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• Class III and Class V restorations
• Small Class I restoration
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The provided text from the FDA 510(k) clearance letter for the Shofu Dental Corporation's "FIT SA" device does not contain the detailed information necessary to fully answer all the questions about acceptance criteria and a study proving the device meets them. This document is a clearance letter, which means the FDA has reviewed the manufacturer's submission and found the device substantially equivalent to a legally marketed predicate. However, it typically does not include the specifics of the performance studies themselves.

The information provided only states the indications for use and general regulatory information. It does not describe any specific acceptance criteria for a performance study, nor does it detail a study that proves the device meets those criteria.

Therefore, for almost all of the requested information, the answer is "Information not provided in the input text."

Here's a breakdown of what can be inferred or stated based on the provided text, and what is missing:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

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

• Information not provided in the input text. The clearance letter does not list specific performance metrics or acceptance criteria for the FIT SA device. It only states the device's indications for use.

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

• Information not provided in the input text. The letter does not mention any sample sizes, types of data (retrospective/prospective), or data provenance for any testing.

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)

• Information not provided in the input text. This detail would typically be part of a clinical or performance study report, which is not included in the FDA clearance letter.

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

• Information not provided in the input text. Adjudication methods are specific to how discrepancies in ground truth establishment are resolved, which is not mentioned here.

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

• Information not provided in the input text. This type of study is typically for AI-assisted diagnostic devices. FIT SA is a dental restorative material, so an MRMC study related to AI assistance would not be applicable. The letter does not mention any MRMC studies.

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

• Information not provided in the input text. Similar to point 5, this is not applicable to a restorative dental material. The device itself is not an algorithm.

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

• Information not provided in the input text. As there's no mention of a performance study with a test set, there's no information on how ground truth would have been established. For dental restorative materials, performance is typically assessed through physical, mechanical, and biocompatibility testing, potentially in vitro or in vivo studies, but not in the way an AI diagnostic device uses "ground truth."

8. The sample size for the training set

• Information not provided in the input text. As the device is a material and not an AI algorithm, the concept of a "training set" in this context is not applicable.

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

• Information not provided in the input text. (Not applicable for this type of device.)

Summary regarding the provided text:

The provided FDA 510(k) clearance letter for the Shofu Dental Corporation's FIT SA device is a regulatory document confirming clearance based on substantial equivalence. It does not contain the detailed technical or clinical study results, acceptance criteria, or ground truth establishment methods that would be typically found in a clinical study report or the technical sections of a 510(k) submission. Therefore, the specific information requested in the questions cannot be extracted from this document.

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