(65 days)
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This material is light cure Prodigy except for minor modifications in the polymerization chemistry and the addition of a small amount of a Fluoride release agent. Specifically, the camphorquinone / amine visible light initiation components were replaced with the traditional chemical cure additives, Benzoyl Peroxide in the catalyst paste and DHEPT [ N, N-Di-(2hydroxvethyl)-4-toluidine 1 in the base paste. To provide the benefits associated with a Fluoride releasing material, 2 % by weight Sodium Hexafluorosilicate ( Na,SiF ) was added to all paste formulations. Kerr intends to market this device in two distinct package configurations. The first, the Prodigy AC autocure composite restorative material, will be offered in a kit containing one 5 gram jar of catalyst paste along with one 5 gram jar of each of three base paste shades ( Light, Universal, and Dark ). The second, Prodigy AC Core Buildup Material, tentatively being referred to as ProCore, will be supplied in a kit containing one 5 gram syringes each of the catalysts ( High and Low Viscosity ), and one 5 gram syringe of a dual cure White base paste ( This paste formula will be light and chemically activated. ).
The provided text is a 510(k) summary for the "Prodigy Autocure Restorative and Core Buildup Material." This document focuses on demonstrating substantial equivalence to a predicate device, specifically the original Prodigy light-cured composite (K944659), rather than detailing a
full study with specific acceptance criteria and detailed performance metrics as one might find for a novel, high-risk medical device.
Therefore, much of the requested information cannot be extracted from this summary. This document primarily asserts similarity in composition and infers similar performance based on that similarity and "side-by-side comparison" with predicate devices, without providing the granular detail asked for in your prompt.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or specific numerical performance metrics for the Prodigy AC material. It simply states that the device "performed as well or better than the predicate devices" in "side by side comparison testing." This
is a qualitative statement, not a scientific criteria-performance table.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Similar to predicate devices in "suitability to its intended purpose" | "Performed as well or better than the predicate devices" in side-by-side comparison testing. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "side by side comparison with several predicate devices currently on the market."
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. The "ground truth" for material efficacy in this context would likely be in-vitro physical property testing (e.g., strength, wear resistance, bond strength) and possibly some limited clinical observations, rather than a diagnostic accuracy study requiring expert human interpretation for ground truth.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, this is not a study requiring adjudication of expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This type of study is for evaluating human performance (e.g., diagnostic accuracy of radiologists) with and without AI assistance. This document is for a dental restorative material, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is for a dental material, not an algorithm.
7. Type of Ground Truth Used:
For a dental restorative material, the "ground truth" for effectiveness would typically be established through:
- In-vitro physical and mechanical property testing (e.g., compressive strength, flexural strength, wear resistance, water sorption, solubility, bond strength).
- Chemical stability and biocompatibility assessments.
- Potentially, limited in-vivo clinical observations or trials, though the summary does not detail these.
The document states, "The efficacy of this product, with respect to it's suitability to it's intended purpose, is demonstrated by the fact that when tested in side by side comparison with several predicate devices currently on the market, it performed as well or better than the predicate devices." This implies various physical and chemical tests were performed.
8. Sample Size for the Training Set:
Not applicable. There is no "training set" in the context of a dental restorative material as described here. This is not an AI/machine learning model.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.