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The Life Essence Universal Porcelain System is a dental porcelain material to be used in conjunction with metal, zirconia, or pressable ceramic framework in the construction of crowns and/or bridgework and veneers.

Life Essence Universal Porcelain is dental porcelain used by dental technicians to create crowns, bridges, and veneers. It consists of three categories: low fusing, and zirconia porcelain. The application, indication, and performance is the same for all three categories; therefore, it is a porcelain system. It includes Pressable Ingots, Opaque Pastes, Opaque Powders, Opacious Dentins, Dentins, Incisal Powders, Stains, Incisal Transluscents, Dentin Modifiers, Correction Powder, Glaze Powder, Glaze Liquid, Spray Glaze, Modeling Liquid, and Opaque Liquid. The dental technician will use various components of the system to create the specific, desired dental prosthetic, for the sole use of individual dental patients. It is for prescription use only.

The provided document is a 510(k) summary for the Life Essence Universal Porcelain System, a dental porcelain material. It describes the device, its indications for use, and compares it to a predicate device (Luminesse Porcelain K140848).

However, this document does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or any details related to device performance metrics typically associated with AI/software devices.

The product described is a physical dental material (porcelain powder) and the 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on material properties and intended use. The "study" mentioned is "Bench testing (according to ISO 6872:2008 Dentistry-Ceramic Materials) to determine flexural strength, solubility and glass transition temperature." This is a standard materials science test, not a clinical trial or an AI performance study.

Therefore, I cannot provide the requested information for the following reasons:

1. No Acceptance Criteria Table: The document does not define explicit acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or statistical thresholds. The "acceptance" here refers to FDA's determination of substantial equivalence, not a pre-defined performance target for an AI/software device.
2. No Device Performance Metrics: The document lists "flexural strength, solubility and glass transition temperature" as evaluated parameters, but it does not report specific numerical values for these properties for the Life Essence Universal Porcelain System or a comparison against the predicate device. It only states that the average coefficient of thermal expansion has been adjusted to allow fusion to base materials.
3. Irrelevant AI/Software-related Information: The document is for a physical dental material, not an AI/software-based medical device. Therefore, questions about:
   • Sample size for test set and data provenance
   • Number of experts for ground truth and qualifications
   • Adjudication method
   • Multi-reader multi-case (MRMC) comparative effectiveness study
   • Standalone algorithm performance
   • Type of ground truth (beyond material standards)
   • Sample size for training set
   • How ground truth for training set was established
     are not applicable to this document or the described device.

The "study" that proves the device meets "acceptance criteria" (in the context of this 510(k)) is the bench testing according to ISO 6872:2008, which aims to show that the material's properties are suitable for its intended dental use and are comparable to legally marketed similar devices. The conclusion broadly states that the device is "substantially equivalent" based on technological characteristics, chemical composition, and manufacturing process.

Summary of what is available:

• Device Type: Physical dental porcelain material.
• "Study": Bench testing according to ISO 6872:2008 Dentistry-Ceramic Materials.
• Parameters Tested: Flexural strength, solubility, and glass transition temperature.
• Conclusion: The device is substantially equivalent to the predicate device (Luminesse Porcelain K140848) in terms of indications for use, chemical composition, manufacturing, and technological characteristics.

To reiterate, the original request's framework (acceptance criteria table, sample sizes, expert ground truth, MRMC, standalone performance) is designed for AI/software medical devices, which is not what the Life Essence Universal Porcelain System is.

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