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The Coltolux Comfort LED Curing Light is indicated for the polymerization of intra- and extraoral dental restorations fabricated from materials (commonly referred to as visible light cured dental restoratives and/or composites and/or dental adhesives) that contain Camphorquinone as the photoinitiator.

The proposed Coltolux Comfort LED Curing Light (Coltolux Comfort) is used for the polymerization of light-cured resin materials used in dental restorations. The Coltolux Comfort incorporates a focused high-power LED to produce light in the "deep blue" spectrum (wavelength 440 - 470 nm) for activating Camphorquinone (CQ) photo-initiators. The device is utilized by placement of the lens within close proximity to the surface of the material to be cured, activation of the curing light via the pushbutton switch, and retention of the tip near the dental material until the composite is cured.

The provided text describes the 510(k) summary for the Coltolux Comfort LED Curing Light (K223142). Here's an analysis of the acceptance criteria and study information provided:

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

The document does not explicitly provide a table of acceptance criteria with corresponding device performance for specific quantitative metrics. Instead, it states that "Performance testing was conducted to verify that the proposed Coltolux Comfort Curing Light meets the requirements as defined in FDA Guidance Document 'Dental Curing Lights - Premarket Notification [510(k)' and in accordance with IEC 60601-1-2."

It lists the types of non-clinical tests performed:

• Light output uniformity and dropoff testing
• Peak wavelength testing (ISO 10650:2018)
• Irradiance output (ISO 10650:2018)
• Depth of cure
• Endurance testing
• Light attenuation through barrier sleeve
• Light shield filtration
• Life testing
• Duty cycle (IEC 60601-1:2012)
• EMC (IEC 60601-1-2:2014)
• Electromagnetic disturbances (IEC 60601-1-2:2014)
• Photobiological safety (IEC 62471:2006)

The conclusion states: "Based on the non-clinical performance data the proposed Coltolux Comfort Curing Light is as safe, as effective, and performs as well as or better than the predicate device Coltolux LED Curing Light (K040551, 21 CRF 872.6070, product code EBZ)." This implies that the device met the acceptance criteria defined by the listed standards and guidance documents, but the specific numerical targets and measured results are not detailed in this summary.

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 focuses on non-clinical performance testing (bench testing). Therefore, the concept of "test set" in terms of subject data (like in a clinical trial) is not directly applicable. For bench testing, test articles (the devices themselves) are used. The sample size for these component-level tests (e.g., number of devices tested for endurance, light output) is not specified in this summary. The provenance of this bench testing data would typically be the manufacturer's lab, often in the country of origin of the manufacturer (Switzerland) or a contracted testing facility. The nature of these tests is inherently prospective as they are performed specifically to evaluate the new device.

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 is not applicable as the summary describes non-clinical, bench testing of a dental curing light, not an AI or diagnostic device that requires expert ground truth for interpretation of clinical data.

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

This is not applicable for the same reasons as #3. Adjudication methods are used in clinical studies, particularly for diagnostic devices, to establish a consensus ground truth from expert readings.

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 is not applicable. The device is a dental curing light, not an AI-assisted diagnostic or interpretative tool.

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

This is not applicable. The device is a physical medical device (a curing light), not an algorithm.

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

For the non-clinical tests, the "ground truth" or reference standards are derived from established international standards (e.g., ISO 10650:2018, IEC 60601-1:2012, IEC 60601-1-2:2014, IEC 62471:2006) and FDA guidance documents. For instance, irradiance output is measured against defined limits or performance of a predicate device according to the ISO standard. Depth of cure would be assessed against a material's known curing characteristics.

8. The sample size for the training set

This is not applicable as the device is not an AI/machine learning product and therefore does not have a "training set" in that context.

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

This is not applicable for the same reason as #8.

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