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coDiagnostiX is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in the field of application. The software reads imaging information output from medical scanners such as CBCT or CT scanners.

It is indicated for pre-operative simulation and evaluation of patient anatomy, dental implant placement, surgical instrument positioning, and surgical treatment options, in edentulous, partial edentulous or dentition situations, which may require a surgical guide. It is further indicated for the user to design such guides for, alone or in combination, the guiding of a surgical path along a trajectory or a profile, or to help evaluate a surgical preparation or step.

coDiagnostiX software allows for surgical guide export to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires a validated process using CAM equipment (additive manufacturing system, including software and associated tooling) and compatible material (biocompatible and sterilizable). A surgical guide may require to be used with accessories.

The main uses and capabilities of the coDiagnostiX software are unchanged from the primary predicate version.

As in the primary predicate version, it is a software for dental surgical treatment planning. It is designed for the evaluation and analysis of 3-dimensional datasets and the precise image-guided and reproducible preoperative planning of dental surgeries.

The first main steps in its workflow include the patient image data being received from CBCT (Cone Beam Computed Tomography) or CT. The data in DICOM format is then read with the coDiagnostiX DICOM transfer module according to the standard, converted into 3-dimensional datasets and stored in a database.

The pre-operative planning is performed by the computation of several views (such as a virtual Orthopantomogram or a 3-dimensional reconstruction of the image dataset), by the analysis of the image data, and the placement of surgical items (i.e. sleeves, implants) upon the given views. The pre-operative planning is then followed as decided by the design of a corresponding surgical guide that reflects the assigned placement of the surgical items.

Additional functions are available to the user for refinement of the preoperative planning, such as:

• · Active measurement tools, length and angle, for the assessment of surgical treatment options:
• · Nerve module to assist in distinguishing the nervus mandibularis canal;
• 3D sectional views through the jaw for fine adjustment of surgical treatment options; .
• Segmentation module for coloring several areas inside the slice dataset, e.g., jawbone, . native teeth, or types of tissue such as bone or skin, and creating a 3D reconstruction for the dataset;
• Parallelizing function for the adjustment of adjacent images; and
• · Bone densitometry assessment, with a density statistic in areas of interest.

All working steps are automatically saved to the patient file may contain multiple surgical treatment plan proposals which allows the user to choose the ideal surgical treatment plan. The output file of the surgical guide and/or the guided surgical is then generated from the final surgical treatment plan.

coDiagnostiX software allows for surgical guide export to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires a validated process using CAM equipment (additive manufacturing system, including software and associated tooling) and compatible material (biocompatible and sterilizable). A surgical quide may require to be used with accessories.

The provided document is a 510(k) Premarket Notification from the FDA for the coDiagnostiX dental implant planning and surgery planning software. It details the device's indications for use, comparison to predicate/reference devices, and non-clinical performance data used to demonstrate substantial equivalence.

However, the document does not contain specific acceptance criteria for a device's performance (e.g., accuracy metrics or thresholds), nor does it describe a comparative study that proves the device meets such criteria with detailed quantitative results. The section on "Non-Clinical Performance Data" broadly discusses verification and validation, but lacks the granular data requested.

Therefore, many of the requested points cannot be answered from the provided text.

Here's an attempt to answer based on the available information, noting where information is absent:

Device: coDiagnostiX (K193301)

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Provided in Document: The document does not specify quantitative acceptance criteria or provide a table of reported device performance metrics against such criteria. It states that "The acceptance criteria are met" for sterilization validation and "Expected results are met" for process performance qualifications, but does not provide details on what those criteria or results actually were.

2. Sample Size and Data Provenance for Test Set

Information Not Provided in Document: The document mentions "software verification and validation" and "Biocompatibility testing" but does not specify sample sizes for any test sets (e.g., number of patient scans, number of manufactured guides). There is also no explicit mention of data provenance (e.g., country of origin, retrospective/prospective collection).

3. Number and Qualifications of Experts for Ground Truth Establishment

Information Not Provided in Document: The document states "software verification and validation is conducted to assure requirements and specifications as well as risk mitigations (design inputs) are correctly and completely implemented and traceable to design outputs." However, it does not specify if experts were involved in establishing ground truth for a test set, their number, or their qualifications. The device is intended for "dental professionals who have appropriate knowledge in the field of application."

4. Adjudication Method for Test Set

Information Not Provided in Document: No information regarding an adjudication method (e.g., 2+1, 3+1, none) for a test set is provided.

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

Information Not Provided in Document: The document focuses on demonstrating substantial equivalence primarily through technological characteristics and non-clinical data, rather than through an MRMC comparative effectiveness study involving human readers. There is no mention of such a study or an effect size for human reader improvement with AI assistance.

6. Standalone (Algorithm Only) Performance Study

Information Not Provided in Document: While the document refers to "software verification and validation" to demonstrate that "the software performs as intended" and "the base accuracy is identical as compared to the predicate device," it does not provide details of a standalone (algorithm only) performance study with specific metrics, such as sensitivity, specificity, or accuracy values. It implies the software's capabilities (CAD type, image sources, output files) are unchanged from the predicate, and therefore its base accuracy is "identical."

7. Type of Ground Truth Used

Information Not Provided in Document: The document does not specify the type of ground truth used for any testing. It mentions "evaluation and analysis of 3-dimensional datasets" from CBCT or CT scans, but not how ground truth (e.g., for specific anatomical features, surgical path accuracy, etc.) was established for validation purposes.

8. Sample Size for Training Set

Information Not Provided in Document: The document does not provide any information about a training set or its sample size. This is a 510(k) submission primarily comparing the device to a predicate, not detailing the development or training of an AI algorithm from scratch. The changes described are primarily feature expansions to an existing software.

9. How Ground Truth for Training Set Was Established

Information Not Provided in Document: As no information on a training set is provided, there is no information on how its ground truth was established.

Summary of Document's Approach to Meeting Requirements:

The document primarily relies on demonstrating substantial equivalence to an existing predicate device (K130724 coDiagnostiX Implant Planning Software) and reference devices rather than presenting a de novo performance study with specific acceptance criteria and detailed quantitative results.

The key arguments for substantial equivalence are:

• The device has the "same intended use" as the primary predicate device.
• It has "similar technological characteristics" (software, interface, inputs, outputs are either identical or considered similar with addressed impacts).
• Changes are described as "feature expansions" and "minor updates" to an existing, cleared software.
• Non-clinical data, including software verification and validation, biocompatibility testing, sterilization validation, and manufacturing process qualifications, are stated to have met acceptance criteria and demonstrated that the device "performs as intended" and is "safe and effective."

The non-clinical data section broadly implies that the software's core accuracy functions are maintained from the predicate device, since its fundamental CAD capabilities, image sources, and output file functions are unchanged. The new features ("planning of a surgical path along a trajectory," "planning of a surgical path along a profile," and "planning to help evaluate surgical preparation or step") are leveraged from the predicate's general implant planning and surgical planning indications. The document asserts that these changes "do not change the intended use or the applicable fundamental technology, and do not raise any new questions of safety or effectiveness."

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coDiagnostiX is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dental implantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT or DVT scanners. It allows pre-operative simulation and evaluation of patient anatomy and dental implant placement.

For automated manufacturing of drill guides in the dental laboratory environment, the coDiagnostiX software allows for export of data to 3D manufacturing systems. Alternatively, coDiagnostiX can provide printouts of template plans for the creation of surgical templates using a manually operated gonyX table.

coDiagnostiX Implant Planning Software is designed for diagnosis of 3dimensional datasets and precise image-guided and reproducible preoperative planning of dental implants. The software is provided in three configurations: station, client or server. Patient image data is received from various sources such as CT or DVT scanning. The scanned data will be read with the coDiagnostiX DICOM transfer module using the DICOM format, converted into 3dimensional datasets and stored in a database. Surgical planning is performed through the calculation of special views, analysis of graphic data and the placement of virtual dental implants. Additional functions are available to the user for refinement of the surgical planning, such as:

• Active measurement tools, length and angle, for individual measuring of implant positions
• · Nerve module to assist in distinguishing 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 types of tissue, e.g., bone, skin, and creating a 3D reconstruction for 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, and transverse to, the implant cover area is displayed

All working steps are saved automatically to the patient file; one patient file may contain multiple surgical plan proposals which allow the user to choose the ideal surgical plan. The guided surgical template plan, STL file and/or guided surgical protocol is generated from the final surgical plan.

The provided text is a 510(k) Summary for the coDiagnostiX Implant Planning Software. It indicates that "Software verification and validation testing were performed to ensure that the device subject to this 510(k) Premarket Notification functions as intended and that design input matches design output." and "The proposed software met the acceptance criteria."

However, the document does not provide specific details regarding:

• A table of acceptance criteria and the reported device performance. While it states the software met acceptance criteria, the criteria themselves and the performance metrics are not listed.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• Whether a standalone performance study (algorithm only) was done.
• The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• The sample size for the training set.
• How the ground truth for the training set was established.

The document primarily focuses on establishing substantial equivalence to a predicate device (K071636, IVS coDiagnostiX) based on intended use, technological characteristics, and a statement that verification and validation testing was performed. It references the "General Principles of Software Validation: Final Guidance for Industry and FDA Staff," issued on January 11, 2002, as the guiding document for testing.

Conclusion based on the provided text:

The document states that the software met the acceptance criteria, and verification and validation testing was performed. However, it does not provide the specific details of the acceptance criteria or the study results to prove the device met these criteria. Therefore, most of the requested information cannot be extracted from this 510(k) summary.

Information that can be extracted (limited):

• Acceptance Criteria Summary: The overall acceptance criterion was that "the device subject to this 510(k) Premarket Notification functions as intended and that design input matches design output."
• Study Proving Acceptance: "Software verification and validation testing were performed."
• Guidance followed: "Testing has been carried out in accordance with the FDA guidance document, 'General Principles of Software Validation: Final Guidance for Industry and FDA Staff,' issued on January 11, 2002."

Table of Acceptance Criteria and Reported Device Performance (Cannot be generated from the provided text):

Details of the Study (Mostly N/A from provided text):

• Sample size used for the test set and the data provenance: Not specified.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
• Adjudication method for the test set: Not specified.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not specified. The document does not describe any human reader studies.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states "Software verification and validation testing were performed," which implies standalone testing of the software's functionality, but no specific performance metrics are provided.
• The type of ground truth used: Not specified.
• The sample size for the training set: Not applicable, as this is a software for planning, not a machine learning model that undergoes "training" in the typical AI sense. The document describes traditional software verification and validation, not AI model development.
• How the ground truth for the training set was established: Not applicable for the same reason as above.

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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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