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SmarTemp® X I is a self-curing composite for the fabrication of temporary crowns and bridges, inlays and veneers. SmarTemp® X1 is intended for the fabrication of: temporary crowns, bridges, inlays, long-term temporaries, and temporary veneers.

SmarTemp® X1 is a self-curing, resin-based composite, suitable for the fabrication of temporary crowns, bridges, inlays, onlays, and veneers. It is a bis-acryl resin-based material comprising a 10:1 ratio of base to catalyst components, which when expressed by the user from dual-chamber syringes or cartridges mix through standard snap-in accessory mixing tips. SmarTemp® X1 self-cures in approximately 6 minutes at mouth temperature.

SmarTemp® X1 is packaged in any standard, opaque, dual-chamber syringe or cartridge suitable for containing a 10:1 ratio of base and catalyst components, respectively. The syringe or cartridge is accompanied by standard snap-in automix tips.

The provided text describes the regulatory clearance of a dental material, SmarTemp X1, as substantially equivalent to a predicate device, Luxatemp Ultra/Star. It does not contain information about a clinical study or acceptance criteria related to an AI/ML powered medical device.

However, based on the provided document, I can extract information related to the acceptance criteria and testing for the SmarTemp X1 dental material, which serves as a substitute for the requested AI/ML device information.

Here's the breakdown of the acceptance criteria and the study (bench performance testing) for SmarTemp® X1:

SmarTemp® X1 Acceptance Criteria and Bench Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for SmarTemp® X1 appear to be based on demonstrating equivalence or meeting certain thresholds compared to the predicate device, Luxatemp® Ultra/Star, for critical physical properties.

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

The document does not explicitly state the sample sizes used for the bench performance tests (compressive strength, volumetric shrinkage, water sorption, water solubility). It refers to "testing was conducted on both SmarTemp® X1 and the predicate device."

The data provenance is from bench testing presumably conducted by Parkell, Inc. or a contracted lab. There is no information regarding country of origin or whether it's retrospective or prospective, as these are not typically relevant for bench testing of material properties.

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

Not applicable. For material property testing like compressive strength, shrinkage, water sorption, and solubility, "ground truth" is established through standardized laboratory measurement methods as defined by relevant ISO standards (though specific standards for these properties are not detailed in the document, they are implied by the nature of the tests). Expert consensus from medical professionals is not used to establish these physical characteristics.

4. Adjudication Method for the Test Set

Not applicable. This concept (e.g., 2+1, 3+1) is relevant for clinical studies involving human interpretation or expert review of data. Bench testing of material properties typically involves direct measurements and adherence to specific test protocols for which adjudication methods are irrelevant.

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 device is a dental material, not an AI/ML medical device. Therefore, no MRMC study or AI assistance was involved in its evaluation.

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

Not applicable. This is a dental material, not an AI algorithm.

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

The "ground truth" for the material properties tested (compressive strength, flexural strength, shrinkage, water sorption, water solubility) is established via direct physical and chemical measurements obtained through standardized laboratory testing methods. These are objective measurements rather than subjective expert consensus or clinical outcomes.

8. The Sample Size for the Training Set

Not applicable. This is a dental material, not an AI/ML device 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 an AI/ML model, this question is not relevant.

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