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Premise Flowable Modified is a nano-filled, light cure, resin dental restorative suitable for Class I - V restorations. Additional functions include: base/liner material, repair of enamel defects, repair of temporaries, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing area, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions and core build-ups.

Premise Flowable Modified is a medium viscosity, light-cured, nano filled, resin restorative material, dispensed in a syringe with single-use tips. It is suitable for Class I - V restorations. This nano composite technology incorporates three different fillers resulting in a flowable, yet sculptable and non-slumping material.

The provided text is a 510(k) summary for a dental restorative material. It does not contain information about acceptance criteria, device performance metrics, or any studies involving a test set, expert ground truth, or human-AI comparison.

The document discusses the device's name, description, intended use, and claims of substantial equivalence to a legally marketed predicate device (Premise Flowable by Kerr Corporation). It also includes the FDA's clearance letter.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and a study proving the device meets them, as that information is not present in the provided text. This document is a regulatory submission summary, not a scientific study report.

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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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Premise Flowable is a nano-filled, light cure, resin dental restorative suitable for Class I - V restorations. Additional functions include: base/liner material, repair of enamel defects, repair of temporaries, repair of porcelain restorations, minor occlusal build-ups in nonstress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.

Premise Flowable is a nano-filled, light-cure, resin restorative material dispensed in a syringe with single-use tips. Premise Flowable uses pre-polymerized filler and nanofillers combined with proven Point 4 technology to deliver strength and durability.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary for a dental restorative material called "Premise Flowable," outlining its intended use, description, and claiming substantial equivalence to predicate devices, but it does not detail specific performance studies or acceptance criteria for those studies.

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

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

This 510(k) summary (K032921) describes a dental composite restorative material called "Premise." It primarily focuses on demonstrating substantial equivalence to a predicate device ("Point 4 Modified") and does not contain detailed information about specific acceptance criteria and a study proving those criteria are met for the new device.

The document is a 510(k) premarket notification, which means the manufacturer is essentially stating that their new device is as safe and effective as a legally marketed predicate device. This process typically relies on demonstrating similar performance characteristics to the predicate device, rather than conducting new, extensive clinical trials to establish novel acceptance criteria or device performance.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, and expert adjudication are not provided in this regulatory document.

However, I can extract the information that is present and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific quantitative acceptance criteria (e.g., "Polishability score > X," "Flexural strength > Y MPa") are not provided. The document relies on qualitative claims of "similar to" or "designed to offer" in comparison to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. 510(k) summaries often do not include the raw data or detailed study designs for performance tests if the substantial equivalence is primarily based on material composition and intended use similarity to a well-established predicate.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided as there is no mention of a specific "test set" and "ground truth" establishment in the context of expert human review for a new device study. The document focuses on material properties and intended use.

4. Adjudication Method

This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided. MRMC studies are typically for imaging or diagnostic devices where human interpretation is a key factor. This device is a dental restorative material.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable/not provided. This is a physical dental material, not an algorithm.

7. Type of Ground Truth Used

This information is not provided as no specific study in the context of establishing "ground truth" for a new device's performance is detailed. The substantial equivalence relies on comparison of material properties and intended use to an existing predicate. For material properties, "ground truth" would typically refer to laboratory measurements against established standards.

8. Sample Size for the Training Set

This information is not applicable/not provided. There is no "training set" in the context of an AI/ML algorithm for this physical dental material.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided.

Summary of the Study Discussed in the Document (Focus on Substantial Equivalence):

The document effectively describes the study for substantial equivalence. This "study" is the process of comparing the new device, "Premise," to a legally marketed predicate device, "Point 4 Modified."

• Objective: To demonstrate that "Premise" is substantially equivalent to "Point 4 Modified" in terms of safety and effectiveness.
• Methodology: The submission highlights that "Premise" "functions in a manner similar to and is intended for the same use as Point 4 Modified." This typically involves comparing:
  • Intended Use: Both devices are for "use in all classes of cavities."
  • Device Description/Technological Characteristics: Premise uses "three types of fillers" to offer "high polishability, high mechanical strength, and decreased polymerization shrinkage," implying these characteristics are comparable to or improved upon the predicate.
  • Performance Data: While not explicitly detailed, in a 510(k) for a material, this would generally involve laboratory testing of properties like:
    • Flexural Strength
    • Compressive Strength
    • Radiopacity
    • Depth of Cure
    • Wear Resistance
    • Polymerization Shrinkage
    • Water Sorption/Solubility
    • Polishability retention
    • Biocompatibility (often by referencing components known to be biocompatible in other devices)

Conclusion from the Document: The FDA reviewed the 510(k) submission and determined that "Premise" is substantially equivalent to the predicate device, allowing it to be marketed. This determination is based on the information provided by the manufacturer, which presumably included data comparing the new device's characteristics to the predicate's established performance. The document itself does not present the detailed results of these comparative tests.

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