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

LOOP™ is a LED (Light Emitting Diode) light source for polymerization of dental materials for use 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 LOOP™ 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.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the LOOP LED Curing Light System (K200775).

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and performance data for every aspect of the device. Consequently, some of the requested information (especially for AI/ML-specific questions like MRMC studies, ground truth establishment, or training set details) will not be present as this is a physical medical device, not an AI/ML-driven one.

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a typical pass/fail numerical sense for the entire device. Instead, it compares specific technical characteristics of the LOOP device to its predicate device, VALO Cordless Dental Curing Light (K110582), to demonstrate "substantial equivalence." The "acceptance" is implied by the similarity and non-inferiority to the predicate.

Here's a table based on the comparisons provided, with the understanding that "performance" here refers to the characteristics that were compared for substantial equivalence.

Study Details

This device is not an AI/ML-driven device; therefore, questions pertaining to AI/ML specific aspects like ground truth, training sets, experts, or MRMC studies are not applicable. The studies performed are standard engineering and safety tests for a medical device.

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

• Irradiance Comparison: The document mentions "Comparative testing was performed by Garrison Dental Solutions for evaluation of the published irradiance outputs." It doesn't specify the sample size of devices or materials tested.
• Biocompatibility: The tests used Hartley Guinea Pigs for hypersensitivity and New Zealand White Rabbits for intracutaneous reactivity. The exact number of animals is not specified in this summary.
• Mechanical & Engineering Testing: No specific sample sizes for units tested are provided for the various mechanical and engineering tests listed.
• Data Provenance: The studies were conducted by Garrison Dental Solutions, LLC. The country of origin of the data is not specified but is implicitly the USA where Garrison Dental Solutions is located. The studies are prospective in nature, as they involve testing the newly developed 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)

• Not applicable. This is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for performance is based on established engineering standards and comparison to a legally marketed predicate device.

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

• Not applicable. This is not an AI/ML device requiring adjudication of expert interpretations.

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

• No, a MRMC study was not done. This device is a physical curing light, not an AI-assisted diagnostic or interpretive tool.

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

• Not applicable. This device is a physical curing light. Its "performance" is its ability to cure dental materials, not an algorithm's output. The "standalone" performance is assessed through its physical characteristics and direct measurements (e.g., irradiance output).

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

• Not applicable in the AI/ML sense. The "ground truth" for the device's technical specifications and safety is based on:
  • Engineering Standards: Adherence to IEC standards (e.g., IEC 60601-1 for electrical safety).
  • Material Science Principles: Verification of curing capabilities against known properties of dental materials.
  • Biocompatibility Standards: ISO 10993 standards.
  • Predicate Device Performance: The established, legally marketed performance of the VALO Cordless Dental Curing Light (K110582).

8. The sample size for the training set

• Not applicable. This device does not use machine learning algorithms that require a "training set."

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

• Not applicable. As above, there is no training set for a machine learning algorithm.

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

LED Curing Light is used to restore teeth on dental patient. The device can only be used by the dentist who is qualified and well trained. This product is used on dental patient in the place of hospital or professional medical site.

LED Curing Light adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of high-power LED, main unit, curing light shield, charger and charge station. The main unit contains the ON/OFF button, display screen, mode button and time button.

LED Curing Light provides TURBO mode and NORMAL mode with different preset exposure time. The high-power LED can produce visible blue light in the 430nm to 490nm waveband of spectrum with a power density of 1000m W/cm² to 1800m W/cm². Using different modes gives dental professionals the flexibility to polymerize virtually almost all types of composites, boding agents and sealants available in the market.

The enclosure of main unit was composed of ABS material and Aluminum, and the light guide base (patient contact part) was made from ABS material.

Here's a breakdown of the acceptance criteria and study information for the LED Curing Light, Model CV-215, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a Class II medical device, the "acceptance criteria" are primarily based on established performance standards and comparability to a predicate device, rather than specific numerical thresholds for diagnostic accuracy. The reported device performance is demonstrated through its compliance with these standards.

2. Sample size used for the test set and the data provenance
The document does not describe a clinical study with a "test set" in the traditional sense of patient data. The evaluations were primarily conducted through lab bench testing by the manufacturer against recognized industry standards. Therefore, there is no information on sample size for a test set or data provenance from patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The evaluations were based on compliance with engineering and biocompatibility standards, not expert-adjudicated ground truth from patient data.

4. Adjudication method for the test set
Not applicable, as there was no test set requiring ground truth adjudication.

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
No MRMC comparative effectiveness study was conducted. This device is an LED Curing Light, not an AI-powered diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical dental device, not an algorithm, so standalone performance in that context is not relevant.

7. The type of ground truth used
The "ground truth" for the device's acceptable performance is defined by its compliance with international and national standards for safety (electrical, EMC, biocompatibility) and performance (light output for dental curing). These standards outline measurable parameters and testing methodologies.

8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning.

9. How the ground truth for the training set was established
Not applicable, as there was no training set.

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The Cybird LED 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 400-480 nm waveband of visible light.

Cybird is a LED curing light intended for polymerization of light-cured materials by dental professionals. This product is effective on various light-cured materials. Cybird's body is made from industrial-grade aluminum which is a durable material intended to ensure heat dissipation. The Cybird features multiple curing modes to ensure functionality.

The provided text describes the 510(k) summary for the Cybird LED Curing Light (Model: Cybird WPT) and its comparison to a predicate device. It explicitly states that clinical testing was not required to demonstrate substantial equivalence, meaning a study proving the device meets specific acceptance criteria based on clinical outcomes or human reader performance was not performed or provided.

Instead, the submission relies on non-clinical tests and a comparison of technical specifications to a previously cleared predicate device. Therefore, it's not possible to provide all the requested information, specifically points 2 through 9, as they pertain to clinical or human-reader studies.

Here's a breakdown of what information can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal "acceptance criteria" table with specific thresholds that the device had to meet to be deemed effective in a clinical context. Instead, it compares the performance attributes of the Cybird WPT to its predicate device, the Cybird LED Curing Light (Model: Gold & XD, K173876). The "acceptance criteria" here implicitly relates to demonstrating that the new device performs "similar or better" than the predicate in non-clinical tests and that the differences do not "represent significant issues to clinical evaluation."

Summary of Acceptance: The Cybird WPT LED Curing Light was deemed substantially equivalent based on:

• Identical intended use.
• Demonstration through non-clinical performance and material testing that differences in device design (wireless charger, adjusted curing times for black light guides) and resulting light intensity do not negatively impact the device's ability to achieve polymerization of dental materials, and that the depth of cure is similar to the predicate.
• Compliance with voluntary standards for biocompatibility, electrical safety, EMC, and software verification/validation.

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

• Not applicable. No clinical test set data was used. Non-clinical tests were performed on the device itself and material samples. The text does not specify the sample sizes for these non-clinical tests (e.g., how many devices were tested for irradiance intensity or depth of cure) nor the country of origin of this testing 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)

• Not applicable. No clinical "ground truth" established by experts was used, as clinical testing was not required for this submission.

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

• Not applicable. No clinical test set requiring adjudication 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. This device is an LED curing light, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.

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

• Not applicable. This device is hardware for polymerization; it does not involve an algorithm with standalone performance in the context of diagnostic or interpretive tasks. Software verification and validation were done for its internal operation.

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

• For the non-clinical tests, the "ground truth" or reference for performance would be established by:
  • Validated laboratory methods and standards: Such as those for measuring irradiance intensity, spectral output, and depth of cure (e.g., ADA Specification No. 48).
  • Predicate device performance: The performance of the predicate device (Cybird Gold / XD) served as the benchmark for comparison for most attributes.
  • Material specifications: For biocompatibility, materials were tested against ISO standards (ISO 10993-5, 10993-10).

8. The sample size for the training set

• Not applicable. This device does not use machine learning or AI models that require a training set.

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

• Not applicable. No training set was used.

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

LED Curing Light is used to restore teeth on dental patient. The device can only be used by the dentist who is qualified and well trained. This product is used on dental patient in the place of hospital or professional medical site.

LED Curing Light adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of high-power LED, main unit, curing light shield, charger and charge station. The main unit contains the ON/OFF button, display screen, mode button and time button.

LED Curing Light provides TURBO mode and NORMAL mode with different preset exposure time. The high-power LED can produce visible blue light in the 430nm to 490nm waveband of spectrum with a power density of 1000m W/cm² to 1800m W/cm². Using different modes gives dental professionals the flexibility to polymerize virtually almost all types of composites, boding agents and sealants available in the market.

The enclosure of main unit was composed of ABS material and Aluminum, and the light quide base (patient contact part) was made from ABS material.

Here's an analysis of the provided text regarding the acceptance criteria and study for the LED Curing Light (Model: VK-018), presented in the requested format.

It's important to note that this document is a 510(k) summary, which aims to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove the device meets specific clinical acceptance criteria from a standalone study. The performance testing here focuses on technical and safety specifications against recognized standards, rather than direct clinical outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of clinical trials or artificial intelligence evaluation with human data. The testing described is primarily bench testing and compliance testing against recognized standards for the device itself. Therefore, specific sample sizes for human subjects or patient data are not applicable here.

• Data Provenance: N/A (bench testing of the device hardware and software).
• Retrospective or Prospective: N/A (bench testing).

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

Not applicable. This submission focuses on technical and safety compliance based on recognized standards and bench testing, not on comparison to expert-established ground truth from clinical images or data.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a human-adjudicated test set.

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

No. The document explicitly states: "Clinical data were not required in this submission to support a finding of substantial equivalence." (Page 6). Therefore, an MRMC study related to human reader performance with or without AI assistance was not conducted or reported.

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

Not applicable. This device is a hardware product (LED Curing Light), not a software algorithm that performs diagnostic or assistive functions. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is defined by the recognized international and national standards (e.g., ANSI ADA 48, IEC 60601 series, ISO 10993 series) and the technical specifications of the predicate device. The device's performance against these standards and specifications serves as its ground truth.

8. Sample Size for the Training Set

Not applicable. As this is a hardware medical device and not an AI/Machine Learning algorithm, there is no "training set."

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

Not applicable. No training set was used.

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