(72 days)
Revolution Formula 2 is a flowable, light cure hybrid resin restorative designed to be used as a filling material for Class III, Class IV, and Class V restorations. Additional functions include: repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.
The device is a light cured, hybrid resin dental restorative which incorporates BIS-GMA chemistry along with a proprietary glass filler (approximately 60%) to yield a flowable non-slumping anong with a propriously gass into (epport 2 combination of flowability and direct application system simplifies material placement and minimizes finishing to result in a consistently superior restoration.
The provided text describes a 510(k) premarket notification for a dental restorative material, "Revolution Formula 2." It focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study measuring acceptance criteria and device performance in a clinical or standalone setting.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not available in the provided document. The document primarily discusses the device description, intended use, and substantial equivalence to a legally marketed predicate device (Kerr Corporation, Prodigy 3).
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document. The 510(k) summary focuses on asserting substantial equivalence based on similar material composition and intended use, rather than presenting specific quantitative acceptance criteria and performance data from a clinical trial or bench test against those criteria.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided. The document does not describe a clinical "test set" or provide details on any studies (clinical or otherwise) with specific sample sizes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided. As no "test set" study is described, there's no mention of experts establishing ground truth.
4. Adjudication Method for the Test Set:
This information is not provided. No adjudication method is mentioned as no specific study of a "test set" is detailed.
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 is not applicable. The device is a dental restorative material (a physical product), not an AI diagnostic or assistance tool that would involve human "readers" or an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a dental restorative material, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
This information is not provided. As no specific performance study is detailed, no ground truth method is mentioned. The equivalence claim is based on the material's properties and intended use being similar to the predicate.
8. The Sample Size for the Training Set:
This information is not applicable/not provided. The device is a material, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
This information is not applicable/not provided. As above, the concept of a "training set" and its associated ground truth is not relevant to this type of device submission.
Summary of available information:
- Device Name: Revolution Formula 2 (Light-Curable Dental Restorative Material)
- Intended Use: Restoration of Class III, Class IV, and Class V cavities, repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.
- Predicate Device: Kerr Corporation, Prodigy 3
- Claim of Substantial Equivalence: Revolution Formula 2 is "substantially equivalent to other legally marketed devices in the United States" and functions "in a manner similar to and is intended for the same use as" the predicate product. The equivalence is based on the device being a "light cured, hybrid resin dental restorative which incorporates BIS-GMA chemistry along with a proprietary glass filler (approximately 60%) to yield a flowable non-slumping along with a proprietary glass into a composition of flowability and direct application."
The provided content is a regulatory submission for premarket notification (510(k)) and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results with specific acceptance criteria.
§ 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.