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Accusil Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

Accusil Dental Impression Materials are designed for dental applications to define and reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal models and dental implant restorative devices. Base and catalyst components are mixed in an equal ratio 1:1, placed into an impression tray and inserted into the patient's mouth. The material will conform to the patient's dentition and when set will produce a reproduction of the patient's teeth and occlusion.

The document describes the acceptance criteria and performance of Accusil Dental Impression Materials as part of a 510(k) premarket notification for FDA clearance.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that Accusil Dental Impression Materials were tested against specific ISO standards (ISO 4823 and ISO 48-4) and internal protocols. The "Acceptance Criteria" are implicitly derived from the requirements of these standards. The "Reported Device Performance" for Accusil is provided in the comparative table with predicate and reference devices.

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The Dental Impression Material is intended for use with all crowns, bridges, and orthodontic impression techniques to reproduce the structure of a patient's teeth and gums.

The Dental Impression Material is a kind of addition-cure rubber impression material composed of vinyl polysiloxane and various fillers, with neutral smell and applicable to impression in dentistry.

The Dental Impression Material is very easy to mix and has good dimensional stability which helps to make precise impression taking.

The information provided describes the acceptance criteria and performance of the Dental Impression Material by Chemoment Materials Co.,ltd, as detailed in the 510(k) summary K221668.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

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

The document does not specify the exact sample size for each performance test. It states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications as same or similar to the predicate device." These tests were conducted according to ISO standards (ISO 10993-05, ISO 10993-10, and ISO 4823:2021). The data provenance is not explicitly mentioned but is implied to be from laboratory testing performed by or for Chemoment Materials Co.,ltd as part of their regulatory submission. The tests are non-clinical, meaning they don't involve human subjects, and are therefore not classified as retrospective or prospective human data.

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. The device's performance was evaluated against established engineering and material science standards (ISO standards), not against a ground truth established by medical experts for diagnostic purposes.

4. Adjudication method for the test set

This information is not applicable as the tests are objective measurements against established standards, not subjective assessments requiring expert 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

No such study was conducted. This device is a material (dental impression material), not an AI-powered diagnostic or assistive tool for human readers.

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

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

7. The type of ground truth used

The "ground truth" for the device's performance is defined by the objective pass/fail criteria set forth in the international standards ISO 4823:2021, and the biocompatibility standards ISO 10993-05:2009 and ISO 10993-10:2010. These standards provide specific measurable parameters for acceptable performance for dental impression materials.

8. The sample size for the training set

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

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The Dental Impression Material is intended for use with all crowns, bridges, and orthodontic impression techniques to reproduce the structure of a patient's teeth and gums.

The Dental Impression Material is a kind of addition-cure rubber impression material composed of vinyl polysiloxane and various fillers, with neutral smell and applicable to impression in dentistry. The Dental Impression Material is very easy to mix and has good dimensional stability, helps to make precise impression taking.

The provided document describes the acceptance criteria and a study for the Nanchang Dental Bright Technology Co., Ltd's Dental Impression Material.

1. Table of Acceptance Criteria and Reported Device Performance:

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Identic Alginate Dental Impression Materials are irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define the required interventions and/or check their effectiveness. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

KromaFaze Alginate Dental Impression Materials are irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define the required interventions and/or check their effectiveness. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Alginate impression materials are elastic, irreversible hydrocolloid impression materials made from seaweed. They are used to take primary or preliminary impressions of a patient's teeth and gums. Alginate impressions are taken to obtain diagnostic study models, which are the positive reproductions of the teeth and surrounding structures. Identic Alginate is cinnamon flavored and comes in three options - Regular Set, Fast Set, and Extra Fast Set. KromaFaze Alginate is mint flavored and comes in two options – Regular Set and Fast Set. KromaFaze Alginate has a color change feature that offers a visual guide for consistent impression making.

The provided text describes the 510(k) premarket notification for "Identic and KromaFaze Alginate Dental Impression Materials." This document focuses on demonstrating substantial equivalence to a predicate device (Kromopan Impression Material, K121824) rather than proving that an AI-driven device meets specific acceptance criteria through a study involving human readers or sophisticated ground truth establishment.

Therefore, many of the requested details about acceptance criteria, study design for AI, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set information are not applicable to this type of medical device submission.

This submission is for a dental impression material, which is a physical material, not an AI/software device. The "performance data" refers to the physical properties of the material itself.

However, I can extract the acceptance criteria and performance related to the physical properties of the dental impression material as presented in the document.

Here's a breakdown of the requested information based on the provided document:

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

The document uses the ISO 1563:1990 standard for Dental Elastic Impression Materials, Part 2 Alginate Dental Impression Material, as the basis for acceptance criteria for most physical properties. The "acceptance criteria" are implied by the standard's requirements, which the devices are stated to "Pass."

Notes:

• The term "Acceptance Criteria" is not explicitly defined with numerical thresholds in the table, but implied by compliance with ISO 1563 and the "Pass" status.
• "Unknown" for predicate indicates the specific data point for the predicate was not provided in the comparison table, but the predicate itself was cleared.
• "N/A" (Not Applicable) for certain flow, viscosity, and wettability properties indicates these properties do not apply to alginate impression materials.

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of impressions or tests performed) for each physical property test. It only states that "Non-clinical performance data included testing for..." various properties.
• Data Provenance: The document states that "Biocompatibility testing was performed at a third party laboratory." No country of origin is specified for the testing data. The data is non-clinical performance data, likely from laboratory testing rather than human subject studies (as indicated by "Clinical performance testing has not been performed"). Therefore, the terms retrospective or prospective do not apply in the context of clinical trial data.

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. This submission is for a physical dental material, not an AI or diagnostic imaging device that requires expert review for ground truth establishment. The "ground truth" for these tests are the objective measurements of the material's physical and chemical properties as defined by ISO standards.

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

• This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or for establishing consensus ground truth, typically in the context of diagnostic interpretations (e.g., by radiologists). The testing reported here is for the physical properties of a material, which are measured objectively.

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. This is not an AI-assisted diagnostic device, nor does it involve human readers interpreting cases.

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

• This is not applicable. This is not an algorithm or software device. It is a physical dental impression material.

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

• The "ground truth" for the non-clinical performance data (physical and chemical properties) is established by conformance to internationally recognized standards (ISO 1563:1990, ISO 10993 series) through validated laboratory test methods. There is no expert consensus on case interpretations, pathology, or outcomes data used for the "ground truth" of material properties.

8. The sample size for the training set

• This is not applicable. This device is a physical material, not an AI or machine learning model that requires a "training set."

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

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

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Fresh, Dental Impression Material is intended for use with all crowns, bridges, occlusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums.

The Fresh, Dental Impression Material is described as a Class II , impression material that is used to reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal and dental implant.

The provided document describes the "Fresh, Dental Impression Material" and its 510(k) premarket notification. However, it does not contain any information about acceptance criteria or a study proving the device meets specific performance criteria.

The document states:

• The device is a Class II material, regulated under 21 CFR part 872.3660, Product Code: ELW.
• It's designed to define and reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal, and dental implants.
• The material is based on the principle of mixing base and catalyst components to produce an accurate reproduction of the patient's dentition.
• The material is compared to a predicate device, K 052090, Splash Dental Impression Material, for substantial equivalence.
• It has benefited from design, development, testing, and production procedures certified to ISO 9001 and ISO 14385, and the EU Declaration of Conformity for Medical Products.
• It states that the material "is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy." However, no specific test results, acceptance criteria, or study details are provided to support this claim.

Therefore, I cannot provide the requested information because it is not present in the given text. The document is primarily a 510(k) summary and the FDA's clearance letter, focusing on substantial equivalence to a predicate device rather than detailed performance study results.

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Correct is used for all crown and bridge and implant impression techniques.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a dental impression material named "Correct Dental Impression Material." It does not contain any information about acceptance criteria, device performance, study details, ground truth, or sample sizes.

Therefore, I cannot fulfill your request using the provided input. The document is solely a regulatory clearance for a medical device and does not describe any specific studies or performance metrics.

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Rhodia hydrophilic dental impression materials are intended for use with PUTTY set for second impression (impression of correction) in the technique of double impression.

Rhodia hydrophilic dental impression material is intended for use for making intra-oral impressions. The device is a two-part vinyl polysiloxane paste with an addition-cure reaction. The base and catalyst pastes are extruded from dual-barrel cartridges through a mixing tip onto the surfaces of the teeth or onto a tray. The material quickly cures into a rigid impression. The hydrophilic property of the dental impression material helps to capture and reproduce perfect detail even in a moist environment.

This document is a 510(k) summary for the Rhodia Hydrophilic Dental Impression Material. It does not contain the detailed study information generally required to describe acceptance criteria and device performance in the way you're requesting for a medical device that claims diagnostic or prognostic capabilities based on specific performance metrics like accuracy, sensitivity, or specificity.

Dental impression materials are typically evaluated against physical and chemical properties and their ability to accurately replicate oral structures. The provided text indicates the device has been tested according to the criteria established in the Guidance Document, "Dental Impression Materials-Premarket Notification". However, it does not list specific acceptance criteria or report device performance data in terms of those criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details on sample sizes, ground truth establishment, expert involvement, or comparative effectiveness studies related to diagnostic accuracy, as this information is not present in the provided 510(k) summary.

The 510(k) process for this type of device primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device based on its intended use, technological characteristics, and safety and effectiveness, often through adherence to recognized standards for materials.

Based on the provided text, the following information can be extracted:

• Device Name: Rhodia Hydrophilic Dental Impression Material
• Intended Use: For making intra-oral impressions, specifically for "PUTTY set for second impression (impression of correction) in the technique of double impression."
• Device Type: Two-part vinyl polysiloxane paste with an addition-cure reaction.

The following information cannot be extracted from the provided text, as it's not relevant to this type of device's 510(k) submission or is simply not present:

• A table of acceptance criteria and reported device performance (in terms of specific quantitative metrics like accuracy, sensitivity, etc., which are not typically defined for impression materials in a 510k summary).
• Sample sizes used for a "test set" in the context of diagnostic accuracy.
• Data provenance.
• Number of experts used to establish ground truth.
• Qualifications of experts.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study information.
• Standalone (algorithm only) performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Summary of what can be gleaned about the study/testing:

The submission states: "Rhodia dental impression material is substantially equivalent to preamendment vinyl polysiloxane dental impression materials and has been tested according to the criteria established in the Guidance Document, "Dental Impression Materials-Premarket Notification"."

This indicates that testing was performed to demonstrate compliance with a recognized guidance document for dental impression materials. This testing would typically involve evaluating physical and chemical properties relevant to impression materials (e.g., tear strength, dimensional stability, working time, setting time, contact angle for hydrophilicity), rather than diagnostic accuracy. The specific results of these tests and the acceptance criteria are not detailed in this 510(k) summary.

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