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The X-View 3D PAN/X-View 2D PAN panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images of examined volume for the reconstruction of 3D view. The X-View 3D PAN/X-View 2D PAN dental panoramic and cephalometric device is intended for general populations as long as they are older than 10 years.

The device must only be operated and used by dentists and other legally qualified professionals.

The X-View PAN is manufactured by Trident s.r.l. and it can be sold under two different commercial names:

• X-View 3D PAN
• X-View 2D PAN

Both devices, depending on the configuration chosen, can be equipped with a cephalometric arm equipped with a 24x30 cm flat panel sensor for the execution of cephalometric radiographs of various formats and latero-lateral and antero-posterior projections. The cephalometric device can also be added in the field.

The device can be set in the configurations: Floor version with column and wall bracket and Floor version with column and standard base.

The subject dental X-ray system X-View is supported by software (firmware). The software is of Moderate Level of concern and is FDA-cleared.

The provided text is a 510(k) Summary for a medical device called X-VIEW 3D PAN/X-VIEW 2D PAN. It describes the device, its intended use, comparison to predicate devices, and performance data. However, the document does not contain information about specific acceptance criteria, a detailed study proving the device meets those criteria, or the specific performance metrics (e.g., sensitivity, specificity) of the device.

The document primarily focuses on demonstrating substantial equivalence by:

• Comparing technological characteristics with predicate devices.
• Listing adherence to various international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6/IEC 62366-1, IEC 60601-2-63, IEC 60825-1).
• Mentioning software verification and validation, risk analysis (ISO 14971), and biocompatibility.
• Stating that "Clinical tests were performed both in Italy at the University of Genoa and the clinical judgment made by ABR, President of Dental Imaging Consultants, LLC, have demonstrated the clinical validity of the X-View systems both in the execution of PAN-type exams and 3D volumetric exams. Images were presented and approved by the ABR Consultant." This is a general statement about clinical validation, not a detailed performance study with specific metrics, sample sizes, or ground truth establishment.

Therefore, I cannot provide the requested information from the given document as it does not contain quantifiable performance data or specified acceptance criteria for algorithm performance. The document focuses on showing the device is substantially equivalent to existing devices based on technical specifications and adherence to safety and performance standards rather than demonstrating specific diagnostic performance metrics of an AI or algorithmic component.

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The X-VIEW, IMAGEN, a panoramic x-ray imaging system with cephalometric capabilities, is an extraoral source x-ray system intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMI studies and cephalometry. It has the capability of using cone beam volumetric technology techniques to generate dento-maxillofacial 3D images. The device uses a cone shaped x-ray beam projected onto a flat panel detector, and the examined volume image is reconstructed to be viewed via 3D viewing stations. 2D Images are obtained using the standard narrow beam technique. The device is to be operated and used by dentists, radiologists and other legally qualified health care professionals.

X-VIEW, IMAGEN is a 3-dimensional CBCT system that allows the execution of all commonly used x-rays in both dental and orthodontic fields (excluding intraoral radiographs) and also allows the acquisition of tomographic radiographs, or volumetric 3D. It uses CBCT (Cone Beam Computed Tomography) with a flat panel detector to provide high-definition volumetric images.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the X-VIEW, IMAGEN device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define acceptance criteria in a quantitative manner (e.g., minimum sensitivity, specificity, or resolution thresholds for clinical performance). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through technical specifications and adherence to safety and performance standards.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: The document mentions that a "Clinical Evaluation report in which volumetric reconstructive images of a human subject were acquired." This indicates a very limited sample size of one human subject for the clinical evaluation component and is explicitly stated as one human subject.
• Data Provenance: The document does not specify the country of origin of the data. It implies a prospective test set since it describes images being "acquired."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide information on the number of experts used to establish ground truth or their specific qualifications (e.g., radiologist with X years of experience). The clinical evaluation report simply states that "all test results were satisfactory," implying an internal assessment rather than an independent expert review with explicit ground truth labeling.

4. Adjudication method for the test set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done, nor is there any mention of human readers improving with or without AI assistance. The device is an imaging system, and the evaluation focuses on its technical performance and equivalence to predicates, not on the impact of AI on human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not directly applicable in the typical sense of AI algorithms. The "device" here is a hardware imaging system (X-VIEW, IMAGEN) with associated imaging processing software (OnDemand3D). The evaluation is of the imaging system's ability to acquire and reconstruct images, not of a standalone AI algorithm to interpret images. The performance metrics (MTF, DQE, Dynamic Range) relate to the detector's standalone technical performance as an imaging component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth used for the clinical evaluation. Given the nature of a CBCT system, the "satisfactory" test results for images of a human subject likely imply that the images were deemed diagnostically acceptable and of sufficient quality for their intended use by the evaluating party, possibly against known anatomical features or expected image characteristics, but it doesn't specify a formal ground truth like pathology or expert consensus on clinical findings.

8. The sample size for the training set

No training set is mentioned or implied for the evaluation of this device. The X-VIEW, IMAGEN is an imaging acquisition system. Its evaluation focused on hardware specifications, compliance with standards, and a limited clinical evaluation, not on the performance of a machine learning model that would require a training set.

9. How the ground truth for the training set was established

Not applicable, as no training set is mentioned.

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The X -- VIEW System is a device used to provide instant images of the human oral tissue and teeth without the use of conventional x-ray films. While an X-Ray machine is still utilized, the acquisition of an image requires up to 90% less radiation than a conventional system would require to produce the same image.

X View device consists of 3 components: the sensor and its cable, data box, and a PC with sensor adapter. The sensors outer body is made of hermitically sealed polymer shell which encapsulates a black and white CCD. The sensor attaches to the processing unit via a 3 m cable. The outer dimensions are approximately 40 x 25 x 5 mm with rounded edges.

The Data box relays the data to the computer for display. The data box is white 4 x 9 inch box with a 5 ft USB cable connection.

The X-View System is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional x-ray films. The sensor, upon radiation exposure, Captures the images into a computer for viewing, storage, and printing

The X-View System, along with the aforementioned other systems, consists of a sensor and its cable, a sensor adapter, and a personal computer. The sensor and cable are fully waterproof ( IXP 7 standard ) and may be sterilized by full immersion in a disinfectant solution. The sensor's outer body is made of hermetically sealed polymer shell, which encapsulates a black and white CCD. It has an active sensitive area of 600 mm2, an image matrix of 960,000 pixels and renders a minimum 15 lines / mm and a maximum 18 lines /mm.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific criteria. The document is primarily a 510(k) summary and FDA clearance letter, which focuses on device description, intended use, and substantial equivalence to predicate devices, rather than detailed performance study results against predefined acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about the study from the given input. The document mentions the device renders a minimum 15 lines/mm and a maximum 18 lines/mm, but this is presented as a characteristic, not an acceptance criterion with reported performance from a study.

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