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Volumetric Tomography is intended to be used for producing crosssectional (tomographic) radiographic images from the edentulous or dentate area of the jaws. The cross-sectional images provide dimensional information for dental implant planning and information about location of impacted teeth.

The Volumetric Tomography imaging option for Orthopantomograph® OP100 and OP200 product families utilizes Statistical Inversion (SI) that is used to reconstruct tomographic images from a set of pre-acquired projection radiographic images of the object. To reconstruct means producing cross-sectional images from a set of projection images by using computer calculation. Projection image means a radiographic image from a certain angle in which the structures of the object are seen superimposed. Tomographic means viewing an object as a series of thin slices. Projection images are captured with a digital panoramic unit using scanning as the imaging method. Scanning projection images is previously known technique and commonly used for example in digital cephalometric units. Along with the object a set of fiducials are recorded on the projection images to be used for geometry refinement and cross-registration between the reconstructed image set and a separate panoramic scout image. Tomographic images are then reconstructed from the projection images with a computer. For dimensional information for dental implant planning and information about location of impacted teeth all three imaging modalities can be used: projection image set, the panoramic image and the reconstructed image set. The tomographic slice and the slice angle are selectable after reconstruction to ensure the correct positioning of the slice referenced to the anatomy. In addition to the selection of the tomographic slice also the slice angle is user adjustable to ensure the correct position and angle compared to the anatomy.

The provided text is a 510(k) summary for the Volumetric Tomography device. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot populate the table or answer most of the specific questions based on the provided text. The document focuses on regulatory submission details rather than a detailed technical study report.

Here's what can be extracted:

Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria or report specific device performance metrics (e.g., accuracy, sensitivity, specificity, image quality scores) from a study. It generally states that the device is "similar in design, composition and function" to a predicate device and that "The comparison of characteristics supports substantial equivalence."

Study Information

The document references two scientific publications that describe the "Statistical Inversion" algorithm more thoroughly:

1. "Statistical inversion for medical x-ray tomography with few radiographs: I. General theory;" Phys. Med. Biol. 48 (2003) 1437–1463
2. "Statistical inversion for medical x-ray tomography with few radiographs: II. Application to dental radiology;" Phys. Med. Biol. 48 (2003) 1465–1490

However, the provided 510(k) summary itself does not contain the details of these studies regarding sample sizes, data provenance, ground truth, experts, or performance metrics. It only cites them as a description of the underlying algorithm.

Here's a breakdown of what cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample sizes used for the test set and the data provenance: Not provided within this document. The referenced studies might contain this.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided within this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided within this document.
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: Not provided within this document. The device is a reconstruction algorithm, not explicitly an AI-assisted diagnostic tool in the sense of comparing human readers with and without AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No specific standalone performance study details are presented here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided within this document.
8. The sample size for the training set: Not provided within this document.
9. How the ground truth for the training set was established: Not provided within this document.

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