(105 days)
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."
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Met/Did Not Meet) |
|---|---|
| ISO 10477:2004 Dentistry - Polymer based crown and bridge materials (for Surface finish, Flexural Strength, Bond strength, Water Sorption, Solubility, Shade Consistency, Color stability) | Met all requirements |
| ISO 20795-1:2013 Dentistry - Base Polymers - Part 1: Denture Base Polymers (for Modulus of Elasticity, Residual monomer) | Met these requirements |
| ISO 179-1:2010 Charpy toughness | Conducted (no pass/fail stated, but implied positive for "additional insight") |
| ISO 180:2000 Izod impact strength | Conducted (no pass/fail stated, but implied positive for "additional insight") |
| ISO 868:2003 Vickers Hardness (converted from Shore D) | Conducted (no pass/fail stated, but implied positive for "additional insight") |
| ISO 10993-1 Biocompatibility | No new elements, no change in biocompatibility |
| ISO 7504 Biocompatibility | No new elements, no change in biocompatibility |
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.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.