(113 days)
The Dentivera™ Milling Disc is a thermoplastic denture base resin designed for the manufacture of full and partial removable dentures and overdentures.
The Dentivera™ Milling Discs are cylindrical, puck-shaped discs made from Ultaire™ AKP, an arylketone thermoplastic polymer resin with zinc oxide (ZnO) as an additive stabilizer. The milling discs are machined into partial or full removable denture frames using available dental CAD/CAM systems. The nominal dimensions are 98 mm in diameter and 28 mm thick.
The provided text describes a 510(k) premarket notification for a medical device called the Dentivera™ Milling Disc. It outlines the device's characteristics and compares it to a predicate device, Paladon 65, to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria are primarily based on meeting or exceeding the minimum requirements of the ISO 20795-1 standard for Dentistry - Base polymers Part 1: Denture base polymers, specifically for mechanical properties. The device also underwent biocompatibility testing according to various ISO 10993 standards and USP .
| Acceptance Criterion (Standard & Requirement) | Reported Device Performance (Dentivera™ Milling Disc) |
|---|---|
| Mechanical Properties (ISO 20795-1) | |
| Flexural Strength > 65 MPa | Pass |
| Flexural Modulus > 2000 MPa | Pass |
| Water Sorption ≤ 32 ug/mm³ | Pass |
| Water Solubility ≤ 1.6 ug/mm³ | Pass |
| Biocompatibility | |
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic |
| Sensitization (ISO 10993-10) | Non-sensitizing |
| Intracutaneous Reactivity (ISO 10993-10) | Non-irritating |
| Systemic Toxicity Acute (ISO 10993-11) | Non-toxic |
| 13 Week Subchronic Systemic Toxicity (ISO 10993-6) | Non-toxic |
| Intramuscular Implantation Study - 4 Week (ISO 10993-6) | Non-irritating |
| Bacterial Reverse Mutation Assay (ISO 10993-3) | Non-mutagenic |
| Genotoxicity: Mouse Peripheral Blood Micronucleus Study (ISO 10993-3) | Non-genotoxic |
| Genotoxicity: Mouse Lymphoma Assay (ISO 10993-3) | Non-genotoxic |
| Pyrogen Test (USP ) | Non-pyrogenic |
| Chemical Characterization (ISO 10993-18) | Pass |
| Biological Risk Assessment (ISO 10993-1, ISO 14071) | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Side-by-side testing of the Dentivera™ Milling Disc resin and the Paladon 65 resins showed that both materials are compliant". However, the specific sample sizes for the mechanical property tests (Flexural Strength, Flexural Modulus, Water Sorption, Water Solubility) are not explicitly stated in the provided text. The data provenance is implied to be from laboratory testing as part of the submission, but no country of origin is specified. The studies are prospective in the sense that they were conducted specifically for this submission to demonstrate equivalence.
For the biocompatibility tests, the sample sizes are not explicitly stated either, which is common for summaries of these types of standardized tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This document is for a material (denture base resin) and not an AI-powered diagnostic device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of clinical interpretation (e.g., radiologists, pathologists) does not apply here. The "ground truth" for the material performance is established by compliance with internationally recognized standards (ISO, USP) through laboratory testing by qualified personnel using validated methods.
4. Adjudication Method for the Test Set:
Not applicable in this context. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation of data where there might be disagreements, often for AI diagnostic devices. For material testing against defined standards, the outcome is typically a pass/fail based on pre-defined thresholds.
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 as the device is a material (denture base resin) and not an AI-powered diagnostic tool requiring human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable as the device is a material and does not involve an algorithm or AI.
7. The Type of Ground Truth Used:
The ground truth for the device's performance is established by conformance to established international standards (ISO 20795-1 for mechanical properties, ISO 10993 series for biocompatibility, and USP for pyrogenicity). These standards define the acceptable range of physical, chemical, and biological properties for these types of materials.
8. The Sample Size for the Training Set:
This information is not applicable. The Dentivera™ Milling Disc is a physical material, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable. As stated above, the device is not an AI model.
§ 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.