(106 days)
IvoBase CAD for Zenotec, IvoBase CAD Bond and Modelling Liquid is a system used. For the fabrication of removable dentures,e.g .: - . partial and complete denture prosthetics - . hybrid denture prosthetics - . combined denture prosthetics - . mouthguards - implant-supported denture prosthetics .
use industrially polymerized disc made primarily from PMMA. The denture base disc is milled using the CAD/CAM technique to form the base of a partial, full denture or mouthguard. Commercially available preformed denture teeth are then bonded to the denture base using lvoBase CAD Bond and IvoBase CAD Modelling Liquid.
The provided document is a 510(k) Summary for a dental device, IvoBase CAD for Zenotec, IvoBase CAD Bond, and Modelling Liquid. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of acceptance criteria and device performance in the context of an AI/ML device.
Therefore, many of the requested items, such as specific acceptance criteria for AI algorithms, sample sizes for test sets in a machine learning context, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable or cannot be extracted from this type of document.
However, I can provide the available information relevant to the device's testing and comparison to predicates, framed as closely as possible to your request.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the standards and predicate device comparisons rather than explicitly listed with numerical targets. The "reported device performance" is a statement of substantial equivalence to the predicate based on these tests.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Properties (Denture Base) | Comparable to EN ISO 20795-1:2013 for powder/liquid materials, specifically for ultimate flexural strength, flexural modulus, maximum stress intensity factor, total fracture work, residual MMA, water sorption (7 days), and solubility (7 days). | Material was tested in accordance with EN ISO 20795:2013 for the specified parameters. (Specific values not provided, but deemed "substantially equivalent" to predicate based on these tests). |
| Mechanical Properties (Bond Materials) | Comparable to predicate device Probase Cold (K913655) for water sorption and solubility. | IvoBase Bond materials were tested for water sorption and solubility and found to be "comparable" with the predicate device. |
| Bonding Quality (Teeth to Denture Base) | Cohesive fracture when tested in accordance with EN ISO 22112:2005 Dentistry: Artificial Teeth for dental prosthesis. | A "cohesive fracture" was verified, indicating strong bonding. |
| Biocompatibility | Meet requirements of ISO 10993 and ISO 7405 for Dentistry; no cytotoxicity or genotoxicity; low irritation and sensitization risks. | Tests showed "no cytotoxic or genotoxic results." Irritation and sensitization risks "found to be low." Overall "equivalent to the predicate" based on assessment. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not specify sample sizes for mechanical or biocompatibility tests, nor does it refer to "test sets" in the context of data used for AI/ML validation. The data provenance is not mentioned beyond the fact that testing was conducted for the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of device and testing. This is a medical device clearance submission for a dental material, not an AI/ML diagnostic or prognostic tool that would require expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable for this type of device and testing.
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 device is a dental material, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device does not involve an algorithm.
7. The Type of Ground Truth Used
The ground truth or reference standard for testing was established through:
- Compliance with international standards (EN ISO 20795-1:2013, EN ISO 22112:2005, ISO 10993, ISO 7405).
- Comparison to legally marketed predicate devices' known properties and performance.
- Laboratory testing results (e.g., verification of cohesive fracture, lack of cytotoxicity).
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning and therefore has no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.