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Prodigy 4 Translucent Shades is a dental composite restorative material intended to be used in all classes of cavities.

The device is a micro-hybrid, light cured, resin-based dental restorative which contains approximately 70% by weight inorganic filler but with a particle size nearly half that of Kerr's Herculite XRV and Prodigy. This breakthrough in filler technology provides a higher, longer-lasting polish similar to a microfill, without any negative effects to the physical properties.

The provided document is a 510(k) Summary of Safety and Effectiveness for a dental composite restorative material, Prodigy 4 Translucent Shades, and an FDA clearance letter. It does not contain information about a study based on acceptance criteria or statistical evaluations typically associated with device performance against specific metrics.

The document emphasizes substantial equivalence to a previously marketed device (Kerr Corporation, Prodigy 4) rather than providing detailed performance study data against defined acceptance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: The document does not specify acceptance criteria for this device, nor does it present detailed performance data in this manner.
2. Sample size used for the test set and the data provenance: No test set information is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such study is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
6. If a standalone (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.

Explanation of the provided document's focus:

The document focuses on demonstrating that Prodigy 4 Translucent Shades is substantially equivalent to a predicate device (Kerr Corporation, Prodigy 4). Substantial equivalence means that the new device is as safe and effective as a legally marketed device that is not subject to premarket approval (PMA). This is typically shown by demonstrating:

• Same intended use: Both devices are for "use in all classes of cavities."
• Same technological characteristics: The document describes the device as a "micro-hybrid, light cured, resin-based dental restorative" with "70% by weight inorganic filler" and an improved particle size for polish, comparing it to the predicate device's filler technology.

The 510(k) process often relies on existing data and comparisons to predicate devices, rather than requiring extensive new clinical studies with detailed acceptance criteria as one might see for novel, high-risk devices or software as a medical device (SaMD) requiring AI performance validation.

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The intended use of Prodigy 4 is for use in all classes of cavities.

The device is a micro-hybrid light cured resin-based dental restorative which contains approximately 79% by weight (59% by volume) inorganic filler but with a particle size nearly half that of Kerr's Herculite XRV and Prodigy. This breakthrough in filler technology provides a higher, longer-lasting polish similar to a microfill, without any negative effects to the physical properties.

The provided text is a 510(k) summary for a dental composite restorative material called "Prodigy 4." It details the device's description, intended use, and its claim of substantial equivalence to existing legally marketed devices. However, the document does NOT contain information about acceptance criteria or a study proving the device meets those criteria.

The 510(k) summary focuses on demonstrating substantial equivalence, which is a regulatory pathway for medical devices. For this type of device, substantial equivalence is primarily established by comparing its physical and chemical properties, intended use, and performance characteristics to those of predicate devices already on the market. It does not typically require the submission of clinical study data with acceptance criteria in the same way a novel high-risk device might.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them because this information is not present in the provided text.

Ask a specific question about this device