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DoxaDent is a dental ceramic composed of calcium aluminate cement and oxides that is intended to restore carious lesions or structural defects in teeth. Specifically, DoxaDent is indicated for use as a restorative dental material for permanent application in the treatment of class I, II, and V cavities.

DoxaDent™ is a dental ceramic composed of a calcium aluminate cement and oxides, i.e., silica and zirconium oxide, and iron oxide colorants, as a filler material, in a blend of fine irregularly shaped particles ranging from 0.5 to 5 um in diameter and microfine particles having a diameter of 0.02 to 0.2 um. Trace concentrations of iron oxide additives (

The provided text is a 510(k) summary for Doxa Certex AB's DoxaDent™, a dental ceramic. The document describes the device, its intended use, technological characteristics, and predicate devices. It also lists performance tests conducted but does not explicitly define acceptance criteria for these tests, nor does it provide detailed study results that explicitly prove the device meets pre-defined acceptance criteria in a quantitative manner.

Therefore, I cannot fully complete the table and answer all questions as requested due to the absence of this information in the provided text.

Here's a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document lists performance tests conducted, but does not specify the acceptance criteria used for each test. It only states, "In all instances, the DoxaDent™ functioned as intended and performance observed was as expected." This general statement prevents a quantitative comparison against specific criteria.

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 (Test Set): Not specified in the provided text for any of the performance or clinical tests.
• Data Provenance: The performance tests were conducted by Doxa Certex AB. Doxa Certex AB is located in Uppsala, Sweden, suggesting the data originated from Sweden. The document does not specify if the studies were retrospective or prospective, though clinical evaluations often imply prospective data collection.

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)

• Experts and Qualifications: Not specified in the provided text.

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

• Adjudication Method: Not specified in the provided text.

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

• MRMC Study: No, this device is a dental ceramic material, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed.

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

• Standalone Performance: Not applicable. This is a material, not an algorithm.

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

• For the physical/chemical tests (flexural properties, hardness, etc.): The ground truth would be established by standardized testing methodologies and measurements, comparing against established material science parameters or industry standards (e.g., ISO, EN). The text mentions specific standards like EN 29917:1994/ISO 9917:1991 for acid erosion.
• For the "Study on the marginal adaptation of DoxaDent™ in extracted teeth" and "X-ray analysis of DoxaDent implants and evaluation of gingival reactions and plaque formation": The ground truth would likely be based on direct observation, imaging, and potentially histological analysis by qualified dental professionals, though this is not explicitly stated.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is a medical device material, not a machine learning algorithm that requires a training set.

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

• Training Set Ground Truth Establishment: Not applicable. This is a medical device material, not a machine learning algorithm.

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