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Match Master low fusing porcelain is to be used in conjunction with metal or pressable ceramic framework in the construction of crowns and/or bridgework.

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This document is a letter from the FDA to Davis Schottlander & Davis Limited regarding their device, Schottlander MATCH MASTER Low Fusing Porcelain. The letter states that the FDA has reviewed the company's premarket notification (510(k)) and determined that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the FDA's regulatory decision regarding market clearance based on substantial equivalence. Therefore, I cannot provide the requested information from the given text.

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Match Press pressable ceramic is to be used in the construction of crown substructures to be veneered with conventional porcelain. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.

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This document is a 510(k) premarket notification approval letter for a dental device. It does not contain information about acceptance criteria, device performance metrics, or study details as requested. The content is an FDA regulatory approval, not a scientific study report.

Therefore, I cannot provide the requested information based on the given text.

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ENIGMA denture base is to be used in conjunction with denture teeth in the construction of full and partial dentures. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.

Schottlander ENIGMA HI-BASE Denture base material

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication method, MRMC study, standalone performance, training set details), or the type of ground truth used.

The document is an FDA 510(k) clearance letter for a dental device (Enigma Hi Base Denture-Base Material), indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and compliance requirements. Attachment #4 provides the "INDICATIONS FOR USE" for the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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NATURA teeth are to be used in conjunction with denture base resin for the construction of full and partial dentures. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.

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The provided text is a 510(k) premarket notification letter from the FDA regarding "Natura Denture Teeth" and an "Indications For Use" statement. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI/CAD medical device.

Therefore, I cannot extract the requested information from the given input. The document is a regulatory approval letter for a dental product, not a technical report on a diagnostic device's performance.

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ENIGMA teeth are to be used in conjunction with denture base resin for the construction of full and partial dentures. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.

Schottlander ENIGMA denture teeth

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for "Enigma Denture Teeth" and does not contain the detailed information required to describe acceptance criteria and a study proving device adherence to these criteria. The document acknowledges FDA's review and determination of substantial equivalence to a predicate device, allowing the product to be marketed.

To answer your request, I would need a document that includes sections on:

• Performance testing results
• Acceptance criteria definitions
• Methodology of studies (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods)
• Results of standalone device performance or comparative effectiveness studies.

The provided text focuses on regulatory clearance and indications for use, not the technical study details you are asking for.

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The device is a feldspathic porcelain supplied for fusing to a metal sub-structure to form an aesthetic restoration which is then fitted as a crown or bridge.

The device is a feldspathic porcelain supplied for fusing to a metal sub-structure to form an aesthetic restoration which is then fitted as a crown or bridge.

The provided text is a 510(k) Notification for a dental product (porcelain) and does not describe a software-based medical device or AI system. Therefore, most of the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, MRMC studies, standalone performance) is not applicable to this document.

The document discusses the substantial equivalence of the "Matchmaker/Propaque porcelain" to a predicate device named "Creation". The equivalence is based on chemical similarities, application similarities, and performance similarities.

Here's a breakdown of what can be extracted from the provided text, aligning with the spirit of your request where possible, but acknowledging it's not an AI/software device:

1. Table of Acceptance Criteria and Reported Device Performance

This product is demonstrated to meet acceptance criteria by conforming to an established international standard for dental materials.

The document states, "Both products are manufactured to conform to ISO 9693:1991 Dental Ceramic Fused to Metal Restorative Material." This implies that the Matchmaker/Propaque porcelain, to achieve substantial equivalence, meets the performance criteria specified in this standard.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a material science claim, not a data-driven AI device. The "test set" would be physical samples of the porcelain material tested according to ISO 9693 methods. The sample sizes for these material tests are not specified in the provided text.

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)

Not applicable. Ground truth for material properties is established by standardized physical and chemical testing methods, not by expert consensus on interpretations as in medical imaging.

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

Not applicable. Adjudication methods are relevant for subjective interpretations or diagnostic decisions, not for objective material property measurements.

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 is not an AI device.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for this device's performance is objective measurements of physical and chemical properties as defined and standardized by ISO 9693:1991 Dental Ceramic Fused to Metal Restorative Material. This standard specifies how to measure properties like flexural strength, chemical solubility, etc.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that uses training sets.

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

Not applicable. This is not an AI/machine learning device.

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