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The SEAC Advanced Dents System is a self-contained dental delivery system with a built-in air compressor, vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handvises connections. The Micadent is used to perform intra-oral air abrasion procedures including etching and preparing surfaces for composite restoration,

The SEAC Advanced Dents System is a self-contained dental delivery system with a built-in air compressor, vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handvises connections. The Micadent is used to perform intra-oral air abrasion procedures including etching and preparing surfaces for composite restoration,

I apologize, but the provided text from the FDA 510(k) letter does not contain the information required to describe the acceptance criteria and the study that proves the device meets them.

The document is a clearance letter for a "Seac Advanced Dental System" (Model 2001 or 2020), indicating that the device has been found substantially equivalent to a predicate device. It confirms that the device can be marketed.

However, it does not include:

1. A table of acceptance criteria and reported device performance: This type of information would be found in the premarket submission itself, detailing the performance standards the manufacturer set for their device and the results of their testing.
2. Sample size used for the test set and data provenance: Again, this data is part of the studies submitted, not typically in the clearance letter.
3. Number of experts and their qualifications for ground truth: This would be part of the study design and methodology.
4. Adjudication method: Similar to the above, this is a detail of the study design.
5. Multi-reader multi-case (MRMC) comparative effectiveness study details: This type of study is not mentioned or described in the provided text.
6. Standalone (algorithm only) performance: This device is a physical dental system, not an algorithm, so this criterion is not applicable.
7. Type of ground truth used: Not explicitly stated.
8. Training set sample size and ground truth establishment for training set: Not applicable as it's a physical device and not an AI/ML algorithm that requires training data in the same way.

The document primarily focuses on the regulatory clearance process and the determination of substantial equivalence, based on the device's design, function, and indications for use, rather than detailed performance study results.

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