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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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Fabrication of temporary crowns, bridges, inlays, onlays and veneers.
Fabrication of long-lasting temporary restorations. Lining material for prefabricated temporary crowns made of composite and metal.

TempXN28 is a temporary crown and bridge resin intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. Temporary crown and bridge resin is designated at 21 C.F.R § 872.3770 as a Class II device.
Like Protemp™ 3 Garant™, TempXN28 is available in the proven Garant™ mixing and dispensing system.

The provided text is a 510(k) Summary for a dental material (TempXN28) and not a study describing the performance of an AI/ML powered device. As such, the requested information pertaining to AI/ML device acceptance criteria, study design, and performance metrics (e.g., sample size for test set, ground truth establishment, MRMC studies, standalone performance) is not available in the given document.

The document discusses the safety and effectiveness of the dental material TempXN28 by demonstrating its substantial equivalence to predicate devices (Protemp™ 3 Garant™, Luxatemp Fluorescence, and Sinfony).

Here's what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics for a software/AI device. For this dental material, acceptance criteria would typically involve biocompatibility, mechanical properties (e.g., flexural strength, wear resistance), polishability, color stability, and ease of use, all within acceptable ranges or comparable to predicate devices.
• Reported Device Performance: The document generally states: "To provide evidence for safety biocompatibility testing was carried out. The results show that TempXN28 is a safe device. The comparison for chemistry, performance data and indications for use shows that TempXN28 is substantially equivalent to the predicate devices."
  • No specific performance values (e.g., strength in MPa, fill rate, etc.) are provided in this summary.

The following questions cannot be answered from the provided text as they relate to AI/ML device evaluation, which is not the subject of this 510(k) summary:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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