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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)

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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.

Ask a specific question about this device