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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.

N/A

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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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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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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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This "LED Curing Light GT-2000 Carbon" is a dental curing unit utilizing visible light programmed for the polymerization of light curing materials in the wavelength range of 360-420 nm and 420-490 nm by dental professionals.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter for a dental curing light. It does not contain any information about acceptance criteria, device performance, a study, or any of the other specific details requested in your prompt regarding AI/ML device evaluation.

Therefore, I cannot extract the requested information from this document.

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LED Curing Light LD-M4 . LD-M4P is a dental curing unit utilizing visible light programmed for the polymerization of light curing materials in the wavelength range of 420-490 nm by dental professionals.

Not Found

I am sorry, but the provided text from the FDA 510(k) letter for the LED Curing Light LD-M4, LD-M4P (K152192) does not contain the specific information required to answer your request.

This document is a notification of substantial equivalence for a medical device and primarily focuses on regulatory approval. It does not include:

• Acceptance criteria and reported device performance (Table 1): While it states the device cures materials in the 420-490 nm wavelength, it doesn't provide specific performance metrics, quality standards, or the criteria for what would be considered "acceptable."
• Study details: There is no mention of a specific study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training sets or how ground truth was established.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar technological characteristics and is intended for the same use as a device already on the market. The FDA's substantial equivalence determination does not usually involve a detailed breakdown of a new study's results in the public summary letter, but rather a comparison to an existing device.

To obtain the information you're looking for, you would typically need to consult the full 510(k) submission, which contains the detailed technical and performance data submitted by the manufacturer to the FDA. This information is not typically made public in its entirety, though summaries may be available.

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This "LED Curing Light GT-2000" is a dental curing unit utilizing visible light programmed for the polymerization of light curing materials in the wavelength range of 360-420 nm and 420-490 nm by dental professionals.

Not Found

The provided document is an FDA 510(k) clearance letter for the "LED Curing Light GT-2000." This type of document does not typically contain the detailed study information (acceptance criteria, sample sizes, ground truth establishment, or specific performance metrics) that would be present in a clinical or performance study report.

The letter primarily states that the device has been found substantially equivalent to a predicate device and can be legally marketed. It references the indications for use but does not detail the studies proving its performance against specific criteria.

Therefore,Based on the provided FDA 510(k) clearance letter:

1. A table of acceptance criteria and the reported device performance: This information is not available in the provided document. The 510(k) letter confirms substantial equivalence but does not detail specific performance studies, acceptance criteria, or reported device performance metrics like sensitivity, specificity, or AUC.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not available in the provided document.

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 information is not available in the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not available in the provided document.

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 information is not available in the provided document. The device is an "LED Curing Light," which is a dental tool, not an AI diagnostic device. Therefore, a MRMC study for AI assistance would not be applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This information is not available in the provided document. As mentioned, this is a hardware device for dental curing, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not available in the provided document. For a curing light, the 'ground truth' related to its performance would likely involve objective measurements of light output, curing effectiveness on dental materials, and safety standards, rather than diagnostic ground truth typically established by experts or pathology.

8. The sample size for the training set: This information is not available in the provided document.

9. How the ground truth for the training set was established: This information is not available in the provided document.

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BlueLEX LED Curing Light LD-109 is for the polymerization of light cure materials.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a dental curing light, the BlueLEX LED Curing Light LD-109. This type of document primarily confirms that a new device is substantially equivalent to existing legally marketed devices. It does not typically contain detailed information about specific acceptance criteria or studies proving device performance beyond confirming substantial equivalence for its stated indications for use.

Therefore, most of the information requested in your prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies, standalone performance, ground truth types, and training set information) is not available in this document.

Here's what can be extracted:

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

• Acceptance Criteria: Not explicitly stated in this document. Substantial equivalence to a predicate device is the overarching acceptance criterion for a 510(k) clearance.
• Reported Device Performance: The device is indicated for "polymerization of light cure materials." The letter indicates substantial equivalence, implying its performance is comparable to legally marketed predicate devices for this function. Specific performance metrics (e.g., light intensity, curing depth, curing time) are not detailed here.

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

• Test Set Sample Size: Not provided.
• Data Provenance: Not provided.

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

• This information is not provided in a 510(k) clearance letter.

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

• This information is not provided in a 510(k) clearance letter.

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

• MRMC Study: No. This device is a dental curing light, not an AI-assisted diagnostic tool for human readers.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable as this is a physical device, not an algorithm.

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

• The concept of "ground truth" as typically applied to diagnostic or AI studies is not relevant here for a dental curing light. The performance would likely be evaluated against physical standards or performance of predicate devices.

8. The sample size for the training set

• Not applicable/Not provided.

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

• Not applicable/Not provided.

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This" LED Curing Light LD-M1" is for the polymerization of light cure materials.

Not Found

This is a 510(k) clearance letter from the FDA for a dental curing light, the "LED Curing Light LD-M1". This type of document typically determines substantial equivalence to a predicate device based on performance testing to recognized standards, rather than providing a detailed study description with specific acceptance criteria and detailed device performance reports like those found for AI/ML devices or diagnostic tools.

Therefore, the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size) is not available within this document.

The letter states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the indications for use provided. The "Indications for Use" section (page 2) simply states: "This "LED Curing Light LD-M1" is for the polymerization of light cure materials."

To fulfill the request, if this were a clinical study report for a diagnostic or AI/ML device, the following would typically be provided:

• Acceptance Criteria Table and Reported Device Performance: This would detail metrics like sensitivity, specificity, accuracy, precision, etc., for the device against an established benchmark, along with the predefined thresholds for acceptance.
• Sample Size and Data Provenance: Information on the number of cases, their origin (e.g., US, Europe), and whether the data was collected specifically for the study (prospective) or from existing archives (retrospective).
• Number and Qualifications of Experts: Details about the radiologists, pathologists, or other specialists who reviewed the cases to establish ground truth, including their experience levels.
• Adjudication Method: How disagreements among experts were resolved (e.g., a third expert reviewed discordant cases, or a consensus meeting was held).
• MRMC Study: If applicable, an analysis comparing human reader performance with and without the AI device, quantified by an effect size (e.g., AUC improvement, sensitivity increase).
• Standalone Performance: The performance of the algorithm itself, independent of human interaction.
• Type of Ground Truth: The gold standard used (e.g., confirmed pathology, long-term patient outcomes, expert consensus).
• Training Set Sample Size: The number of data points or cases used to train the algorithm.
• Training Set Ground Truth Establishment: How the ground truth for the training data was determined.

Since this document is a 510(k) clearance for a physical device (a dental curing light), these clinical study details are not relevant or provided. The clearance is based on demonstrating that the device is as safe and effective as a legally marketed predicate device, often through engineering and performance testing rather than complex clinical studies involving human readers or AI algorithms.

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