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The Isolux Ilc OptiLux LED Illuminator is indicated for use in transmitting light for illumination purposes from an LED source via a fiber optic cable and attached to either an endoscope, surgical head light or other tools that contain in providing illumination to body cavities during examinations or surgical procedures.

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The provided documents are a 510(k) clearance letter and an Indications for Use statement for the "OptiLux LED Illuminator." These documents, from the FDA, confirm the device's regulatory clearance and its intended use but do not contain any information regarding acceptance criteria, device performance studies, or data about the device's accuracy or efficacy.

Therefore, I cannot fulfill your request for information on the following:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not available.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The OptiLux LED Illuminator is a physical device for illumination, not an algorithm. Therefore, this type of study is not applicable, and no information about it would be found here.
7. The type of ground truth used: Not applicable and not available.
8. The sample size for the training set: Not applicable and not available.
9. How the ground truth for the training set was established: Not applicable and not available.

The documents primarily focus on:

• The FDA's determination of substantial equivalence to a predicate device.
• The regulatory classification of the device (Class II).
• The indications for use: "transmitting light for illumination purposes from an LED source via a fiber optic cable and attached to either an endoscope, surgical head light or other tools that contain in providing illumination to body cavities during examinations or surgical procedures."

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The Headlight is indicated for use in transmitting illumination to a body cavity or surgical procedure.

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I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for the IsoLED AC-Powered LED Headlight System, indicating that the device has been found substantially equivalent to a predicate device.

It includes:

• Device name: IsoLED AC-Powered LED Headlight System
• Regulation Number and Name: 21 CFR 878.4580, Surgical lamp
• Regulatory Class: Class II
• Product Code: FST
• Indications for Use: "The Headlight is indicated for use in light transmitting illumination and body cavity illumination procedures."

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods).
• Information on MRMC comparative effectiveness studies or standalone performance.
• Training set details.

Therefore, I cannot fulfill your request based on the provided text.

Ask a specific question about this device

Ask a specific question about this device