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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

4. Adjudication method for the test set

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

Not applicable. This device does not use an algorithm or AI. It is a manually operated medical device.

7. The type of ground truth used

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

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

8. The sample size for the training set

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

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

Not applicable, as there is no training set.

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Dr's Finder is intended for detecting the apex of root canal.

The device allows the relative position of a dental file and the apex to be determined electrically. Using a standard dental file inserted into the root canal as an electrode, the device emits very small electrical currents having frequencies of 400 Hz, and 10400 Hz. The current between the file and mouth is measured at each of these frequencies, and the readout of the relative proximity to the apex will appear on the meter.

The Dr's Finder device is an apex locator "intended for detecting the apex of root canal."

Here's an analysis of its acceptance criteria and the study conducted to prove it:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

The document mentions "comparison testing on Dr's Finder and the predicate device (RCM-7, K090925) was performed to compare the measurement performance of locating apex root using extracted tooth."

• Sample Size: The exact number of extracted teeth used is not specified in the provided document.
• Data Provenance: The study was conducted using extracted teeth, which implies a "non-clinical" setting. The country of origin for the data is not explicitly stated, but the manufacturer, "Good Doctors Co., Ltd.," is located in "Incheon, Republic of Korea."

3. Number of Experts and Qualifications:

The document does not specify the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method:

The adjudication method for establishing ground truth is not mentioned in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. The study focused on comparing the performance of the device against a predicate device using test cases, not on human reader improvement with or without AI assistance.

6. Standalone Performance Study:

Yes, a standalone performance study was conducted. The "comparison testing" on the Dr's Finder focused on its performance in locating the apex of root canals in extracted teeth, which is an evaluation of the algorithm/device's performance in isolation.

7. Type of Ground Truth Used:

The ground truth for the performance study was established by measurements on extracted teeth. The document does not elaborate on how this ground truth measurement was precisely determined (e.g., direct visual inspection, microscopic analysis, etc.), but it is implied to be a direct physical measurement.

8. Sample Size for Training Set:

The document does not mention a training set or its sample size. This suggests that the device's development might not have involved a typical machine learning training and testing paradigm as is common with some AI devices. It's more likely based on established electrical impedance principles.

9. How Ground Truth for Training Set Was Established:

Since no training set is mentioned, the method for establishing its ground truth is not applicable based on the provided information.

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The CL-DC20 and CL-DC21 Dental Curing Lights are indicated for the curing of dental composites using visible light.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details that would allow me to answer your request. The document is an FDA 510(k) clearance letter for dental curing lights, which confirms the device's substantial equivalence to a predicate device but does not include the detailed study information you've requested.

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Curing of dental composites using visible light.

Doctor's Light LED Dental Curing Light is a hand-held polymerization light intended for use in curing dental composites. This product uses a rechargeable Li-ion Battery for cordless operation.

The provided text is a 510(k) summary for a dental curing light, which is a physical device, not an AI/ML algorithm. Therefore, many of the requested categories for AI/ML device studies, such as sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment, are not applicable.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable for this type of device and submission. The performance was assessed through bench testing and comparison to predicate devices, not through a data-driven test set.

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

Not applicable. Ground truth establishment with experts is relevant for diagnostic or AI/ML devices, not for a dental curing light whose performance is determined by physical characteristics and safety standards.

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

Not applicable.

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 is not an AI-assisted diagnostic device.

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

Not applicable. This is a standalone physical device, not an algorithm.

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

The "ground truth" equivalent for this device type would be the established scientific and engineering principles for dental curing lights, as well as the specifications of the predicate devices. Performance was verified against these benchmarks and relevant industry standards (IEC 60601-1, IEC 60601-1-2).

8. The sample size for the training set

Not applicable. There is no training set for a dental curing light.

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

Not applicable.

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