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Maven Pro is intended for use as a front-end software interface for the transfer of imaging information from a medical scanner such as a Dental CT scanner. It is also intended for use as a planning and simulation software in the placement of dental implants and surgical treatment.

Maven Pro Graphic Station is a fully-featured 3D imaging application in medicine. Its unique open architecture and modular framework make customization and integration options trivial. On demand, nSequence will create a fully customized 3D medical imaging solution.

Maven Pro Graphic Station supports all the common 3D medical imaging functionalities used by professional doctors to support their diagnosis. It includes various Volume and IsoSurface rendering, segmentation tools, masking and sculpting, MPR, 2D and 3D measurement and analysis tools. Since 2D imaging is still an important feature, it is possible to switch with a single click to a 2D view, use an even more sophisticated MPR view or switch back to the 3D view.

Maven Pro software is characterized by its intuitive user interface, 2D, MPR and 3D imaging, prime image quality and extensive visualization options, fast image rendering, measurement and analysis tools, and easy integrated reporting.

The provided text does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria. The 510(k) summary focuses on establishing substantial equivalence to a predicate device based on similar technological characteristics and intended use, rather than presenting a performance study with acceptance criteria.

The document states:

• "A comparison of the predicate device and Maven Pro shows that many of technological characteristics of the two devices are similar. The differences between the two devices do not raise new questions of safety and effectiveness."
• "Maven Pro is substantially equivalent to a legally marketed device. Although it has some technological characteristics that differ from that of predicate, it has the same intended use as the predicate and raises no new questions of safety and effectiveness."

This indicates that the regulatory clearance was based on a comparison to a predicate device, rather than a separate performance study with defined acceptance criteria for the Maven Pro itself.

Therefore, I cannot extract the following information because it is not present in the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document primarily describes the device's features, intended use, and its claim of substantial equivalence to a predicate device (Invivodental, K070803). It does not outline a specific performance study dataset, expert reviews, ground truth establishment, or statistical metrics against acceptance criteria.

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