(57 days)
Fabrication of temporary crowns, bridges, inlays, onlays and veneers.
Crown lining material for 3M ESPE Prefabricated Temporary Crowns.
Protemp 3 Garant is a temporary crown and bridge resin intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. Temporary crown and bridge resin is designated at 21 C.F.R § 872.3770 as a Class II device.
Like Protemp H, Protemp 3 Garant is available in the proven Garant™ mixing and dispensing system.
The provided text is a 510(k) summary for the Protemp™ 3 Garant™ temporary crown and bridge resin. It focuses on demonstrating substantial equivalence to predicate devices, primarily through biocompatibility testing and a comparison of performance characteristics.
Based on the provided document, here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in the typical sense (e.g., "tensile strength must be > X MPa"). Instead, the acceptance criteria are implied by the comparison to predicate devices, indicating that the new device should perform "at least as well as" or "comparably to" the predicates for relevant characteristics. The study presented is primarily a comparative one.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Protemp™ 3 Garant™) |
|---|---|---|
| Biocompatibility | Biocompatible (based on ISO 10993) | "Protemp 3 Garant is a safe device." |
| General Performance Characteristics (e.g., mechanical properties, handling) | Comparable to Protemp™ H and 3M™ Quik Temp | "performance characteristics of Protemp 3 Garant were compared to those of the respective predicate devices." "substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for performance characteristic comparisons. It also does not specify the provenance of the data (e.g., country of origin, retrospective or prospective). Given the nature of a 510(k) for a dental material, these tests are typically conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for material properties is established through standardized laboratory testing methods, not by expert consensus in the clinical sense.
4. Adjudication Method for the Test Set
This information is not applicable as the "test set" in this context refers to laboratory samples evaluated for material properties, not patient data requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or algorithms that involve human interpretation of medical cases. Protemp™ 3 Garant™ is a dental material, not a diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. Protemp™ 3 Garant™ is a material, not an algorithm.
7. The Type of Ground Truth Used
For biocompatibility, the "ground truth" is established by adherence to recognized standards like ISO 10993, which involves specific biological tests to assess safety (e.g., cytotoxicity, sensitization, irritation).
For effectiveness and performance characteristics (e.g., mechanical properties, handling), the "ground truth" is established through comparative testing against established predicate devices using validated laboratory methods (e.g., measuring tensile strength, flexural modulus, working time, setting time). The document implies that the "effectiveness" was proven by demonstrating comparable performance to the predicate devices.
8. The Sample Size for the Training Set
This information is not applicable. Protemp™ 3 Garant™ is a material and its development does not involve training a machine learning algorithm, hence there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as point 8.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.