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The INTEGO Family of Dental Treatment Units with accessories is intended to supply power to and serve as a base for dental devices and accessories. Each unit includes a dental chair. The units are intended for use in the dental clinic environment and are used by trained dentists and/or dental assistants.

The MOTOR BL ISO E is used to drive rotating and oscillating straight and contra-angle handpieces in connection with the dental treatment units for endodontic and general dental purposes.

The SPRAYVIT E multifunctional syringe is used for dental treatment with unheated air and unheated water. The SPRAYVIT E multifunctional syringe is also used to illuminate the preparation field.

The INTEGO family dental treatment unit is a dental operating system. INTEGO and INTEGO pro dental treatment units constitute the INTEGO Family. These are the successors of C8+. Components and functional principles are taken over or widely derived from this C8+. The units include a patient chair, foot control, dentist element and a water unit. The units may also include an assistant element, a cuspidor a dental operating light, and a monitor.

The design concept of the INTEGO treatment unit is similar to commonly available treatment units.

The dimensions of the components, their movements and shapes are designed for ergonomic treatment; i.e. the dentist and, where applicable, the assistant can perform their treatments in a healthy working posture.

Surfaces are smooth to enable easy cleaning and disinfecting. This simplifies, in line with detachable parts and barriers as well as simple maintenance routines, efficient infection control.

The operating concept is designed to make treatments easy and intuitive to prevent mal-operations and provide an unimpeded workflow. Depending on the selected foot control and user interface version, a significant portion of functions can be operated hands-free to improve infection control and treatment workflow.

Styling and colors were selected under aesthetic aspects.

The provided text is a 510(k) Summary for the Sirona Dental Systems INTEGO Family and Accessories. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria and device performance in the way a clinical study for a novel device would.

Therefore, many of the requested elements (like sample size, number of experts, adjudication method, MRMC studies, standalone performance with metrics like AUC, sensitivity, specificity, ground truth type for test/training sets) are not applicable in this regulatory context, as it's a submission for a Class I device based on substantial equivalence, not a new high-risk device requiring extensive clinical validation.

However, I can extract information related to the device's adherence to relevant standards and its demonstrated equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the device's compliance with various national and international standards. The "Reported Device Performance" is stated by the manufacturer to be substantially equivalent to the predicate devices and compliant with these standards. Since this is a substantial equivalence submission, specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) are not provided in the document for the device itself against a specific acceptance criterion.

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

• Not Applicable. This document describes a 510(k) submission for a Class I dental operative unit, not a device requiring clinical performance testing with test sets in the typical sense (e.g., for diagnostic accuracy). The evaluation is primarily based on compliance with recognized consensus standards and comparison of technological characteristics to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. See point 2. The evaluation relied on "an evaluation using relevant literature and a critical appraisal of the Dental Treatment Unit and accessories by a medical professional." The number and specific qualifications of this medical professional are not detailed.

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

• Not Applicable. See point 2.

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. This is not an AI/CADe/CADx device. No MRMC study was performed.

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

• Not Applicable. This is not an algorithmic device in the AI sense.

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

• Not Applicable in the traditional clinical validation sense. The "ground truth" for this type of submission is the established performance and safety demonstrated by predicate devices and the requirements set forth in the referenced consensus standards.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device that uses a "training set."

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

• Not Applicable. See point 8.

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