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The 3M™ Unitek™ Lava™ Chairside Oral Scanner is an optical impression system (CAD/CAM) used to record the topographical characteristics of teeth. Data generated from the 3M™ Unitek ™ Lava™ Chairside Oral Scanner may be used in conjunction with the production of orthodontic appliances, retainers and accessories.

The 3M™ Unitek™ Lava™ Chairside Oral Scanner is a system intended to obtain 3D images of the topographical characteristics of Teeth. The System consists of a computer, proprietary software and a hand held dental 'wand' for scanning the surface of the teeth.

Using the wand in close proximity to the teeth, the image of the teeth is communicated to the software and a 3D model is created by the software. The 3D model is then stored on disk along with pertinent patient information.

In this 510K pre-market notification, the software has been modified to adapt to the revised intended use statement, which adds a new device with the application of generating models for orthodontic appliances, retainers and accessories. An analysis of the changes to the device along with In-Vitro test data demonstrates that no new issues of safety or effectiveness are raised by the changes to the device discussed in this premarket notification.

The 3M™ Unitek™ Lava™ Chairside Oral Scanner will be manufactured by Brontes Technologies, Inc., a 3M Company, and distributed by 3M Unitek, another 3M Company,

The provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Instead, the document primarily consists of a 510(k) summary for the 3M™ Unitek™ Lava™ Chairside Oral Scanner, focusing on its substantial equivalence to a predicate device for an expanded intended use (orthodontic appliances).

Here's a breakdown of what the document does provide:

• Device Description: The 3M™ Unitek™ Lava™ Chairside Oral Scanner is an optical impression system (CAD/CAM) that uses a handheld dental "wand" and proprietary software to create 3D models of teeth.
• Intended Use: To record topographical characteristics of teeth for the production of orthodontic appliances, retainers, and accessories.
• Predicate Device: 3M™ ESPE Lava™ Chairside Oral Scanner (K073199).
• Performance Standards: The device meets several performance standards, including Tripartite Guidance, Special Controls Guidance for Optical Impression Systems, and various ISO/EN and IEC standards related to biocompatibility, electrical safety, and risk management.
• Conclusion: The document states that the similarities between the new device and the predicate outweigh the differences, and that the device is safe and effective when used as intended by qualified personnel.
• FDA Approval Letter: Confirms substantial equivalence (K081961) to legally marketed predicate devices.

Missing Information:

The document explicitly states: "An analysis of the changes to the device along with In-Vitro test data demonstrates that no new issues of safety or effectiveness are raised by the changes to the device discussed in this premarket notification."

This sentence implies that some form of in-vitro testing was performed, but it does not provide any specific acceptance criteria, test results, sample sizes, ground truth methodology, or details of a study that would allow for the completion of the requested table and information.

Therefore, I cannot provide the requested table or answer the specific questions about the study, as the necessary details are simply not present in the provided text.

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