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3M True Definition Scanner is an optical impression system used to record the topographical characteristics of the dentition and/or full arch and preparation areas (including features such as implant scan locator fixtures, braces, brackets, etc.). In addition it can record the topographical characteristics of the oral anatomy (such as soft tissue, gingivae and palate).

The three dimensional (3D) model generated from the scan may be further used for the design and manufacturing of dental restorations including implant supported prostheses and partial frameworks, and can be used to design and manufacture physical models of the teeth.

It may also be used in conjunction with production of orthodontic appliances, retainers and accessories.

The 3M True Definition Scanner is a digital impression generating system consisting of a computer system on a mobile cart, a lightweight scanning wand, and embedded software (including firmware). Accessory items include a contrast powder to be applied to the patient's teeth and/or oral anatomy and a battery powered powder sprayer.

The computer system consists of a commercial off-the-shelf personal computer (PC) and a touch screen monitor.

The scanning wand is a hand held optical device that captures high-resolution video images, in real time, as the patient is being scanned. The wand contains an optical system comprised of low intensity LED's, a light sensor, a lens and supporting electronics. The wand is connected to the cart via a high speed data transfer cable. The wand is designed to be easily maneuvered inside the patient's mouth and captures video imagery at 20 frames per second. Those images are converted to 3D data sets and displayed in real time.

The software contains high-speed image processing algorithms, real-time modeling, case management, and archival functionality.

3M True Definition Scanner facilitates a digital workflow which reduces or eliminates many steps traditionally required by the dentist and lab, including tray selection, plaster pouring, material dispensing, base & pin, material setting, die cutting, trimming, articulation, packaging and shipping.

The 3M True Definition Scanner (Model G5) is an optical impression system for CAD/CAM applications, used to record topographical characteristics of dentition, full arch, preparation areas, and oral anatomy for the design and manufacturing of dental restorations, implant-supported prostheses, partial frameworks, physical models of teeth, and orthodontic appliances.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not explicitly state the sample size used for the accuracy test set or the data provenance (e.g., country of origin, retrospective/prospective). However, the "Accuracy Comparison" table indicates the results of an accuracy test were performed.

3. Number and Qualifications of Experts for Ground Truth

The document does not provide information on the number of experts used to establish ground truth for the test set or their qualifications.

4. Adjudication Method for Test Set

The document does not describe any adjudication method for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in this 510(k) summary. The comparison focuses on the technological aspects and accuracy of the device itself against predicate devices, not on human reader performance with or without AI assistance.

6. Standalone Performance Study (Algorithm Only)

The accuracy comparison presented is a standalone (algorithm only) performance study of the 3M True Definition Scanner compared to its predicate devices. The "Accuracy Comparison" table explicitly presents the "Initial Average Error (%)" and "Initial Max Error (%)" for both the new device and the predicate Lava COS. This directly measures the algorithm's performance in generating accurate 3D data.

7. Type of Ground Truth Used

The document implies that the ground truth for accuracy testing would have been established through highly precise measurements of physical models or objects, likely using a 'gold standard' measurement system. While not explicitly stated, for an optical impression system, ground truth typically involves comparing the 3D model generated by the scanner against the known, highly accurate dimensions of the scanned object.

8. Sample Size for Training Set

The document does not specify the sample size used for the training set.

9. How Ground Truth for Training Set Was Established

The document does not describe how the ground truth for the training set was established. Given the nature of accuracy testing for an optical impression system, it's likely that a similar method to the test set (i.e., highly precise measurement of physical objects) would have been employed.

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