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1. Class III and V restorations
2. Restoration of primary teeth
3. Core build-up
4. Cases where radiopacity is required
5. Base material for Class I and Class II cavities using a sandwich laminate technique.

GC Fuji Direct is a light-cured resin-modified restorative glass ionomer cement. The device consists of two pastes filled in a Paste Pak Cartridge. Paste A and B are dispensed with Paste Pak Dispenser II and hand mixed. Paste A and B can also be automixed by attaching the GC Fuji Direct Mixing Tip to the Paste Pak Dispenser II and applied directly to the prepared cavity. The bioactive material sets by acid-base reaction of fluoroalumino-silicate glass and Polyacrylic acid, and polymerization of methacrylate monomers.

Here's a breakdown of the acceptance criteria and study information based on the provided text, structured to include all your requested points:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

The document primarily describes bench testing against ISO standards and biocompatibility assessments. Therefore, there isn't a "test set" in the context of a clinical study with human or biological samples in the way this question typically implies for AI/diagnostic devices. The data provenance is related to laboratory testing, likely conducted by or for GC America Inc., a US-based company, referencing the specified international standards. No country of origin for the specific test data is given beyond the company's location. The testing appears to be prospective (as part of the 510(k) submission).

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

N/A. This is a bench test and biocompatibility assessment against technical specifications rather than an evaluation requiring expert-established ground truth on a test set (e.g., medical image interpretation). The "ground truth" for these tests is the quantitative and qualitative requirements of the ISO standard.

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

N/A. This is a bench test against technical specifications, not a study requiring adjudication of expert interpretations.

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

N/A. This device is a dental cement, not an AI software/diagnostic device that would typically involve human readers or AI assistance.

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

N/A. This device is a dental cement, not an algorithm, so this question is not applicable.

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

The "ground truth" for the performance testing is adherence to the technical specifications defined in ISO 9917-2:2010 (Dentistry - Water-based cements - Part 2: Resin-modified cements) and the protocols outlined in ISO 10993-1:2009, ISO 10993-5, and ISO 10993-10 for biocompatibility. These are objective, predefined standards for material properties and biological response.

8. The sample size for the training set

N/A. This is a dental material, not an AI model, so there is no "training set."

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

N/A. As there is no training set for an AI model, this question is not applicable.

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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.

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1. Direct restorative for class I, II, III, IV, V cavities.
2. Direct restorative for wedge-shaped defects and root surface cavities.
3. Direct restorative for veneers and diastema closure.

MFP-051 is a light-cured, nano-filled radiopaque composite resin filled in either a syringe or unitip. The device is a universal type. The material is available in 17 shades. The device is used for the restorations of both anterior and posterior teeth.

The provided document is a 510(k) summary for a dental restorative material (MFP-051). It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study of the device's performance against specific acceptance criteria in a clinical or simulated clinical setting. As such, most of the requested information regarding acceptance criteria and performance studies is not available in this document.

Here is a breakdown of the information that can be extracted or deduced from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not explicitly stated in the document. The document refers to meeting ISO standards and equivalence, implying testing was done, but details about the sample size, test methods, or data provenance (e.g., country of origin, retrospective/prospective) are not provided for specific performance tests. This submission relies on demonstrating compositional and functional similarity to already cleared devices and compliance with an international standard.

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

• Not applicable. This document does not describe a study involving expert assessment or "ground truth" establishment in the context of clinical or diagnostic performance. The evaluation is based on material properties and regulatory standards.

4. Adjudication method for the test set:

• Not applicable. See point 3.

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 dental restorative material, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant.

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

• Not applicable. This is a physical dental material, not an algorithm.

7. The type of ground truth used:

• For the material properties (flexural strength, water sorption, solubility), the "ground truth" would be established by validated laboratory testing methods against the requirements of ISO 4049:2009.
• For the claim of "substantial equivalence" of components and indications, the ground truth is the characterization of the predicate devices and their established safety and effectiveness.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a "training set."

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

• Not applicable. See point 8.

In summary:

This 510(k) submission for MFP-051 demonstrates substantial equivalence by showing that the device complies with ISO 4049:2009, contains components already used in predicate devices, and shows equivalence in key material properties (flexural strength, water sorption, solubility) to similar legally marketed devices. It does not contain details of specific clinical performance studies with acceptance criteria, sample sizes, or expert adjudication as would be relevant for a diagnostic or AI device. The "acceptance criteria" primarily revolve around meeting an international standard (ISO 4049) and demonstrating technical and functional similarity to predicate devices.

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