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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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DIOnavi-Denture is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with DIOnavi-Denture requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture based on a digital impression, a digital light processing (DLP) printer, and curing light equipment.

DIOnavi-Denture is a photo-cured resin intended to fabricate full and partial removable dentures in a CAD/CAM additive printing process. The material is an alternative to traditional heat cured and auto polymerization resins. It is denture base resins, Photo-cured product family comprises a family of dimethacrylate resins. The dimethacrylate resin is polymerized via photo initiators in a 3D printer. The color of the denture is determined by the addition of pigments. The material is used in a 3D printer. which prints the shape determined by a 3D drawing. After printed product is placed in a UVlight curing box for final polymerization. 3D printer and UV-light curing box is not included with the device.

The denture fabrication process begins with a traditional impression or optical impression of the oral region in the dentist office. This impression is sent to a dental lab. The denture base is then made layer-bylayer in a DLP (digital light processing) printer. After attachment of preformed plastic teeth, the denture is cured in a light chamber, and, lastly, sent back to the dentist for try-in and final adjustment.

The provided text is a 510(k) summary for the DIOnavi-Denture, a light-curable resin used for fabricating and repairing dentures. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria through a clinical study. Therefore, several of the requested categories for acceptance criteria and study details are not directly applicable or available in this M.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document refers to adherence to international standards and internal testing to demonstrate substantial equivalence, rather than defining specific clinical acceptance criteria for performance measures like diagnostic accuracy. The "acceptance criteria" are implied by meeting the requirements of the standards for similar devices.

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

The document does not detail specific sample sizes for non-clinical performance tests. The testing was laboratory-based, not clinical, so direct provenance like "country of origin" or "retrospective/prospective" data in a clinical sense is not applicable. The tests performed were outlined to meet ISO standards.

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

Not applicable. This was a non-clinical, bench-testing study of material properties, not a study involving expert assessment or ground truth establishment based on human interpretation.

4. Adjudication Method for the Test Set

Not applicable. There was no element of human judgment or interpretation requiring adjudication.

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. The DIOnavi-Denture is a tangible dental material and not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.

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

Not applicable. This is not an algorithm or software device. The product is a resin for dental fabrication.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical testing was defined by the established criteria and physical/chemical measurement techniques specified in the relevant ISO standards (ISO 20795-1 for dental base polymers and ISO 10993 for biocompatibility). For example, flexural strength is measured directly rather than requiring expert consensus.

8. The Sample Size for the Training Set

Not applicable. This is a physical material, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set.

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Whip Mix VeriSplint is a light-cured resin. It is a polymer used to create removable structures for therapeutic restorations i.e., bite guards/splints and occlusal night guards/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the system.

The VeriSplint ®OS system is a combination of a scanner, resin, 3D printer, and curing unit. The system components work together to manufacture a splint/bite guard. The additive manufactured appliance is part of a photo-cured product family that is a combination of methacrylate resins. In general, the products in this family are composed of a 3-component methacrylic system, polymerized via photo initiators in a 3D printer setting. The material is an alternative to traditional heat cured and auto polymerizing resins.

The provided text describes the Whip Mix VeriSplint device and its performance testing to demonstrate substantial equivalence to predicate devices, primarily for its physical and chemical properties as a dental material. It does not describe a study involving human-in-the-loop performance, expert ground truth establishment for a test set, or MRMC studies, as would be common for AI/ML-based medical devices.

Therefore, many of the requested elements for the acceptance criteria and study proving device performance (specifically those related to AI/ML and human reading studies) are not applicable to the information provided in this document.

Here's the information that can be extracted from the provided text, focusing on the material characteristics and the regulatory review process for VeriSplint:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on the requirements of ISO 20795-2:2013, Dentistry – Base Polymers – Part 2: Orthodontic base polymers, and comparison to predicate devices.

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