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The TAURUS C1 Dental System and accessories are intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.

TAURAUS C1 is a dental chair and units to be used to take for diagnosis and therapy of patients. It consists of the main unit and accessories.

The dental chair is used for patient to sit during the dental diagnosis, treatment and /or operation. The dental unit consists of patient chair, dentist table with instrument holders, assistant table, water unit, arm system, cuspidor (spittoon) and dental light. The dental unit system is used by trained dentists and /or dental assistants to supply air, water, vacuum and electrical power to dental devices and accessories to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.

The provided text is a 510(k) summary for the TAURUS C1 Dental System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving stand-alone clinical accuracy or comparative effectiveness with human readers through typical acceptance criteria studies.

Therefore, the document does not contain the information requested regarding acceptance criteria related to device performance in terms of diagnostic accuracy, sensitivity, specificity, or other performance metrics commonly associated with AI/algorithm-driven devices. It also does not include information on sample sizes for test sets, data provenance, expert ground truth adjudication, MRMC studies, or training set details.

The "performance data" section (Section VII) focuses on non-clinical testing to ensure safety and compliance with relevant standards, rather than clinical performance metrics.

Here's a breakdown of why the requested information is not present based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable in this context. The "acceptance criteria" here are compliance with international safety and performance standards (e.g., IEC, ISO). The "reported device performance" refers to the successful completion of these non-clinical tests.

   Acceptance Criterion (Standard Compliance)	Reported Device Performance
   IEC 60601-1 (Basic safety & essential performance)	Fulfilled
   IEC 60601-1-2 (EMC)	Fulfilled
   ISO 7494-1 (Dental units - General req.)	Pass
   ISO 7494-2 (Dental units - Water & air supply)	Pass
   ISO 6875 (Dental patient chair req.)	Pass
   Biocompatibility	Materials already cleared for patient contact, similar to predicate device

2. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the sense of clinical data or images for performance evaluation. The testing involved physical device compliance with standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth established by experts for performance evaluation. The "ground truth" relates to the technical specifications and safety requirements of the device.

4. Adjudication method for the test set: Not applicable.

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: Not applicable. This device is a dental operative unit, not an AI-driven diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-only device.

7. The type of ground truth used: For the purposes of this submission, the "ground truth" is compliance with the technical specifications and safety standards (e.g., a chair must articulate in a certain way, the electrical system must meet specific safety ratings).

8. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details a 510(k) submission for a physical dental operative unit. The "performance data" section refers to engineering and safety compliance testing against recognized international standards, not clinical performance or artificial intelligence algorithm evaluation.

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