(20 days)
The CARRARA INTERACTION CERAMIC SYSTEM is indicated for veneering of metal-ceramic or full ceramic restorative systems.
The CARRARA INTERACTION CERAMIC SYSTEM is a dental porcelain system used for the preparation of fixed prosthodontic devices. The CARRARA INTERACTION CERAMIC SYSTEM consists of Paste Opaque, Dentine, Enamel, Margin, and Glaze porcelains.
The provided text describes a 510(k) summary for the "CARRARA INTERACTION CERAMIC SYSTEM," a dental porcelain system. However, it does not contain specific information about acceptance criteria or a study proving the device meets those criteria, as typically found in reports detailing performance data, statistical analysis, or clinical trials for medical devices with measurable outputs.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices, the intended use, and the technological characteristics, highlighting that the components have been previously marketed and that the product itself has been on the European market.
Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document.
Here's an attempt to answer based on the absence of information in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
Explanation: The document does not provide any specific quantitative acceptance criteria (e.g., strength, wear resistance, color stability) or reported performance metrics against such criteria. The submission relies on the concept of "substantial equivalence" to predicate devices and historical market use.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable/Not specified. The document does not describe a "test set" of data or a specific study with a defined sample size for performance evaluation.
- Data Provenance: The document mentions that the system has been on the European market since 2002 with "over 1 million units placed." This implies historical market data and experience, but not a controlled "test set" for a specific study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable/Not specified.
- Qualifications of Experts: Not applicable/Not specified.
Explanation: Since no specific test set or study is described, there's no mention of experts establishing a ground truth.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable/Not specified.
Explanation: No test set is described, so no adjudication method is relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done or at least not described in this document.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a dental material (porcelain system), not a software algorithm or an AI device.
7. The Type of Ground Truth Used:
- The concept of "ground truth" as typically used for diagnostic devices (e.g., pathology, outcomes data) is not applicable here. The device is a dental material for restorative systems. Its "ground truth" would be related to its physical, chemical, and biological properties, as well as its clinical performance over time, which are inferred through comparison to predicate devices and historical use, rather than a specific "ground truth" dataset for performance evaluation.
8. The Sample Size for the Training Set:
- Not applicable/Not specified. As this is a dental material, not a machine learning model, the concept of a "training set" is not relevant.
9. How the Ground Truth for the Training Set was Established:
- Not applicable/Not specified. The concept of a "training set" and its "ground truth" is not relevant to this type of device.
Summary of what can be inferred from the document:
The submission relies heavily on:
- Substantial equivalence: The "CARRARA INTERACTION CERAMIC SYSTEM" is described as "very similar in formulation to legally marketed dental ceramics" and produced from the same frits as predicate devices (Elephant's Carrara K981000 and Antagon K982129 Ceramics).
- Prior market history/experience: The device has been on the "European market since 2002 with over 1 million units placed."
- Prior use of components: "All of the components found in the CARRARA INTERACTION CERAMIC SYSTEM have been used in legally marketed devices."
The document states: "We believe that the prior use of the components of the CARRARA INTERACTION CERAMIC SYSTEM in legally marketed devices, the performance data provided, and the historical use of the device in Europe support the safety and effectiveness of the CARRARA INTERACTION CERAMIC SYSTEM for the intended use." This suggests that "performance data provided" refers to the formulation similarity and the successful market use rather than explicit, detailed, quantitative studies with defined acceptance criteria.
§ 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.