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The MSI is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds to:
· View and digitally record images of a wound.
· Measure and digitally record the size of a wound.

• · View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light.
  · View and digitally record thermal images of a wound.
  The MSI does not diagnose or treat skin wounds.

The MSI Kit includes the following: the MSI, a Universal Serial Bus (USB-C) cable, a wall adapter, and a carrying case.
The MSI captures and processes optical data of an imaged wound. The MSI consists of three imaging modalities: white light, autofluorescence and thermal. The MSI has 395nm excitation LEDs for autofluorescence imaging, a sensor for measuring distance to the wound, and a thermal sensor for capturing temperature gradients.
The MSI is powered by an onboard rechargeable battery and has a USB-C connection for uploading images to a computer. The manual provides users of the MSI with detailed instructions for proper use, maintenance, and storage.

The provided text outlines the general safety and performance testing conducted for the Multispectral Imager Kit (MSI Kit) to establish its substantial equivalence to predicate devices, but it does not contain the specific acceptance criteria or detailed results of a study demonstrating the device meets those criteria.

However, based on the information provided, here's a breakdown of what can be inferred and what is missing:

Acceptance Criteria and Reported Device Performance:

The document lists various performance tests, implying certain acceptance criteria for each, but the specific numerical targets or thresholds are not provided. The conclusion statement indicates that the clinical and non-clinical data "indicate that the MSI Kit is as safe and effective as the predicate devices," which serves as a general statement of meeting underlying acceptance criteria for equivalence.

Missing information: The actual acceptance criteria (e.g., minimum accuracy for wound measurement, specific signal-to-noise ratio requirements for fluorescence imaging) and the quantitative results from the study demonstrating the device's performance against these criteria are not detailed in the provided text.

Detailed Information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, specific acceptance criteria and detailed quantitative results are not provided in the document. The document lists the types of tests performed and generally states that the device's performance was evaluated, leading to a conclusion of safety and effectiveness comparable to predicate devices.

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

• Test Set Sample Size: The document does not specify the sample size for any of the performance tests, including the clinical study.
• Data Provenance:
  • Clinical Study: "A clinical study was conducted under anticipated conditions with anticipated users." The location (country of origin) is not specified, nor is whether it was retrospective or prospective. Given the phrasing "conducted," it implies a prospective study.
  • Bench Studies: Performed to verify various performance aspects. No information on data provenance other than being "bench studies."

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

The document states that the MSI is "a handheld imaging tool that allows clinicians diagnosing and treating skin wounds to: ... View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light," and that it "does not diagnose or treat skin wounds." The clinical study evaluated the "ability of the MSI to detect autofluorescence signals from tissues or structures consistent with the indications for use."

This implies that the assessment of autofluorescence signals in wounds would typically require clinical experts. However, the document does not specify the number of experts or their qualifications used to establish ground truth for any test set.

4. Adjudication method for the test set

The document does not specify any adjudication method for establishing ground truth in the clinical study or any other performance testing.

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

The document does not mention a multi-reader, multi-case (MRMC) comparative effectiveness study, nor does it refer to AI assistance or human reader improvement with AI. The device is described as an "imaging tool" for clinicians, not as an AI-powered diagnostic aid that assists in interpretation.

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

The device description focuses on its imaging capabilities and the output of images (white light, fluorescence, thermal) for clinician evaluation. None of the performance data sections suggest a standalone algorithm-only performance assessment where the device makes interpretations without human involvement. The indications for use specifically state it "does not diagnose or treat skin wounds" and provides images for clinicians.

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

The document does not explicitly state the type of ground truth used in the clinical study. For "autofluorescence signals from tissues or structures consistent with the indications for use," the ground truth would likely involve a clinical assessment by wound care specialists or potentially correlated with wound characteristics that are known to exhibit certain autofluorescence, but this is not specified.

8. The sample size for the training set

The document does not mention a training set or its sample size. This suggests that the device's functionality does not rely on a machine learning model that requires a labeled training dataset in the way a diagnostic AI would. The device's operation, as described, appears to be based on capturing and processing optical and thermal data rather than learning from data.

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

Since no training set is mentioned, there is no information on how ground truth for a training set was established.

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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, (i)
• Measure and digitally record the size of a wound, and (ii)
• View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light. (iii)

The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >104 CFU per gram as compared to examination of clinical signs and symptoms alone. The MolecuLight i:X device should not be used to rule-out the presence of bacteria in a wound.

The MolecuLight i:X does not diagnose or treat skin wounds.

The MolecuLight i:X Imaging Device is a handheld medical imaging device comprised of a high-resolution color LCD display and touch-sensitive screen with integrated optical and microelectronic components. Moleculight i:X uses its patented technology to enable real-time standard digital imaging and fluorescence imaging in wounds and surrounding healthy skin of patients as well as wound area measurements.

Here's a breakdown of the acceptance criteria and the study that proves the MolecuLight i:X device meets them, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The core clinical claim for the MolecuLight i:X related to bacterial identification is: "The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >10^4 CFU per gram as compared to examination of clinical signs and symptoms alone."

While the document doesn't explicitly state quantitative acceptance criteria in the "we will achieve X performance" format, the demonstrated performance serves as the evidence for meeting their stated claim. The crucial part of the performance is the improvement in identifying wounds with relevant bacterial loads.

Acceptance Criteria (Implied by Clinical Claim and Study Results)

^1 The document states: "The use of the MolecuLight i:X in combination with clinical signs and symptoms resulted in a <10% increase as compared to CSS alone in the rate in wounds that were incorrectly identified as having bacterial load >10^4 CFU/g, whose resulting bacterial load determined by conventional microbiological analysis was <10^4 CFU/q." This is a specific claim about the false positive rate.

2. Sample Size and Data Provenance

• Sample Size for Test Set: n = 350 wound sites (referred to as "All patients")
  • Microbiology Positive (>10^4 CFU/g): n = 287
  • Microbiology Negative (<10^4 CFU/g): n = 63
• Data Provenance: The document does not specify the country of origin. It indicates it was a "clinical study," implying prospective data collection for this purpose.

3. Number of Experts and Qualifications for Ground Truth

• The document mentions "clinicians" evaluating clinical signs and symptoms (CSS) and then interpreting MolecuLight i:X fluorescence images. However, it does not specify the number or qualifications of these clinicians related to establishing the clinical ground truth for the test set.
• The primary ground truth for bacterial load (>10^4 CFU/g) was "quantitative microbiological analysis," which is a lab-based, objective method, not dependent on expert consensus.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method for the clinical evaluation of CSS or the interpretation of MolecuLight i:X images. It compares these clinical assessments directly against the quantitative microbiological analysis. This suggests that individual clinicians' interpretations were the data points, rather than a consensus interpretation.

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

• A formal MRMC study is not explicitly mentioned as having been performed. The study evaluates the likelihood that clinicians can identify wounds, comparing performance with and without the device. While it involves multiple clinicians, it's presented as a direct comparison of the combined CSS+iX approach versus CSS alone, rather than a statistical comparison of reader performance improvement.
• Effect Size:
  • The sensitivity for identifying high bacterial loads increased from 15.33% (CSS alone) to 60.98% (CSS + iX). This is a substantial increase, making the device significantly more likely to flag relevant wounds.
  • The specificity decreased from 93.65% (CSS alone) to 84.13% (CSS + iX). This indicates a trade-off where more wounds were incorrectly identified as having high bacterial loads with the device, but the report explicitly states this increase in false positives was "<10%".

6. Standalone Performance (Algorithm Only)

• Not applicable/Not done. The MolecuLight i:X is described as a "handheld imaging tool" used by "clinicians." Its function is to provide an image that clinicians interpret. It is not an AI/algorithm that provides a standalone diagnosis or classification. The "performance" reported is the combination of the device's output and human interpretation ("clinician's interpretation of the MolecuLight i:X fluorescence image and CSS").

7. Type of Ground Truth Used

• The primary ground truth for validation of the bacterial load identification claim was quantitative microbiological analysis (i.e., bacterial culture results defining >10^4 CFU per gram). This is an objective and laboratory-confirmed ground truth, considered a strong reference standard for bacterial burden.

8. Sample Size for the Training Set

• The document does not specify a separate training set or its size. This is typical for a medical device that provides direct imaging for human interpretation, rather than a machine learning algorithm that is "trained" on data. The clinical study described here functions as the pivotal performance validation.

9. How Ground Truth for the Training Set was Established

• As no separate training set or AI/ML training is indicated, this point is not applicable. The ground truth for the clinical study was established by quantitative microbiological analysis of wound samples.

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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.

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