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HygePLUS Alginate Impression Material is irreversible hydrocolloids for dental Impressions used by the dentist to take the anatomical data of the patient's mouth. The device is Intended to provide models for study and for production of restorative prosthetic devices, such as gold Inlays and dentures.

HygePLUS Alginate Impression Material is a alginate impression material for general dental practice and for orthodontics. It is presented in the form of a homogeneous yellow powder with spearmint flavour.

The provided text describes a 510(k) premarket notification for an alginate impression material, not an AI-powered device. Therefore, much of the requested information regarding AI models, such as sample sizes for training and test sets, multi-reader multi-case studies, and ground truth establishment methods for AI, is not applicable.

However, I can provide information based on the performance testing conducted for this device, which focuses on physical properties compared against an established standard.

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 exact sample sizes used for testing each physical parameter. The testing was conducted internally by the manufacturer (Hygedent Inc.) to validate and verify that the proposed device met design specifications. The data provenance is from the manufacturer's performance testing.

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

This information is not applicable as the "ground truth" for this device is based on performance against established industry standards (ADA Spec No.18), not on expert consensus of medical images or patient outcomes.

4. Adjudication method for the test set:

Not applicable. The performance was measured objectively against quantitative standards.

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:

Not applicable. This is not an AI-powered device.

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

Not applicable. This is not an AI-powered device.

7. The type of ground truth used:

The ground truth used for evaluating the device's performance was the ADA Spec No.18 recommendations for alginate impression materials. This constitutes established industry standards for physical properties.

8. The sample size for the training set:

Not applicable. This is not an AI-powered device and therefore does not have a training set in that context.

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

Not applicable. This is not an AI-powered device. The "ground truth" for the performance tests was established by industry standards (ADA Spec No.18).

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MARK3 is an irreversible hydrocolloid dental impression material used by the dentist for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression materials for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions.

MARK3 alginate impression material is a dust free alginate impression material with a creamy consistency for general dental practice and for orthodontics. It is presented in the form of a homogeneous pink colored powder with nice mint flavor. The material has exceptional good elastic properties and a high tear-resistance. The impression surface is smooth, which gives excellent gypsum compatibility

The provided document describes the MARK3 Alginate Impression Material (K141092) and its performance data. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated in the provided document. The document simply states "Performance Data" and lists "Complies" for each parameter without indicating the number of samples tested for each physical property.
• Data Provenance: Not explicitly stated. It is implied that the testing was conducted by Cavex Holland BV, given the nature of the submission. The origin (e.g., country) of the specific data is not mentioned, nor is a retrospective or prospective study design.

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

• This type of information is not applicable to this submission. The device is an impression material, and its performance criteria are based on physical properties defined by industry standards (ADA18 Requirements), not on expert interpretations of medical images or patient outcomes. Therefore, no experts were used to establish "ground truth" in the clinical sense for this type of device.

4. Adjudication method for the test set:

• This is not applicable as the evaluation is based on objective physical measurements against established standards, not on subjective interpretations requiring adjudication.

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. The device is an alginate impression material, a physical product, not an AI-assisted diagnostic or therapeutic tool. Therefore, no MRMC study or AI assistance evaluation was performed.

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

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

7. The type of ground truth used:

• The "ground truth" for evaluating the MARK3 Alginate Impression Material is based on pre-established physical and mechanical property requirements specified by the ADA18 standard. These are objective measurements rather than expert consensus on clinical findings or pathological outcomes.

8. The sample size for the training set:

• This is not applicable. This is a physical product, not a machine learning model, so there is no concept of a "training set" for model development.

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

• This is not applicable for the same reason as above.

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