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• Fabrication of temporary crowns, bridges, inlays, onlays and veneers;
• Fabrication of long-lasting temporary restorations;
• Rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal.

Self-curing composite that is highly efficient for the production of temporary pieces for indirect dental procedures such as inlays, onlays, crowns, veneers and bridges. The product consists of a base paste and a catalyzing paste stored in a cartridge and in a double-body syringe, from where they are automatically dispensed in the correct proportion (1:1), providing practical clinical procedures with reduced chances of errors or incorporated bubbles.

The provided text is a 510(k) summary for the device PrimmaArt, a temporary crown and bridge resin. It describes the device, its indications for use, comparison with a predicate device (Structur 3), and non-clinical testing results.

However, the document does not contain information regarding a study involving human readers, ground truth establishment, sample sizes for test or training sets, or expert qualifications for AI/ML device performance analysis. The acceptance criteria and "device performance" in the context of this document refer to physical and chemical properties of the dental resin, not the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information for acceptance criteria and study details related to an AI/ML device per the input prompt's structure. The device described, PrimmaArt, is a material, not a software or AI/ML device.

However, I can extract the acceptance criteria and reported device performance for the dental resin based on the provided tables:

1. Table of Acceptance Criteria and Reported Device Performance (for PrimmaArt dental resin):

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

• This information is not applicable as the study involves material testing, not an AI/ML algorithm or dataset. The tests are performed on samples of the PrimmaArt resin. The data provenance is DentsCare LTDA, Brazil, as the manufacturer.

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

• Not applicable as this is not an AI/ML device. Ground truth, in this context, refers to the adherence of the material's properties to international standards (e.g., ISO) and internal design inputs.

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

• Not applicable as this is not an AI/ML device evaluated by human readers. The assessment is based on direct measurement against established material performance standards.

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. The performance tests are for the material itself.

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

• For the non-clinical testing of the dental resin, the "ground truth" or reference for acceptance is defined by recognized international standards (e.g., ISO 7491, ISO 10477, ISO 4049) and the device's internal design input specifications.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device. There is no concept of a "training set" for a dental resin material in this context.

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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Opallis (Sculptable version)

• The composite is suitable for use in permanent and deciduous teeth:
• Direct restorations in anterior and posterior teeth Classes I, II, III, IV, V and VI.
• Direct veneers with composites.
• Cementation of tooth fragments.
• Core build-ups.
• Teeth splinting.
• Diastema closing or reduction.
• Modification of teeth's shape (e.g .: conoid teeth).
• Porcelain/composite repairs.

Opallis Flow (Flowable version)

• Base/lining underneath direct restorations.
• Small, non-occlusal stress-bearing class I restorations according to minimally invasive filling therapy
• Pit and fissure sealant.
• Tunnel-type preparation.
• Repair of enamel defects.
• Bonding of tooth fragments.
• Repairs in composite resin.
• Non-carious cervical lesions.
• Planning of preparation walls.

Opallis is a, radiopaque, light-curing composite resin with fluorescent and opalescent properties. It is an aesthetic restorative material used for restorations of anterior and posterior teeth.

Opallis Flow is a light-curing composite resin used for the restoration of slightly invasive preparations, pit and fissure sealant, base/lining underneath direct restorations, in tunnel-type preparations, radiopaque lining of cavities, repairs of enamel defects, restorations of primary teeth, repairs in composite resin, bonding of tooth fragments, class I, III and V restorations, non-carious cervical lesions. Opallis Flow can be used separately or with Opallis composites.

The provided text describes the acceptance criteria and performance data for two dental composite resins, Opallis and Opallis Flow, to demonstrate their substantial equivalence to predicate devices for FDA 510(k) clearance.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance (Opallis and Opallis Flow):

All results > specified threshold. | Opaque shades: 2.97 mm
Non-opaque shades: 3.01 mm

All results > specified threshold. |
| Color tone stability | No more than a small change in color, as determined by visual inspection by three observers with normal vision in a D65 light chamber, comparing specimen on a diffuse white background against a gray background. (ISO 4049 and ISO 7491) | All comparisons carried out by three observers with normal eyesight; no color difference attested. | All comparisons carried out by three observers with normal eyesight; no color difference attested. |
| Radiopacity | Values found in specimens demonstrating they are radiolucent, typically between the second and third scale of the aluminum part. (ISO 4049) | 2.46 mm. Values found are between the second and third scale of the aluminum part. | 2.49 mm. Values found are between the second and third scale of the aluminum part. |
| Flexural Strength | ≥ 80 MPa (EN ISO 4049) | 93.38 MPa. All results > specified threshold. | 137.80 MPa. All results > specified threshold. |
| Water Sorption | Maximum of 40 µg/mm³ (ISO 4049) | 28.93 µg/mm³. Complies with specification. | 27.92 µg/mm³. Complies with specification. |
| Solubility | Maximum of 7.5 µg/mm³ (ISO 4049) | 5.53 µg/mm³. Complies with specification. | 5.46 µg/mm³. Complies with specification. |
| Shelf Life (Accelerated Stability) | Confirmed shelf-life based on accelerated degradation studies (e.g., 3 years at 30°C). | 3 years at 30°C confirmed based on 274 days test. | 3 years at 30°C confirmed based on 274 days test. |
| Shelf Life (Long-Term Stability) | Confirmed shelf-life based on physical and chemical characteristics during expected shelf life (e.g., 3 years at 30°C). | 3 years at 30°C confirmed based on 36 months test. | 3 years at 30°C confirmed based on 36 months test. |

2. Sample size 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 explicitly state the specific numerical sample size (e.g., number of specimens tested for each physical property). It refers to "the samples" for various tests.
• Data Provenance: The tests are non-clinical and performed by the manufacturer, Dentscare LTDA, which is based in Joinville, Santa Catarina, Brazil. The studies appear to be prospective, laboratory-based tests comparing the manufactured devices against ISO standards.

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

• For the Color tone stability test: "three observers with normal eyesight, certified by a competent physician" were used for visual inspection. No further qualifications (e.g., years of experience, specific medical specialty) are provided beyond "normal vision" and "certified by a competent physician."
• For other physical property tests (e.g., flexural strength, depth of cure), the "ground truth" is established by adherence to International Standards (ISO 4049) rather than expert consensus on individual outcomes.

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

• For Color tone stability, it states: "All comparisons were carried out by three observers... They did not attest to any color difference in the samples analyzed." This implies a form of consensus or 3/3 agreement among these observers. There is no explicit mention of an adjudication process like "2+1" if there were disagreement, but the stated outcome implies unanimous agreement.
• For other tests, adherence to the numerical specifications of ISO standards serves as the "adjudication."

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 MRMC comparative effectiveness study was done. This device is a dental restorative material (composite resin), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

• Not applicable. This is a physical dental material, not an algorithm or software.

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

• For physical and chemical properties, the ground truth is based on International Standards specifications (specifically ISO 4049) and objective measurements compared against these predefined ranges.
• For biocompatibility, the ground truth is established through laboratory in-vitro and in-vivo tests (e.g., cytotoxicity, sensitization, irritation, genotoxicity, implantation) conducted according to ISO 10993 standards. Additionally, the pre-existence of similar products on the market ("long term (10 years) the subject devices are in the market with no chronic toxicity reported") and comparison to predicates with more complex formulations (Vittra APS) informs the biocompatibility conclusions.
• For Color tone stability, a form of expert visual consensus (3 certified observers) is used against a control.

8. The sample size for the training set:

• Not applicable. This is a physical dental material. The "training" for such devices would be the manufacturing process development and quality control, not a data-driven training set in the AI sense.

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

• Not applicable, as there is no "training set" in the context of an AI/algorithm where ground truth is established. The manufacturing and material specifications are developed and validated against industry standards and internal quality controls.

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