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LuxaCrown is a self-curing composite for the fabrication of semi-permanent crowns and bridges. The material is mixed automatically. Specifically: Crown restorations: For restoration of the anatomical form in order to provide durable protection for the remaining tooth; In order to restore chewing function; For esthetic corrections. Bridge restorations: In order to restore chewing function; For esthetic corrections.

LuxaCrown is a bis-acrylic resin-based self-curing composite for the fabrication of semipermanent crowns and bridges. LuxaCrown is available in a range of shades to ensure an aesthetically-pleasing restoration. LuxaCrown is a non-sterile device intended for use by licensed dental professionals. Because LuxaCrown is intended for the fabrication of semi-permanent dental restorations, it may remain in the oral cavity for more than 30 days. LuxaCrown is supplied in dual-barreled syringes for use with the DMG Automix selfmixing dispenser and Automix Tips, which were previously cleared in K101710 (DMG LuxaTemp Ultra), K013674 (DMG LuxaTemp) and K924830 (DMG LuxaTemp Automix).

The provided text describes a 510(k) premarket notification for a dental material called LuxaCrown, a self-curing composite for fabricating semi-permanent crowns and bridges. The document focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technical specifications, biocompatibility, and physical properties.

However, the document does not contain any information about acceptance criteria or a study that specifically proves the device meets those criteria in the format requested. The "Discussion of Non-Clinical Tests" section mentions various tests performed (ISO 10447, internal DMG methods, biocompatibility testing) and states that "All samples met the requirements of internal product specifications and were within the limits specified in ISO 10477." This indicates that there are internal specifications and ISO limits, but the document does not list them as "acceptance criteria" in a table or provide detailed study results that meticulously "prove" the device meets them with specific performance metrics beyond a general statement of compliance.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

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

The document states: "All samples met the requirements of internal product specifications and were within the limits specified in ISO 10477." However, it does not provide the specific numerical acceptance criteria nor detailed reported performance data in a tabular format. It only lists the types of tests conducted.

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 for Test Set: Not specified for any of the tests mentioned (flexural strength, water sorption, water solubility, working time, setting time, compressive strength, biocompatibility, shelf life).
• Data Provenance: The tests were performed by DMG Chemisch-Pharmazeutische Fabrik GmbH, which is a German company (Hamburg, Germany). It's implied these are laboratory tests, not clinical studies with human data, so "retrospective or prospective" is not fully applicable in the conventional sense for patient 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 question is not applicable. The tests are for physical and chemical properties of a material, not for diagnostic accuracy or human interpretation requiring expert consensus.

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

Not applicable, as there's no human interpretation or ground truth establishment in this context.

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

Not applicable. This is a material science and biocompatibility assessment, not a study involving human readers or AI assistance.

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

Not applicable. This is a material science assessment.

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

For the physical and chemical tests, the "ground truth" is established by the specified standards (ISO 10447, ISO 10993-3, -5, -10, ASTM F1980) and the manufacturer's internal product specifications. For biocompatibility, it's compliance with established biological safety requirements.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device.

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

Not applicable. This is not a machine learning or AI-based device.

Summary Table (with available information):

In conclusion, while the document confirms that testing was done and met specified requirements, it does not provide the granular detail needed to fill out all aspects of the requested table, particularly the specific numerical acceptance criteria and the detailed reported performance data.

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