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Once finalized into a suitable design, the Amber Mill O Series and Amber Mill Direct Series are indicated for use as inlays, onlays, veneer, partial crowns and crowns.

Amber Mill Q Series and Amber Mill Direct Series are a lithium disilicate ceramic to be supplied in the form of Blocks. Amber Mill O Series & Amber Mill Direct Series can be fabricated using CAD/CAM technologies. The subject devices are intended to be milled to produce prosthetic restorations for natural and endosseous dental implant abutment borne teeth. The subject devices are glass type material used for aesthetic purposes of veneers, inlays, onlays, single-unit anterior and posterior crowns. The ceramics material is composed of SiO2, Li2O, K2O, P2O5, A12O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface. The subject device offers 18 different size/shape series and each series offers 45 different shades. 18 different sizes are to be used with various equipment for CAD/CAM milling and to meet the needs of patients' various tooth shapes. 45 different shades are offered to meet the needs of different patient's tooth colors. The subject devices don't need sintering since they are provided fully crystallized. The only difference between Amber Mill Q Series and Amber Mill Direct Series is that the Amber Mill Q series has a hole in the center combined with a zirconia cap. The holes in Amber Mill Q are sizes compatible with abutment, through which are bonded to abutment to be connected to the implant.

The provided document is a 510(k) summary for the Amber Mill Q Series & Amber Mill Direct Series, which are dental ceramic materials. The document focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against acceptance criteria for an AI/CADe system or a clinical diagnostic device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details for a test set, expert involvement, MRMC studies, standalone performance, or training set details for an AI/CADe device.

The document primarily addresses the physical, chemical, and biological properties of the dental ceramic and compares them to an existing ceramic product. The "tests" mentioned are for material properties (e.g., flexural strength, chemical solubility, biocompatibility), typical for materials science, not for diagnostic performance in the context of an AI algorithm.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

• No Acceptance Criteria for AI/CADe: The document does not define acceptance criteria such as sensitivity, specificity, AUC, or other metrics common for AI performance evaluation.
• No Reported Device Performance for AI/CADe: There are no performance metrics like those for an AI system. The performance reported is for material properties (e.g., flexural strength > 300MPa) for the dental ceramic, not an AI algorithm.
• No Test Set/Data Provenance for AI: There is no mention of a test set of images or patient data, nor its size, origin (country), or whether it was retrospective or prospective.
• No Experts/Ground Truth for AI: The document does not discuss experts establishing ground truth for diagnostic purposes because it's a material, not a diagnostic AI. Ground truth, in this context, would be material property measurements, not clinical diagnoses.
• No Adjudication Method: Adjudication is irrelevant for material property testing.
• No MRMC Comparative Effectiveness Study: This type of study is for evaluating human performance with and without AI assistance, which is not applicable here.
• No Standalone AI Performance: The device itself is a ceramic material, not a software algorithm, so "standalone performance" doesn't apply in the AI sense.
• Type of Ground Truth: The "ground truth" for this device would be direct measurements of its material properties according to ISO standards, not expert consensus or pathology on clinical images.
• No Training Set for AI: There's no training set mentioned because the device is not an AI algorithm that learns from data.
• No Ground Truth Establishment for Training Set: Again, not applicable as it's not an AI device.

In summary, the provided text describes a medical device clearance for a dental ceramic material (Amber Mill Q Series & Amber Mill Direct Series) and demonstrates its substantial equivalence to an already marketed predicate device based on material properties and intended use. It does not contain information related to the acceptance criteria or study details for an artificial intelligence (AI) or computer-aided detection (CADe) device.

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