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1. Liner or base
2. Blocking out undercuts
3. Repair of (in) direct aesthetic restorations, temporary crown & bridge, defect margins are in enamel
4. Sealing hypersensitive areas
5. Fissure sealant
6. Direct restorative for Class I, II, III, IV, V cavities
7. Core build-up

NMF004A is a light cured nano-filled radiopaque composite resin filled in a syringe. The device is used for the restorations of both anterior and posterior teeth. The material is available in 30 shades.

The provided text describes a 510(k) premarket notification for a dental device named NMF004A. This document asserts the device's substantial equivalence to previously cleared predicate devices by outlining its characteristics, indications for use, and performance bench tests against a recognized standard (ISO 4049:2009).

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

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

The document states that "The applicant device complies with all the requirements of ISO 4049: 2009 (Dentistry - Polymer-based restorative materials)." While specific measured values for NMF004A are not explicitly provided in the table, the text implies that NMF004A's performance meets these requirements. The table below presents the acceptance criteria from ISO 4049:2009 as listed in the document.

2. Sample size used for the test set and the data provenance:

The document does not specify the sample sizes used for the performance bench tests. It also does not provide information regarding the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The "performance bench tests" described are laboratory tests against ISO standards, not studies involving expert evaluation of clinical data for ground truth.

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

This information is not applicable and therefore not provided in the document. The performance tests are objective measurements against ISO standards, not subjective evaluations requiring adjudication.

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 provided and is not applicable. The device, NMF004A, is a tooth shade resin material, not an AI-assisted diagnostic tool or an imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.

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

This information is not provided and is not applicable. NMF004A is a physical dental material, not an algorithm.

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

The "ground truth" for the performance bench tests is the established requirements of the ISO 4049:2009 standard (Dentistry - Polymer-based restorative materials). These are objective, scientifically defined physical and chemical properties of dental materials.

8. The sample size for the training set:

This information is not provided and is not applicable. The device is a physical material, not a machine learning model; therefore, it does not have a "training set."

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

This information is not provided and is not applicable for the reasons stated above.

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