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510(k) Data Aggregation
(164 days)
Amann Girrbach AG
Ceramill A-Splint is indicated for the fabrication of removable bite splints.
Ceramill A-Splint are ready to use, polymethyl methacrylate (PMMA) based computer-aided design/computer-aided manufacturing (CAD-CAM) blanks, for milling splints. Ceramill A-Splint is available as a disk (round form) or as an arch-form (or "U"-shape).
This document, concerning the Ceramill A-Splint, primarily details a substantial equivalence determination by the FDA for a medical device and does not describe the acceptance criteria and a study proving a device meets them in the context of an AI/algorithmic device. There is no mention of AI, machine learning, or software performance in this document.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance using AI or algorithmic methods from the provided text.
The closest information available that might relate to "acceptance criteria" for this device, which is a physical material for dental applications, are the bench performance testing results compared against the ISO 20795-2:2013 standard.
Here's a breakdown of what can be extracted, interpreting "acceptance criteria" as the performance requirements from the referenced international standard for the physical materials:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Attribute | Acceptance Criteria (from ISO 20795-2:2013) | Ceramill A-Splint Performance | Predicate Device (M-PM-Disc) Performance | Comparison to Predicate / Acceptance |
|---|---|---|---|---|
| Residual Monomer | 100 MPa | 91.5 MPa - 96.6 MPa | Similar; meets ISO 20795-2:2013 (≥50) | |
| Water Solubility | ≤ 5 µg/mm³ |
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(87 days)
Amann Girrbach AG
- Temporary anterior and posterior crowns with a wearing time of maximum three years
- Temporary anterior and posterior bridges with a maximum of two connected pontics and a maximum wearing time of three years
- Verifying the fit on the plaster model/mouth before the final restoration
Ceramill A-Temp are ready to use, polymethyl methacrylate (PMMA) based computeraided manufacturing (CADCAM) blanks, for milling long-term temporary crowns and bridges and for verifying the fit on the plaster model/mouth before the final restoration is manufactured.
Ceramill A-Temp is available as a disk (round form) or as an arch-form (or "U"-shape) disk or as block shape blanks.
Here's a breakdown of the acceptance criteria and study information for the Ceramill A-Temp device, based on the provided FDA 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Requirement) | Ceramill A-Temp Performance | Comparison to Predicate Device |
|---|---|---|
| Residual monomer (ISO 10477:2018 requirement: 135 MPa | Similar to predicate (≥ 114 MPa); both exceed requirement. | |
| Water solubility (ISO 10477:2018 requirement: ≤ 7.5 µg/mm³) |
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(89 days)
Amann Girrbach AG
Zirconium-oxide blanks for permanent and removable dental prosthetics.
Amann Girrbach AG Ceramill® Zolid HT+ white is an all-ceramic core dental material made of Yttria-Stabilized Zirconium Oxide (zirconia, YSZ). It is provided as a disk shape (U-shape or round-shape). CAD/CAM fabrication of core material can then be used to produce copings and substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of permanent and removable prosthetic restorations. The material is then fired in an oven to harden the ZrO2. The milling and final oven hardening is completed by the customer (the dental technician).
This document is a 510(k) Pre-market Notification for a dental material, Ceramill® Zolid HT+ white, and focuses on demonstrating its substantial equivalence to a predicate device, Ceramill® ZI. It is not an AI/ML device, so many of the requested criteria regarding AI model performance or human reader studies are not applicable.
Here's an analysis of the provided information based on the request:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (zirconium-oxide blanks for dental prosthetics), acceptance criteria are typically defined by recognized international standards for ceramic dental materials. The study's goal is to show that the new device meets or is equivalent to the predicate device in key performance characteristics relevant to these standards.
| Characteristic | Acceptance Criteria (Predicate Ceramill® ZI) | Reported Device Performance (Ceramill® Zolid HT+ white) | Device Comparison / Acceptance Met |
|---|---|---|---|
| Material Composition | |||
| ZrO2 + HfO2 + Y2O3 | ≥ 99.0% | ≥ 99.0% | Same |
| Y2O3 | 4.5 - 5.6% | 6.7 - 7.2% | Similar (variance, but no new safety/effectiveness concerns) |
| HfO2 | ≤ 5% | ≤ 5% | Same |
| Al2O3 | ≤ 0.5% | ≤ 0.5% | Same |
| Other oxides | ≤ 1% | ≤ 1% | Same |
| Physical Properties | |||
| Sintering Temperature/Duration | 1450°C — 2 hours | 1450°C — 2 hours | Same (Both meet ISO 6872:2015) |
| Shelf Life | 5 years | 5 years | Same |
| Opacity (%) | 69.0 ± 1.5% | 60.0 ± 1.5% | Different (lower opacity/higher translucency, but equivalent high bending strength) |
| Flexural Bending Strength (3-point) (MPa) | 1200 ± 150 (≥8 Weibull modulus) | 1100 ± 150 (≥8 Weibull modulus) | Similar (Both meet ISO 6872:2015 minimum average of 800 MPa; 100 MPa difference not significant; Type II, Class 5) |
| Flexural Bending Strength (4-point) (MPa) | 1000 ± 150 (≥8 Weibull modulus) | 1000 ± 150 (≥8 Weibull modulus) | Same |
| E-module (GPa) | ≥ 200 | ≥ 200 | Same |
| Thermal Expansion Coefficient (CTE) (10⁻⁶/K) (25-500°C) | 10.4 ± 0.5 | 10.4 ± 0.5 | Same |
| Chemical Solubility (µg/cm²) |
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