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Build-It Light Cure is a translucent, light activated composite material designed for core build ups. It is used as core-building material on vital teeth as well as on non-vital teeth, in combination with or without a dental post. It may also be used as a final restorative filling material.

Build-It light Cure is a line extension to the current two-component dual curable Build-If FR core material. It is available in a translucent shade only. The depth of cure of the material is > 7 mm to facilitate the bulk is available in a tallslucein silade only. The depart of on the resin mixture and the fillers are immy. The combination of the material dalbarumborosilicate glasses with a little sodium fluoride. The cosonially the connecter of the material facilitates easy adaption to the tooth.

The provided K091512 document is a 510(k) summary for a dental restorative material called "Build-It Light Cure." It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about specific acceptance criteria or a detailed study proving the device meets quantified performance benchmarks.

The document discusses the device's technical characteristics, its intended use, and its equivalence to an existing device (Clearfil Photo Core). It does not present data from a study designed to evaluate the performance against predefined acceptance criteria for attributes like cure depth, strength, or other material properties.

Therefore, I cannot provide the requested information. The document focuses on regulatory submission and equivalence rather than a detailed performance study with acceptance criteria.

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RM Bond Adhesive product is indicated for orthodontic applications using an indirect bonding treatment technique.

The subject device is a light-cured resin adhesive in a methacrylate-based formulation; the light curing feature provides the clinician appropriate flexibility for bracket placement working-time considerations. Product is supplied as refills in a variety of delivery systems; multi-use bottle or syringe as well as a single dose delivery system.

This document is a 510(k) summary for a dental adhesive (RM Bond Adhesive) and does not contain the detailed study information typically found in a clinical trial report or a performance study. The provided text indicates that the device is substantially equivalent to a predicate device but does not include acceptance criteria, performance data, or study methodologies that would allow for a comprehensive answer to your questions.

Therefore, I cannot provide the requested table or detailed information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The content is focused on regulatory submission for substantial equivalence, not on a detailed scientific or clinical study report.

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Generation 8 SE Adhesive product is indicated for direct bonding of composite and compomer materials to enamel and dentin. Additionally, device use is appropriate for adhesive bonding of other dental materials, such as composite material to ceramics, composite material to composite material and composite material to metals and amalgam.

The subject device is a light-cured self-etching, self-priming adhesive in a solvent-free resin formulation. The Generation 8 SE Adhesive performs the etching/priming/bonding process as a single step once the restorative site has been properly prepared. Device composition is approximately 40% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for Generation 8 SE Adhesive is a barium borosilicate glass. This filler type provides the subject device with the required strength and radiopacity features. Product is supplied as refills in a variety of delivery systems; multi-use bottle or syringe as well as a single dose delivery system.

The given text is a 510(k) summary for the "Generation 8 SE Adhesive" device. It describes the device, its intended use, and states that a review for safety and effectiveness was performed and found not to have been affected. However, it does not contain specific acceptance criteria, detailed study results, or information about sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The document states: "A review for safety and effectiveness was performed and found not to have been affected." This is a general statement and does not provide quantifiable acceptance criteria or the specific performance metrics of the device as would be presented in a formal study report.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: The document does not specify quantitative acceptance criteria or detailed performance data.
2. Sample sized used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method: This information is not present.
5. Multi reader multi case (MRMC) comparative effectiveness study: This information is not present. The document focuses on substantial equivalence to a predicate device, not a comparative effectiveness study with human readers.
6. Standalone performance: While the document implies the device performs an intended function, it does not provide detailed standalone performance metrics or studies.
7. Type of ground truth used: This information is not present.
8. Sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (One Coat SE Bond, K033760) based on intended function, composition, and general performance, rather than presenting a detailed study with specific acceptance criteria and performance data.

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Artiste SE Flowable Composite product is a self-etch, self-adhesive flowable resin composite indicated for light-cured dental restorations. Applications include:

• Self-etch base liner
• Restorations of carious lesions
• Class 1, III, and V cavity preparations
• Pit and fissure sealant.

The subject device is a light-cured self-etching, self-adhesive composite in a BisGMA-free resin formulation. The Artiste SE Flowable Composite requires no application of etchant, primer or adhesive prior to device use once the restorative site has been properly prepared. Device composition is approximately 65% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for Artiste SE Flowable Composite is a barium boro-silicate glass. This filler type provides the subject device with the required strength and radiopacity features. Product is supplied in various shades either in multi-use syringe or single dose delivery systems. Product packaging includes kit or refill configuration.

The provided text does not contain detailed information about specific acceptance criteria and the results of a study designed to prove the device meets those criteria. The document is a 510(k) summary for the Artiste SE Flowable Composite, focused on establishing substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot populate the table or answer the other questions based on the provided text. The document states: "A review for safety and effectiveness was performed and found not to have been affected," which is a general statement about the review, not a detailed description of a performance study with defined acceptance criteria.

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Nano-Bond II Adhesive System is used for the adhesion of dentin to various polymeric filling materials (composites) and used with other conditioners or combination of conditioners for bonding composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to dentin and enamel.

Nano-Bond II Adhesive System is a light-cured, reinforced dentin bonding agent. It is provided in a kit containing two components, Nano-Bond Self-Etch Primer and Nano-Bond II Adhesive and an optional component, Nano-Bond II Dual Cure Activator. The components also are available individually as refills.

This document describes a 510(k) premarket notification for the "Nano-Bond II Adhesive System". This submission is for a dental adhesive, not an AI/ML powered device. As such, the information you've requested regarding AI/ML device performance criteria, studies, and data provenance is not applicable to this 510(k) submission.

The document focuses on demonstrating substantial equivalence to a predicate device ("Nano Bond (Bond-3 Adhesive) (K020499)") based on intended use and design principles. It does not contain sections on acceptance criteria in the context of diagnostic performance metrics, details of clinical study design with human readers, ground truth establishment, or sample sizes for training/test sets as would be relevant for an AI/ML medical device.

Therefore, I cannot extract the requested information because it is not present in the provided text, which pertains to a traditional dental adhesive system.

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SE Epiphany Root Canal Sealant is intended for permanent obturation of root canals of teeth in combination with root canal points.

The subject device is a self-etch methacrylate resin root canal sealant in a catalyst/base paste formulation. Due to its self-etching and adhering properties, SE Epiphany Root Canal Sealant does not require the use of an etchant, primer or adhesive to achieve its intended function. SE Epiphany Root Canal Sealant has been designed for dual cure capabilities. Device composition is approximately 60-70% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for SE Epiphany Root Canal Sealant is a barium boro-silicate glass. This filler type provides the subject device with the required strength and radiopacity features. Product is supplied within automix dual barrel syringes for ease of dispensing directly into the restorative site.

The provided document is a 510(k) summary for a medical device (SE Epiphany Root Canal Sealant) and its FDA clearance letter. It does not describe an AI medical device or a study involving an AI algorithm. Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI device meets those criteria.

The document pertains to a dental root canal sealant and its substantial equivalence to a predicate device based on its intended function, composition, and manufacturing process. It's a traditional medical device submission, not one related to AI or algorithmic performance evaluation.

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Cement-It All Purpose product is intended for cementation of porcelain, resin and metal-based inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations.

The subject device is a self-etch adhesive resin cement in a catalyst/base paste formulation and is a dual cure luting agent. Due to its self-etching and adhering properties, Cement-It All Purpose does not require the use of an etchant, primer or adhesive. Device composition is approximately 65% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for Cement-It All Purpose is a barium borosilicate glass. This filler type provides the subject device with the required strength and radiopacity features. Product is supplied within automix dual barrel syringes for ease of dispensing directly into the restorative site.

This exemption refers to a 510(k) premarket notification for a dental cement product. For such submissions, the acceptance criteria are generally established through a comparison to a legally marketed predicate device, demonstrating substantial equivalence rather than through a standalone study with specific performance metrics and acceptance criteria.

Therefore, the provided documents do not contain the typical information one would find for a study that proves a device meets specific, quantitative acceptance criteria through a clinical or performance study with statistical endpoints. Instead, the "study" demonstrating performance is the comparison to a predicate device, supported by laboratory testing to ensure physical and chemical properties are comparable and safe.

Here's an analysis based on the provided text, outlining what can be inferred and what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, this document focuses on substantial equivalence rather than meeting specific quantitative acceptance criteria like those found in a clinical trial. The "acceptance criteria" here are implicitly that the new device performs "the same intended function" and has similar "safety and effectiveness" as the predicate device.

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The Avante LED curing light is used as a light activation system for dental restorative resins.

The Avante LED curing light performs the same intended function as its predicate device, Versalux (reference K010133). Both devices are both used as a light activation system for dental restorative resins.

The physical features of the Avante LED curing light provide the dentist with a compact shape and cordless design to facilitate ease of use while using standard light emitting diode technology for optimum curing functions. The Avante LED curing light provides minimum output of 1.000 MW/cm2 which results in typical curing times of 10 seconds for most composite materials. Peak output is measured at 470nm. Curing time can be set between 1- 40 seconds for greater versatility in individual applications.

Accessories include the Avante light guides which are available in four diameters to accommodate dentist preference and use.

The effective portability of the Avante LED curing light is maintained through use of a charging light which is incorporated into the device stand. Included as well in the charging light is a radiometer display to verify proper light output. Lithium-ion batteries power the device and provide 45 minutes on average between charging times.

This submission is for a medical device (Avante LED curing light), not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for AI/ML performance is not applicable. The provided text describes the device's function, physical features, and substantial equivalence to a predicate device, but does not include information about clinical trials or performance metrics in a way that would directly translate to the requested AI/ML-specific criteria.

The submission focuses on establishing substantial equivalence to a legally marketed predicate device (Versalux, K010133) for its intended use as a light activation system for dental restorative resins.

However, I can extract the device's reported performance characteristics from the provided text:

Device Performance Information Extracted from the Text:

Since the request is about acceptance criteria and study that proves the device meets the acceptance criteria and the context is a 510(k) submission for a non-AI/ML medical device, the "study" demonstrating it meets acceptance criteria for this type of device is typically a device comparison/equivalence study rather than a clinical outcome study. The provided document states:

• "The Avante LED curing light performs the same intended function as its predicate device, Versalux (reference K010133)."
• "A review for safety and effectiveness was performed and found not to have been affected."
• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This indicates that the device was deemed acceptable due to its substantial equivalence to a predicate device, rather than through a a trial with a defined test set, experts, and ground truth as would be relevant for an AI/ML device.

Therefore, for the specific questions related to AI/ML device validation:

1. A table of acceptance criteria and the reported device performance: See table above for device performance. Acceptance criteria for this type of device would generally relate to performance specifications (light output, wavelength, curing time range, battery life) and safety, largely demonstrated through engineering testing and comparison to the predicate. The document doesn't explicitly list "acceptance criteria" values against which performance is measured, but rather states the device's capabilities.
2. Sample size used for the test set and the data provenance: Not applicable for this type of device submission's "study."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device submission's "study."
4. Adjudication method: 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.
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: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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