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Fixtemp® C&B is a resin based material used to fabricate temporary crowns and bridges.

Fixtemp® C&B is a two-component automatically mixable composite on the basis of multifunctional (meth)acrylates provided in standard double cartridges. The material is dispensed and mixed by cartridge/mixing tip combination and it is used for the manufacturing of temporary crowns and bridges for use until the permanent restoration is fabricated. It can be also used for inlays, onlays and veneers and is available in tooth-colors A1, A2, A3, A3.5, B1, Bleach X and D2. This is a prescription only material. The labeling and working instructions are designed for health care professionals.

Acceptance Criteria and Device Performance for Fixtemp® C&B

The Fixtemp® C&B device is a resin-based material used to fabricate temporary crowns and bridges. Its performance was evaluated against a set of non-clinical criteria to establish substantial equivalence to a predicate device.

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 specific sample sizes used for each individual test (e.g., number of specimens for compressive strength). It generally refers to "a series of in-house tests" and adherence to specific ISO standards (e.g., DIN EN ISO 4049:2010).

For the cytotoxicity testing, the test was conducted by the independent laboratory Toxikon Europe. The provenance of the data is indicated as "Toxikon Europe Final GLP Report: 17-01389-G1". The country of origin for the manufacturing company (Dreve Dentamid GmbH) is Germany. It is implied that these are prospective tests performed on the Fixtemp® C&B material.

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

This information is not provided in the document. The performance evaluation relies on standardized tests (e.g., ISO standards) and laboratory findings rather than expert consensus on a test set in the typical sense of diagnostic imaging or clinical studies. The cytotoxicity test was conducted by an "independent laboratory," but the qualifications of the individuals establishing the ground truth (i.e., interpreting the cytotoxicity results) are not detailed.

4. Adjudication Method for the Test Set

Not applicable. The reported tests are objective measurements based on standardized procedures and laboratory analysis, not subjective interpretations requiring adjudication by multiple experts.

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

No MRMC comparative effectiveness study was done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data. Fixtemp® C&B is a material for fabricating dental prosthetics, and its performance is evaluated through material properties and biocompatibility, not reader interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. Fixtemp® C&B is a dental material, not an algorithm or software. Its performance is inherent to its physical and chemical properties.

7. The Type of Ground Truth Used

The ground truth for the performance tests consists of:

• Standardized measurement directly from testing: This applies to properties like working time, curing time, setting time, hardness, compressive strength, flexural strength, E-modulus, water absorption, and radiopacity, where the "ground truth" is a measured physical or chemical property that meets or exceeds a predefined numerical threshold from an established standard (e.g., DIN EN ISO 4049:2010).
• Laboratory findings: For cytotoxicity, the ground truth is established by the results of the ISO 10993-5 test conducted by an independent laboratory, indicating the absence of biological reactivity.
• Evaluations and assessments: For carcinogenic, mutagenic, and irritating/sensitizing potentials, the ground truth is based on "different evaluations and assessments" indicating no evidence of these effects within the specified time frame. While the specifics of these evaluations are not detailed, they likely rely on established toxicological principles and potentially other in-vitro or in-vivo studies not explicitly listed.

8. The Sample Size for the Training Set

Not applicable. Fixtemp® C&B is a physical material, not an AI model or software that requires a training set.

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

Not applicable, as there is no training set for this device.

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FixTemp C&B ™ is a chemically catalyzed, highly filled, resin based restorative material used to fabricate temporary crowns and bridges.
The intended use of the FixTemp C&B "" is to form short and long term dental provisional prosthetics.

The FixTemp C&B *** is a Class II (nonexempt) device that is ideal suited as a dental acrylic to fabricate temporary crown and bridges.
FixTemp C&B "" provisional material is a two component, catalyst and base, material dispensed and mixed by a industry standard cartridge/static mixing tip combination. FixTemp C&B "" is intended for . use in both short and long term crown and bridge temporaries. The material is compatible with light cured composites for repair and characterization. FixTemp C&B "" contains methacrylate components and is radiopaque for easy radiographic identification.
The scientific concept on which this device is based is the principle that ethoxylated Bis-GMA is a multifunctional acrylates and inorganic fillers as silinated barium glass and silinated silicic acid to form a suitable structure for a short and long term crown and bridge temporaries. This device functions by providing a dental material to short and long term dental provisional prosthetics.

The provided text is a 510(k) summary for a dental device called "FixTemp C&B". This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against acceptance criteria for a new AI/software device.

Therefore, many of the requested elements for an AI/software device are not applicable to this submission. This is a traditional medical device submission, not a software as a medical device (SaMD) submission.

Here's a breakdown of the requested information based on the provided text, highlighting what is not applicable:

Acceptance Criteria and Device Performance for FixTemp C&B

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text. For biocompatibility tests, sample sizes are typically standardized by the test methods (e.g., number of cell cultures, animals) but specific numbers are not given here.
• Data Provenance: Not explicitly stated but implied to be from laboratory bench testing. No mention of country of origin or whether clinical (retrospective/prospective) data was used, as this is a material science device, not a data-driven AI device.

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

• Not Applicable. This is a material testing submission. "Ground truth" in the context of expert consensus is relevant for diagnostic AI systems, not for biocompatibility testing of dental materials. Biocompatibility results are based on objective laboratory measurements and biological responses defined by standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations in diagnostic studies, particularly in AI performance validation. This is not relevant to chemical and biological material testing.

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

• Not Applicable. An MRMC study is designed to evaluate human reader performance, often with and without AI assistance, in interpreting medical images or data. This is irrelevant for a dental material (Crown & Bridge Temporary resin).

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not Applicable. There is no algorithm or software component described that would require a standalone performance study.

7. Type of Ground Truth Used

• Laboratory Test Results / Standardized Biological Responses: The "ground truth" for the device's performance is established by the results of standardized biological and chemical tests (e.g., cytotoxicity assays, sensitization tests, genotoxicity assays) performed according to international standards (e.g., ISO 10993 parts, ASTM F720-81). These tests provide objective measures of the material's interaction with biological systems.

8. Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is a medical device clearance based on material properties and substantial equivalence, not a machine learning model.

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

• Not Applicable. See point 8.

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