(52 days)
Premise is a dental composite restorative material intended to be used in all classes of cavites.
The device is a light cured resin based composite dental restorative designed for direct placement. By utilizing three types of fillers, Premise is designed to offer high polishability, high mechanical strength, and decreased polymerization shrinkage.
This 510(k) summary (K032921) describes a dental composite restorative material called "Premise." It primarily focuses on demonstrating substantial equivalence to a predicate device ("Point 4 Modified") and does not contain detailed information about specific acceptance criteria and a study proving those criteria are met for the new device.
The document is a 510(k) premarket notification, which means the manufacturer is essentially stating that their new device is as safe and effective as a legally marketed predicate device. This process typically relies on demonstrating similar performance characteristics to the predicate device, rather than conducting new, extensive clinical trials to establish novel acceptance criteria or device performance.
Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, and expert adjudication are not provided in this regulatory document.
However, I can extract the information that is present and highlight what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (from predicate) | Reported Device Performance (Premise) |
|---|---|---|
| High Polishability | Similar to Point 4 Modified | Designed to offer high polishability |
| High Mechanical Strength | Similar to Point 4 Modified | Designed to offer high mechanical strength |
| Decreased Polymerization Shrinkage | Similar to Point 4 Modified | Designed to offer decreased polymerization shrinkage |
| Intended Use | For use in all classes of cavities (for predicate) | For use in all classes of cavities |
Missing Information: Specific quantitative acceptance criteria (e.g., "Polishability score > X," "Flexural strength > Y MPa") are not provided. The document relies on qualitative claims of "similar to" or "designed to offer" in comparison to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. 510(k) summaries often do not include the raw data or detailed study designs for performance tests if the substantial equivalence is primarily based on material composition and intended use similarity to a well-established predicate.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided as there is no mention of a specific "test set" and "ground truth" establishment in the context of expert human review for a new device study. The document focuses on material properties and intended use.
4. Adjudication Method
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided. MRMC studies are typically for imaging or diagnostic devices where human interpretation is a key factor. This device is a dental restorative material.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable/not provided. This is a physical dental material, not an algorithm.
7. Type of Ground Truth Used
This information is not provided as no specific study in the context of establishing "ground truth" for a new device's performance is detailed. The substantial equivalence relies on comparison of material properties and intended use to an existing predicate. For material properties, "ground truth" would typically refer to laboratory measurements against established standards.
8. Sample Size for the Training Set
This information is not applicable/not provided. There is no "training set" in the context of an AI/ML algorithm for this physical dental material.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided.
Summary of the Study Discussed in the Document (Focus on Substantial Equivalence):
The document effectively describes the study for substantial equivalence. This "study" is the process of comparing the new device, "Premise," to a legally marketed predicate device, "Point 4 Modified."
- Objective: To demonstrate that "Premise" is substantially equivalent to "Point 4 Modified" in terms of safety and effectiveness.
- Methodology: The submission highlights that "Premise" "functions in a manner similar to and is intended for the same use as Point 4 Modified." This typically involves comparing:
- Intended Use: Both devices are for "use in all classes of cavities."
- Device Description/Technological Characteristics: Premise uses "three types of fillers" to offer "high polishability, high mechanical strength, and decreased polymerization shrinkage," implying these characteristics are comparable to or improved upon the predicate.
- Performance Data: While not explicitly detailed, in a 510(k) for a material, this would generally involve laboratory testing of properties like:
- Flexural Strength
- Compressive Strength
- Radiopacity
- Depth of Cure
- Wear Resistance
- Polymerization Shrinkage
- Water Sorption/Solubility
- Polishability retention
- Biocompatibility (often by referencing components known to be biocompatible in other devices)
Conclusion from the Document: The FDA reviewed the 510(k) submission and determined that "Premise" is substantially equivalent to the predicate device, allowing it to be marketed. This determination is based on the information provided by the manufacturer, which presumably included data comparing the new device's characteristics to the predicate's established performance. The document itself does not present the detailed results of these comparative tests.
§ 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.