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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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Amber Mill Series are indicated for fabricating glass ceramic restorations such as single-unit anterior and posterior crowns, veneers, inlays/onlays, and anterior 3-unit bridges using CAD/CAM System.

Amber Press Series are indicated for fabricating glass ceramic restorations such as single-unit anterior and posterior crowns, veneers, inlays/onlays, and anterior 3-unit bridges using hot press technique.

Amber Mill Series and Amber Press Series are a lithium silicate ceramic to be supplied in the form of Ingots & Blocks. Amber Mill can be fabricated using CAD/CAM technologies and Amber Press can be fabricated using hot press technique.

This dental material is glass type material used for aesthetic purposes of veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns. The ceramics material is composed of SiO2, Li20, K20, P205, Al2O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface.

The subject device offers 31 different size/shape series and each series offers 45 different shades. 31 different sizes are to be used with various equipments for CAD/CAM milling or hot press and to meet the needs of patients' various tooth shapes. 45 different shades are offered to meet the needs of different patients tooth colors.

Here's a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for each of the non-clinical tests or the data provenance (e.g., country of origin, retrospective/prospective). The tests listed are primarily bench tests on the material itself, not clinical studies involving human subjects or real-world data collection. The tests seem to be conducted in a laboratory setting as part of the material characterization.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The tests performed are objective, quantitative material property tests according to international standards (ISO). Ground truth in this context is established by the specified standards and measured values, not by expert consensus or interpretation of images/cases.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, the tests are objective material property measurements against defined standards. There is no need for an adjudication method for interpreting results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This device is a dental material, not an AI-assisted diagnostic or imaging device used by human readers for interpretation.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a dental material. The performance tests are specific to the physical, chemical, and biological properties of the material itself.

7. Type of Ground Truth Used:

The ground truth used for these tests is based on the objective requirements and criteria specified in international standards (ISO 6872, ISO 10993-3, ISO 10993-5, ISO 10993-10, ISO 10993-11) and internal bench testing requirements. This is essentially definitive physical/chemical/biological measurement standards.

8. Sample Size for the Training Set:

Not applicable. This is a material, not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set for this device.

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MonoBloc BM Series is indicated for use as a dental restoration including inlays, onlays, veneers, and crowns.

MonoBloc BM Series is glass type material used for aesthetic purposes of inlays, onlays, veneers and crowns. This looks like a block form and corresponds to ISO 6872 Type 2 Class 1. It can be fabricated using dental CAD/CAM devices such as CERECTM inLab and CERECTM MCXL.

The provided text describes the submission of a 510(k) for the "MonoBloc BM Series", a dental frame material. This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through showing that its physical characteristics meet established international standards.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the tests. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The "ground truth" for this device appears to be the specified ISO standards, rather than expert consensus on clinical cases.

4. Adjudication method for the test set

This information is not provided. Given that the evaluation is against ISO standards for physical characteristics, a traditional adjudication method for clinical data is not applicable here.

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

An MRMC comparative effectiveness study was not conducted. This device is a material for dental prostheses, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of human reader improvement with or without AI assistance is not relevant.

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

This is not applicable. The device is a material, not an algorithm.

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

The ground truth used for evaluating the MonoBloc BM Series is the criteria set by international standards (ISO 6872 and ISO 9693) for dental materials.

8. The sample size for the training set

This information is not applicable. The device is a material, not a machine learning algorithm that requires a "training set."

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

This information is not applicable as there is no training set for this type of device.

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HASS Zirtooth is indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crown, bridges, inlays, and onlays.

HASS Zirtooth is a zirconia porcelain product to be used to make the core of the all porcelain crown. It consists of ceramic blocks and corresponds to ISO 6872 Type 2 Class 1. This ceramic product provides the supporting structure for mounting the ceramic restoration. The shelf life of the ceramic block is semi-permanent.

The provided text describes a 510(k) submission for a dental device, "HASS Zirtooth," and focuses on its substantial equivalence to a predicate device based on physical characteristics. However, it does not contain information about a clinical study involving human subjects or AI performance. The summary details engineering and materials testing, not a clinical trial with specific performance metrics like sensitivity, specificity, or reader improvement.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot, based on your request:

Acceptance Criteria and Study Details for HASS Zirtooth (HASS Corp.)

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

Note: The document states: "The following properties were tested for the device according to ISO 6872 and 9693 and all the results met the test criteria." It lists some of the properties under each standard (e.g., Uniformity, Extraneous Materials, Chemical Solubility, Flexural Strength, Radioactivity of dental ceramic, Flexural strength after the low-temperature deterioration for ISO 6872; Coefficient of thermal expansion and Bonding strength with veneer ceramic for ISO 9693). Specific numerical thresholds for acceptance criteria and the exact numerical performance values are not provided in this summary.

2. Sample size used for the test set and the data provenance

• Sample Size for test set: Not specified. The study was a materials engineering test, not a clinical study on a patient population.
• Data Provenance: Not applicable in the context of clinical data. It's an in-vitro materials test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This question is not applicable as the study was based on material property testing according to established ISO standards, not expert clinical assessment for ground truth.

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

• Not applicable. This relates to clinical interpretation and adjudication, which was not part of this materials standard testing.

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

• No, an MRMC comparative effectiveness study was not done. This submission is for a dental material, not an AI-powered diagnostic device.

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

• Not applicable. This device is a ceramic material, not an algorithm.

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

• The "ground truth" for this device's performance was adherence to material property specifications defined by ISO 6872 and ISO 9693 standards.

8. The sample size for the training set

• Not applicable. There was no "training set" as this is a physical material, not a machine learning model.

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

• Not applicable. There was no "training set" or corresponding ground truth establishment in the context of machine learning.

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