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Acteon Imaging Suite software program is indicated for general dental and maxillofacial diagnostic imaging. It controls exam retrieval, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.

AIS-Acteon Imaging Suite is an application software suite providing a set of tools used to meet the imaging requirements set by different types of dental facilities – from small clinics to large hospitals. It enables practitioners to process and permanently archive (in connection with patients) diagnostic images relating to intraoral, maxillofacial and ear nose throat areas. Images can be originated by: intraoral digital sensors, dental panoramic and cephalometric equipment, CBCT equipment, intraoral cameras and all the future ACTEON digital imaging devices. The devices that are intended to be used with AIS are X-MIND trium, X-MIND PRIME and Cameras, Sopix², Sopix2 ACE, PSPix, PSPix2, SOPROCare camera and SOPROLife (with SDK provided by ACTEON-SOPRO). AIS supports DICOM format, which makes the system flexible and ready to be connected to other compatible devices and applications.

The information provided does not contain a discrete table of acceptance criteria or reported device performance metrics in the format requested. However, it does outline a clinical suitability assessment that served as the performance testing for the device. Here's a summary based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria in a table format with corresponding reported device performance. Instead, it states that the device's clinical effectiveness was assessed by comparing its image rendering to that of predicate devices. The acceptance was qualitative: "image quality (anatomical coverage, density and image contrast and anatomical structures) to assess suitability for clinical use." The implied acceptance criterion was that the image rendering of the Acteon Imaging Suite should be comparable and clinically suitable to the predicate devices. The reported device performance is that this comparison led to the conclusion of "substantial equivalence" based on "bench tests that compare clinical suitability of the rendering performed by Acteon Imaging Suite with the predicates."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "the same images" were evaluated, but it does not specify the sample size (number of images or cases) used for the test set.
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data mentioned.

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

• Number of Experts: Three independent reviewers.
• Qualifications: "having different backgrounds (maxillofacial surgery, orthodontics, dentistry)." No specific years of experience are provided.

4. Adjudication Method

The adjudication method appears to be consensus-based among the three independent reviewers judging "the image quality (anatomical coverage, density and image contrast and anatomical structures) to assess suitability for clinical use." No specific 2+1 or 3+1 method is described, but the phrase "Three independent reviewers... evaluated" implies a collective assessment rather than individual decisions.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly stated as such. The study described was a qualitative comparison of image rendering for clinical suitability, where human readers (the three experts) compared the proposed device's output against predicate devices. The document does not report an effect size of how much human readers improve with AI vs without AI assistance because the device is an imaging suite, not an AI-powered diagnostic tool, and the study focused on image quality comparison, not diagnostic accuracy improvement.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

The device, "Acteon Imaging Suite," is an application software suite for general dental and maxillofacial diagnostic imaging, controlling image retrieval, display, enhancement, and saving. It is not an AI algorithm with standalone diagnostic capabilities. Therefore, a standalone performance study in the context of an "algorithm only without human-in-the-loop performance" was not conducted as the device's function is to facilitate human interpretation and management of images. The performance testing described relates to the quality of the image rendering by the software, which is then interpreted by humans.

7. Type of Ground Truth Used

The "ground truth" for the test set was effectively expert consensus regarding the clinical suitability of the rendered images. It was not pathology, outcomes data, or another objective measure, but rather the subjective expert evaluation of image quality for diagnostic purposes.

8. Sample Size for the Training Set

The document does not mention a training set sample size. The evaluation described is a performance comparison of the final product with predicate devices, not the training of a machine learning model.

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

As no training set is mentioned in the provided text, there is no information on how ground truth for a training set was established.

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