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The Bluemoon is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photopolymerized in the 385~515nm waveband of visible light.

The Bluemoon Dental Curing Light is an instrument for photopolymerizing dental materials and starting agents by irradiating them with visible light between 385-515nm wavelength. It offers four modes (HYPER, TURBO, LOW, and SOFT START) depending on the output intensity and irradiation time.

The FDA 510(k) clearance letter for the Bluemoon Dental Curing Light provides information on several aspects of device testing, but it does not detail acceptance criteria for all performance metrics, nor does it present the study in a format that directly addresses the specific questions about AI/human-in-the-loop and ground truth establishment for AI models. This device is a dental curing light, a hardware device, not an AI/ML software. Therefore, the concepts of "AI assistance," "human readers," "test set," "training set," "ground truth" as typically defined for AI/ML performance studies are not directly applicable here.

However, I can extract and interpret the provided information to answer the relevant questions as best as possible for a hardware medical device.

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

The document lists "Performance Data" which includes various properties and their corresponding values. These values can be interpreted as the acceptance criteria for those specific properties, and the implicit reported performance is that the device meets these criteria, as stated in the conclusion.

1. Purple: 400nm ± 5%
2. Blue: 455nm ± 5% | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device met these wavelength specifications.) |
   | Polymerization strength measurement | ≥ 80 MPa | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device achieved ≥ 80 MPa.) |
   | Depth of cure | ≥ 2.0 mm | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device achieved ≥ 2.0 mm.) |
   | Light Probe temperature | ≤ 41 ℃ | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device maintained ≤ 41 ℃.) |
   | Energy-saving mode | 60 ± 2s | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device functioned within 60 ± 2s for energy-saving mode.) |
   | Turn off energy-saving mode | 1) Buzzer sounds once,
3. LCD on | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device demonstrated these behaviors.) |
   | Auto power off | 10 minutes ± 2 seconds | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device auto-powered off correctly.) |

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

The document describes "performance bench testing" but does not explicitly state the sample size (e.g., number of devices tested, number of dental material samples cured) for each test. Given it's a hardware device, the "test set" would refer to the units of the device and the materials it acts upon, rather than a dataset of clinical cases. The provenance of the data is not specified; however, the company is based in the Republic of Korea. The testing would be prospective (i.e., new tests conducted on the manufactured device) rather than retrospective clinical 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 question is not applicable to a hardware dental curing light. "Ground truth" for this device is established by objective physical measurements (e.g., wavelength, power output, temperature, polymerization depth and strength measured by calibrated instruments) rather than expert interpretation of images or clinical findings. Therefore, no experts in the sense of trained clinicians interpreting data were used for establishing ground truth for the performance tests.

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

This question is not applicable to a hardware dental curing light. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical or image-based studies where expert consensus is required for ambiguous cases. The performance tests for this device involve objective measurements.

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

This question is not applicable. The Bluemoon is a dental curing light, not an AI-powered diagnostic or assistive tool. It does not involve "human readers" or "AI assistance."

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

This question is not applicable. The Bluemoon is a hardware device; there is no standalone algorithm to evaluate.

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

For the performance data listed (Irradiation time, Peak wavelength, Polymerization strength, Depth of cure, Light Probe temperature, Energy-saving mode, Auto power off), the "ground truth" is established through objective physical measurements using calibrated instruments and standardized test methods. For biocompatibility, the ground truth is established by the results of specific biocompatibility tests (Cytotoxicity, Skin Sensitization, Intracutaneous reactivity) conducted according to ISO 10993 standards.

8. The sample size for the training set

This question is not applicable. The Bluemoon is a hardware device and does not involve a "training set" in the context of machine learning or AI models. Its design and manufacturing process are validated through engineering principles and bench testing.

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

This question is not applicable as there is no training set for this hardware device.

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For dental clinics treatment to irradiate polymer-based restorative materials to cure them. The instrument must only be used in hospital environments, clinics or dental offices, by qualified practitioners.

The LED Curing Lights (Model: DB686 HALO) is an oral device for repairing teeth. It uses the principle of light curing to make the dental repair resin material solidify rapidly under the action of light wave in the specific wavelength range (385~515nm), so as to fill the tooth cavity or bond the bracket. It is a cordless pen-style device, and consists of handpiece, LED cure tip, charging base, power adapter, eyes protector, eye protector unit and disposable protective sleeve. The LED Curing Lights protects the handpiece and LED cure tip from gross contamination and prevent cross infection between patients by applying the disposable protective sleeve. The disposable protective sleeve (patient contact part) is made of PP material.

The provided FDA 510(k) clearance letter and summary for the LED Curing Light (DB686 HALO) describes a device that uses light to cure dental materials. It is crucial to understand that this submission primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance and safety data, rather than conducting a comparative effectiveness study with human readers or presenting clinical trial data.

Therefore, many of the requested points, particularly those related to clinical studies, human reader performance, expert consensus, and ground truth establishment from patient data, are not applicable to this type of 510(k) submission for a non-diagnostic, non-AI device. The device is a direct energy device (light source) that acts on materials, not a diagnostic AI device that interprets images.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)

The "acceptance criteria" here are implicitly the standards and specifications that the device must meet to demonstrate substantial equivalence to its predicate devices. The "reported device performance" are the results of the non-clinical tests proving compliance with these standards.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details (Focus on Non-Clinical Demonstrations)

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

• For a device like an LED curing light, the "test set" and "data provenance" refer to the physical devices and materials tested in the non-clinical studies.
• The document does not specify the exact sample size (number of devices or material samples) used for each non-clinical test. This information would typically be detailed in the full test reports submitted to the FDA, but is summarized in the 510(k) summary.
• Data Provenance: The tests are described as "Non-clinical data" and "All nonclinical testing performed on new devices." This implies that the tests were conducted on the manufacturer's own (proposed) devices and materials as part of their design verification and validation activities. The country of origin for the data generation (testing laboratories) is not explicitly stated, but the applicant is based in China. The testing would be considered prospective in the sense that it was conducted specifically for this 510(k) submission.

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

• Not Applicable. This device is an active medical device (light source) for material polymerization and caries detection, not a diagnostic imaging AI algorithm. Therefore, there is no "ground truth" based on expert image interpretation or patient outcomes in the context of diagnostic accuracy, nor were human experts involved in establishing a "ground truth" for the performance testing of the device's physical parameters (e.g., light intensity, wavelength, electrical safety, biocompatibility, curing efficacy as measured by ISO standards). The "ground truth" for these tests is defined by the technical specifications and standards themselves.

4. Adjudication Method for the Test Set:

• Not Applicable. As there are no human readers or expert interpretations involved in the stated non-clinical performance and safety testing, there is no adjudication method required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No. An MRMC study is designed to evaluate how AI assistance impacts human reader performance (e.g., radiologists interpreting images). This device is a light curing unit, not a diagnostic AI system. Its clearance is based on demonstrating substantial equivalence in its ability to cure dental materials and meet safety standards, not on improving human diagnostic accuracy.

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

• Not Applicable. This is not an algorithm or software-only device. Its performance is measured as a standalone physical device (its light output, safety, biocompatibility, and ability to cure materials as per ISO standards).

7. The Type of Ground Truth Used:

• The "ground truth" for this device's acceptance is based on engineering and performance standards (e.g., ISO 10650, ISO 4049 for curing performance; IEC 60601 series for electrical safety; IEC 62471 for photobiological safety; ISO 10993 series for biocompatibility). The device's measured parameters must fall within acceptable ranges defined by these standards, and its performance must be comparable to the predicate devices.
• For the Caries Detection Mode (EAQ product code), while it's a diagnostic aid, the document doesn't detail specific "ground truth" for its diagnostic performance, rather it implies functional equivalence based on violet light emission for fluorescent reaction.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/machine learning device that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. As there is no training set for an AI model, this question is irrelevant to this device.

In summary, the 510(k) for the LED Curing Light (DB686 HALO) is a traditional submission focused on demonstrating technical conformity to established safety and performance standards and substantial equivalence to existing predicate devices through non-clinical testing. It does not involve AI, diagnostic image interpretation, multi-reader studies, or clinical trials for comparative effectiveness.

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LED Curing Light is intended for use by trained dental professionals only for the purpose of light curing dental resins and composites.

LED Curing Light is classified as an Ultraviolet Activator for Polymerization (21 CFR 872.6070). It is used for polymerization of dental light cured materials by dental professionals. The device is based on blue LED (light emitting diode) technology. It has four curing modes. Using different modes gives dental professionals the flexibility to polymerize virtually dental resins and composites.

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The LOOP™ is a source of illumination for curing photo-activated dental restorative materials and adhesives.

LOOP™ is a high-performance LED (Light Emitting Diode) light source for polymerization of dental materials used by trained dental professionals. It is suitable for use with a broad range of light-cured dental materials including materials for restoratives such as light-cured and dual-cure cements, composites, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations such as ceramic inlays. LOOP™ consists of a wireless handpiece and a charging base with an integrated calibration station. The device is a medical electrical device in accordance with IEC 60601-1-2. LOOP™ features a patented coaxial feedback sensing system that measures the actual irradiance, which is the light power striking the targeted tooth. The feedback data allows LOOPTM to make corrective adjustments to the LED power output hundreds of times per second. This continual corrected "closed loop" operation ensures that the targeted surface of the restorative dental material receives the intended irradiance independent of operator-induced distance variations.

This document is a 510(k) premarket notification for a dental device, the LOOP™ LED Curing Light System. It does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and study proving the device meets those criteria, specifically concerning AI/ML capabilities, human expert adjudication, or large-scale clinical performance studies.

The provided text primarily focuses on demonstrating substantial equivalence to a predicate device based on technical specifications, intended use, and general safety and performance testing. It does not describe an AI/ML-driven device or studies that would typically involve acceptance criteria related to algorithmic performance metrics (e.g., sensitivity, specificity, AUC), human reader studies, or expert ground truth establishment for such a device.

Here's why the document doesn't provide the requested information:

• Device Type: The LOOP™ LED Curing Light System is a physical dental curing light. It is described as having a "patented coaxial feedback sensing system that measures the actual irradiance" and makes "corrective adjustments to the LED power output." This describes a control system, not an AI/ML algorithm that makes diagnoses, predictions, or image interpretations.
• Performance Data: The "Performance Data" section lists various engineering, electrical safety, biocompatibility, and software verification/validation tests. These are standard tests for medical devices, particularly electronic hardware. It explicitly states, "No animal or clinical studies were conducted." This confirms that no clinical performance study, particularly one involving human readers or comparative effectiveness, was performed or submitted.
• Lack of AI/ML Specifics: There is no mention of algorithms, machine learning models, training data, test data, ground truth establishment by experts, or any of the typical components of an AI/ML device submission. The "Software Verification and Validation Testing" section refers to software as a "moderate" level of concern due to potential minor injury from failure, which is standard for embedded software in medical devices, not for AI/ML functionality.

Therefore, I cannot populate the requested table or answer the specific questions about AI/ML study design, expert involvement, and performance metrics because this information is not present in the provided document.

The document describes a different type of device and a different type of substantial equivalence demonstration. If you are looking for information on AI/ML device approvals, this specific document does not provide such details.

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The MaxCure9 is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 385~515nm waveband of visible light.

This Curing Light is a device which generates high intensity light for polymerization of light curing materials used for dental curing purpose. This curing light is intended for use by trained dental professionals for the purpose of light curing dental resins and composites and used to restore teeth.

The provided text is a 510(k) summary for the MaxCure 9 Curing Light. This document focuses on demonstrating substantial equivalence to a predicate device, not on proving that the device meets specific performance acceptance criteria for an AI/Software as a Medical Device (SaMD) product.

Therefore, the information required to answer your questions about acceptance criteria for AI performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, is not present in this document.

The document primarily addresses:

• Device Description: The MaxCure 9 is a curing light used to polymerize dental materials.
• Comparison to Predicate: It compares the MaxCure 9 to the D-Lux+ predicate device, highlighting similarities and differences in features, specifications, and operation.
• Performance Data (Non-clinical): It lists the non-clinical tests performed, including biocompatibility, software validation, and electrical safety/EMC standards (e.g., IEC 60601-1, IEC 60601-1-2).
• Conclusion: It states that based on the similarities and test results, the device is substantially equivalent to the predicate.

In summary, this document is for a traditional medical device (a curing light), not an AI/SaMD. As such, the information you've requested regarding AI acceptance criteria and study details is not applicable to this specific submission.

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This "BASE290 LED Curing Light" is a dental curing unit utilizing visible light programmed for the polymerization of light curing materials in the wavelength range of 380-500 nm by dental professionals.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental curing light. It does not contain information about the acceptance criteria, study details, or performance metrics of a device, nor does it discuss ground truth, human experts, or AI.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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CL-DP40 (Dr's Light PRIME)/CL-DP40 (Dr's Light CHOICE)is a hand held LED polymerization light intended to cure dental composites using visible light.

This unit is a battery type wireless LED curing light. User can adjust light intensity and time by selecting six program modes. Both of Dr's Light PRIME and Dr's Light Choice are characterized by high power intensity, slim head height, large irradiation area (12mm), adjustable intensity power, highly readable color touch screen, 360° twistable head and big capacity of the battery.

The provided text describes a 510(k) premarket notification for a dental curing light, CL-DP40 (Dr's Light PRIME) / CL-DP40 (Dr's Light CHOICE). This submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the technical specifications of the predicate device, particularly the primary predicate, "Dr's Light 2" (K173157). The subject device is deemed substantially equivalent because its performance metrics are comparable or superior to the predicate.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of a clinical study with patients or samples. Instead, non-clinical tests were performed on the device itself.

• Sample Size: Not explicitly stated for each test (e.g., how many devices were tested for depth of cure, electrical safety).
• Data Provenance: The tests were non-clinical, likely conducted in a laboratory setting. There is no information regarding country of origin or whether they were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a dental curing light, and the evaluation did not involve human interpretation of medical images or data requiring expert-established ground truth. The "ground truth" for its performance is based on established engineering and materials science principles and measurements (e.g., light intensity, depth of cure).

4. Adjudication method for the test set

Not applicable, as there was no test set requiring expert adjudication for ground truth.

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 document is for a dental curing light, not an AI-powered diagnostic device. No MRMC study was conducted.

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 or AI. It is a manually operated medical device.

7. The type of ground truth used

The "ground truth" for the performance evaluation relies on:

• Physical measurements: For parameters like light intensity, peak wavelength, and depth of cure, standardized measurement techniques appropriate for dental curing lights would have been used. These measurements serve as the factual basis for performance.
• Engineering standards: Compliance with standards like IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (EMC & EMI) serves as the "ground truth" for electrical safety and electromagnetic compatibility.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, so there is no training set.

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

Not applicable, as there is no training set.

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The Coltolux Comfort LED Curing Light is indicated for the polymerization of intra- and extraoral dental restorations fabricated from materials (commonly referred to as visible light cured dental restoratives and/or composites and/or dental adhesives) that contain Camphorquinone as the photoinitiator.

The proposed Coltolux Comfort LED Curing Light (Coltolux Comfort) is used for the polymerization of light-cured resin materials used in dental restorations. The Coltolux Comfort incorporates a focused high-power LED to produce light in the "deep blue" spectrum (wavelength 440 - 470 nm) for activating Camphorquinone (CQ) photo-initiators. The device is utilized by placement of the lens within close proximity to the surface of the material to be cured, activation of the curing light via the pushbutton switch, and retention of the tip near the dental material until the composite is cured.

The provided text describes the 510(k) summary for the Coltolux Comfort LED Curing Light (K223142). Here's an analysis of the acceptance criteria and study information provided:

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

The document does not explicitly provide a table of acceptance criteria with corresponding device performance for specific quantitative metrics. Instead, it states that "Performance testing was conducted to verify that the proposed Coltolux Comfort Curing Light meets the requirements as defined in FDA Guidance Document 'Dental Curing Lights - Premarket Notification [510(k)' and in accordance with IEC 60601-1-2."

It lists the types of non-clinical tests performed:

• Light output uniformity and dropoff testing
• Peak wavelength testing (ISO 10650:2018)
• Irradiance output (ISO 10650:2018)
• Depth of cure
• Endurance testing
• Light attenuation through barrier sleeve
• Light shield filtration
• Life testing
• Duty cycle (IEC 60601-1:2012)
• EMC (IEC 60601-1-2:2014)
• Electromagnetic disturbances (IEC 60601-1-2:2014)
• Photobiological safety (IEC 62471:2006)

The conclusion states: "Based on the non-clinical performance data the proposed Coltolux Comfort Curing Light is as safe, as effective, and performs as well as or better than the predicate device Coltolux LED Curing Light (K040551, 21 CRF 872.6070, product code EBZ)." This implies that the device met the acceptance criteria defined by the listed standards and guidance documents, but the specific numerical targets and measured results are not detailed in this summary.

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

The document focuses on non-clinical performance testing (bench testing). Therefore, the concept of "test set" in terms of subject data (like in a clinical trial) is not directly applicable. For bench testing, test articles (the devices themselves) are used. The sample size for these component-level tests (e.g., number of devices tested for endurance, light output) is not specified in this summary. The provenance of this bench testing data would typically be the manufacturer's lab, often in the country of origin of the manufacturer (Switzerland) or a contracted testing facility. The nature of these tests is inherently prospective as they are performed specifically to evaluate the new device.

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 is not applicable as the summary describes non-clinical, bench testing of a dental curing light, not an AI or diagnostic device that requires expert ground truth for interpretation of clinical data.

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

This is not applicable for the same reasons as #3. Adjudication methods are used in clinical studies, particularly for diagnostic devices, to establish a consensus ground truth from expert readings.

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

This is not applicable. The device is a dental curing light, not an AI-assisted diagnostic or interpretative tool.

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

This is not applicable. The device is a physical medical device (a curing light), not an algorithm.

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

For the non-clinical tests, the "ground truth" or reference standards are derived from established international standards (e.g., ISO 10650:2018, IEC 60601-1:2012, IEC 60601-1-2:2014, IEC 62471:2006) and FDA guidance documents. For instance, irradiance output is measured against defined limits or performance of a predicate device according to the ISO standard. Depth of cure would be assessed against a material's known curing characteristics.

8. The sample size for the training set

This is not applicable as the device is not an AI/machine learning product and therefore does not have a "training set" in that context.

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

This is not applicable for the same reason as #8.

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

The LED Curing Light is used for light curing polymerization of dental composites, luting materials, cements and other light cured materials. The device is a cordless pen style, LED light polymerization device for use by dental professionals in dental offices or dental laboratories.

The LED Curing Light protect the handpiece from gross contamination and prevent cross infection between patients by applying the single use protective sleeve. The protective sleeve (patient contact part) is made of PP material.

DB686 NANO:
The LED Curing Light DB686 NANO adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of handpiece, cure tip, battery pack, charging base, adapter and protective sleeve. The handpiece contains the Rotary switch, Indicator light and Start key.

The LED Curing Light DB686 NANO has one mode namely: Curing light mode.

DB686 SWIFT:
The LED Curing Light DB686 SWIFT adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of handpiece, cure tip, battery, charging base, adapter and protective sleeve. The handpiece contains the Power/Start button, Mode/ Timer button and LED Display.

The LED Curing Light DB686 SWIFT integrates three modes namely: soft up mode, high power mode and orthodontic mode.

The provided text describes a 510(k) premarket notification for a medical device called "LED Curing Light" (models DB686 NANO and DB686 SWIFT). It aims to demonstrate substantial equivalence to a predicate device (D-Lux+) and a reference device (Bluephase Style 20i) rather than presenting a study where the device meets specific acceptance criteria in a clinical or performance assessment.

Therefore, much of the requested information (acceptance criteria table, sample size, ground truth, expert qualifications, MRMC study, standalone performance) is not available in this document. The document focuses on regulatory compliance and comparison to existing devices.

Here's an attempt to extract the relevant information based on the prompt's structure:

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

This document does not present a table of acceptance criteria and reported device performance in the typical sense of a clinical study or a specific performance benchmark for the device itself. Instead, it demonstrates compliance with recognized medical device standards and outlines the specifications of the proposed device compared to predicate devices to establish substantial equivalence.

The "acceptance criteria" here are essentially the standards the device was tested against to confirm its safety and effectiveness, inferred from the non-clinical tests. The "reported device performance" is given in terms of features and conformity to these standards.

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

The document does not specify a "test set" in the context of clinical data or performance data with a specific sample size. The tests conducted are non-clinical, related to compliance with standards (e.g., biological evaluation, electrical safety). The nature of these tests does not typically involve sample sizes in the same way clinical studies do. The data provenance is implied by the testing against international standards, but specific country of origin or retrospective/prospective nature isn't stated for the non-clinical tests.

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. This document refers to non-clinical tests and demonstrations of compliance with standards, not a study involving expert-established ground truth for a test set of data.

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

Not applicable. There is no mention of a test set requiring adjudication in the context of this 510(k) submission.

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. The device is an "LED Curing Light," which is a physical device used for polymerization, not an AI-assisted diagnostic or interpretative tool. Therefore, an MRMC study or AI-related effectiveness is not relevant.

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

Not applicable. The device is a physical LED curing light and does not involve an algorithm working in "standalone" mode.

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

Not applicable. For the non-clinical tests, "ground truth" would be defined by the technical specifications of the device and the requirements of the standards themselves (e.g., a certain current tolerance for electrical safety, or lack of cytotoxic effect in a cell culture test). There is no "expert consensus" or "pathology" in the context of this device's non-clinical testing.

8. The sample size for the training set

Not applicable. This is a 510(k) submission for a physical medical device, not an AI/machine learning model, so there is no training set.

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

Not applicable. As there is no training set, this question is not relevant.

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The CuringPen Dental Curing Light is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 380~515nm waveband of visible light.

This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel and not used in the oxygen-rich environment.

The CuringPen Dental Curing Light is designed to polymerize all photo-activated dental materials in the wavelength range of 380-515 nm per ISO 10650:2018. It is a cordless pen-style, LED light polymerization device, and must only be used in hospital environments, clinics or dental offices by qualified dental personnel and not used in the oxygen-rich environment.

This document describes the premarket notification for the CuringPen Dental Curing Light. The information provided is for a traditional 510(k) submission, demonstrating substantial equivalence to a predicate device, not an AI/ML software device study. Therefore, many of the requested categories related to AI/ML software performance studies are not applicable.

Here's an attempt to answer the questions based on the provided text, indicating "Not Applicable" or "Not Provided" where relevant for AI/ML specific criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

This is not an AI/ML study involving a test set of data. This is a medical device clearance.

• Test Set Sample Size: Not Applicable for an AI/ML test set. The performance testing was conducted on the device itself.
• Data Provenance: Not Applicable. The testing was conducted internally or by accredited labs on the physical device.

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

This is not an AI/ML study.

• Number of Experts: Not Applicable.
• Qualifications of Experts: Not Applicable. Performance was measured against established physical and electrical properties, and biological safety standards.

4. Adjudication Method for the Test Set

This is not an AI/ML study.

• Adjudication Method: Not Applicable. Performance was measured objectively against engineering and biological standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, a multi-reader, multi-case comparative effectiveness study was not done. This device is a dental curing light, not an AI/ML diagnostic or assistive tool for human readers.
• Effect Size of Human Readers' Improvement with AI: Not Applicable.

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

• Standalone Study: Not Applicable. This is a physical device, not an algorithm. Performance tests were conducted on the device itself (standalone in terms of being tested independently).

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on established engineering standards, physical measurements, and biological safety standards.

• Engineering Standards: ISO 10650:2018 (dental curing lights), IEC 60601 series (electrical safety and EMC).
• Biocompatibility Standards: ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization, irritation).
• Specific Device Performance: Measured irradiance, wavelength, depth of cure, heat generation.

8. The Sample Size for the Training Set

This is not an AI/ML study.

• Training Set Sample Size: Not Applicable. There is no AI/ML model being trained.

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

This is not an AI/ML study.

• Ground Truth for Training Set: Not Applicable.

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