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ION Dental Resin System is indicated for the fabrication and/or repair of prescription therapeutic dental appliances (e.g. occlusal guards) used to mitigate damage associated with parafunctional dental habits (e.g. bruxism).

The ION Dental Resin System includes visible light cured materials in arch form, intended for the fabrication of prescription therapeutic interdental appliances (such as occlusal guards or splints) used to mitigate damage associated with parafunctional dental habits.

The provided text is related to a 510(k) submission for the "ION Dental Resin System." This device is a dental material used for fabricating therapeutic interdental appliances. The information provided heavily focuses on regulatory aspects, intended use, and substantial equivalence to a predicate device, rather than detailed performance studies against specific acceptance criteria.

Therefore, many of the requested sections about acceptance criteria and study details cannot be fully answered or are not applicable based on the provided text. The document is a 510(k) summary, which typically focuses on showing substantial equivalence rather than presenting extensive performance study data in the way a clinical trial for a diagnostic AI device would.

Here's an attempt to answer the questions based only on the provided text, indicating where information is absent:

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

Based on the provided text, specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and corresponding reported performance metrics are not explicitly stated. The submission emphasizes substantial equivalence and biocompatibility.

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

This information is not provided in the text. The submission references "performance data provided" but does not detail the specifics of any test set used, its size, or provenance.

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 provided in the text. The device is a dental resin system, not a diagnostic imaging device that would typically involve expert ground truth for image interpretation.

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

This information is not provided in the text. As noted, the submission does not detail a test set requiring adjudication in this manner.

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 material for fabricating dental appliances, not an AI-powered diagnostic tool, and therefore an MRMC study comparing human readers with and without AI assistance is not relevant or described in the provided context.

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

Not Applicable. This device is a material, not an algorithm, so a standalone performance study in this context is not relevant.

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

For the biocompatibility testing, the "ground truth" would be established by standard accredited laboratory testing methods and interpretation of results against established safety thresholds for cytotoxicity, mutagenicity, and dermal sensitization. Details of these standards are not provided in the text. For the overall performance, the "ground truth" is implied by the safety and performance of the predicate device (K032892) and the proven safety of its components.

8. The sample size for the training set

This information is not provided in the text. The concept of a "training set" as it applies to machine learning algorithms is not relevant to this device.

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

Not Applicable. As above, the concept of a "training set" and its ground truth is not applicable to this type of medical device (dental resin).

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