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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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The Straumann n!ce Glass Ceramic A14 Blocks are intended to be ceramic mesostructures cemented to the Ti-base for a two-piece hybrid abutment for single tooth restorations or hybrid abutment crowns, used in conjunction with endosseous dental implant to restore chewing function. The following compatibilities apply:

Straumann® n!ce® glass ceramic is a proprietary lithium disilicate (Li2O-SiO2) dental glass ceramic material. The n!ce® glass-ceramic A14 blocks feature a pre milled interface that fits the Straumann® Variobase® for CEREC®. The blocks are further processed by the trained professional to make individually designed mesostructure that are milled into the desired shape of a hybrid abutment or hybrid abutment crown using the Sirona inLab (Version3.65) and CEREC® software (Version 4.2). n!ce® mesostructures can be additional crystallization firing. Stain & glaze techniques can be applied.

n!ce® A14 blocks are available in two levels of translucency: HT (High Translucency) and LT (Low Translucency). Both translucencies are available in shades , A1, A2, A3, B2, B4 and C2 for flexibility and application variety to meet individual patient needs. n!ce®A14 blocks are available with one interface size large (L)

The provided text describes the submission for a 510(k) premarket notification for the "Straumann® n!ce Glass Ceramic A14 Blocks," a dental device. It focuses on demonstrating substantial equivalence to a predicate device, rather than outlining acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device.

Therefore, many of the requested items (Acceptance Criteria Table, Sample Size for Test Set, Data Provenance, Number of Experts, Adjudication method, MRMC study, Standalone performance, Training set size, Training set GT establishment) are not applicable to this type of regulatory submission, as it is for a physical dental material block, not an AI/ML algorithm.

However, I can extract the "Performance Data" section which describes the types of tests conducted to support the device's safety and effectiveness and its substantial equivalence.

Here's the information that can be extracted from the document, focusing on what is relevant to "acceptance criteria" and "study."

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" paired with "reported device performance" in the way one might expect for an AI/ML device (e.g., sensitivity, specificity thresholds). Instead, it lists the types of performance tests that were conducted and implied their results supported substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to various standards and guidances but does not detail the specific sample sizes or the provenance of the data for each test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the document describes a physical dental material, not an AI/ML device requiring expert-established ground truth for a diagnostic task.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the document describes a physical dental material.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the document describes a physical dental material.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable as the document describes a physical dental material.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This is not applicable in the context of an AI/ML diagnostic device. For the dental material, "ground truth" would relate to its physical, chemical, and mechanical properties as defined by relevant ISO and ASTM standards and confirmed through laboratory testing.

8. The sample size for the training set

This is not applicable as the document describes a physical dental material, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable as the document describes a physical dental material.

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The Straumann® Variobase® Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® Abutments are indicated for screwretained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

The purpose of the subject submission is to add the previously cleared Straumann n!ce glass ceramic material (K160262) as a cleared material suitable for fabrication of the coping or crown that, when bonded to the previously cleared Variobase abutment base (K142890), forms a finished dental prosthesis. The Straumann Variobase Abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases". Straumann Variobase Abutments are available to fit Straumann dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit), and RC (Regular CrossFit). A dental laboratory technician would design the corresponding coping and/or crown (the second component of the Variobase two-piece abutment) and/or prosthetic restoration in the dental laboratory via their preferred workflow. The coping and/or crown would be manufactured via traditional laboratory methods for pressing or casting, or via validated Straumann milling.

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