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E-Dent 1000 is a light-curable resin indicated for the fabrication of:

• individual and fixed permanent full single crowns, permanent partial crowns in front and posterior area,
• individual and fixed single veneers,
• artificial teeth for dental prostheses, which are used for removable permanent full dentures,
• individual and removable monolithic full and partial dentures

in dental laboratories. The material is an alternative dental material. E-Dent 1000 is intended exclusively for professional dental work. Fabrications with E-Dent 1000 requires a computer aided and manufacturing (CAD/CAM) system that includes the following components: digital dental files based on a digital impression, or in case of artificial teeth for dental prostheses the digital dental files based on manufacturer's data, a digital light processing (DLP) printer, and curing light equipment.

The E-Dent 1000 system combines a scanner with design software, the light-curable resin, a 3D printer and a curing unit. These components are used together during the manufacture of the customized E-Dent 1000 restorative dental products.

The light-curable resin is a proprietary composition of acrylates, methacrylates, methacrylated oligomers and monomers, photo initiators, colorants/dyes and absorbers. It is used by dental laboratories to make the customized temporary crowns and bridges for patients who need restoration of their natural teeth.

E-Dent 1000 is available in six different colors.

The resin is packaged in lightproof 1 kg PE bottles along with a programmed RFID chip (referred to as TAG), which is required for use with the validated 3D printers. The TAG contains information identifying the resin material, name and amount.

E-Dent 1000 resin is an alternative material to heat-curable and auto-polymerizable resins.

EnvisionTECs Perfactory® 3D-Printer DLP models designed and validated for use with the E-Dent 1000 light cured resin are:
• EnvisionOne cDLM, with LED
• Micro series, with LED
• Vida Series, with LED
• P4K Series, with LED
• D4K Series, with LED

The provided text describes a 510(k) premarket notification for a dental material (E-Dent 1000), not an AI/ML medical device. Therefore, a direct answer to the request regarding acceptance criteria and a study proving an AI/ML device meets them, including details like sample size for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, and training set details, cannot be extracted from the given document.

The document focuses on the substantial equivalence of the E-Dent 1000 resin to predicate dental materials based on physical and chemical properties, biocompatibility, and manufacturing processes, not on the performance of a software algorithm.

However, I can extract the relevant information about the non-AI device's performance testing and acceptance criteria as described in the document:

Here's the information about the E-Dent 1000 device's performance and acceptance criteria, adapted to the closest relevant sections of your request, noting where the information is not applicable to an AI/ML device:

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

The document states that testing was conducted to evaluate the performance of manufactured crowns, artificial teeth, veneers, and dentures according to specific ISO standards. The "acceptance criteria" are implied by compliance with these standards, and "reported device performance" is the statement that the device meets these requirements.

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

• Sample Size: Not explicitly stated for each test, but implied by the successful completion of testing according to ISO standards. Sample sizes for material testing are standard for these types of evaluations.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is a material test, not a patient data study.

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

• Not Applicable: This is a material science and biocompatibility study, not a study involving expert-established ground truth from images or clinical data. The "ground truth" is defined by compliance with established international standards for dental materials.

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

• Not Applicable: No human adjudication is involved in these laboratory material tests.

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 not an AI/ML device.

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

• Not Applicable: This is not an AI/ML device.

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

• Type of Ground Truth: Established international standards for dental materials (e.g., ISO 10477, ISO 4049, ISO 7491, ISO 20795-1) for physical/mechanical properties, and ISO 10993 for biocompatibility.

8. The sample size for the training set

• Not Applicable: There is no "training set" as this is not an AI/ML device. For material development, formulation and process optimization would occur, but these are not referred to as "training sets" in this context.

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

• Not Applicable: See point 8.

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