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Infinix™ Universal Composite:

• Restorations in the posterior region (Class I and II)
• Anterior restorations (Class III, IV)
• Class V restorations (cervical caries, root erosion, wedge-shaped defects)
• Veneering of discolored anterior teeth
• Splinting of mobile teeth
• Extended fissure sealing in molars and premolars
• Repair of composite/ceramic veneers
  The addition of the QASi particles to the Infinix™ Universal Composite reduces demineralization, which is part of the caries-formation process.

Infinix™ Flowable Composite:

• Class III and V restorations
• Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations)
• As base/liner under direct or indirect restorations
• Repair of small defects in aesthetic indirect restorations
• Pit and fissure sealant
• Blocking out of undercuts
• Repair of resin and acrylic temporary materials
  The addition of the QASi particles to the Infinix™ Flowable Composite reduces demineralization, which is part of the caries-formation process.

Infinix™ Bulk Fill Flow Composite:

• Base under Class I and II direct restorations
• Liner under direct restorative materials
• Pit and fissure sealant
• Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations)
• Class III and V restorations
• Blocking out of undercuts
• Repair of small enamel defects
• Repair of small defects in esthetic indirect restorations
• Repair of resin and acrylic temporary materials
• As a core build-up where at least half the coronal tooth structure is remaining to provide structural support for the crown
  The addition of the OASi particles to the Infinix™ Bulk Fill Flow Composite reduces demineralization, which is part of the caries-formation process.

The Infinix™ Family of Dental Composites include the following light-cured, resinbased composite materials:

• Universal Composite
• Flowable Composite
• Bulk Fill Flow Composite
  Some of the silica-based filler particles (max 1.2% wt/wt of the total formulation) contained in all the Infinix™ composites are decorated with quaternary ammonium functional groups that are covalently bound to the filler particles' silica core via a silane linker (herein referred to as "QASi"). Following light induced polymerization, QASi particles (produced by Nobio) remain permanently entrapped within the composite restoration and destroy microorganisms by contact. As the cell membrane of microorganisms is negatively charged and the QASi particles have strong positive charges, microorganisms are electrostatically attracted to the positively charged cured material's surface resulting in disruption of their cell membrane and immediate microbial lysis.

This document is a 510(k) Premarket Notification from the FDA regarding dental composites. It does not contain information about an AI/ML medical device. Therefore, I cannot provide details on acceptance criteria and study proving device meets criteria as requested in the prompt, as the provided text doesn't describe such a device or study.

The document discusses the substantial equivalence of the "Infinix™ Family of Dental Composites" to their predicate devices, emphasizing a new claim related to the reduction of demineralization due to the addition of QASi particles. The clinical performance section describes an in-situ clinical study comparing a composite with QASi particles to one without, focusing on mineral loss in enamel slabs. This study is for dental materials, not an AI/ML algorithm.

Therefore, I cannot fulfill the request as it pertains to an AI/ML device and its acceptance criteria, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies, because this information is not present in the provided text.

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The InfinixTM Universal Composite is indicated for:

• · Restorations in the posterior region (Class I and II)
• · Anterior restorations (Class III, IV)
• · Class V restorations (cervical caries, root erosion, wedge-shaped defects)
• · Veneering of discolored anterior teeth
• · Splinting of mobile teeth
• · Extended fissure sealing in molars and premolars
• · Repair of composite/ceramic veneers

Infinix™ Universal Composite is a packable (high viscosity) dental composite filling material, intended for direct anterior and posterior restorations, class V restorations, veneering of discolored anterior teeth, and repair of composite/ceramic veneers. The resin matrix of the Infinix™ Universal Composite contains Urethane dimethacrylate (UDMA), Bisphenol-a glycidyl dimethacrylate (Bis-GMA) and triethylene glycol dimethacrylate (TEGDMA). The inorganic filler of the Infinix™ Universal Composite is a mix of particles of alumino-silicate-based glasses, silica dioxide and pigments. A small percentage of the silica-based filler particles are covalently bound to quaternary ammonium residues (OASi), added to maintain the integrity of the restoration. The Infinix™ Universal Composite is provided in syringes (4 g) and in single-dose capsules (0.2 g) and is available in five shades (A1, A2, A3, B1 and translucent).

The provided document is a 510(k) Premarket Notification from the FDA for a dental resin material named "Infinix™ Universal Composite". This submission focuses on demonstrating substantial equivalence to a predicate device based on material properties and non-clinical testing. It does not describe a study involving algorithms, human readers, or image analysis for diagnostic purposes.

Therefore, most of the requested information regarding acceptance criteria, device performance in a diagnostic context, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document as it pertains to a different type of medical device and evaluation.

However, I can extract the non-clinical performance criteria and reported performance from the document.

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

The document lists various non-clinical tests performed on the Infinix™ Universal Composite to establish substantial equivalence to the predicate device, Tetric EvoCeram®, and compliance with ISO 4049 and FDA guidance. The acceptance criteria are implicitly those defined by these standards and guidance documents. The document states that the device "performs as intended based on the bench testing per ISO 4049 and FDA guidance document". Specific numerical results for "reported device performance" are not provided in this summary, but the general conclusion is that the device met these criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided. The study pertains to non-clinical bench testing and biocompatibility assessments of a dental material, not a diagnostic device with test sets of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. Ground truth in the context of this device would relate to the physicochemical properties and biocompatibility of the material, not expert interpretation of diagnostic data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are relevant for expert review of human data, not for material property testing.

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

No such study was done or is described. This device is a dental filling material, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No such study was done or is described. This device is a dental filling material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's evaluation is based on established scientific and regulatory standards for material properties and biocompatibility as outlined in ISO 4049, ISO 10993, ISO 7405, and FDA guidance for dental composite resin devices. It's objective, quantitative measurements against these standards.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" in the context of material property evaluation for a dental composite.

9. How the ground truth for the training set was established

This information is not applicable and not provided for the reasons stated above.

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