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Stratasys TrueDent™ is a light-curable resin indicated for the fabrication of dental appliances including removable full and partial dentures, denture bases, denture teeth, bridges, crowns, inlays, and veneers in dental laboratories. The material is an alternative to traditional heat-curable and auto polymerizing resins. Stratasys TrueDent™ is intended exclusively for professional dental work.

Stratasys TrueDent™ is a light-curable methacrylate-based resin, that enables fabrication of monolithic, high quality, functional, and aesthetic dental appliances, including full and partial removable dentures, denture bases, denture teeth, bridges, crowns, inlays, onlays and veneers in a CAD/CAM additive manufacturing process. This material is intended to be used by trained dental professionals for the fabrication of various dental appliances in a CAD/CAM additive manufacturing process that includes the following components: digital dental files based on a digital impression, a Stratasys Poly Jet 3D printer, and curing light equipment. It is an alternative to traditional heat cured and auto polymerization resins. The predesigned color of the dental appliance is achieved by digitally mixing colored resins. The resins are available in five (5) different base colors (clear, white, cyan, magenta, and yellow). Stratasys TrueDent can be used only with Stratasys J5 Series printers. Stratasys J5 Series printers include a 3D printing system that utilizes PolyJet technology, with drop-on-demand inkjet printing process, 3 print heads, and a UV LED (395nm) curing process. The dental appliance is then cured in the Stratasys TrueDent™ Cure curing chamber and sent back to the dentist for try-in and final adjustment.

The provided text describes the regulatory clearance for the Stratasys TrueDent™ device and includes a comparison to predicate and reference devices. It details non-clinical performance data but does not include information about clinical studies with human subjects, AI assistance, or expert adjudication. Therefore, many of the requested items related to clinical studies and AI are not available in the given document.

Here's the information that can be extracted or inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to international standards for dental materials and biocompatibility. The reported device performance indicates that the Stratasys TrueDent™ meets these requirements.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for the non-clinical performance and biocompatibility tests. The data provenance is "Non-clinical testing data submitted to demonstrate substantial equivalence." No country of origin for the data is specified, but the manufacturer is Stratasys Ltd. based in Israel. The tests are non-clinical (bench testing), so the terms "retrospective or prospective" do not directly apply in the same way as clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in a clinical context. The provided study is non-clinical (bench testing and biocompatibility assessments). The "ground truth" for these types of tests is the established scientific and regulatory standards (e.g., ISO standards, FDA guidance).

4. Adjudication method for the test set

Not applicable, as this was a non-clinical study focused on meeting specified standards. There was no mention of human-in-the-loop performance or expert adjudication of outputs.

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

No such study was mentioned. The device is a dental material for fabrication of appliances, not an AI-powered diagnostic or assistive tool for human readers.

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

This would not be applicable in the context of this device. The device itself (a resin) is the "standalone" component being evaluated for its physical, mechanical, and biocompatibility properties. The manufacturing process involves CAD/CAM, but the focus of the performance data is on the cured material, not an algorithm's diagnostic performance.

7. The type of ground truth used

The ground truth for the non-clinical performance data (mechanical and physical properties) and biocompatibility data is defined by established international standards (ISO 10477, ISO 4049, ISO 20795 for mechanical properties; ISO 7405, ISO 10993 for biocompatibility). These standards specify the test methodologies and acceptance criteria.

8. The sample size for the training set

This information is not applicable. The device is a physical material (resin), not an AI model that requires a training set.

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

Not applicable, as the device is not an AI model requiring a training set.

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