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[1] Direct restorations using light-cured composite resin

[2] Cavity sealing as a pretreatment for indirect restorations

[3] Treatment of exposed root surfaces

[4] Treatment of hypersensitive teeth

[5] Intraoral repairs of fractured restorations

[6] Post cementation and core build-ups

[7] Cementation of indirect restorations

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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 bonding agent (CLEARFIL Universal Bond Quick) and focuses on regulatory approval rather than a detailed study report with performance metrics, sample sizes, or ground truth establishment.

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Fabrication of inlays, onlays, veneers and full contour crown restorations, using a dental CAD/CAM system.

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The provided document is an FDA 510(k) clearance letter for a dental material (KATANA AVENCIA Block) and does not contain information about the acceptance criteria or study details for an AI/ML-enabled medical device performance evaluation.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance
2. Sample size and data provenance for the test set
3. Number and qualifications of experts for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance details
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

This document is solely a regulatory clearance for a physical dental block and does not involve AI/ML software.

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[1] Cementation of crowns, bridges, inlays and onlays
[2] Cementation of veneers
[3] Cementation of adhesion bridges and splints
[4] Cementation of prosthetic restorations on implant abutments and frames
[5] Cementation of posts and cores
[6] Amalgam bonding

The subject device is an adhesive resin cement system. It consists of the cement paste (Paste), Try-in Paste, Tooth Primer, CLEARFIL CERAMIC PRIMER PLUS and K-ETCHANT Syringe. The Paste is a dual-cure (light- and/or self-cure), fluoride-releasing, radiopaque resin cement for ceramics (lithium disilicate, zirconia, etc.), hybrid ceramics, composite resins, and metal restorations. It is supplied in an automix delivery system which mixes equal amounts of two components. It is available in the following 5 shades; Universal (A2), Clear, Brown (A4), White, and Opaque. The Opaque shade should be self-cured for final curing due to its strong opacity. The Try-in Paste is a shade matching material which has approximate color and transparency as the hardened mixture of Paste. The Tooth Primer is a self-etching primer to tooth structures that accelerates the polymerization of the Paste.

The provided text is a 510(k) Summary for the dental cement "PANAVIA V5". It describes the device, its intended use, and comparative studies against predicate devices to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample sizes used for the test set and the data provenance

The document does not specify exact sample sizes for each test in the performance evaluation. It only states that tests were performed "according to ISO 4049: 2009" and "ISO/TS 11405: 2003" and that "in-house standard" was used for shear bond strengths. It does not provide information on the country of origin of the data or whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The studies conducted are primarily in-vitro physical, mechanical, and biological tests, not studies relying on expert clinical assessment for ground truth.

4. Adjudication method for the test set

This information is not applicable as the studies are in-vitro tests and do not involve human adjudication of results in the way a clinical study with image interpretation, for example, would. The results are based on objective measurements against international standards.

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

No, an MRMC comparative effectiveness study was not done. This document is for a dental cement, and such studies are typically performed for diagnostic imaging AI devices, not for material properties.

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

This question is not applicable as the device is a dental cement, not an AI algorithm. The performance evaluation focuses on the material's physical, mechanical, and biological properties.

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

The "ground truth" for the performance criteria is based on:

• International Standards: ISO 4049: 2009 (Dentistry - Polymer-based restorative and materials) and ISO/TS 11405: 2003 (Dentistry - Testing of adhesion to tooth structure and dental restorative materials).
• In-house standards: For shear bond strength tests.
• Biocompatibility Standards: ISO 10993 series and ISO 7405.

These standards define the acceptable range or benchmark for different physical, mechanical, and biological properties.

8. The sample size for the training set

This question is not applicable. The device is a dental cement, and there is no "training set" in the context of an AI algorithm creating a model from data. The tests are direct measurements of the material's properties.

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

This question is not applicable for the same reasons as #8.

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KATANA Zirconia is used for the fabrication of the all-ceramic restorations (frameworks, FCZ crowns, FCZ bridges, inlays, onlays and veneers).

Not Found

This document is a 510(k) clearance letter for the KATANA Zirconia device, a material used for dental restorations. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the requested information from this document.

The document primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed, subject to general controls and regulations.

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[1] Cementation of crowns, bridges, inlays and onlays
[2] Cementation of prosthetic restorations on implant abutments and frames
[3] Cementation of adhesion bridges and splints
[4] Cementation of posts and cores
[5] Amalgam bonding

The subject device is a dual-cure (light- and/or self-cure), fluoride releasing, radiopaque self-adhesive resin cement for ceramic (porcelain, lithium disilicate, zirconia, etc.), composite resin, and metal restorations.

The provided document is a 510(k) premarket notification for a dental cement device, PANAVIA SA Cement Plus Handmix. It is not an AI/ML medical device, therefore, the requested information about acceptance criteria, study details for AI/ML performance, and human reader comparative effectiveness studies is not applicable.

This document describes the substantial equivalence of the new device to existing predicate devices based on:

1. Intended Uses: The intended uses of the subject device are substantially equivalent to those of the predicate devices.
2. Chemical Ingredients/Safety: While the subject device contains 5 new ingredients, biological safety tests (referring to ISO 10993 series and ISO 7405) concluded substantial equivalence to the predicate device in biological safety.
3. Technological Characteristics/Effectiveness and Performance: Physical and mechanical properties were evaluated according to ISO 4049:2009. Tensile bond strength to bovine dentin and shear bond strength to implant abutment were evaluated according to ISO/TS 11405:2003. Released fluorine ion levels were also compared.

Table of Acceptance Criteria and Reported Device Performance (based on provided information):

Summary of Device Evaluation for AI/ML-specific questions:

The provided document does not pertain to an AI/ML medical device. Therefore, the following information is not present and not applicable:

• Sample size for the test set and data provenance: Not applicable.
• Number of experts used to establish ground truth for the test set and their qualifications: Not applicable.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance study: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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