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

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

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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.

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

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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.

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