Ceramill A-Splint

• K Number: K191836
• Device Name: Ceramill A-Splint
• Manufacturer: Amann Girrbach AG
• Date Cleared: 2019-12-20 ( 164 days)
• Product Code: MQC
• Regulation Number: N/A
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: K134015

Intended Use

Ceramill A-Splint is indicated for the fabrication of removable bite splints.

Device Description

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).

AI/ML Overview

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

Regulation Number and Section

N/A