(42 days)
The OPC 3G All-Ceramic System, Core and Overlay Porcelains are intended for either hot pressing or CAD/CAM machining all-ceramic dental restorations. The OPC 3G All-Ceramic System, Core and Overlay Porcelains should be used with 3G All-Ceramic materials only and not intermixed with other manufacturers products/porcelains. The system is used for fabrication of dental restorations including inlays, onlays, veneers, single units, and anterior SUSE Underges up to the first premolar ...
The OPC 3G All-Ceramic System, Core and Overlay Porcelains comprise a lithium disilicate glassceramic core used for all-ceramic dental restorations. Subsequent layers of porcelain are applied over top to provide additional aesthetics and charactcrizations. This system offers high strength, low wear, the aesthetics of a metal-free system, and better thermal shock properties due to the lower thermal expansion of the materials used.
The dental restoration is prepared by a lost wax technique. The dental restorations are designed in a wax pattern and invested into refractory. The refractory is burned out to remove the wax and leave a cavity of the dental design. Pellets of 3G All-Ceramic are placed into the investment cavity and transferred to a hot pressing furnace where the investment/pellets are brought to a higher temperature. The temperature is maintained long enough for the glass-ceramic to become molten and then pressed into the cavity creating an exact duplicate of the original wax pattern.
In addition, dental restorations can be made by forming the material into pre made blocks of ceramics, which are milled to the coping/bridge shape by CAD/CAM cquipment.
The OPC 3G All-Ceramic System, Core and Overlay Porcelains will include Corc pcllcts, Corc Stains, Bodies, Incisals, Glazes, Investment, Investment Liquids, Acid Solutions (Shipped Separately), Acid Neutrilizers, Glaze Liquids, Disposable Plungers, Paper Rings, Plastic Scoops, MSDS and Instructions.
The provided text is a 510(k) summary for the Jeneric/Pentron OPC 3G All-Ceramic System. This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a formalized study with a test set, ground truth, and expert adjudication.
Therefore, the requested information cannot be fully extracted as such a study is not described.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not present in the provided 510(k) summary. The document does not describe specific acceptance criteria (e.g., minimum strength, maximum wear) or present a table of the device's measured performance against such criteria. Instead, it relies on the similarity of composition and function to predicate devices to establish substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not applicable/not provided. The document does not describe a performance study with a distinct "test set" in the context of clinical or in vitro performance evaluation against acceptance criteria. There's no mention of a sample size or data provenance for such a test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not applicable/not provided. As no specific performance study with a test set and ground truth is described, there's no mention of experts involved in establishing ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable/not provided. Without a described performance study and ground truth establishment, there's no adjudication method mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
This information is not applicable/not provided. MRMC studies are typically done for diagnostic devices where human readers interpret images or data. The OPC 3G All-Ceramic System is a dental material, not a diagnostic device, and thus an MRMC study is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/not provided. The device is a dental material, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.
7. The Type of Ground Truth Used:
This information is not applicable/not provided. Since no performance study against acceptance criteria is explicitly detailed, the type of ground truth used is not mentioned. The approval is based on "substantial equivalence" to predicate devices, implying that the established performance and safety of the predicate devices serve as the "ground truth" for comparison.
8. The Sample Size for the Training Set:
This information is not applicable/not provided. As the submission is for a dental material based on substantial equivalence, there is no "training set" in the context of machine learning or AI algorithm development described.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable/not provided. As there is no training set described, the method for establishing its ground truth is also not mentioned.
Summary of the 510(k) Submission's Approach:
The Jeneric/Pentron 510(k) submission for the OPC 3G All-Ceramic System relies entirely on the concept of substantial equivalence to predicate devices (Finesse All-Ceramic Core, K971869, and Empress2 Core, K982616, and their corresponding overlay porcelains).
The core argument for equivalence is:
- Similar Composition: The compositions for 3G All-Ceramic Core are similar to the predicate devices.
- Similar Function: The device functions similarly to the predicate devices.
- Intended Use: The intended use (all-ceramic dental restorations including inlays, onlays, veneers, single units, and anterior bridges) is consistent with devices already on the market.
- Performance Characteristics: The description highlights desired characteristics like "high strength, low wear, the aesthetics of a metal-free system, and better thermal shock properties due to the lower thermal expansion." However, these are presented as inherent properties and benefits, not as measured results against specific acceptance criteria for a new clinical study.
The FDA's letter explicitly states that the device is deemed "substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified." This means a formal clinical trial or a performance study with defined acceptance criteria and expert adjudication against a ground truth dataset, as described in your prompt, was not the primary method used for this specific 510(k) clearance.
§ 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.