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The 3M ESPE Lava Chairside Oral Scanner (COS) is an optical impression system (CAD/CAM) used to record the topographical characteristics of teeth.

The 3M ESPE Lava Chairside Oral Scanner (Lava COS) 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, a powdering material and powder sprayer is added as an accessory. The 'patterning powder' to be applied to the teeth prior to obtaining 3D CAD/CAM images. The powder is intended to enhance the contrast level of the image and allow for better resolution and accuracy of the CAD/CAM images obtained by the 3M ESPE Lava Chairside Oral Scanner System. This powder is similar in composition to powders sold for use with the predicate device and as a 'stand alone' material. The powder provided by Brontes meets the applicable requirements for biocompatibility under the recognized standard ISO 10993 and does not add any new issues of safety or effectiveness.

The provided text is a 510(k) summary for the 3M ESPE Lava Chairside Oral Scanner (COS). It details the device's intended use and performance standards but lacks specific acceptance criteria, detailed study results, or information about sample sizes, ground truth establishment, or expert involvement for performance evaluation.

Therefore, I cannot fully complete the requested table or answer all sub-questions based solely on the provided text. The document primarily focuses on establishing substantial equivalence to a predicate device and adherence to general performance standards and biocompatibility requirements.

Here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Device Performance

Based on the provided text, specific quantitative acceptance criteria or detailed results of a study demonstrating the device meets those criteria are not available. The document states the device "meets the following Performance Standards" which are general regulatory and safety standards, not specific performance metrics like accuracy, resolution, or scanning speed.

Study Details (Based on available information)

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

   • Not explicitly stated in the document. The 510(k) summary does not describe a specific clinical or performance study with a defined test set sample size. The focus is on regulatory compliance and substantial equivalence to a predicate device.

2. 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 explicitly stated in the document. This type of information would typically be part of a detailed performance study, which is not summarized here.

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

   • Not explicitly stated in the document. Adjudication methods are usually relevant for studies involving human interpretation or subjective assessments, which are not described in this regulatory summary.

4. 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. Not applicable/Not performed. The 3M ESPE Lava Chairside Oral Scanner is an "optical impression system (CAD/CAM) used to record the topographical characteristics of teeth." It is a device for image acquisition to create 3D models, not an AI-assisted diagnostic tool that would involve human readers or interpretation in the way an MRMC study typically assesses. The document does not describe any AI component in this context.

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

   • Standalone performance implied for core function but details absent. The device's primary function is to capture 3D topographical data. The software automatically creates a 3D model. While this process is inherently "standalone" in its data capture and model generation, the document does not provide metrics for this standalone performance (e.g., accuracy of the 3D model compared to a physical reference) from a specific study.

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

   • Not explicitly stated in the document. For a device that measures topographical characteristics, ground truth would typically be highly accurate physical measurements (e.g., from CMMs or highly precise optical scanners) of the actual teeth/models. However, no such ground truth method is described. The biocompatibility ground truth is established via ISO standard testing.

7. The sample size for the training set:

   • Not applicable/Not stated. This device is an optical scanner and CAD/CAM system, not typically an AI/machine learning system that relies on a "training set" in the conventional sense for deep learning. Its performance is based on optical principles and software algorithms for 3D reconstruction.

8. How the ground truth for the training set was established:

   • Not applicable/Not stated. As above, the concept of a training set and its associated ground truth doesn't apply to the described device in the manner usually associated with AI/ML systems.

Summary of what is known:

• The device is an optical impression system for CAD/CAM in dentistry.
• It captures 3D images of teeth using a wand, computer, and proprietary software.
• A powder accessory enhances contrast for better resolution and accuracy.
• The powder's biocompatibility was assessed according to ISO 10993.
• The device claims to meet various regulatory and safety standards (listed under "Performance Standards").
• The 510(k) established substantial equivalence to the Sirona Dental Systems GmbH. CEREC 3 Ceramic Dental Restoration System.

What is not provided in this 510(k) summary:

• Specific quantitative acceptance criteria for performance metrics (e.g., accuracy, precision, resolution).
• Results from any specific performance study, including sample sizes, data provenance, ground truth methodologies, or expert involvement.
• Information about AI components, MRMC studies, or training sets.

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