Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

"This" LED Curing Light GT-1500" is for the polymerization of light cure materials.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "LED Curing Light GT-1500." It primarily addresses the device's substantial equivalence to previously marketed devices and outlines regulatory responsibilities.

Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training/ground truth data.

The FDA 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with specific acceptance criteria as you've requested. While a manufacturer might have performed such studies to support their 510(k) submission, the details of those studies are not typically included in the public clearance letter.

Therefore, I cannot provide the requested information based on the provided text. The document is strictly a regulatory approval notice.

Ask a specific question about this device

This" LED Curing Light GT-1200" is for the polymerization of light cure materials.

Not Found

The provided text is related to a 510(k) premarket notification for a dental device (LED Curing Light GT-1200) and contains communications from the FDA regarding its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria, a specific study proving device performance, sample sizes for test or training sets, expert qualifications, or ground truth establishment.

This document is a regulatory approval letter, not a scientific study report. Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

This Blue Luxcer, Curing Light is a visible curing unit programmed for polymerization of light cured materials by dental professionals.

Not Found

This document does not contain the specific information required to complete the request. The provided text is a 510(k) summary for a dental curing light, and while it indicates that performance testing was done to validate the device's performance for substantial equivalence to a predicate device, it does not provide details about:

• Acceptance criteria: What specific performance metrics (e.g., light intensity, curing depth, curing time) were used as acceptance criteria.
• Reported device performance: The actual quantitative results of the performance tests against those criteria.
• Study design details: Sample sizes, data provenance, ground truth establishment methods, expert qualifications, or adjudication methods for any studies.
• Comparative effectiveness studies (MRMC): There's no mention of a study involving human readers or their improvement with AI assistance. This device is not an AI-powered diagnostic tool.
• Standalone algorithm performance: This device is a curing light, not an algorithm.

The document primarily focuses on establishing substantial equivalence to a predicate device based on intended use, technological characteristics, and a general statement about performance testing. It does not provide the detailed scientific study results typically found in a clinical trial report or a comprehensive validation study.

Therefore, I cannot populate the table or answer the specific questions based on the provided text.

Ask a specific question about this device

The intended use of the BlueLEX LD-105 is for the polymerization of light cure materials.

Not Found

The provided text is a 510(k) premarket notification approval letter for a dental device, the BlueLEX LD-105 Ultraviolet Activator for Polymerization. It does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. Therefore, I cannot generate the requested information based on the input.

Ask a specific question about this device