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With its "Polywave" LED with broadband spectrum, Bluephase PowerCure is suitable for the polymerization of all light-curing dental materials curing in the wavelength range of 385-515 nm. These materials include restoratives, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations, such as ceramic inlays.

Bluephase® PowerCure is an LED curing light that produces blue light. It is used for the polymerization of light-curing dental materials immediately in the oral cavity of patients. The intended place of application is in the dental practice, medical practice or in the hospital by the dentist or dental assistant. The curing light must only be operated by trained dental personnel.

• The handpiece has the shape of a pen
• Operational notes: 4 programs (3s, Turbo, High, PreCure)
• Light source: Polywave LED
• Power Source: Li-lons batterv

Here's a breakdown of the acceptance criteria and study information for the Ivoclar Vivadent Bluephase PowerCure, based on the provided FDA 510(k) summary:

This device is not an AI/ML device, therefore some of the requested information (like expert readers, stand-alone performance, MRMC studies, or training set details) are not applicable. The document focuses on demonstrating substantial equivalence to a predicate device primarily through technical specifications, safety standards, and functional equivalence for a non-AI medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Notes on "Reported Device Performance": For a 510(k) submission, "reported device performance" typically refers to how the new device matches or exceeds the performance characteristics of the predicate device, or meets relevant recognized standards. The summary indicates that the Bluephase PowerCure either has "no difference" or "conforms to the current version of the same standards" or offers an "innovation... with higher irradiance" but still achieves the same functional objective.

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

• Sample Size: Not explicitly stated for specific test sets in this summary document.
• Data Provenance: The document does not specify country of origin for testing data. The "study" itself is a comparison to a predicate device and adherence to recognized standards. It's a regulatory submission, not a clinical trial with a "test set" in the traditional sense of patient data. The testing mentioned pertains to engineering, electrical safety, software, and sterilization validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable. This is a dental curing light, not a diagnostic device requiring expert interpretation of results, nor does it involve a "ground truth" derived from expert consensus in a clinical context. The "truth" is established by adherence to technical specifications and recognized standards.

4. Adjudication Method for the Test Set

• Not Applicable. See explanation above.

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. This device is an LED polymerization light and does not involve AI or human readers for diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This device does not use an algorithm for diagnostic purposes. Its standalone performance is demonstrated by its physical and electrical specifications (e.g., light irradiance, wavelength, safety standards).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for this device's performance is established by:
  • Technical Specifications: Measuring the irradiance, wavelength, and other physical properties to ensure they meet the design specifications and are suitable for the intended use (polymerization of dental materials).
  • Compliance with Recognized Standards: Adherence to standards like IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility), and ISO 14937 (Sterilization).
  • Functional Equivalence: Demonstrating that the device performs the same function as the legally marketed predicate device (Bluephase Style 20i) and reference device (VALO Grand Corded) in polymerizing dental materials.

8. The Sample Size for the Training Set

• Not Applicable. This device is not an AI/ML device that requires a training set.

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

• Not Applicable. See explanation above.

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With its "Polywave" broadband spectrum, Bluephase® Style 20i is suitable for the polymerization of all light curing dental materials curing in the wavelength range of 385-515 nm. These materials include restoratives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations, such as ceramic inlays.

Bluephase® Style 20i is an LED polymerization light that produces energy-rich blue plight. It is used for the polymerization of light-curing dental materials immediately at the dental unit. It consists of 1 Polywave LED in the probe.

• The handpiece has the shape of a pen
  Operational notes: 2 programs (Turbo, High Power)
  Light source: Polywave LED
  Power source: Li-Po battery

The provided text is a 510(k) premarket notification for a medical device called "Bluephase Style 20i," a dental light-curing unit. It does not contain specific details about acceptance criteria, device performance tables, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for an AI/ML-based medical device.

The document primarily focuses on establishing substantial equivalence to a predicate device (Bluephase 20i) based on:

• Indications for Use: Both devices are for polymerization of light-curing dental materials.
• Working Principle: Both use an LED polymerization light to cure dental materials.
• Material Composition: Stated as "No difference."
• Electrical Safety: Both conform to the same IEC standards.
• Biocompatibility: Stated that construction materials are substantially the same as the predicate.
• Software Validation: Mentions full validation and adherence to FDA guidance, but no performance metrics.
• Bench Testing: Confirmed the heat sink switch-off temperature met design specifications.

The document is a regulatory submission for a physical device, not an AI/ML software as a medical device. Therefore, the information requested in your prompt regarding AI/ML device testing (e.g., ground truth, MRMC studies, standalone performance) is not applicable or present in this document.

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For light curing polymerization of light-curing dental materials curing in the wavelength range of 385-515 nm. These materials include restoratives, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting mateirals for brackets and indirect restorations, such as ceramic inlays.

Not Found

This document is a 510(k) clearance letter from the FDA for a dental curing light, the Bluephase® Style. It approves the device based on substantial equivalence to existing devices. However, this type of document does not contain the detailed study information, acceptance criteria, or performance data that you are requesting.

The FDA 510(k) clearance process primarily assesses whether a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics, or if it has different technological characteristics, that it does not raise different questions of safety and effectiveness and that the data demonstrate that the device is at least as safe and effective as the legally marketed device. This often relies on a comparison to predicate devices rather than requiring extensive new clinical trials with detailed performance metrics and statistical analyses as would be found in a PMA (Premarket Approval) application.

Therefore, I cannot extract the information you requested from this document. The document only confirms the device's clearance and its intended use.

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For the polymerization of light-curing dental materials curing in the wavelength range of 380-515 nm.

Not Found

This document is an FDA 510(k) clearance letter for the bluephase® 20i, an ultraviolet activator for polymerization, and does not contain the detailed information required to fill out the table and answer the questions about acceptance criteria and a study proving device performance.

The FDA letter confirms that the device is substantially equivalent to a legally marketed predicate device, but it does not provide:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test or training sets.
• Information on data provenance.
• The number or qualifications of experts for ground truth.
• Adjudication methods.
• Whether MRMC or standalone studies were performed, or their results.
• The type of ground truth used.
• How ground truth for training data was established.

This kind of detailed performance data and study methodology is typically found in the 510(k) submission itself or in a separate clinical or performance study report, which is not part of this FDA clearance letter.

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For light curing polymerization of dental composites, luting materials, cements and other light cured materials.

Not Found

This document is a 510(k) clearance letter from the FDA for a dental light-curing device called "Bluephase 16i." It certifies that the device is substantially equivalent to legally marketed predicate devices.

The letter does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed presentation of performance studies against acceptance criteria.

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Bluephase® is a hand held LED polymerization light intended to cure dental composites using visible light.

Bluephase® is a hand held LED polymerization light

I am sorry, but the provided text does not contain the detailed information necessary to complete the request. The document is essentially an FDA clearance letter for a dental curing light, "Bluephase®", and while it confirms the device's classification and substantial equivalence, it does not include studies, acceptance criteria, sample sizes, or ground truth information relevant to AI/ML device performance. Therefore, I cannot generate the table or the detailed breakdown of a study's methodology as requested.

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