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AMBARINO® High-Class is indicated for fabrication of inlays / onlays, laminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental professionals and manufacturers using a dental CAD/CAM system.

The AMBARINO® High-Class CAD/CAM formed materials consist of interpenetrating networks of glass ceramic and polymer material to form a solid block of material. The unique marriage of the two materials creates a dual-network hybrid, which lends the positive physical properties of each individual material to the other. This results in a material with significantly lower brittleness compared to a pure ceramic and better abrasion than a pure resin (similar to natural enamel). This non-sterile material is milled in a dental CAD/CAM machine into restorative form for single patient use.

The provided document is an FDA 510(k) clearance letter for a dental material, "AMBARINO® High-Class." It outlines the basis for demonstrating substantial equivalence to a predicate device, focusing on material composition, physical properties, and intended use. This type of document is about regulatory clearance of a medical device, not a study proving a device meets acceptance criteria for an AI or imaging diagnostic algorithm.

Therefore, the specific information requested in the prompt, such as:

• Acceptance criteria for an AI/diagnostic algorithm
• Device performance in terms of AI metrics (e.g., sensitivity, specificity, AUC)
• Sample sizes for test sets (in the context of image data)
• Data provenance (country of origin, retrospective/prospective)
• Number of experts for ground truth, their qualifications, and adjudication methods
• MRMC comparative effectiveness study details (human reader improvement with AI)
• Standalone AI performance
• Type of ground truth (pathology, outcomes data, etc.)
• Training set size and ground truth establishment for training set

are not present in this document.

The document details the following related to acceptance criteria and performance:

• Acceptance Criteria (in the context of material properties): The device (AMBARINO® High-Class) is expected to meet or exceed certain minimum test standards for physical properties and biocompatibility. These are largely defined by international standards (ISO 4049, ISO 7405, ISO 10993-1) and the performance of the predicate device (Shofu Block HC).
• Reported Device Performance:
  • Flexural Strength: AMBARINO® High-Class: 175 MPa (Predicate: 191 MPa). This is stated as "Similar."
  • Modulus of Elasticity: AMBARINO® High-Class: 9.9 GPa (Predicate: 9.6 GPa). This is stated as "Similar."
  • Compressive Strength: AMBARINO® High-Class: 490 MPa (Predicate: 472 MPa). This is stated as "Similar."
  • Biocompatibility: Conforms with ISO 10993-1.
  • General Performance: Conforms with ISO 4049.

The study proves the device meets (or is substantially equivalent to predicate performance, and thus acceptable) these criteria through non-clinical performance data including extensive testing in accordance with the aforementioned ISO standards and the company's own internal test protocols. The conclusion states that "all documented test results were substantially equivalent to the predicate device" and that the "subject device exceeded all minimum test standards."

In summary, this document describes the regulatory clearance of a dental material based on its physical and biological properties compared to a predicate, not the performance of an AI diagnostic device. Therefore, it does not contain the specific information requested about AI acceptance criteria and study methodologies.

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