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Direct restoration of Class I, II, III and V cavities (ideally Class I and II), base or liner, core build-ups.

DenMat Bulk Fill is a tooth shaded, radiopaque, dual-cured (auto-cure with light-cure acceleration) composite that offers an unlimited depth of cure in a single application without multiple layers and lightcuring when allowed to self-cure. DenMat Bulk Fill has the handling properties of a low viscosity or "flowable" composite that allows for adaptation to the prepared cavity walls. DenMat Bulk Fill is also ideal for core buildups, and any application where light transmission is inadequate. It is provided in multiple shades.

This a medical device for tooth restoration, not an AI/ML device. Thus, the questions surrounding AI/ML device performance are not applicable.

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify exact sample sizes for each performance test. It refers to "Non-clinical performance evaluations" and "DenMat internal testing methods." There is no information regarding the country of origin of the data or whether it was retrospective or prospective.

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 a non-AI/ML medical device submission. The concept of "ground truth" established by experts, as typically applied in AI/ML studies (e.g., radiologists interpreting images), is not relevant here. Performance criteria are based on established international standards for dental materials (e.g., ISO 4049).

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

Not applicable, as this is a non-AI/ML medical device submission. Adjudication methods are typically used in clinical trials involving human readers or evaluators, which is not the primary mode of evaluation for this materials-based device.

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, as this is a non-AI/ML medical device submission.

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

Not applicable, as this is a non-AI/ML medical device submission.

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

The "ground truth" for this device's performance is based on well-established international standards for dental materials (e.g., ISO 4049:2019, ANSI/ADA Standard No. 27-2016, ISO 7491:2000) and internal testing methods. For biocompatibility, it's based on ISO 10993 series of standards. These standards define the acceptable physical, chemical, and biological properties for these types of materials.

8. The sample size for the training set:

Not applicable, as this is a non-AI/ML medical device submission. There is no concept of a "training set" for this type of device.

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

Not applicable, as this is a non-AI/ML medical device submission.

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TurboTemp EZ is a is a self-cure crown-and-bridge composite indicated for the fabrication of long- and short-term provisional restorations including veneers, inlays/onlays, crowns, bridges and long-span bridges. TurboTemp EZ is also indicated for incorporation of most mechanically anchored attachment components into the acrylic base of a denture, an overdenture, or a partial denture.

TurboTemp EZ is a provisional resin based material intended to be used for the fabrication of crowns, bridges, inlays, onlays, and veneers. The composite material is provided in a dual-barrel cartridge that when combined in the mixing tip, it is dispensed as a self-curing restorative material.

The provided text describes the regulatory clearance of a dental device, "TurboTemp EZ," and includes information relevant to its performance testing and comparison to predicate devices, rather than a study proving the device meets acceptance criteria in terms of algorithm performance for an AI/ML device.

Based on the content provided, here's an analysis structured according to your request, with the understanding that this is for a physical medical device, not an AI/ML algorithm:

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

For a physical dental material, acceptance criteria often relate to physical, chemical, and biological properties, usually benchmarked against industry standards or predicate devices.

Note: While the Transverse Strength of TurboTemp EZ (94 MPa) is slightly lower than the predicate (100 MPa), the FDA deemed it "substantially equivalent." This suggests the overall profile of properties, including compliance with standards, was considered acceptable for the intended use.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for the physical and chemical performance tests (e.g., transverse strength, water sorption) or the provenance of the data. It merely states that "Performance testing of TurboTemp EZ has demonstrated compliance" to certain ISO standards and FDA guidance.

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 as the document describes a physical dental material, not an AI/ML device requiring expert ground truth for image or data interpretation. The "ground truth" for this type of device is established through standardized laboratory testing and material characterization.

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

Not applicable, as this is not an AI/ML device involving human interpretation or 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

Not applicable, as 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, as this is not an AI/ML device.

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

For this physical device, the "ground truth" is based on:

• Standardized laboratory measurements: Physical properties like transverse strength and water sorption are measured objectively using established methods defined in ISO standards (e.g., ISO 10477, ISO 4049).
• Biocompatibility testing: Compliance with ISO 7405 and ISO 10993-1, which involves standardized biological evaluations to ensure safety when in contact with human tissue.
• Comparison to predicate device: The characteristics of the legally marketed predicate device (Luxatemp Ultra) serve as a benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device. The "training set" concept is not relevant here.

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

Not applicable, as this is not an AI/ML device.

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