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UltraSeal XT plus bioprotection by Nobio sealant - UltraSeal XT plus sealant for prophylactic sealing of pits and fissures and can be used where the use of a flowable composite is indicated. The bioprotection by Nobio reduces demineralization, which is part of the caries formation process.

UltraSeal XT hydro bioprotection by Nobio sealant - Use UltraSeal XT hydro sealant for prophylactic sealing of pits and fissures. The addition of the bioprotection by Nobio reduces demineralization, which is part of the caries formation process.

UltraSeal XT plus bioprotection by Nobio sealant and flowable composite – UltraSeal XT plus sealant is a 58% filled, light-cured, radiopaque, methacrylate-based, thixotropic resin sealant. It is used with PrimaDry drying and priming agent to aid in avoiding moisture contamination which can cause microleakage and poor retention. It is a Type 1 Class 2 Group 1 polymer-based dental restorative flowable resin which is suitable for occlusal surfaces. It can be used where the use of a flowable is indicated. It is compatible with adhesives and bonding agents. UltraSeal XT plus sealant has a radiopacity value of 1.44 mm of aluminum. Aluminum has a radiopacity equivalent to that of dentin. Thus, 1 mm of material (having a radiopacity equivalent to 1 mm of aluminum) has a radiopacity equivalent to that of dentin-and 2 mm of aluminum is equivalent to enamel. The addition of the bioprotection by Nobio reduces demineralization, which is part of the caries formation process.

UltraSeal XT hydro bioprotection by Nobio sealant – UltraSeal XT hydro sealant is a Class 2, 53% filled, light-cured, radiopaque, methacrylate-based, thixotropic resin sealant. It is partly hydrophobic and hydrophilic before it is cured, hydrophobic once cured, and has a selfadhesive quality. UltraSeal XT hydro sealant chemistry provides the option of a visual verification for marginal retention-with the use of a black light upon placement and at recall visits. The UV light is not included in the UltraSeal XT hydro sealant kit. The addition of the bioprotection by Nobio reduces demineralization, which is part of the caries formation process.

Some of the silica-based filler particles (max 1.2% wt/wt of the total formulation) contained in all the UltraSeal XT plus Bioprotection by Nobio and UltraSeal XT hydro Bioprotection by Nobio 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 sealant 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.

Both subject devices have a depth of cure ≥ 1.5mm, are curable at wavelengths of 385-515nm and will remain uncured after light exposure while in their primary container. UltraSeal XT plus Bioprotection by Nobio is also indicated for use as a flowable composite. It has a flexural strength of ≥ 80 MPa, Water Sortpion ≤ 40 µ g/mm3, Water Solubility ≤ 7.5 µ g/mm3, Radio-Opacity, ≥ 1mm of Al, Surface Hardness ≥ 20 HK and Ambient light sensistivity resulting in the product being physically homogeneous after 60 seconds.

The provided text focuses on the substantial equivalence determination for dental sealants and does not contain information about a medical device involving AI or machine learning. Therefore, I cannot extract acceptance criteria and study details related to AI/ML device performance from this document.

The document discusses physical and chemical properties of dental sealants and their biocompatibility, which are typically evaluated through bench testing and ISO standards, not through clinical studies with human readers or AI algorithms. As such, information regarding sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, training sets, or ground truth establishment in the context of AI/ML is absent.

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Use UltraSeal XT® hydro™ for prophylactic sealing of pits and fissures.

UltraSeal XT® hydro is a 53% filled, light cure, radiopaque, methacrylatebased, thixotropic resin sealant. It is hydrophyllic and has a self-adhesive quality. UltraSeal XT® hydro™ chemistry provides the option of a visual verification for marginal retention with the use of a UV light, upon placement and at recall visits. The UV light is not included in the Ultra Seal XT® hydro™ kit.

The provided text describes a Special 510(k) premarket summary for a dental device called UltraSeal XT® hydro™. The document focuses on establishing substantial equivalence to predicate devices and detailing the technological characteristics and performance testing of the new device. However, it does not contain the kind of information typically found in a study proving a device meets acceptance criteria, particularly in the context of AI/ML-based medical devices as implied by your request.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance in the format you requested, nor does it specify numerical performance targets.
• Mention of a "test set" with sample size, data provenance, or ground truth establishment.
• Information about experts, adjudication methods, or multi-reader multi-case (MRMC) comparative effectiveness studies.
• Details on standalone algorithm performance or training set characteristics (sample size, ground truth).

The text describes various physical and chemical property tests performed on the dental sealant to demonstrate its performance and establish an 18-month shelf life. These are standard tests for material science and dental products, not for AI/ML algorithms.

Here's a breakdown of what is available in the document, framed against your request, while highlighting what's missing:

Acceptance Criteria and Study to Prove Device Meets Criteria:

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

The document lists several tests performed, implying that certain performance thresholds were met for each, but it does not provide numerical acceptance criteria or specific reported performance values in a table for UltraSeal XT® hydro™. Instead, it gives qualitative statements about the desired outcomes of the tests in comparison to predicate devices.

Qualitative Performance Claims (Implied Acceptance):

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 provided in the document. The tests described are laboratory-based material property tests, not clinical performance studies with 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 provided as the device is a physical dental sealant, not an AI/ML algorithm requiring expert interpretation of medical images.

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

This information is not provided. Not applicable for physical material tests.

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

Such a study was not performed or mentioned. This is a material science product, not an AI-assisted diagnostic tool.

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

This is not applicable as the device is a physical pit and fissure sealant, not a software algorithm.

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

"Ground truth" as understood in AI/ML is not applicable here. The "truth" for material properties is established through standardized physical and chemical testing methods (e.g., measuring shear bond strength in MPa).

8. The sample size for the training set

This is not applicable as the device does not employ a training set (it is not an AI/ML device).

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

This is not applicable.

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