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coDiagnostix® is intended for use by medical trained people as a Windows®- based diagnosis and implant planning software.

This software is an interface for the transfer of imaging information from medical scanners such as CT or DVT scanners and also a pre- operative software for simulation dental implant placement and surgical treatment options.

The patient population will be the general public.

coDiagnostiX® is not intended to be used in direct contact with the patient nor is it intended to be used with life sustaining devices.

It's possible to use coDiagnostiX® as a pattern for manufacturing drilling templates with conventional rotary tables or the gonyX® table from IVS Solutions AG in laboratory environment. This drilling template is then used in direct contact with the patient to realize the implant planning with coDiggnostiX®.

coDiagnostiX® is designed for diagnosis of 3dimensional datasets and precise image- quided and reproducible pre- operative planning of dental implants.

The software will be provided either as station version, client or server version.

Basically, patient's medical image data from different sources like CT (computer tomography) - or DVT (Digital Volume Tomography resp. NewTom) scanner will be read in with the coDiggnostix® DICOM transfer module, transferred into 3dimensional datasets and stored in a database.

The succeeded planning is realized through the calculation of special views, the analysis of graphic data and the placement of dental implants. For assistance of the planning procedure, several functions are available:

• Active measurement tools (length and angle) for individual measuring of implant positions -
• Nerve module for distinguishing the behaviour of the nervus mandibularis channel -
• -3D Cut for a 3dimensional cut through the jaw for fine adjustment of the implant position
• -Segmentation module for coloring several areas inside the slice dataset (e.g. jaw bone, natural tooth series) or kinds of tissue (e.g. bone, skin) and creating a 3D reconstruction of the dataset
• -Parallelizing function for adjustment of adjacent images
• -Bone densitometry with a density statistic for density measuring in the area around the positioned implant; a density allocation along the and transverse to the implant cover area is displayed

All working steps will be saved automatically to the actual plan of the patient. For each patient several plans are possible to generate several proposals, so that the dentist or lab is free to choose the ideal proposal for generating an according drilling template needed for realization of the planning during the main operation.

As in the station version of the coDiognostiX® software all functions are available, the client version needs the patient data provided by the server version.

Here's an analysis of the provided text regarding the acceptance criteria and study for coDiagnostiX® software.

Based on the provided 510(k) summary, there is no detailed information about specific acceptance criteria or a study that quantitatively "proves" the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

The document is a 510(k) Premarket Notification Summary for coDiagnostiX® software, which focuses on demonstrating substantial equivalence to predicate devices. In the context of 510(k) submissions, the primary "study" is often a comparison to legally marketed predicate devices to show that the new device has similar intended use, technological characteristics, and does not raise new questions of safety or effectiveness.

Therefore, many of the requested details about specific performance metrics, sample sizes for test sets, expert qualifications, and MRMC studies are not present in this type of regulatory document, which aims to establish substantial equivalence rather than a full, de novo performance study.

Here's an attempt to answer your questions based on the available information:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)

Since direct performance metrics are not provided, the "acceptance criteria" and "reported device performance" are implicitly tied to demonstrating substantial equivalence to predicate devices, which implies similar clinical utility and safety.

Detailed Study Information (Based on Available Text)

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

  • See table above. The acceptance criteria are broadly defined by the requirements for substantial equivalence in a 510(k) submission, rather than specific quantitative performance targets. The "reported device performance" is primarily the FDA's finding of substantial equivalence.

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

  • Not specified in the document. This 510(k) summary does not detail a specific clinical or performance test set with a defined sample size for evaluating the device's accuracy or efficacy in a clinical setting. The focus is on technical comparison to predicate devices and adherence to standards.

• 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/Not specified. As no specific "test set" or "ground truth" establishment in a traditional performance study sense is described, this information is not provided.

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

  • Not applicable/Not specified. This pertains to clinical performance studies, which are not detailed in this 510(k) summary.

• 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:

  • No MRMC study mentioned. This document does not describe such a study. coDiagnostiX® is described as an image processing and planning software, not explicitly an AI-assisted diagnostic tool in the modern sense that would typically involve human reader improvement metrics.

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

  • Not explicitly detailed as a standalone performance study. The software is described as a "diagnosis and implant planning software" for "medical trained people," indicating it is an aid for humans, not a fully autonomous diagnostic device. Performance is implicitly demonstrated via substantial equivalence to existing human-assisted predicate devices.

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

  • Not specified. No specific ground truth methodology for a performance study is described. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate devices to which coDiagnostiX® is compared.

• 8. The sample size for the training set:

  • Not applicable/Not specified. This software, from 2007, likely predates the widespread use of "training sets" in the context of deep learning or machine learning for medical devices. The document does not describe any machine learning component that would necessitate a training set in this sense. If there were internal verification/validation datasets for software development, their sizes are not disclosed here.

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

  • Not applicable/Not specified. Similar to the above, this information is not relevant or provided given the nature of the submission and the technology described.

Summary of Device Context:

The coDiagnostiX® software (version 5.7.2) is a computer-aided tool for dental 3D diagnosis and implant planning. Its core functions involve processing 3D medical image data (CT, DVT), allowing for measurement, nerve module analysis, 3D cuts, segmentation, parallelizing functions, and bone densitometry to assist medical professionals in pre-operative planning of dental implants. It is intended for use by "medical trained people" and acts as an interface and a planning tool. The submission is a 510(k) demonstrating substantial equivalence to other legally marketed dental implant planning software (SimPlant System and Vimplant™).

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