cone beam computed tomography x-ray imaging system that acquires a 360 degree rotational sequences of the head including the ENT, dento-maxillofacial complex, temporo-mandibular-joint (TMJ), other areas of human skull and neck with sections of upper cervical spine for use in diagnostic support. The device accomplishes this task by reconstructing a three dimensional matrix of the examined volume and producing two dimensional views of this volume, displaying both two and three dimensional images. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.

NewTom 5G is a cone beam computed tomography x-ray imaging system that acquires a 360 derree rotational sequences of the head including the ENT, dento-maxillofacial complex, temporo-mandibular-joint (TMJ), other areas of human skull and neck with sections of upper cervical spine for use in diagnostic support. The device accomplishes this task by reconstructing a three dimensional matrix of the examined volume and producing two dimensional views of this volume, displaying both two and three dimensional images. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.

NewTom 5G is especially designed for:

• dento-maxillo-facial complex imaging;
• teeth, mandible and jaw imaging for implant planning;
• temporal-mandibular joint (TMJ) imaging;
• ear, nose and throat (ENT) analysis;
• sections of upper cervical-spine imaging;

NewTom VGi and NewTom 5G are cone beam computed tomography x-ray imaging systems that acquire a 360 degree rotational sequences of the head. The devices reconstruct a three dimensional matrix of the examined volume and produce two dimensional views of this volume, displaying both two and three dimensional images.

Based on the provided documents for K130442, which describe the NewTom VGi and NewTom 5G computed tomography x-ray systems, the information requested to describe acceptance criteria and associated studies is not available.

These documents are a 510(k) clearance letter and Indications for Use statements. They specify the regulatory clearance of the devices for diagnostic support in various anatomical regions of the head and neck. They do not contain clinical study data, performance metrics, acceptance criteria, sample sizes, or details about ground truth establishment.

To answer your request, detailed performance data from the 510(k) submission itself would be needed, which is not part of these publicly available summary documents.

Therefore, I cannot provide the requested table and study details. If you have access to the full 510(k) submission, that would be the source for this information.

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The NewTom 5G Computed Tomography X-Ray System is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery.

The NewTom 5G accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two-dimensional images and three-dimensional renderings.

The NewTom 5G is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images. It reconstructs a three-dimensional matrix of the examined volume and produces two-dimensional views of such volume, displaying both two- and three-dimensional images. The NewTom 5G can measure distances and thickness on two-dimensional images. Such images can be printed or exported on magnetic and optical media.

The NewTom 5G hardware, including a scanner unit (comprised of the X-ray source, flat panel detector and the motorized arm) and a motorized patient support, facilitates the acquisition of a full X-ray sequence by the device software. The NewTom 5G software runs on an x86 architecture based workstation. The NewTom 5G reconstructs a three-dimensional model of X-ray images similar to the three-dimensional model obtained using the parent NewTom VG Computed Tomography X-Ray System.

This document describes the NewTom 5G Computed Tomography X-Ray System. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a standalone study for a new AI/software component. Therefore, much of the requested information regarding AI device performance, sample sizes for test/training sets, expert consensus for ground truth, and MRMC studies is not available in the provided text.

The submission highlights minor technological differences between the NewTom 5G and its predicate device, the NewTom VG, primarily concerning patient positioning and image quality/reliability improvements through hardware and software modifications. The core imaging principle (360-degree rotational X-ray sequence to reconstruct 3D models for diagnostic support in dento-maxillofacial radiology) remains the same.

Here's the information that can be extracted or inferred from the provided text, along with a clear indication of what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes for Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document primarily focuses on demonstrating substantial equivalence through technological comparison and general safety/effectiveness testing, not a detailed clinical performance study with a specific test set for AI.
• Data Provenance: Not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable/not specified. The provided text does not describe a clinical study involving experts establishing ground truth for a test set. This type of information is typically part of a performance study for AI/software, which is not the primary focus of this 510(k) summary.
• Qualifications of Experts: Not applicable/not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done? No. The document does not describe an MRMC study comparing human readers with and without AI assistance. This device is an imaging system, and while it produces images that humans interpret, it doesn't describe an AI-powered diagnostic aid that would typically be evaluated with an MRMC study in this context.
• Effect Size of Human Readers with/without AI: Not applicable, as no such study was described.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done? No. This submission describes an imaging device, not a standalone algorithm. The "software" mentioned is for image acquisition and reconstruction, not autonomous diagnostic interpretation.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable/not specified in the context of a performance study. The "ground truth" for this device's evaluation is primarily its ability to produce diagnostically acceptable images and function safely and effectively, demonstrating substantial equivalence to its predicate device. This is assessed through engineering tests, V&V, and comparison of technical characteristics, not by comparing its outputs against independent clinical ground truth like pathology for specific disease detection in a clinical study.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/not specified. The device is not described as using machine learning models that require a "training set" in the conventional sense for AI clinical applications. Its software performs image reconstruction, not learned pattern recognition from a large dataset.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable/not specified, as there is no mention of a training set for an AI algorithm.

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