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Ascent Dental Cleanser is indicated for:

• The cleansing and disinfecting only of tooth cavity preparations in conjunction with dental restorative procedures

The Ascent Dental Cleanser is a water-based tooth cavity preparation cleanser containing chlorhexidine gluconate and a solvent. This composition, when introduced into a cavity preparation, works to dislodge unwanted and/or foreign material. The cleanser is dispensed from a prefilled applicator directly to the desired site. The applicator may be in the form of a one-time unit dose configuration, or may be supplied in a larger prefilled quantity that accommodates single-use disposable tips of varying size and length to accommodate the needs of a particular procedure.

Here's an analysis of the provided text regarding the Ascent Dental Cleanser's acceptance criteria and the study proving it, based on the provided document.

It's important to note that the provided document is a 510(k) Summary and the associated FDA approval letter for a dental cleanser, not an AI medical device. Therefore, the questions related to AI device performance metrics (MRMC studies, stand-alone algorithm performance, training set details, ground truth establishment for AI) are not applicable (N/A) to this specific submission. This document focuses on demonstrating substantial equivalence to a predicate device for a physical product, not an AI algorithm.

Acceptance Criteria and Device Performance for Ascent Dental Cleanser

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not describe a test set in the context of clinical trials or data-driven performance evaluation for an AI device. This submission is for a physical medical device (dental cleanser) seeking substantial equivalence based on its formulation, intended use, and application methods compared to an already marketed predicate device. The "Performance Data" section merely refers to "Part 7: Performance Data," but this detailed report is not included in the provided text. However, such a report for this type of device typically involves bench testing, biocompatibility, and potentially in-vitro studies, not patient data in the sense of a "test set" for an algorithm.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

N/A – This is not an AI device, and the concept of an expert-established "ground truth for the test set" as relevant to AI performance metrics does not apply here.

4. Adjudication Method for the Test Set

N/A – Same as above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

N/A – This is not an AI-assisted diagnostic or therapeutic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A – This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For this type of traditional medical device, "ground truth" would not be established in the same way as for an AI algorithm. Instead, its "truth" or efficacy is demonstrated through:

• Chemical composition analysis: Verifying the presence and concentration of active ingredients.
• Biocompatibility testing: Ensuring the materials are safe for biological contact (as mentioned: "Exact information regarding the material's constituents is found in Part 8: Biocompatibility Assessment").
• Bench testing/in-vitro studies: To show its ability to dislodge unwanted material and disinfect, likely through laboratory experiments on simulated cavity surfaces or bacterial cultures.
• Comparison to predicate device: The fundamental "ground truth" of this submission is that it is chemically, functionally, and biologically equivalent to a device already deemed safe and effective.

8. The Sample Size for the Training Set

N/A – This is not an AI device.

9. How the Ground Truth for the Training Set Was Established

N/A – This is not an AI device.

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