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AeroPro™ Cordless Prophy System is a high performance cordless prophylaxis handpiece with a centrol button for use with disposable prophylaxis angles to perform cleaning and polishing procedures on teeth.

AeroPro™ Cordless Prophy System is a high performance cordless prophylaxis handpiece with a centrol button for use with disposable prophylaxis angles to perform cleaning and polishing procedures on teeth.

The provided text is an FDA 510(k) clearance letter for the AeroPro™ Cordless Prophy System. It indicates that the device has been found substantially equivalent to a predicate device. However, this document does not contain information regarding specific acceptance criteria, performance data, or studies of the type requested (e.g., sample size, ground truth, expert qualifications, MRMC studies) as these are typically found in the 510(k) summary or detailed submission, not the clearance letter itself.

Therefore, I cannot provide the requested information from the given text. The text only describes the device's indications for use and the regulatory clearance process.

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Premier Sealant, a prescription only medical device used for prophylactic sealing of pits and fissures. It may also be used for micro-restorative or "initial layer" of composite restorations.

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I am sorry, but the provided text from the FDA 510(k) premarket notification for the "Premier Sealant" does not contain any information about a medical device that uses artificial intelligence (AI) or machine learning.

The document is a standard FDA clearance letter for a dental pit and fissure sealant, which is a physical product, not a software-based diagnostic or assistive device that would involve acceptance criteria for AI performance.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test set or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness study or human reader improvement with AI.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size.
9. How ground truth for the training set was established.

This information is simply not present in the provided text as the device in question is a traditional dental material, not an AI-powered diagnostic tool.

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Zeramic Adhesive Resin Cement is a prescription only, dual cured, radiopaque resin cement intended to be used for cementation of porcelain, ceramic, resin, metal-based inlays/onlays, crowns, bridges, core build up material, posts and veneers. It is also used for cementation of crown restorations to implants.

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The FDA letter provided refers to the Zeramic Adhesive Resin Cement (K150601). While it mentions general regulatory information, it does not contain details about specific acceptance criteria or the studies performed to demonstrate the device meets these criteria.

The letter is a notification of substantial equivalence based on a 510(k) submission, meaning the FDA determined the device is as safe and effective as a legally marketed predicate device. The information requested regarding acceptance criteria, study design, sample sizes, expert ground truth, and comparative effectiveness studies would typically be found within the 510(k) summary or the full 510(k) submission document itself, which are not included in the provided text.

Therefore, I cannot provide the requested information based solely on the provided document. The document primarily focuses on regulatory approval and classification rather than the technical details of device performance testing.

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