Search Results

The MolecuLight i:X is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to

• view and digitally record images of a wound, and (i)
• view and digitally record images of fluorescence emitted from a wound (ii) when exposed to an excitation light.

The MolecuLight i:X is for prescription use only.

The MolecuLight i:X is a handheld, portable, and battery operated white light and fluorescence imaging tool. The MolecuLight i:X can (i) view and digitally record standard (ST) digital images of a wound.

Standard digital images/video capture the appearance of the wound under illumination of broad band white light, like regular photography. This Standard Imaging Mode does not require contact with the patient and the distance between the device and wound is kept consistent (8 - 12 cm) between imaging sessions through the use of the built in range finder

The MolecuLight i:X can also capture fluorescence features of wounds in real-time when used in Fluorescence Imaging Mode and it enables the user to document this fluorescence information. When the level of ambient light in the examination room is acceptable, an indicator light informs the user that fluorescence images (or videos) can be acquired. The distance between the device to the patient is maintained at 8 - 12 cm as guided by the range finder indicator light. The device has 450nm excitation light and is capable to detect fluorescence signals in 500-545 and 600-665nm wavelengths. The Moleculight i:X is not intended to quantify the fluorescence emitted from a wound.

The MolecuLight i:X is a wound autofluorescence imaging device. The device is not intended to provide quantitative or diagnostic information, but rather to allow clinicians to view and digitally record images of wounds and fluorescence emitted from wounds.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

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

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

The document primarily describes bench testing for device performance. For the clinical information, "Photographs of standard white light and fluorescent images from different wound types, sizes, and locations were taken with the device in human patients and reviewed." However, a specific numerical sample size for this "test set" of patient images is not provided. The provenance is indicated as "human patients" with various wound types, confirming it's from clinical use, but it's retrospective data (existing images reviewed) rather than a prospective study setup to collect specific test data for performance evaluation against ground truth. The country of origin for the clinical data is not specified, but the manufacturer is based in Canada.

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

The document states, "The images were evaluated for quality and consistency." It does not specify the number of experts or their qualifications used to establish ground truth for the clinical images. Given the device's stated purpose ("not intended to provide quantitative or diagnostic information") and the nature of the clinical "testing" (reviewing images for quality and consistency), it's unlikely a formal expert ground truth establishment process, as seen in diagnostic device studies, was performed for this aspect.

4. Adjudication method for the test set

The document does not describe any adjudication method for the clinical image review. This aligns with the "tool-type" nature of the device and the lack of a formal diagnostic claim. The evaluation seems to have been primarily an internal assessment of image quality and consistency.

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

No MRMC comparative effectiveness study was done and the document does not mention AI assistance. The device is an imaging tool, not a diagnostic aid with integrated AI for human reader performance improvement.

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

The device is a direct imaging tool. The bench testing involved evaluating detection limits, linearity, SNR, etc., which are essentially standalone performance measures of the device's optical and sensor capabilities. There is no "algorithm only" performance in the context of a diagnostic interpretation as the device does not provide interpretation.

7. The type of ground truth used

For the bench testing, the ground truth was established using known controlled phantom properties and controlled concentrations of fluorescent agents (e.g., green and red quantum dots, fluorescein dye, PpIX) within an optical tissue phantom. This provides an objective, measurable ground truth for the physical capabilities of the device (detection depth, linearity, SNR).

For the clinical information, the "ground truth" was simply the photographs of actual wounds combined with general knowledge of wound types. There was no explicit, independent "ground truth" (like pathology or outcomes data) established to validate the device's diagnostic accuracy because it is explicitly stated that the device "is not intended to provide quantitative or diagnostic information."

8. The sample size for the training set

The document does not describe a training set for the device. As an imaging tool that captures raw fluorescence data without making diagnostic claims or employing complex AI models that require training, a traditional training set with labeled data is not applicable. The device's operation is based on its physical and optical characteristics.

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

As there is no described training set, the establishment of ground truth for a training set is not applicable.

Ask a specific question about this device