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The D-Lux+ is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 385~515nm waveband of visible light.

The subject device is packaged with the following: D-Lux+ Handpiece, D-Lux+ Charger, Light Probe, Light Protector, C-Battery, Adapter, Power Cord, Disposable Sheaths(200ea/Box), Instruction Manual. The D-Lux+ Handpiece turns on/off the power, sets the mode and time, and controls the operation. The handpiece includes a battery. The C-Battery is included in the handpiece and supplies power to the handpiece. The D-Lux+ Charger charges the battery when the handpiece is placed on this device. The Adapter supplies power to the charger. The Power Cord is a cord to conduct power to an adapter. Disposable sheaths protect products and patients from contamination. Disposable, so reuse is prohibited. The Light Probe is connected to the handpiece so that the light emitted from the light source (LED) reaches the restoration. The Light Protector is inserted into the handpiece and used to protect the eyes from emitted light. The Instruction Manual is a document that describes information that the user needs to know, such as precautions, operating procedures, and how to use the device.

{"1": "No specific acceptance criteria or performance metrics were reported in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device based on similar characteristics and non-clinical testing.", "2": "The document states "No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices." Therefore, no sample size for a test set or data provenance can be provided.", "3": "No clinical data was collected, thus no experts were used to establish ground truth for a test set.", "4": "No clinical data was collected, thus no adjudication method was used.", "5": "No MRMC comparative effectiveness study was done as no clinical data was collected.", "6": "A standalone study was not done; the evaluation relied on non-clinical bench testing to demonstrate conformance with harmonized standards and substantial equivalence.", "7": "The ground truth for demonstrating substantial equivalence appears to be based on compliance with harmonized standards and successful non-clinical bench testing, rather than expert consensus, pathology, or outcomes data.", "8": "No specific training set size is mentioned as no clinical data was collected or used for an algorithm.", "9": "Not applicable, as no training set was used for an algorithm."}

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The D-LUX is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 420~490nm waveband of visible light.

The D-Lux is a cordless LED curing light, which is intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod. It is portable and battery rechargeable.

Here's a breakdown of the acceptance criteria and study information for the D-LUX device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Notes:

• The document primarily relies on substantial equivalence to a predicate device (Cybird LED Curing Light).
• The key performance metric explicitly stated and compared is the depth of cure. The predicate device's depth of cure was 2.97mm, demonstrating the D-LUX device's comparable performance.
• The D-LUX also conforms to IEC 60601-1, IEC 60601-1-2, and ADA 48[2009] standards; however, specific acceptance values for these standards are not provided in this summary.

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

The provided summary does not explicitly state the sample size used for the depth of cure test.

• Data Provenance: Not specified, but given the manufacturer is based in Korea and the testing aligns with international standards (ISO and IEC), it's likely the testing was conducted either in Korea or at a certified lab. The document does not indicate if the data was retrospective or prospective.

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

This information is not applicable as the study described is a technical performance test (depth of cure measurement for a dental curing light) rather than a study requiring expert-established ground truth for diagnostic or interpretative tasks.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. The study focused on the technical performance of the device itself (depth of cure) and its equivalence to a predicate device, not on human reader performance with or without the device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the D-LUX is a physical medical device (dental curing light), not an algorithm or AI solution. The "standalone" performance here refers to the device's intrinsic functional capabilities, which are assessed through the depth of cure test.

7. The Type of Ground Truth Used

The "ground truth" for the depth of cure test is established by the standardized measurement protocol outlined in ISO 4049:2000. This standard dictates how the depth of cure is measured, making the measurement itself the "ground truth" for the device's performance in this specific parameter.

8. The Sample Size for the Training Set

This information is not applicable as the D-LUX is a medical device, not an AI or machine learning model that requires a "training set."

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

This information is not applicable (see point 8).

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