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The software is intended to be used at a dental laboratory. The software uses patient-specific data from scanners, e.g. a scanned geometry, and facilitates the CAD of individual restorative solutions based on these data, such as a supporting dental framework, dental abutments, copings, crowns, and bridges. The software also serves as a means of creating and managing of cases, and the ordering of products.

NobelDesign (also marketed as DTX Studio design) is an integrated CAD Software in a cockpit application that enables the user to design dental restorations. The software receives and reads scan data containing topographical characteristics of real teeth and dental impressions from extra and intra-oral scanners. The NobelDesign/DTX Studio design software uses the data and it integrates a third-party software used to perform the CAD design of the dental restorations. Using this software, the user can create and track cases, scan models and design prosthetics restorations (excluded implant/abutment interface). The output of the device is a computer file which contains the dental restoration design in a digital form. The dental restoration is manufactured in Nobel Biocare registered facilities using the digital format. Prosthetic restorations (excluding prosthetic restorations with implant/abutment interface or as part of a multi-piece or Ti-base abutment under 872.3630, NHA) can also be designed with the software but can be manufactured in the dental lab, using 510k cleared material for this purpose (872.3770, EBG).

This document does not contain the detailed information necessary to complete all sections of your request. It is a 510(k) summary for a medical device (NobelDesign/DTX Studio Design software) and focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed performance study with acceptance criteria and results.

Here's what can be extracted and what is missing:

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

This information is not provided in the document. The document states that "Design Control Activities including risk management following the ISO 14971:2012 verification/validation testing, was conducted... This documentation includes testing which demonstrates that the requirements for the features have been met." However, it does not specify what those requirements (acceptance criteria) were or the quantitative results of the performance testing.

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

This information is not explicitly provided for a specific test set. The document mentions "an entire end-to-end validation (scan, design, and order) for multiple worst-case scenario scan and design requirements," but details about the sample size (number of scans, designs, or orders), the nature of the data, or its provenance are absent.

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)

This information is not provided in the document.

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

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in this document. This software is a CAD design tool, not an AI-assisted diagnostic tool for human readers.

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

The document describes the software as enabling "the user to design dental restorations" and facilitating "the CAD of individual restorative solutions." This implies human-in-the-loop operation, as it's a design tool. Therefore, a purely standalone algorithm evaluation would likely not be applicable or relevant to this device's function. The document does not describe a standalone performance study.

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

The document mentions "an entire end-to-end validation (scan, design, and order)." For CAD design software, "ground truth" would likely relate to the accuracy and precision of the digital designs compared to predefined specifications or validated physical models, and the fidelity of the manufacturing output to the digital design. However, the specific type of "ground truth" or how it was established is not detailed. It's implied that designs are evaluated against "design requirements" and "manufacturing specifications."

8. The sample size for the training set

This information is not applicable in the context of this document. The software described is a CAD design tool, not a machine learning model that undergoes "training." Its functionality is based on predefined algorithms for geometric design and integration, not on learning from a large dataset.

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

This information is not applicable as the document does not describe a training set for machine learning.

Summary of what is available from the document:

• Device Name: NobelDesign / DTX Studio Design
• Device Type: CAD Software for dental restorations (abutments, copings, crowns, bridges)
• Purpose of Study (as described): Software verification and validation activities conducted under Design Control Activities, following ISO 14971:2012 and FDA Guidance General Principles of Software Validation. This demonstrated that "requirements for the features have been met."
• Validation Scope: "An entire end-to-end validation (scan, design, and order) for multiple worst-case scenario scan and design requirements."
• Regulatory Compliance: Conformance with IEC 62304:2006 standards. FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" (May 2005) guidance was also followed for documentation.

For a detailed answer to your request, the original 510(k) submission document, particularly the verification and validation reports, would need to be reviewed, as the summary provided here does not contain that level of detail.

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