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• Non-load bearing Class I and II restorations
• Deciduous teeth restorations
• Geriatric restorations
• Intermediate restorative and base material for Class I and II cavities using the sandwich technique
• Cervical (Class V) restorations
• Core build ups
• Temporary fillings
• Dentin replacement

Ceramir Restore QuikCap is a self-curing bioceramic restorative material of glass ionomer type. It is a hybrid between a glass ionomer cement and a ceramic cement based on calcium aluminate. The material is radiopaque.

Ceramir Restore QuikCap contains a ceramic powder and a liquid, separated in different compartments, in a plastic capsule.

The capsule is activated just before use, allowing the powder and liquid to blend in the capsule. The content is mixed by using a high-frequency oscillating or rotating capsule mixer.

A capsule applicator, "Ceramir Applicator 2", is needed to extrude the mixed material into the tooth cavity.

The applied cement is formed using conventional tooth filling techniques. After setting, the material is ready for finishing and dry polishing.

The cement is available in shade A2 and is designated opaque (Vita shade guide).

The provided document is an FDA 510(k) Premarket Notification for a dental cement called Ceramir® Restore QuikCap. It details the device's characteristics, intended use, indications for use, and a comparison to a predicate device (Riva Self Cure) to demonstrate substantial equivalence.

However, the document does not describe acceptance criteria or a study that proves a device meets acceptance criteria in the context of an AI/ML-based medical device performance study.

Instead, this document describes the regulatory process for demonstrating substantial equivalence for a dental cement. The 'performance data' presented are physical and chemical properties of the cement, compared against a predicate device and relevant ISO standards, to show that the new device is as safe and effective as existing legally marketed devices.

Therefore, I cannot provide the requested information, particularly points related to AI/ML device studies such as:

• Acceptance criteria for an AI/ML device
• Sample size for test sets, data provenance, and ground truth establishment (other than the general "conforms to ISO 9917-1" or "FDA guidance document 'Dental Cements - Premarket Notification'")
• Number/qualifications of experts for ground truth establishment
• Adjudication methods
• MRMC comparative effectiveness study
• Standalone algorithm performance
• Training set details

The "study" referenced in the document is a series of non-clinical performance tests and biological evaluations to show the dental cement's properties align with established standards and are comparable to its predicate.

Here's what can be extracted from the document related to "acceptance criteria" in the context of this dental cement, rephrased to fit the actual content:

The acceptance criteria for this dental cement are implicitly defined by the relevant ISO standards (e.g., ISO 9917-1:2007) and FDA guidance documents for dental cements. The "performance data" table effectively serves as a comparison against these standards and the predicate device to demonstrate "substantial equivalence," which is the regulatory goal for a 510(k) submission.

1. Table of "Acceptance Criteria" (Implicit from Comparison) and Reported Device Performance:

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

• Sample Size: Not explicitly stated in terms of number of samples for each test, but the document refers to conformance with ISO standards (e.g., ISO 9917-1), which would specify sample numbers for various tests.
• Data Provenance: The tests were conducted to evaluate a new dental cement for regulatory submission. The document doesn't specify country of origin for the testing data beyond the manufacturer being in Sweden. The tests are prospective in the sense that they were performed specifically for this 510(k) submission.

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

• Not applicable to this type of device (dental cement) or study. "Ground truth" here refers to established material properties measured via standardized laboratory tests, not expert interpretation of medical images.

4. Adjudication method for the test set:

• Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• Not applicable.

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

• Not applicable.

7. The type of ground truth used:

• Laboratory measurements according to established international standards (e.g., ISO 9917-1) and FDA guidance for dental cements. The "truth" is the measured physical and chemical properties of the material.

8. The sample size for the training set:

• Not applicable, as this is not an AI/ML device.

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

• Not applicable.

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Ceramir Crown & Bridge is intended for the permanent cementation of

• Metal and Porcelain Fused to Metal Crowns and Bridges .
• Gold inlays and onlays .
• Cast or prefabricated metal posts .
• Cast of prefabriodical metally provins and bridges suitable for conventional ● righ Strength og. zirconia, alumina, and lithium disilicate)

Not Found

This looks like an FDA 510(k) clearance letter for a dental cement. The provided text does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods. Therefore, I cannot generate the requested table and study details.

The document discusses:

• Device Name: Ceramir Crown & Bridge
• Regulation Number/Name: 21 CFR 872.3275(b) Dental Ceramic
• Product Codes: EMA
• Intended Use: Permanent cementation of various dental restorations (metal, PFM crowns/bridges, gold inlays/onlays, metal posts, high-strength ceramic crowns/bridges).
• Regulatory Clearance: 510(k) substantial equivalence determination.

To fulfill your request, I would need a document from Doxa Dental AB that details the specific performance studies conducted for Ceramir Crown & Bridge to demonstrate substantial equivalence, including the acceptance criteria and results.

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XeraCem is intended for the permanent cementation of

• Porcelain Fused to Metal Crowns and Bridges .
• Metal (gold etc.) crowns and bridges .
• Gold inlays and onlays .
• . Prefabricated metal and cast posts
• . Prefabricated metal provisional crowns
• . All-zirconia or all-alumina ceramic crowns and bridges

XeraCem is a hybrid between glass ionomer cement and ceramic cement based on calcium aluminate. It combines the advantages of glass ionomer cements with those of calcium aluminum based cements. XeraCem is a hand mixed cement and consists of a powder (XeraCem powder) and a liquid (XeraCem liquid).

Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state a sample size for a test set or the data provenance in terms of country of origin or whether a study was retrospective or prospective.

Instead, the submission relies on:

• Comparison to predicate devices: "Various physical and mechanical studies were conducted to compare XeraCem the predical realidas [sic]."
• Biocompatibility testing: "XeraCem has been evaluated and passed biocompatibility testing of cytotoxicity, genotoxicity, irritation, and sensitization."

These are general descriptions of tests, not specific clinical study outlines with sample sizes for a 'test set.'

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

The text does not mention the use of experts to establish ground truth for a test set. The evaluation focuses on physical/mechanical properties and biocompatibility.

4. Adjudication Method for the Test Set

The text does not describe an adjudication method as typically found in studies with human interpretation or subjective endpoints.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a dental cement, and its evaluation does not involve human readers interpreting images or data for diagnostic purposes that would necessitate an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This question is applicable to AI/algorithm-driven devices. XeraCem is a physical dental cement, not an algorithm, so the concept of "standalone performance" in this context does not apply.

7. The Type of Ground Truth Used

The ground truth for XeraCem's evaluation was primarily based on:

• Objective physical and mechanical properties: Comparison to established values or performance of predicate devices.
• Biocompatibility standards: Passing established tests for cytotoxicity, genotoxicity, irritation, and sensitization.
• Performance as intended: Functional performance observed as expected.

8. The Sample Size for the Training Set

The provided text does not mention a training set sample size. This is because XeraCem is a product of materials science and engineering, not a machine learning model that requires training data.

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

Since there is no "training set" in the context of this dental cement, the question of how ground truth was established for it is not applicable. The development and validation of the cement would follow materials science and engineering principles, with testing against established specifications and predicate devices.

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