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The KaVo Everest® ZH-Blank is used in the manufacture of dental prosthetics.

The KaVo Everest® ZH-Blank is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the KaVo Everest® ZH-Blank:

Based on the provided 510(k) summary, the device is a material for dental prosthetics, and its clearance process differs significantly from a typical AI/software-as-a-medical-device (SaMD) study focusing on diagnostic or prognostic performance. Therefore, many of the requested categories (like MRMC studies, expert ground truth, sample sizes for training/test sets) are not applicable or not explicitly detailed in this type of submission.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance for KaVo Everest® ZH-Blank

The submission for the KaVo Everest® ZH-Blank is based on demonstrating substantial equivalence to predicate devices and adherence to the classification for porcelain powders, rather than on specific quantitative performance metrics typically seen for diagnostic devices.

1. Table of Acceptance Criteria and Reported Device Performance

• Comparable chemical composition and physical properties to legally marketed predicate devices (KaVo Everest Z-Blank, KaVo Everest G-Blank, Vita inCeram Zirconia). | The claim of substantial equivalence is based on comparisons of formulations of the KaVo device to legally marketed predicates. The submission concludes the material is substantially equivalent to cited legally marketed predicates. |
  | Intended Use Equivalence:
• Used in the manufacture of dental prosthetics, consistent with predicate devices. | The claim of substantial equivalence is based on comparisons of intended uses of the KaVo device to legally marketed predicates. The device is intended for use in the manufacture of dental prosthetics. |
  | Regulatory Identification Compliance:
• Conforms to the FDA's identification for porcelain powders for clinical use (21 CFR 872.6660). | The submission is based on the IDENTIFICATION of porcelain powders in 21 CFR 872.6660. The device is classified as a Class II medical device under this regulation with product code EIH. |
  | Safety and Effectiveness:
• No new questions of safety or effectiveness are raised compared to predicate devices. | The FDA letter implicitly confirms this by granting substantial equivalence, stating the device is subject to general controls and does not require PMA. |

2. Sample Size Used for the Test Set and Data Provenance

• Not applicable / Not specified. This device is a material, not a diagnostic algorithm. Therefore, there is no "test set" in the context of an AI/SaMD performance evaluation. The substantial equivalence argument relies on comparing material specifications and intended use.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. There is no "ground truth" establishment in the traditional sense for this type of material submission, as it's not a diagnostic device.

4. Adjudication Method for the Test Set

• Not applicable. No test set or expert adjudication was performed as part of this submission type.

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 submission is for a dental material (a physical product), not an AI/SaMD system designed to assist human readers.

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

• Not applicable. This submission is for a dental material, not a standalone algorithm.

7. The Type of Ground Truth Used

• Implicitly "regulatory compliance" and "material property comparison." For this type of submission, the "ground truth" is that the material's formulation and intended use correspond to those of legally marketed predicate devices and the relevant FDA regulation for "Porcelain Powder for Clinical Use." There isn't an "expert consensus," "pathology," or "outcomes data" ground truth in the typical diagnostic sense.

8. The Sample Size for the Training Set

• Not applicable / Not specified. As this is a material submission based on substantial equivalence, there is no "training set" in the context of an AI/SaMD and no data used for machine learning model development.

9. How the Ground Truth for the Training Set was Established

• Not applicable. There is no training set or associated "ground truth" for this type of device submission. The "truth" is established through documented material specifications and their comparison to established predicate devices and regulatory definitions.

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