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GrandTEC is intended for the following applications:

• Stabilisation of teeth:
• After orthodontic treatment
• After periodontal treatment
• For support in treating trauma:
• For immobilising and splinting avulsed and loosened teeth
• Fragment anchoring after fracture
• For the reinforcement/fabrication of provisional bridges made from composite and provisional C & B material
• For temporary treatment after extraction and replacement of a missing tooth with the use of a plastic tooth
• For the temporary or semi-permanent treatment of a tooth space with the use of an extracted natural tooth
• For temporary treatment after placing an implant during the osseointegration of the implant

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The provided document is an FDA 510(k) clearance letter for the device GrandTEC, which is a denture relining, repairing, or rebasing resin. This type of document typically focuses on establishing substantial equivalence to a predicate device based on performance testing for material properties and an assessment of indications for use. It does not contain information about clinical studies involving human readers, AI algorithms, or ground truth establishment in the context of diagnostic performance.

Therefore, an exhaustive response to your query based solely on the provided text is not possible, as it does not detail acceptance criteria related to diagnostic performance or a study demonstrating such performance for an AI device.

However, I can extract the relevant information that is present and explain why other requested information is not available in these documents:

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

The document does not specify quantitative acceptance criteria or reported device performance in the context of an AI/diagnostic algorithm. For a device like GrandTEC (denture resin), acceptance criteria would typically relate to physical and chemical properties (e.g., strength, biocompatibility, polymerization shrinkage, water absorption) and the reported performance would be the results of laboratory tests against these criteria. This information is not included in the provided FDA clearance letter, which summarizes the decision rather than detailing the full technical review.

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. It would be relevant for a diagnostic study, but not for the type of material testing likely performed for GrandTEC.

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. Ground truth establishment is critical for diagnostic performance studies, which are not described here.

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

This information is not provided. Adjudication methods are relevant for resolving discrepancies in expert opinions in diagnostic studies.

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

No such study is mentioned or implied in the document. An MRMC study is specific to evaluating the clinical impact of an AI-assisted diagnostic device, which is not what GrandTEC is.

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

No such study is mentioned. This would be relevant for an AI algorithm's performance, not a dental resin.

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

This information is not provided. For a dental resin, the "ground truth" for its performance would be defined by standardized material testing methods.

8. The sample size for the training set

This information is not provided. This is relevant for AI model development, not for a dental resin's material properties.

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

This information is not provided. This is relevant for AI model development, not for a dental resin's material properties.

Summary of what can be extracted from the provided text:

• Device Name: GrandTEC
• Regulation Number/Name: 21 CFR 872.3760, Denture Relining, Repairing, or Rebasing Resin
• Regulatory Class: II
• Product Code: EBI
• Indications for Use:
  • Stabilisation of teeth (after orthodontic treatment, after periodontal treatment)
  • For support in treating trauma (immobilizing and splinting avulsed and loosened teeth, fragment anchoring after fracture)
  • For the reinforcement/fabrication of provisional bridges Made from composite and provisional C & B material
  • For temporary treatment after extraction and replacement of a missing tooth with the use of a plastic tooth
  • For the temporary or semi-permanent treatment of a tooth space with the use of an extracted natural tooth
  • For temporary treatment after placing an implant during the osseointegration of the implant
• Prescription Use: Yes

The document is an FDA clearance letter indicating that GrandTEC has been found substantially equivalent to predicate devices for its stated indications for use. It does not provide the technical details of the testing performed.

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