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Indications:

• Indirect pulp capping
• Direct pulp capping
• Pulpotomy, after removal of affected coronal pulp to preserve vitality of remaining pulp tissue

Not Found

The provided text is an FDA 510(k) clearance letter for a dental device called "MTA vpt" (Root Canal Filling Resin). This letter does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The 510(k) clearance process is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy or meet specific performance metrics. Therefore, the details requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are generally not part of a standard 510(k) submission for this type of device.

To provide information related to your prompt, I would need a different type of document, such as a clinical study report, a performance testing report, or a summary of safety and effectiveness data, which are not included in this FDA clearance letter.

Based on the provided document, it is not possible to answer your request. The letter confirms the device's clearance based on substantial equivalence, but it does not detail the specific performance data or studies you're asking about.

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• class I to V restorations
• reconstruction of traumatically damaged anteriors
• facetting of discolored anteriors
• correction of shape and shade for improved aesthetic appearance
• locking, splinting of loose teeth
• repairing veneers
• restoration of deciduous teeth
• core-build-up under crowns
• composite inlays

Not Found

The provided FDA 510(k) Clearance Letter for "GrandioSO Unlimited" indicates that the device has been cleared as a "Tooth Shade Resin Material" (Product Code: EBF). This means it is a dental filling material, and the information provided in the document pertains to its substantial equivalence to predicate devices, its intended uses, and regulatory compliance.

Crucially, this document is a regulatory clearance for a physical dental material, not an AI/Software as a Medical Device (SaMD). Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/SaMD performance (e.g., accuracy, sensitivity, specificity for diagnostic or assistive AI) are not applicable to this specific dental material clearance letter.

The clearance for a dental material like GrandioSO Unlimited is based on demonstrating substantial equivalence to a legally marketed predicate device, typically through:

• Material properties testing: Demonstrating that the physical, chemical, and mechanical properties (e.g., flexural strength, wear resistance, color stability, biocompatibility) are comparable to the predicate device.
• Biocompatibility testing: Ensuring the material is safe for use in the body.
• Clinical use claims: Showing that the material can be used for the stated indications (e.g., Class I to V restorations) effectively and safely, often supported by existing literature or non-clinical data if the material formulation is similar to established products.

Therefore, I cannot extract the requested information (1-9) from the provided text because these elements are specific to the validation of AI/SaMD performance, not the regulatory clearance of a dental restorative material.

The document states:

• Device Name: GrandioSO Unlimited
• Regulation Name: Tooth Shade Resin Material
• Product Code: EBF
• Indications for Use: Class I to V restorations, reconstruction of traumatically damaged anteriors, facetting of discolored anteriors, correction of shape and shade for improved aesthetic appearance, locking, splinting of loose teeth, repairing veneers, restoration of deciduous teeth, core-build-up under crowns, composite inlays.

These are typical uses for a dental composite material. The "study" proving it meets "acceptance criteria" would be a battery of standard dental material tests and biocompatibility assessments, demonstrating its equivalence to existing, legally marketed tooth shade resin materials. This letter does not contain the specifics of those material tests or any AI/SaMD-related performance metrics.

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• Retention of aligners e.g. by fabrication of aligner attachments
• Bonding of lingual retainers
• Occlusal build-ups

Not Found

The provided text is an FDA 510(k) clearance letter for the AlignerFlow LC device. It indicates that the device has been found substantially equivalent to predicate devices for its stated indications for use (retention of aligners, bonding of lingual retainers, and occlusal build-ups).

However, the provided document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment methods, expert qualifications, adjudication methods, or MRMC studies. The letter is a regulatory clearance document, not a clinical study report or a technical performance evaluation.

Therefore, I cannot provide the requested table and study details based on the input text.

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• Temporary crowns and bridges

Not Found

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for a dental device (V-Print c&b temp), which primarily confirms that the device is substantially equivalent to legally marketed predicate devices.

It does not include details about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This kind of detailed performance and study information is typically found in the 510(k) submission summary or in a separate study report, neither of which is present in the provided text.

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• Class I to V restorations
• Base in class I and II cavities
• Reconstruction of traumatically damaged anteriors
• Facetting of discoloured anteriors
• Correction of shape and shade for improved aesthetic appearance
• Locking, splinting of loose teeth
• Repairing veneers, small enamel defects and temporary C&B-materials
• Extended fissure sealing
• Restoration of deciduous teeth
• Core build-up
• Composite inlays

Not Found

This is an FDA clearance letter for a dental material (Admira Fusion 5), not a medical device that uses AI or requires a study with specific acceptance criteria related to algorithm performance. Therefore, the provided text does not contain the information needed to answer the questions about acceptance criteria, study design, ground truth, or expert involvement as described in your prompt.

The document is a 510(k) premarket notification clearance letter, which confirms that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory requirements for dental materials.

To answer your questions, I would need a document that describes the clinical performance or validation study of a specific medical device, especially one involving an AI algorithm.

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Removable denture bases

Not Found

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for a dental device (V-Print dentbase) and outlines regulatory information and indications for use. It does not provide details about specific acceptance criteria for a study, performance metrics, sample sizes, expert qualifications, or study methodologies.

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Permanent extraoral and intraoral luting of superstructures (incl. Mesostructures) made of metal, ceramics, zirconium dioxide and polymers (composite, hybrid ceramics or PMMA) on prefabricated adhesive/titanium bases (extraorally only), on customized titanium and zirconium dioxide bases (both extraorally and intraorally) as well as on dental hard tissue.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the "Bifix Hybrid Abutment Cement." It acknowledges the device's substantial equivalence to predicate devices and outlines regulatory requirements. However, this document does NOT contain information about acceptance criteria or a study proving that a device meets those criteria.

This document is a regulatory clearance letter for a dental cement, not a medical device that uses AI or requires performance metrics for an algorithm. Therefore, the requested information (acceptance criteria, device performance table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size, and ground truth establishment for the training set) is not applicable and not available within the provided text.

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• Luting of prefabricated prosthetic teeth and CAD/CAM-produced individual teeth and tooth sections in CAD/CAMproduced denture bases
• Luting of prosthetic teeth in the scope of a repair or extension

Not Found

The provided text is a 510(k) clearance letter from the FDA for a dental resin called CediTEC. It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is primarily administrative, confirming that the device is substantially equivalent to legally marketed predicate devices and outlining regulatory requirements.

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

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For temporary retraction of the marginal gingiva to provide a dry gingival sulcus when the periodontium is healthy prior to, e.g - analogue or digital impressions - cementation of temporary and permanent restorations - preparation of class II and V fillings

Not Found

The provided text is a 510(k) clearance letter from the FDA for a dental product called "VOCO Retraction Paste". This document does not contain any information about acceptance criteria or a study that proves a device meets acceptance criteria. Instead, it outlines the regulatory status of the device, its indications for use, and general regulatory requirements.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study based on the provided input. The details you are asking for, such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set information, and ground truth establishment, are not present in this regulatory clearance letter.

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• Therapeutic splints
• Auxiliary parts and functional parts for diagnostics
• Manufacturing of patient-matched night guards/splints

Not Found

This FDA 510(k) letter for the V-Print splint (K201091) does not contain the information requested to describe the acceptance criteria and the study proving the device meets those criteria.

The provided text only includes:

• The FDA's decision regarding substantial equivalence.
• General information about FDA regulations for medical devices.
• The Indications for Use statement for the V-Print splint.

There is no information within this document about:

1. Acceptance criteria (e.g., specific performance metrics and thresholds).
2. Reported device performance data.
3. Sample size used for testing, or data provenance.
4. Number/qualifications of experts for ground truth establishment.
5. Adjudication method.
6. MRMC study information or effect size.
7. Standalone performance details.
8. Type of ground truth used.
9. Training set sample size.
10. Ground truth establishment for the training set.

To provide the requested information, a different document, such as a summary of safety and effectiveness (SSE), a detailed test report, or a clinical study report, would be required.

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