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This product is a light-cured micro-filled composite resin for use in the following recommended indications: Direct restorative for Class I and II cavities.

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The provided text is a 510(k) clearance letter from the FDA for a medical device called "Gradia Direct X." This document is a regulatory approval, not a scientific study report. It states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the approval is based on a comparison to existing devices, not a new study demonstrating performance against specific acceptance criteria in the manner requested.

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This product is a light-cured fluoride releasing microfilled hybrid composite restorative resin. Recommended Indications: 1. Restoration of Class I, II, III, IV, V cavities (particularly for small Class I cavities/ shallow Class V cavities/ other small cavities). 2. Restoration of root surface caries. 3. Restorations in deciduous teeth. 4. Filling tunnel shaped cavities. 5. Sealing hypersensitive areas. 6. Liner/base/filling in cavity undercuts. 7. Sealant. 8. Fixation of mobile teeth. 9. Additions to composite restorations.

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This document is a 510(k) clearance letter from the FDA for a dental restorative material, not a study report detailing acceptance criteria and performance data for a device involving AI or complex statistical analysis.

Therefore, the requested information elements (1 through 9) related to a study proving device meeting acceptance criteria, especially those pertinent to AI/software performance, are not present in this document.

Specifically, there is no information regarding:

1. A table of acceptance criteria and the reported device performance: This letter indicates substantial equivalence to a predicate device, not a performance study against specific acceptance criteria.
2. Sample size used for the test set and the data provenance: No test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is a dental material, not an AI-assisted diagnostic device.
6. If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

This document serves as an FDA clearance for a dental material (Gradia® Direct LoFlo) based on its substantial equivalence to previously marketed predicate devices, not on a new clinical performance study with detailed acceptance criteria and statistical analysis as would be relevant for devices with diagnostic or AI components.

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GRADIA DIRECT is a visible light-cured micro-filled hybrid resin to be used for the recommended indications listed below:

GRADIA DIRECT ANTERIOR:

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

GRADIA DIRECT POSTERIOR:

1. Direct restorations for Class I and II cavities.

visible light-cured micro-filled hybrid resin

The provided text is a 510(k) summary from the FDA for a dental restorative material named "Gradia Direct." This document is a clearance letter, not a study report. It states that the device is "substantially equivalent" to legally marketed predicate devices.

Therefore, the document does not contain any information regarding:

• Acceptance criteria and reported device performance (in a quantifiable, study-driven manner)
• Sample sizes used for test sets or their data provenance
• Number of experts or their qualifications for establishing ground truth
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness studies
• Standalone algorithm performance studies
• Type of ground truth used (expert consensus, pathology, outcomes data) for performance evaluation
• Sample size for training sets
• How ground truth for training sets was established

This document is solely an FDA clearance letter indicating that the device can be legally marketed based on its substantial equivalence to pre-existing devices, rather than comprehensive performance data from a specific study.

Ask a specific question about this device