Search Results

The NewTom 7G is a computed tomography x-ray imaging system using the cone-beam technology which acquires sequences of images of the head, including ear, nose and throat (ENT), of the dento-maxillofacial complex, teeth, mandible, jaw and temporomandibular joint (TMJ), of the other areas of the human skull and neck with sections of upper cervical spine, of the spine sections, of upper extremities including shoulder, upper arm, forearm, hand, relative joints and of lower extremities including hip, upper leg, lower leg, midfoot, forefoot, relative joints, for use in diagnostic support. The device accomplishes this task by reconstructing a 3D matrix of the examined volume and producing two-dimensional views of this volume, displaying both two- and three-dimensional images. The device is managed and used by doctors, dentists, radiologists and other legally qualified professionals.

NewTom 7G is a computed tomography X-ray system using the cone-beam technology manufactured by CEFLA S.C. The proposed device NewTom 7G is a further development of the predicate device NewTom 5G XL (K183448) manufactured by CEFLA S.C. Like the predicate device NewTom 5G XL the proposed device NewTom 7G is equipped with X-ray tube generator and X-ray sensor (solid state X-ray imaging detector) for radiological images acquisition. The proposed device permits to acquire radiological images at varying radiographic angles by rotating around the patient. The exposed area can be adapted to a specific region of interest to keep the radiation dose as low as possible. This is achieved by collimating the X-ray beam. Furthermore, the radiation dose can be adapted by various parameters such as examination types and exposure technique factors. Class I lasers pointers are utilized to aid the patient positioning. The patient stay lie down on the patient support for a good stabilization. Control panel allow user actions as: patient support adjustment, selection of examination, selection of exposure parameters and delivers information about the unit status. The obtained digital image data are processed to provide a reconstructed image. The images are transferred to a computer. The software used to manage the images is NNT, a radiological imaging software developed by CEFLA S.C.

The provided document describes the NewTom 7G Computed Tomography X-ray system, which is a further development of the NewTom 5G XL (K183448). The submission details the device's characteristics, indications for use, and a comparison to its predicate device to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the NewTom 7G in the way one might see for diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it focuses on conforming to various established standards and demonstrating technical improvements or equivalence to the predicate device. The performance is primarily reported as compliance with regulatory standards and functional equivalence or enhancement compared to the predicate.

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 explicitly states: "Given the differences from the predicate device, no human clinical studies have been considered necessary to support substantial equivalence." This indicates that no clinical test set using patient data was employed to demonstrate the device's performance in diagnosing conditions. The testing was non-clinical, focusing on conformity to technical and safety standards. Therefore, information on sample size, data provenance, retrospective/prospective nature is not applicable for a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no human clinical studies were performed. The "image quality review" likely referred to technical evaluation of image characteristics or phantoms, not clinical interpretation by experts with established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no human clinical studies or expert-based ground truth establishment were performed for a 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

Not applicable. The NewTom 7G is a Computed Tomography X-ray system; there is no mention of an AI component or any MRMC study involving human readers with or without AI assistance. The submission is for the imaging device itself.

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

Not applicable. This is an imaging device, not a standalone algorithm.

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

Not applicable for clinical ground truth. The "ground truth" for the performance evaluation appears to be the technical specifications and requirements of various IEC standards, against which the device's technical performance (e.g., kV, mA, filtration, dose, resolution, physical dimensions) was verified. The "image quality review" mentioned in the Conclusion section likely refers to quantitative and qualitative assessments of image characteristics against expected technical performance, rather than diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set of data.

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

Not applicable. This is not an AI/ML device that requires a training set.

Ask a specific question about this device