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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

(i) View and digitally record images of a wound,

(ii) Measure and digitally record the size of a wound, and

(iii) View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light.

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. 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 (FL) imaging in wounds and surrounding healthy skin of patients as well as wound area measurements.

The MolecuLight i:X is a handheld imaging tool that helps clinicians identify wounds containing elevated bacterial loads. The provided text outlines the acceptance criteria and the study that supports the device's claims.

1. Table of Acceptance Criteria and Reported Device Performance

The provided documentation does not explicitly state "acceptance criteria" as a set of predefined thresholds that the device had to meet for clearance. Instead, it presents performance metrics from a clinical study, which implicitly serve as evidence for addressing the added labeling claims. The key performance metrics are related to the device's ability to guide wound sampling for detecting bacterial burden.

Derived Acceptance Criteria (based on the device's claims and study outcomes) and Reported Device Performance:

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

• Sample Size for Clinical Test Set: Data from a post hoc retrospective analysis of 78 patients were analyzed. The analysis specifically looked at "all wounds that had two samples obtained in the study."
• Data Provenance: The document does not explicitly state the country of origin. The study was a retrospective analysis.

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the clinical test set. The ground truth for bacterial load was established through "wound sampling" implying microbiological culture results (CFU/g).

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the clinical test set. Given that the ground truth appears to be based on microbiological culture results from wound samples, an adjudication process by experts, as might be seen for image interpretation consensus, would not be directly applicable for this type of ground truth.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study, where human readers interpret images with and without AI assistance, was not explicitly described in the provided text. The clinical performance testing focused on comparing the effectiveness of FL-guided wound sampling versus Standard of Care (SoC) guided sampling to detect bacterial burden, rather than a direct comparison of human reader performance with and without AI assistance in image interpretation. The device's role is presented as a tool to guide sampling, not as an AI for image interpretation by clinicians.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The provided information focuses on the device's clinical utility in guiding sampling with a clinician in the loop. While the device itself processes images to show fluorescence, its performance is evaluated in the context of improving a clinical procedure (wound sampling), not as a standalone diagnostic algorithm for automated interpretation. The non-clinical testing mentions a "custom algorithm" to detect red fluorescence, which implies standalone analytical capability, but this is distinct from clinical diagnostic performance.

7. The Type of Ground Truth Used

• Clinical Performance Testing: The ground truth for bacterial load was established by microbiological culture results from wound samples, quantified as Colony Forming Units (CFU) per gram (CFU/g). Specifically, "bacterial loads >10^4 CFU per gram" were the key threshold. Pathogen identification was also a part of the ground truth.
• Non-Clinical Testing: The ground truth for demonstrating red fluorescence production for specific bacterial species was based on sub-culturing on Porphyrin Test Agar (PTA) and direct observation of fluorescence using the MolecuLight i:X.

8. The Sample Size for the Training Set

The document primarily discusses a retrospective analysis for clinical validation and in-vitro testing. It does not mention a separate training set size for any specific AI/algorithm development, as the device's core functionality appears to be based on known autofluorescence properties of bacteria rather than a deep learning model trained on large datasets for complex pattern recognition. The study mentioned ([K191371](https://510k.innolitics.com/search/K191371)) was used to support subsequent claims, implying this may have provided data for initial claims.

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

As no explicit training set for a machine learning algorithm is detailed, the method for establishing ground truth for such a set is not provided. The non-clinical testing described involves culturing specific bacterial species to verify their autofluorescent properties, which would serve as a 'ground truth' for the physical principle the device leverages.

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

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 grams 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 proving the device meets them, based on the provided FDA 510(k) summary for the MolecuLight i:X:

The MolecuLight i:X device is an autofluorescence detection device for general surgery and dermatological use. The 510(k) summary details a modification to the device's labeling to clarify the relationship between cyan fluorescence and the increased likelihood of Pseudomonas aeruginosa bacterial loads. The study's purpose is to demonstrate that this additional labeling statement does not raise new questions of safety or efficacy and is supported by existing clinical data.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to the performance metrics of the device in identifying bacterial loads, specifically Pseudomonas aeruginosa and Total Bacterial Load (TBL), as established in the original K191371 clearance. The current submission's goal is to demonstrate that the expanded labeling around cyan fluorescence's association with P. aeruginosa is supported by the data and does not alter the previous safety and effectiveness profile.

The performance is reported in terms of sensitivity, specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV), and Likelihood Ratio for different fluorescence signatures (Cyan, Red, Red or Cyan) in detecting bacterial loads.

Note: The document states "The additional labeling statement does not raise different questions of safety or efficacy. Retrospective analysis has demonstrated the safety and effectiveness of MolecuLight i:X with regards to the additional labeling statement." This implies that the acceptance criteria are met if the performance metrics continue to support the device's utility in identifying bacterial loads and the new labeling is consistent with the observed data.

2. Sample Size and Data Provenance

• Sample Size for Test Set: Data from 350 patients were retrospectively analyzed.
• Data Provenance: The document does not explicitly state the country of origin but refers to "retrospective analysis" of existing clinical study data. Given MolecuLight Inc. is based in Toronto, Canada, and the clinical study was "reported in support of K191371", it is likely the data was collected in either Canada or the US, or potentially a multi-site international study. The study was retrospective.

3. Number of Experts and their Qualifications

The document does not specify the number of experts used to establish the ground truth for the test set, nor does it explicitly state their qualifications. The interpretation of "fluorescence image, when used in combination with clinical signs and symptoms" suggests that the ground truth was established by clinicians based on the convergence of factors, potentially including microbiological culture results (as indicated by CFU/g measurements).

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set. Given that the analysis is "retrospective analysis" of existing clinical study data, the ground truth was likely established as part of the original study design.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed for this 510(k) submission. This submission is a "Real-World Data" (retrospective analysis) supporting a labeling change for a previously cleared device, not a new device clearance or a comparative effectiveness study with human readers. The document states: "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 grams as compared to examination of clinical signs and symptoms alone." This sentence refers to a finding from the original K191371 clearance, not a new MRMC study in this submission.

6. Standalone (Algorithm Only) Performance

This device, the MolecuLight i:X, is an imaging tool used by clinicians to view and record images of fluorescence. It is not an AI algorithm that generates a diagnosis or interpretation autonomously. Therefore, a standalone (algorithm only) performance study was not applicable or performed in the context of this 510(k). The device provides visual information (fluorescence images) that clinicians interpret in conjunction with clinical signs and symptoms.

7. Type of Ground Truth Used

The ground truth for the test set appears to be microbiological culture results (bacterial loads measured in CFU/g) combined with clinical assessment. The specific phrases "identify wounds containing bacterial loads >10^4 CFU per grams" and "Pseudomonas aeruginosa at Species Specific Levels ≥ 10^4 CFU/q" clearly indicate that quantitative bacterial culture was the definitive ground truth for bacterial presence and load.

8. Sample Size for the Training Set

The document does not describe a training set in the context of an AI/algorithm. The "study" described is a retrospective analysis of previously collected clinical data to support a labeling claim for a medical device. If there was any machine learning involved (which is not directly implied for this device's function as an imaging tool), that would have been part of the original K191371 submission and is not detailed here.

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

As no training set (in the context of an AI/ML algorithm) is described, this question is not applicable based on the provided document. The device's function described (capturing and displaying fluorescence) implies it is a viewing tool, not an AI-powered diagnostic algorithm requiring a training phase for its output beyond the initial development of its optical and imaging capabilities.

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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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