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Zirprime is intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations.

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I am sorry, but the provided text from the FDA 510(k) summary does not contain the detailed information required to answer your request about acceptance criteria and a study proving the device meets those criteria.

The document is primarily a letter from the FDA to Noritake Company, Incorporated, confirming the substantial equivalence of their device, Zirprime, a porcelain powder for clinical use (Product Code: EIH, Regulation Number: 21 CFR 872.6660). It outlines regulatory compliance requirements but does not include:

• A table of acceptance criteria and reported device performance.
• Details about a specific study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• Information about training sets.

To obtain this kind of information, you would typically need to consult a more detailed submission document, such as the full 510(k) submission, if it were publicly available and contained performance data. The provided document is a notification of clearance, not a technical report on performance.

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For use in prosthetic dentistry to create the porcelain exterior on a porcelain fused to metal (PFM) dental prosthesis.

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The provided text describes a 510(k) premarket notification for a dental device, "Super Porcelain EX-3 Universal Opaque." It is a regulatory document from the FDA, not a study report. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria, device performance, or study details.

The document primarily focuses on:

• Device Name: Super Porcelain EX-3 Universal Opaque
• Regulation Number: 21 CFR 872.6660
• Regulation Name: Porcelain Powder for Clinical Use
• Regulatory Class: II
• Product Code: EIH
• Indications for Use: "For use in prosthetic dentistry to create the porcelain exterior on a porcelain fused to metal (PFM) dental prosthesis."
• Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices.

None of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications is present in this regulatory correspondence.

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For use in prosthetic dentistry to create the porcelain exterior on a porcelain fused to metal (PFM) dental prosthesis by using ceramic press technique.

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The provided text is a 510(k) premarket notification letter for a dental porcelain powder, "Super Porcelain EX-3 Press." This document does not describe acceptance criteria or a study proving device performance against such criteria.

The letter is a regulatory approval document from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It confirms that the device can be marketed subject to general controls and other FDA regulations.

Therefore, I cannot provide the requested information based on the provided text. The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes or data provenance for any test set.
3. Information on the number or qualifications of experts for establishing ground truth.
4. Adjudication methods.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone algorithm performance study.
7. The type of ground truth used.
8. The sample size for any training set.
9. How ground truth for any training set was established.

This document is solely an FDA clearance letter and does not delve into the technical study details that would typically be found in a 510(k) submission's performance data section.

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For use in replicating shade variations found in natural teeth For use in replicating Shade Variations using CZR Press LF porcelain.

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I'm sorry, but this document contains a letter from the FDA regarding a 510(k) premarket notification for a dental porcelain product (CZR Press LF Stains), not a study report. Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth information, etc.) is not present in the provided text.

The document essentially states that the FDA has determined the device is substantially equivalent to legally marketed devices and can proceed to market, subject to various regulations. It does not contain any performance data or study results.

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KATANA Zirconia is intended for CAD/CAM fabrication of zirconia frameworks for allceramic dental restorations.

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The provided document is a 510(k) clearance letter from the FDA for a dental device called "Katana Zirconia." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding:

• Acceptance criteria or reported device performance metrics in a table.
• Sample sizes for test or training sets, nor their provenance.
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone (algorithm-only) performance studies.
• Type of ground truth used.
• How ground truth for the training set was established.

This document is a regulatory approval, not a scientific study report or technical specification outlining testing details. Therefore, I cannot provide the requested information based on the input text.

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For use in prosthetic dentistry to create an all-ceramic prosthesis

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I am sorry, but the provided text from the FDA 510(k) K043462 document for "CZR Press LF" porcelain powder does not contain the acceptance criteria or a study that proves the device meets specific performance criteria.

This document is a clearance letter from the FDA indicating that the device has been found substantially equivalent to a legally marketed predicate device. This type of FDA clearance does not typically include detailed performance study results or explicit acceptance criteria. Instead, it relies on demonstrating that the new device is as safe and effective as an existing, cleared device.

Therefore, I cannot fulfill your request for the following sections based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not present in the document.
2. Sample size used for the test set and the data provenance: Not present in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present in the document.
4. Adjudication method: Not present in the document.
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/diagnostic device. The document does not mention any MRMC studies or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/diagnostic device.
7. The type of ground truth used: Not present in the document.
8. The sample size for the training set: Not applicable as this is not a device typically requiring a "training set" in the machine learning sense.
9. How the ground truth for the training set was established: Not applicable.

The document primarily states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed devices marketed in interstate commerce prior to May 28, 1976... and that therefore, market the device, subject to the general controls provisions of the Act."

For devices like porcelain powder, substantial equivalence is often demonstrated through material characterization, biocompatibility testing (if applicable), and comparison to the physical and chemical properties of predicate devices, rather than large-scale clinical performance studies as would be seen for diagnostic or AI-powered devices. These details are not within this specific FDA letter.

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For use in prosthetic dentistry to create an all-ceramic prosthesis

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The provided document is a 510(k) premarket notification letter for a dental device called "Cerabien ZR," which is a porcelain powder for clinical use. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter is an FDA clearance stating that the device is substantially equivalent to a legally marketed predicate device. It indicates that the device can be marketed subject to general controls and, if applicable, special controls.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory clearance, not performance study details.

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For use in prosthetic dentistry to create an all-ceramic prosthesis

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I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Noritake Company, Incorporated regarding their CZR Press device. This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed.

However, the letter does not contain any information about:

• Acceptance criteria or reported device performance metrics.
• Details of any study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input. The document is primarily an FDA clearance letter, not a detailed study report.

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For use in prosthetic dentistry to create an all-ceramic prosthesis.

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The provided document is a 510(k) clearance letter from the FDA for a dental ceramic product called "Grand Ceram." This document does not contain information related to the acceptance criteria, study details, or performance metrics of a device as typically found in a clinical or performance study report for AI/ML-based medical devices.

The letter confirms that "Grand Ceram" is substantially equivalent to a legally marketed predicate device, indicating it's a conventional material rather than a software-as-a-medical-device (SaMD) or an AI-enabled device that would require the kind of detailed performance study you're asking about.

Therefore, I cannot extract the requested information (acceptance criteria, sample sizes, ground truth establishment, MRMC study details, etc.) from this document. The document primarily focuses on regulatory clearance for a dental material based on substantial equivalence.

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For use in prosthetic dentistry to create a porcelain prosthesis on a frame of titanium.

Super Porcelain TI-22 and Accessories

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental porcelain product (Super Porcelain TI-22), indicating that it has been deemed substantially equivalent to a predicate device. It discusses regulatory matters, marketing permissions, and general controls, but it does not include details about device performance, acceptance criteria, or any specific studies with sample sizes, ground truth establishment, or expert involvement.

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