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Resolve 2.0 is recommended for use on dental restorations, external to the mouth, prior to insertion into the mouth. After applying Resolve 2.0 to cleanse the restoration, the surface of the restoration should be washed thoroughly with water, and then air dried before placement in the mouth. For Use only by a Licensed Dentist. Rx Use Only. Non-sterile.

Resolve 2.0 is a thin, non-alcohol based gel containing chlorhexidine gluconate. This thin gel because of its water solubility, abrasive action and low viscosity when applied to dental restorations, acts as a cleaning agent. This gel is provided in easy to use syringes and floc-tipped applicator tips to precisely deliver the gel to the intended areas. For Use only by a Licensed Dentist. Rx Use Only. Non-sterile.

It appears the provided document is a 510(k) premarket notification for a dental device named "Resolve 2.0." This type of document is for demonstrating substantial equivalence to a predicate device, not for establishing novel acceptance criteria or conducting a comprehensive clinical study in the way one might for a new drug or a high-risk AI-powered diagnostic device.

Therefore, the requested information categories related to acceptance criteria, detailed study design, sample sizes for test/training sets, expert adjudication, MRMC studies, or specific ground truths for AI models do not directly apply to this document. This submission focuses on demonstrating similarity to an existing, legally marketed device.

However, I can extract the information relevant to the equivalence demonstration as presented in the document:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present "acceptance criteria" in the traditional sense of a performance study with defined thresholds. Instead, it compares the technological characteristics of Resolve 2.0 to its predicate device, Consepsis. The "acceptance" is based on demonstrating that these characteristics are equivalent.

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

This information is not applicable/not provided in this type of 510(k) submission. The evaluation is based on physicochemical and biocompatibility testing, not clinical data sets in the AI sense.

3. 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):

This information is not applicable/not provided as there is no "test set" and "ground truth" in the context of an AI device. The evaluation is based on laboratory testing and comparison to the predicate.

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

This information is not applicable/not provided.

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:

This information is not applicable/not provided. This is not an AI-powered device.

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

This information is not applicable/not provided. This is not an algorithm.

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

For the properties evaluated (e.g., pH, water solubility, cleansing activity, biocompatibility), the "ground truth" would be established through laboratory testing and established scientific methods/standards (e.g., pH meter readings, solubility tests, accelerated aging protocols, ISO 10993-5 standard for biocompatibility).

8. The sample size for the training set:

This information is not applicable/not provided. This is not an AI device with a training set.

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

This information is not applicable/not provided.

Summary of the Study:

The document describes a benchtop and biocompatibility study to demonstrate that Resolve 2.0 is substantially equivalent to the predicate device, Consepsis. The study involved:

• Comparison of Technological Characteristics: Resolve 2.0 was compared to Consepsis across several physical and chemical properties including cleansing activity, active ingredient (chlorhexidine gluconate), water solubility, pH, presence of silicate (sand), consistency, pigmentation, and accelerated aging/shelf life.
• Biocompatibility Testing: Resolve 2.0 was evaluated per ISO 10993-5 "Biological Evaluation of Medical Devices" for cytotoxicity. The results were compared to those of Consepsis under the same standard. Both devices exhibited "Moderate" cytotoxicity, showing equivalence.

The conclusion drawn from this "study" (which is more accurately a set of comparative tests) is that Resolve 2.0 is substantially equivalent to Consepsis in design, composition, biocompatibility, performance, aging, limited intended uses, and safety and effectiveness. This equivalence allows the device to be marketed without requiring a full Premarket Approval (PMA) process.

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