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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	< 1% (implied by predicate)	< 1%	< 1%	Same; meets ISO 20795-2:2013 (<5)
3-Point Bending Strength	≥ 50 MPa	> 100 MPa	91.5 MPa - 96.6 MPa	Similar; meets ISO 20795-2:2013 (≥50)
Water Solubility	≤ 5 µg/mm³	< 0.7 µg/mm³	0.2 µg/mm³	Similar; meets ISO 20795-2:2013 (≤5)
Water Absorption	≤ 32 µg/mm³	< 25 µg/mm³	26.5 µg/mm³	Similar; meets ISO 20795-2:2013 (≤32)
Flexural Modulus	≥ 1500 MPa	≥ 2000 MPa	Unknown	Meets ISO 20795-2:2013 (≥1500)
Fracture Toughness (Kmax)	≥ 1.1 MPa m½	≥ 1.1 MPa m½	Unknown	Meets ISO 20795-2:2013 (≥1.1)
Fracture Toughness (Wf)	≥ 250 J/m²	≥ 250 J/m²	Unknown	Meets ISO 20795-2:2013 (≥250)
Polishability	Meets standard requirements	Passed testing	Not explicitly stated	Passed
Porosity	Meets standard requirements	Passed testing	Not explicitly stated	Passed
Biocompatibility (Cytotoxicity)	No cytotoxic effects expected	No cytotoxic effects observed	Not explicitly stated	Passed (based on ISO 10993-1)

Regarding the other requested information (which are typically relevant for AI/algorithmic device studies):

Sample size used for the test set and the data provenance: Not applicable. This is not an AI/algorithmic device, but a physical material. The "test set" here refers to samples of the material itself for physical and chemical property testing. No specific sample sizes for these bench tests are provided in the summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established through standardized laboratory testing methods, not expert consensus in the way clinical AI ground truth is established.
Adjudication method for the test set: Not applicable.
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 is not an AI device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithmic device.
The type of ground truth used: For the physical material properties, the "ground truth" is derived from established, standardized laboratory measurement techniques (e.g., ISO 20795-2:2013 for dental polymers, ISO 10993-1 for biocompatibility).
The sample size for the training set: Not applicable. This is not an AI/algorithmic device, so there is no "training set."
How the ground truth for the training set was established: Not applicable.

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