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The NewTom VGi evo is a cone beam computed tomographic x-ray imaging system that acquires 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 (tomographic sections, pan and ceph projections) displaying both two and three dimensional images. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.

The medical electrical equipment NewTom VGi evo is an X-ray imaging device comprising an X-ray acquisition system and the control box, for producing two and three dimensional views for computation and display. It is manufactured by QR s.r.l. and the applicable product code is OAS, Regulation 21CFR 892.1750 Computed tomography x-ray system, Class II.

NewTom VGi evo acquires a sequence of X-ray images rotating around the patient's head and then uses these images to reconstruct a three-dimensional matrix of the volume examined and produce two-dimensional views of this volume. These views can be used to reconstruct additional two-dimensional images, on which distances and angles can be measured, and threedimensional images. Each image produced can then by printed or exported onto optical media. The NewTom VGi evo hardware system is composed of the scanner unit, the control box and the external workstation, which enables the user to acquire data easily with the aid of the specific software. The software requires Windows 7 64bit operating system.

The provided text is a 510(k) Summary for the NewTom VGi evo device, seeking substantial equivalence to its predicate device, NewTom VGi (K130442). It does not contain information about acceptance criteria and a detailed study proving the device meets those criteria in the context of specific clinical performance metrics.

Instead, the document focuses on demonstrating substantial equivalence by comparing the technological characteristics of the new device with the predicate device and citing compliance with various medical device standards (e.g., IEC 60601-1, IEC 62366, IEC 62304).

Therefore, I cannot fulfill your request for the following information based on the provided text:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improvement with/without AI assistance.
• If a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

The document states the following related to performance and testing:

• Performance Data (Section VII):
  • "Electrical safety, EMC/EMI testing, biocompatibility consideration, performance and image quality testing, verification and validation testing were performed to support the hardware and software modifications."
  • The device "was designed, tested and found to be compliant with standards IEC 60601-1 (Ed. 3, 2005), IEC 60601-1-2 (Ed. 3, 2007), IEC 60601-1-3 (Ed. 2, 2008), IEC 60601-1-6 (Ed, 3, 2010), IEC 62366 (Ed. 1, 2015), IEC 60601-2-63 (Ed. 1, 2012), IEC 60825-1 (Ed. 2, 2007) and IEC 62304 (Ed. 1, 2006)."
  • "A risk analysis was performed to analyze the hazards associated with the changes."
  • "Non clinical considerations according to FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed.
  • "The clinical considerations on the images in terms of quality and effectiveness sustained the diagnostic reliability and usefulness of images produced by the NewTom VGi evo applications." (This is a general statement, not a specific study description).
  • "In addition to the 2-D performance data recommended by the Solid State X-ray Imaging guidance, 3-D lab performance data (including 3-D MTF and NPS) was provided to evaluate the cone-beam CT mode of operation." (This indicates lab-based image quality metrics were assessed, but no specific study details are given).

In summary, this document is a regulatory submission focused on demonstrating substantial equivalence based on technical specifications and adherence to standards, rather than detailing a clinical performance study with acceptance criteria and ground truth validation that you've requested.

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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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