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Trusana™ resin is intended to 3D print denture base for use in making removable full and partial dentures or overdentures. Trusana™ is intended exclusively for professional dental work. Fabrication of denture bases with Trusana™ requires a computer-aided and manufacturing (CAD/CAM) system using the Asiga MAX UV or Asiga PRO 4K 3D printer in conjunction with the Asiga Flash curing chamber.

The Trusana device is a light-activated denture base resin, offered in four shades.
The Trusana resin is used with patient-specific *.stl files provided by the dental practitioner to fabricate the customized denture bases for removable denture devices using a 3D (additive) printer and curing unit.
The proprietary light-curable resin is composed of methylacrylated monomers, methacrylated carboxylic acid, phosphine oxide initiator and pigments for color
It is used by dental laboratories and dental practices to make the denture bases for the removable dentures.
The resin is offered in lightproof 1L high density polyethylene (HDPE) bottles.
Trusana resin is an alternative material to heat-curable and auto-polymerizable resins.

The provided text describes the 510(k) premarket notification for Trusana™, a light-activated denture base resin. It includes acceptance criteria and performance data for the device, but it does not describe studies proving device performance with AI assistance, MRMC studies, or multi-reader studies establishing ground truth by medical experts. The context is a material science and manufacturing regulatory submission, not an AI/software medical device submission.

Therefore, many of the requested details, particularly those related to AI, human readers, ground truth establishment by medical experts, and training/test set sample sizes for AI models, are not present in the provided document.

Here's an analysis of the information that is available in relation to your request:

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

The document provides a comparison table between the new device (Trusana™) and the primary predicate device (NextDent Denture 3D+), with specific performance characteristics based on ISO 20795-1.

Acceptance Criteria and Device Performance (for Trusana™ vs. Predicate)

Note: The document states that "The following specification requirements of the 3D-printed denture base material samples were tested and have been met," implying that Trusana™ indeed meets the listed ISO criteria. The exact numerical performance values for Trusana™ are not explicitly stated for each metric as they are for the predicate, but their compliance is asserted.

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: The document does not specify the exact sample sizes (number of specimens) used for each of the laboratory tests (e.g., flexural strength, water sorption). It mentions "samples were tested".
• Data Provenance: Not specified. The testing was conducted to evaluate the performance of a "manufactured denture base". It is laboratory testing of a material, not data from human subjects or clinical cases. The manufacturer is Myerson, LLC, located in Chicago, IL, USA. No information on country of origin of material tests is provided.
• Retrospective or Prospective: Not applicable as this refers to material property testing in a lab setting, not a clinical study.

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 is not applicable. The "ground truth" for this device's performance is established by physical and chemical property measurements according to established international standards (ISO 20795-1, ISO 10993) in a laboratory setting, not by human expert interpretation of clinical data or images.

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

• Not applicable. As above, this is material property testing, not an assessment requiring human adjudication of subjective data.

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 denture base resin, not an AI or imaging diagnostic device that would involve human readers or AI assistance in interpretation.

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

• Not applicable. This device is a material, not an algorithm.

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

• The "ground truth" for this device's performance is defined by physical and chemical measurement standards (e.g., MPa for strength, µg/mm3 for sorption) established by the specified ISO standards (ISO 20795-1 for Dentistry - Base Polymers and ISO 10993-1 for Biocompatibility). This is objective, quantitative data measured in a laboratory, not clinical outcomes or expert consensus.

8. The sample size for the training set

• Not applicable. This device is a material, not an AI model requiring a training set.

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

• Not applicable. See #8.

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