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Renamel® NANO™ +plus is a light-cure composite resin fabricated from multifunctional acrylic monomers and silicaceous fillers. These materials possess physical and mechanical properties that allow them to function in the oral cavity with esthetic qualities that mimic natural tooth appearance.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a dental resin material, Renamel® NANO™ +plus. It focuses on demonstrating substantial equivalence to a predicate device, Renamel® NANO™ (K070583), rather than presenting a study proving a device meets specific acceptance criteria in the context of an AI/human reader performance study.

Therefore, many of the requested details for an AI-medical device study (like sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document. This document primarily focuses on bench testing for physical and chemical properties and biocompatibility to demonstrate equivalence.

Here's a breakdown of the information that can be extracted and how it relates to the prompt, along with explanations for the information that is not available:

1. A table of acceptance criteria and the reported device performance:

The document provides a table comparing several physical and mechanical properties of the new device (Renamel® NANO™ +plus) against its predicate (Renamel® NANO™), including "Specification" which can be interpreted as the acceptance criteria for these properties based on ISO standards.

Property / Standard	Specification	Renamel®NANO™+plus Data (Reported Performance)	Renamel®Nano™ (Predicate Data)
Depth of cure (other than opaque materials)
ISO 4049:2009; Type1, Class2, Group1	≥ 1.5mm	2.0 mm ± 0.2mm	2.0 mm ± 0.2mm
Flexural strength
ISO 4049:2009; Type1, Class2, Group1	≥ 80 MPa	127 MPa ± 12 MPa	125 MPa ± 12 MPa
Water sorption
ISO 4049:2009; Type1, Class2, Group1	≤ 40 µg/mm³	13.5 µg/mm³ ± 0.1 µg/mm³	21.2 µg/mm³ ± 0.1 µg/mm³
Solubility
ISO 4049:2009; Type1, Class2, Group1	≤ 7.5 µg/mm³	0.0 µg/mm³ ± 0.05 µg/mm³	0.13 µg/mm³ ± 0.05 µg/mm³
Radiopacity
ISO 4049:2009; Type1, Class2, Group1	≥ 1mm	2.4 mm ± 0.2mm	2.7 mm ± 0.2mm
Compressive strength	≥ 300 MPa	360 MPa ± 36 MPa	367 MPa ± 36 MPa
Modulus of elasticity	≥ 7000 MPa	10475 MPa ± 1000 MPa	8925 MPa ± 900 MPa

Study Proving Device Meets Acceptance Criteria:

The study presented is a comparative laboratory testing of physical and mechanical properties and a toxicological evaluation to demonstrate biocompatibility. The purpose is to show substantial equivalence to an existing predicate device, not necessarily to meet a standalone clinical performance criterion for an AI system.

Information NOT available in the document (and why):

The following points are relevant for AI/Machine Learning medical device studies, which this document is not. Therefore, the information is not provided.

2. Sample sized used for the test set and the data provenance: This document describes bench testing of materials, not a study involving patient data or images with a test set of cases. The "sample size" would refer to the number of material specimens tested for each property, but this specific detail (e.g., n=X for flexural strength tests) is not explicitly stated. Data provenance (country, retrospective/prospective) is not applicable.
3. 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 methods (e.g., ISO standards), not expert consensus from clinicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for the physical and mechanical properties is established through adherence to specified ISO standards (e.g., ISO 4049:2009) and other accepted laboratory testing methodologies for dental materials. For biocompatibility, it's based on toxicological evaluation and biocompatibility tests (10993-xx).
8. The sample size for the training set: Not applicable. This document is not about an AI/ML model needing training data.
9. How the ground truth for the training set was established: Not applicable.

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