(169 days)
This device is indicated for:
- Fabricating copings and frameworks for inlays, onlays, veneers, crowns and anterior bridge . restorations
3M™ TR System is a ceramic material. It is intended to be used by dental laboratories and dentists (with chair side dental milling units) to create specific restorations.
Here's an analysis of the acceptance criteria and supporting studies for the 3M™ TR System based on the provided text:
Important Note: The provided 510(k) summary focuses on demonstrating substantial equivalence for a dental material (3M™ TR System) to predicate devices. It primarily relies on bench testing of material properties rather than clinical studies with human subjects to evaluate diagnostic or prognostic performance. Therefore, many of the requested categories related to human-in-the-loop performance, ground truth establishment for diagnostic accuracy, and expert consensus are not applicable or not detailed in this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Properties: Comparing key physical and mechanical properties to predicate devices. | Similar Technological Characteristics: Validated by comparing results of published laboratory data and 3M generated bench data. |
| Compressive Strength: Performance compared to predicate devices. | Test results were obtained and compared. (Specific values not provided in the summary, but implied to be comparable or better than predicates). |
| Fracture Toughness: Performance compared to predicate devices. | Test results were obtained and compared. (Specific values not provided in the summary, but implied to be comparable or better than predicates). |
| Flexural Strength: Performance compared to predicate devices. | Test results were obtained and compared. (Specific values not provided in the summary, but implied to be comparable or better than predicates). |
| Safety and Effectiveness: Demonstrating the material is safe and effective for its intended use. | Based on conclusions from safety information, past history of use, bench testing results, and published literature, the 3M™ TR System is stated to be safe, effective, and performs as well or better than predicate devices. |
| Intended Use Equivalence: Ability to be used for fabricating copings and frameworks for inlay, onlay, veneer, crown, and anterior bridge restorations. | The device is indicated for these uses, aligning with the predicates. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The submission refers to "bench data" and "published laboratory data." For material property testing, it would involve multiple samples of the material for each test (e.g., several specimens for compressive strength, fracture toughness, and flexural strength).
- Data Provenance: The data provenance is primarily from "3M generated bench data" and "published laboratory data." This indicates laboratory settings. The country of origin is implicitly the US, where 3M is based, and where the testing would have occurred. It is retrospective in the sense that the data was collected prior to submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable (N/A): For a dental material's physical property testing, the 'ground truth' is established by standardized laboratory testing methods and measurements, not by human expert interpretation or consensus. There are no "experts" establishing a diagnostic ground truth in this context.
4. Adjudication Method for the Test Set
- Not Applicable (N/A): As per the above, this is not a study requiring human adjudication for diagnostic outcomes. The "adjudication" in material science typically refers to the adherence to established ASTM or ISO standards for testing and interpretation of results by qualified laboratory personnel.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, N/A: This submission is for a dental material, not a diagnostic or AI-powered imaging device that would typically undergo MRMC studies comparing human readers with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No, N/A: This is a physical material, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.
7. The Type of Ground Truth Used
- Laboratory Measurements and Standards: The "ground truth" for this device's performance is derived from quantitative measurements of its physical and mechanical properties (compressive strength, fracture toughness, flexural strength) obtained through standardized laboratory testing protocols (e.g., ISO, ASTM standards relevant to dental materials). This is compared against similar measurements for predicate devices.
8. The Sample Size for the Training Set
- Not Applicable (N/A): This is a material, not a machine learning algorithm. There is no "training set" in the context of AI. The device's formulation and manufacturing processes are developed and refined through R&D, but this isn't a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable (N/A): As there is no training set for an AI algorithm, this question is not relevant. The material properties are inherent to its composition and structure, and these are validated through scientific experimentation and testing, not by establishing a ground truth for a training dataset.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.