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Complete edentulism Areas of application: Denture bases in removable complete denture prosthetics

Ivotion® Base Print is a light-curing resin material for stereolithography 3D printing. It is suitable for the fabrication of permanent denture bases in removable complete denture prosthetics. The material can be processed with approved 3D printing system. The dental professional starts with preparation of the printing procedure, cleaning, post-curing, finishing and polishing. A denture fabricated with Ivotion Base Print can be repaired and relined using a conventional self-curing denture base material.

The provided text is a 510(k) summary for the medical device "Ivotion Base Print." It describes the device, its intended use, and its comparison to a predicate device to establish substantial equivalence.

Based on the information provided, this document does not describe a study involving an AI/ML powered device and therefore does not contain the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, or human-in-the-loop studies.

The device "Ivotion Base Print" is a light-curing resin material for stereolithography 3D printing. The studies mentioned are primarily non-clinical performance testing to assess physical properties and biocompatibility testing according to ISO standards, which are standard for dental materials, not AI/ML algorithms.

Therefore, I cannot extract the information requested in your prompt because the provided text is not about an AI/ML powered medical device and the associated performance studies you are asking for.

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For manufacturing by a CAD/CAM System:

• Provisional anterior and posterior crowns with a maximum wear period of up to 12 months

• Provisional anterior and posterior bridges with up to two adjacent pontics for a maximum wear period of up to 12 months

• Provisional inlay and onlays

Telio CAD Multi are PMMA discs used for fabrication of long-term temporaries by means of CAD/CAM technology. The PMMA discs have a Long-term (12-month) wear period and durable shade stability with lifelike layered appearance. The device is available in 8 shades (BL2, A1, A2, A3, A3.5, A4, B1 and B2) and 4 thicknesses 12mm, 16mm, 20mm and 25mm. They are the standard 98.5 mm in diameter to permit use with the Wieland Select Milling equipment or other equipment which accepts 98.5 mm discs. The material exhibits high homogeneity due to industrial manufacturing process and temporaries can be easily reproduced using the CAD/CAM Technology. The device is contraindicated for use in permanent restorations and bridge designs involving more than two adjacent pontics. The device should not be used in patients with para-functional habits, ex. Bruxism or patients known to be allergic to the ingredients.

Here's an analysis of the provided text regarding the acceptance criteria and study for the TelioCAD Multi device, structured to answer your specific questions.

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily references meeting existing ISO standards rather than defining new, specific acceptance criteria with numerical targets. The "Reported Device Performance" simply states that the device "met all requirements of the standard."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for the tests conducted according to the ISO standards.
The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is implied that the testing was conducted by the manufacturer as part of their 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this document. The "ground truth" here is defined by objective physical and chemical measurements against established international standards for dental materials, not through expert consensus or clinical judgment on a test set.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation is based on objective material testing against ISO standards, not on human interpretation that would require an adjudication method.

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

This information is not applicable. TelioCAD Multi is a dental material (PMMA discs for temporary restorations), not an AI-powered diagnostic or assistive device for human readers. Therefore, an MRMC study and effect size in this context are irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. As stated above, this device is a dental material, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device is based on established international standards for dental materials (ISO standards 10477:2004, 20795-1:2013, 179-1:2010, 180:2000, 868:2003, 10993-1, 7504). These standards define the acceptable physical, mechanical, and biological properties for the material's intended use.

8. The Sample Size for the Training Set

This information is not applicable. This device is a material, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process in that context.

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The Accu-Dent XD impression materials are recommended for used to create highly detailed impressions of the hard and soft tissues of the oral cavity includin the following list of indications:

• Complete and partial denture impressions ●
• Opposing models for fixed and removable prosthesis ●
• o Study Model
• Temporary crown & Bridge impressions
• Whitening Trays ●
• Mouth Guards ●
• Orthodontic Impressions o

Accu-Dent XD is a two-part Alginate impression system intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide impressions models for study and for production of restorative prosthetic devices, such as full and partial dentures.

This document describes the premarket notification (510(k)) for the Accu-Dent® XD impression material. It is a Class II medical device used to create detailed impressions of the oral cavity. The submission aims to demonstrate substantial equivalence to predicate devices, Tropicalgin (K043131) and Neocolloid (K981091) by Zhermack sPA.

Below is a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details physical properties for the Accu-Dent® XD and its predicate devices, aligning them with relevant ISO standards.

Note: The discussion section notes that the "primary change from the predicate is the powder/water ratio for the mixed alginate. This change impacts the physical properties, but not in a significant manner. The most notable change is the difference in the Recovery from deformation results. Although lower, the result remains within the acceptance criteria of the ISO 21563 and ISO 1563 of minimum 95%." The conclusion states that "The above data and analysis demonstrates that Accu-Dent XD is substantially equivalent to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes for each physical property test. However, it indicates these tests were conducted to demonstrate compliance with ISO standards (ISO 21563:2013 and ISO 1563:1990) and FDA Guidance.

The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective, but it is implied to be laboratory testing conducted to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The ground truth for these types of dental impression materials is typically established through adherence to standardized laboratory test methods and compliance with ISO standards, not through expert consensus in the clinical sense.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically relevant for studies involving human interpretation or clinical endpoints. This document focuses on the physical and technological characteristics of a material tested against laboratory standards. Therefore, an adjudication method is not applicable in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document does not mention any MRMC comparative effectiveness study. The comparison is based on physical properties tested against ISO standards and existing predicate devices.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is an impression material, not a software algorithm or an AI-based system. Its performance is evaluated through material science and physical property testing.

7. The Type of Ground Truth Used

The ground truth used for evaluating the Accu-Dent® XD is based on standardized laboratory testing and compliance with recognized international standards (ISO 21563:2013 and ISO 1563:1990) for dental impression materials. These standards define the acceptable range for various physical properties such as tear strength, strain in compression, recovery from deformation, and gypsum compatibility.

8. The Sample Size for the Training Set

Not applicable. This device is a material, not an AI or algorithm that requires a "training set" in the machine learning sense. The development of the material would involve various formulations and iterative testing, but this is not referred to as a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of this device. The development process for the Accu-Dent® XD impression material would involve R&D and quality control testing, ensuring the material meets desired performance characteristics, but not by establishing ground truth for a training set.

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Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses.

Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses.

The provided 510(k) summary describes a device, SR Vivodent S, SR Orthotyp S, SR Ortholingual S, which are preformed denture teeth. This notification is for a dental device, not an AI/ML powered medical device. Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, training set size) are not applicable to this type of device submission.

The submission focuses on demonstrating substantial equivalence to predicate devices (SR Vivodent PE, SR Orthotyp PE, and Phonares II) through material composition, performance data, and indications for use.

Here's the information that can be extracted from the provided text according to your request:

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

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

• Not applicable for this type of device. The submission references compliance with international standards for material properties and performance rather than clinical test sets with specified sample sizes or data provenance. The testing would have been conducted in a laboratory setting.

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 in the context of AI/ML or diagnostic devices is not relevant here. The "ground truth" for this device is its adherence to established material and performance standards.

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

• Not applicable.

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 a physical dental device, not an AI-assisted diagnostic tool.

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

• Not applicable.

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

• The "ground truth" for this device's performance is compliance with international standards (ISO 22112:2005, ISO 10477:2004, DIN EN ISO 2039-1, ISO 10993) for material properties and physical performance.

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or a "training set."

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

• Not applicable.

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Restoration of Deciduous teeth Restorations in the posterior region (Classes I and ii) Class V restorations (cervical caries, root erosion, wedge-shaped defects) Extended fissure sealing in molars and premolars

Not Found

The provided document is a 510(k) clearance letter from the FDA for a dental filling material (Tetric EvoCeram Bulk Fill). It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document discusses:

• The FDA's determination of substantial equivalence for the dental material.
• Regulatory classifications and requirements for medical devices.
• Indications for use for the Tetric EvoCeram Bulk Fill material (restoration of deciduous teeth, posterior restorations (Classes I and II), Class V restorations, and extended fissure sealing).

In summary, the provided text does not contain the information necessary to answer your request about acceptance criteria and device performance evaluation for an AI/ML product.

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For light curing polymerization of light-curing dental materials curing in the wavelength range of 385-515 nm. These materials include restoratives, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting mateirals for brackets and indirect restorations, such as ceramic inlays.

Not Found

This document is a 510(k) clearance letter from the FDA for a dental curing light, the Bluephase® Style. It approves the device based on substantial equivalence to existing devices. However, this type of document does not contain the detailed study information, acceptance criteria, or performance data that you are requesting.

The FDA 510(k) clearance process primarily assesses whether a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics, or if it has different technological characteristics, that it does not raise different questions of safety and effectiveness and that the data demonstrate that the device is at least as safe and effective as the legally marketed device. This often relies on a comparison to predicate devices rather than requiring extensive new clinical trials with detailed performance metrics and statistical analyses as would be found in a PMA (Premarket Approval) application.

Therefore, I cannot extract the information you requested from this document. The document only confirms the device's clearance and its intended use.

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IPS e.max® CAD Crystall/Connect and IPS e.max® CAD Crystall/Add-On Connect (for CAD-On Technique) is intended to be used for the fabrication of:
Crowns
Splinted crowns
3-4 unit bridges
Crown, splinted crown or 3-4 unit bridge placed on top of an implant abutment ._

Not Found

This document is an FDA 510(k) clearance letter for a dental device, not a study report or technical specification document. Therefore, it does not contain the detailed information required to answer your request about acceptance criteria and a study proving a device meets those criteria.

The letter explicitly states: "We have 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 predicate devices..."

This means the FDA granted clearance based on substantial equivalence to existing devices, not necessarily on a new standalone study proving performance against defined acceptance criteria for a novel device.

Therefore, I cannot provide the requested information, which would typically be found in a clinical study report or a detailed test report. The document only contains:

• Device Name: IPS e.max® CAD Crystall/Connect and IPS e.max® CAD Crystall/Add-on Connect (for CAD-On Technique)
• Regulation Number: 21 CFR 872.6660
• Regulation Name: Porcelain Powder for Clinical use
• Regulatory Class: II
• Product Code: EIH
• Indications For Use: Crowns, Splinted crowns, 3-4 unit bridges, Crown, splinted crown or 3-4 unit bridge placed on top of an implant abutment.

The acceptance criteria, study details, sample sizes, ground truth establishment, and expert information are not present in this regulatory clearance letter.

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As an intermediate or covering layer in the fabrication of esthetically demanding composite restorations
Repair of composite restorations (in particular filling of voids, levelling out of porosities and minor chips)
As a thin (

Not Found

This document describes the FDA's 510(k) clearance for the IPS Empress Direct Flow device. It does not contain information about acceptance criteria, device performance studies, or details regarding ground truth establishment, sample sizes, or expert qualifications as it pertains to a study in the context of AI/ML device approval.

Therefore, I cannot provide the requested information. The document is a regulatory clearance letter, not a study report.

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IvoBase Hybrid and IvoBase High Impact are intended for the fabrication of PMMA based acrylic dental prosthesis including but not limited to partial and full dentures.

Not Found

The provided text is an FDA 510(k) clearance letter for a dental device (IvoBase Hybrid and IvoBase High Impact). It states that the device is substantially equivalent to a legally marketed predicate device.

However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot populate the requested table and provide the study details based on the provided text. The FDA clearance letter confirms regulatory approval based on substantial equivalence, but it does not include the underlying technical study data or acceptance criteria.

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Telio CS Inlay:
Temporization of deep inlay preparations with paralle! walls
Sealing of implant screw access holes
Relining of pre-fabricated, temporary crowns and bridges made of polycarbonate or methacrylates.

Telio CS Onlay:
Temporization of large, shallow cavities (onlay preparations).

Not Found

The provided text is a letter from the FDA regarding the 510(k) premarket notification for "Telio® CS Inlay and Telio® CS Onlay." This document is a regulatory clearance letter for a dental material (temporary crown and bridge resin), not a study report or clinical trial demonstrating the performance of a medical device against acceptance criteria with AI assistance.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, training set details, and AI-assisted improvements cannot be extracted from this document as it pertains to a different type of medical product and regulatory pathway.

This document confirms substantial equivalence of a temporary dental material to a predicate device, based on its indications for use and material properties, not on a machine learning model's performance.

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