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Take I is an addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.

The device is an addition-cure vinyl polysiloxane dental impression material that is used for all crowns and bridges, edentulous, orthodontic and implant impression techniques. Take 1 is a two-part, base/catalyst - paste/paste system. The product is available in three viscosities, Wash, Tray, and Medium.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) summary for a dental impression material named "Take 1," confirming its substantial equivalence to a legally marketed predicate device.

The document includes:

• Contact information for the submitter.
• Device name, common name, and classification name.
• Identification of the predicate device (Kerr Corporation, Kerr VPS Impression Material).
• Device description and intended use.
• A statement of substantial equivalence to other legally marketed devices.
• FDA's letter acknowledging the 510(k) premarket notification and confirming substantial equivalence.
• Information regarding regulatory compliance and contact details for further inquiries.
• An "Indications for Use" statement for the device.

There is no information regarding specific performance metrics, acceptance criteria, study methodologies, sample sizes for testing or training, expert qualifications for ground truth establishment, adjudication methods, or results of MRMC or standalone studies.

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Premise Modified is a dental composite restorative material intended to be used in all classes of cavities.

The device is a light cured resin based composite dental restorative designed for direct placement. By utilizing three types of fillers, Premise Modified is designed to offer high polishability, high mechanical strength, and decreased polymerization shrinkage.

The provided text is a 510(k) summary for a dental composite restorative material called "Premise Modified." This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way an AI/ML device would. Instead, it focuses on demonstrating that the new device (Premise Modified) is substantially equivalent to an existing device (Premise) based on its intended use, design, and function.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study to prove device performance as it does not exist in the provided text for this type of medical device submission. The questions like "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone algorithm performance," "type of ground truth used," "sample size for the training set," and "how ground truth for the training set was established" are not applicable to this document because it is not describing an AI/ML device or a performance study with such metrics.

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DMC Composite High Viscosity is intended for direct restorations of all caries classes. Additional indications include core buildup material, repair of porcelain restorations, and repair of composite restorations.

DMC Composite Low Viscosity is intended for Class I and II (base/liner), Class III and Class V restorations. Additional indications include pit and fissure sealant, repair of enamel defects, repair of porcelain restorations, blocking out of undercuts, minor occlusal build-ups in non-stress bearing areas and incisal abrasions.

DMC Composite is a light-cure resin composite offered in both high viscosity and low viscosity formulations, and is indicated for all caries classes. This product contains 82% filler by weight and is radiopaque.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a dental composite material, focusing on its substantial equivalence to previously marketed devices. It describes the device, its intended use, and the FDA's decision regarding its market clearance. It does not include details about specific performance studies or acceptance criteria that would typically be found in a clinical trial report or a detailed performance testing document.

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StandOut 2 is an impression material system intended for use on all crown and bridge, edentulous, orthodontic and implant impressions.

StandOut 2 is a dental impression material system that is suitable for all crown and bridge, edentulous, orthodontic and impressions StandOut2 is a two-part, base/catalyst -paste/paste system. The product is available in two viscosities, Wash and Tray.

This 510(k) summary for K072622 describes a dental impression material (StandOut 2) and asserts its substantial equivalence to a predicate device (StandOut). The provided document does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria.

Instead, it focuses on the administrative process of 510(k) clearance, device description, intended use, and substantial equivalence to a legally marketed predicate device.

Therefore, I cannot provide a response with the requested information as it is not present in the provided text. The document does not describe performance testing against specific acceptance criteria.

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The Demetron I.D.S. is a L.E.D. visible light curing unit intended for polymerization of light cure materials by dental professionals.

The LED based Demetron I.D.S. Curing Light is a device used for the polymerization of dental materials. It consists of an LED curing handpiece and flexible cord designed to be connected to a dental chair unit. The plastic molded handpiece will contain an LED light "engine", a cooling fan and a printed circuit board. A digital circuit and microprocessor will be utilized to control 2 different curing modes and power to the LED. Each mode specifies LED curing output timing, fan timing and audible beep timing. A pushbutton "trigger" switch will be used to select the curing mode and activate the LED curing output. The dental chair manufacturer's transformer or power supply will provide power for the handpiece.

Here's an analysis of the provided text regarding the Demetron I.D.S. L.E.D. Curing Light, focusing on your requested information:

Unfortunately, the provided document (K042888) is a 510(k) summary for a dental light-curing unit, not an AI/algorithm-based diagnostic or triaging device. Therefore, the questions related to acceptance criteria for algorithmic performance, ground truth, expert adjudication, sample sizes for AI training/testing, or MRMC studies are not applicable to this type of device.

The 510(k) submission process for a device like a curing light focuses on demonstrating substantial equivalence to a predicate device already on the market, primarily based on similar intended use, technology, and safety/performance characteristics. It does not typically involve the rigorous statistical studies of diagnostic accuracy, sensitivity, and specificity that would be required for an AI-powered device.

However, I can extract the relevant information that is present in the document.

Device: Demetron I.D.S. L.E.D. Curing Light

Device Type: Ultraviolet activator for polymerization (L.E.D. Curing Light)

Intended Use: For the polymerization of visible light cured materials by dental professionals.

Predicate Device: Kerr Corporation, L.E. Demetron

Reason for K042888: To demonstrate substantial equivalence to the predicate device.

Here's how I can answer your questions, highlighting where they are not applicable to this specific device:

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

For a dental curing light, acceptance criteria are generally related to its ability to cure dental materials effectively and safely, matching the performance of a predicate device. This would typically involve measuring light output, wavelength, and the ability to cure various dental resins within specified times. The provided 510(k) summary does not contain a specific table of acceptance criteria or detailed performance data in the way you might find for an AI algorithm. Instead, it relies on the assertion that its function is "similar to" and its intended use is "the same as" the predicate device, implying it meets the same general performance standards.

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

Not Applicable. The 510(k) summary does not describe a "test set" in the context of evaluating an AI algorithm's performance. For a medical device like a curing light, physical and electrical testing would be performed, but this is not typically presented as a "test set" in the same statistical sense for regulatory submissions.

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)

Not Applicable. Ground truth, in the context of algorithms relying on expert interpretation, is not relevant for a dental curing light. Its function is physical (light emission for polymerization), not diagnostic or interpretive.

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

Not Applicable. As there is no "test set" from an algorithmic performance perspective, no adjudication method was used.

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. An MRMC study is designed for evaluating diagnostic devices that assist human readers (e.g., radiologists, pathologists). A dental curing light does not involve human readers' interpretation or an AI component to assist them.

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

Not Applicable. There is no algorithm in this device that would have standalone performance. The device is a physical tool.

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

Not Applicable. As explained above, the concept of "ground truth" for a physical device like a curing light is not relevant. Its performance is evaluated through engineering specifications and the demonstration of equivalent curing capability through laboratory tests (e.g., depth of cure, material hardness), which are not described in detail in this summary but are implied by substantial equivalence.

8. The sample size for the training set

Not Applicable. This device does not use machine learning or AI, and therefore has no "training set."

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

Not Applicable. As there is no AI component or training set, there is no ground truth to establish for such a set.

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Stand Out is an addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous and implant impression techniques.

The device is an addition-cure vinyl polysiloxane dental impression material that is used for all crowns and bridges, edentulous and implant impression techniques. Stand Out is a two-part, base/catalyst - paste/paste system. The product is available in two viscosities, Wash and Tray.

The provided text is a 510(k) Summary of Safety and Effectiveness for a dental impression material named "Stand Out." It contains information about the device's name, common name, classification, predicate devices, device description, and intended use. However, it does not include any information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical studies (such as MRMC or standalone studies).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document focuses on regulatory submission for substantial equivalence rather than reporting detailed study results or performance metrics.

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The Demetron LC is a visible curing unit intended for polymerization of light cure materials and activation of dental bleaching materials.

The Demetron LC curing light is a device used for the polymerization of dental materials. It consists of a gun and a base stand connected by a cord. The base stand will contain an on/off switch, a gun hanger, and a beeper that generates an audible tone at ten second intervals. The gun trigger will turn the light on until the trigger is actuated again to turn off. The fan will run continuously whenever the unit is on.

This looks like a 510(k) premarket notification for a dental curing light, which is a device for polymerization of dental materials, not an AI/ML powered device. As such, the concepts of "acceptance criteria," "study," "ground truth," "training set," and "test set" as they relate to AI/ML device performance are not applicable in this context.

The document describes the device, its intended use, and claims substantial equivalence to another legally marketed device (Kerr Corporation, Optilux 400). The FDA's review confirms this substantial equivalence.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth, as these are evaluation metrics for AI/ML performance and are not found in this type of submission for a non-AI/ML medical device.

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Ask a specific question about this device

Ask a specific question about this device