(82 days)
KaVo Everest Titanblank is indicated for use in the preparation or manufacture of permanent or removable dental appliances.
KaVo Everest Titanblank consists of pure (99.5+%) titanium blanks.
The provided text is a 510(k) summary for the KaVo Everest Titanblank, a dental product. It does not describe a study involving device performance, acceptance criteria, or AI/human reader efficacy. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on material purity.
Therefore, for aspects related to acceptance criteria, device performance, sample size, expert ground truth, adjudication, MRMC studies, standalone performance, or training set details, the answer is "Not applicable / Not provided in the document."
Here's a breakdown based on the information provided in the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable | Not applicable |
- Explanation: The document states: "Performance Data: None required. The claim of substantial equivalence is based on purity of the titanium (99.5+%)." This indicates that performance data in the typical sense (e.g., accuracy, sensitivity, specificity) was not part of the submission for this type of device. The acceptance criterion was implicitly the material purity matching or exceeding the predicate device, which is stated as 99.5+% pure titanium. However, a specific "acceptance criterion" value for purity is not explicitly called out as an acceptance criterion.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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Sample size: Not applicable / Not provided.
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Data provenance: Not applicable / Not provided.
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Explanation: No test set or associated data is mentioned, as performance data was not required.
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)
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Number of experts: Not applicable / Not provided.
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Qualifications of experts: Not applicable / Not provided.
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Explanation: No ground truth establishment was conducted for a test set, as performance data was not required.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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Adjudication method: Not applicable / Not provided.
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Explanation: No test set or related adjudication process is mentioned.
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
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MRMC study: No.
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Effect size: Not applicable / Not provided.
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Explanation: This device (titanium blanks for dental appliances) is a material, not an AI or imaging device, so an MRMC study comparing human readers with and without AI assistance is not relevant to its approval process.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
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Standalone performance: No.
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Explanation: This device is a pure material and does not involve an algorithm or "standalone" performance in the context of AI or diagnostic devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
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Type of ground truth: Not applicable / Not provided.
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Explanation: The approval is based on material purity, not on establishing a "ground truth" for a diagnostic or AI performance evaluation. The "ground truth" for this device would relate to its chemical composition and physical properties, which are inherent to the material itself, rather than requiring expert consensus or pathology data.
8. The sample size for the training set
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Sample size: Not applicable / Not provided.
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Explanation: There is no training set mentioned or implied for this type of material device.
9. How the ground truth for the training set was established
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Method of establishment: Not applicable / Not provided.
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Explanation: There is no training set for which ground truth would need to be established.
§ 872.3710 Base metal alloy.
(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.