(89 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard imaging and measurement functionalities. The performance studies analyze the effectiveness of fluorescence imaging in identifying bacterial loads, not the performance of an AI/ML algorithm.
No.
The device is an imaging tool used for diagnosis and monitoring, and the intended use explicitly states, "The MolecuLight i:X does not diagnose or treat skin wounds."
No
The "Intended Use / Indications for Use" section explicitly states, "The MolecuLight i:X does not diagnose or treat skin wounds." While it aids in identifying wounds with bacterial loads, it does not make a diagnosis itself.
No
The device description explicitly states it is a "handheld medical imaging device comprised of a high-resolution color LCD display and touch-sensitive screen with integrated optical and microelectronic components," indicating it includes significant hardware components beyond just software.
Based on the provided information, the MolecuLight i:X is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The MolecuLight i:X is a handheld imaging tool that directly examines the wound on the patient's skin. It does not analyze samples like blood, urine, tissue biopsies, etc., which are typical for IVDs.
- The device's function is imaging and measurement. While it uses fluorescence to help identify areas with potentially high bacterial loads, it does so by visualizing the fluorescence emitted from the wound itself, not by analyzing a sample taken from the wound.
- The intended use explicitly states it's a "handheld imaging tool" and "does not diagnose or treat skin wounds." This further reinforces its role as an imaging and assessment aid, not a diagnostic test performed on a biological sample.
- The performance studies evaluate the device's ability to identify wounds with certain bacterial loads based on the fluorescence imaging. This is a correlation between the imaging findings and the bacterial load, not a direct measurement or analysis of bacteria in a sample.
In summary, the MolecuLight i:X is a medical imaging device used for visualizing and assessing wounds on the patient's body, not for performing diagnostic tests on biological specimens. Therefore, it falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QJF, FXN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluorescence imaging, Standard digital imaging
Anatomical Site
Skin wounds
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Clinicians, at the point of care
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Data from 350 patients were retrospectively analyzed to evaluate the effectiveness of MolecuLight i:X to identify wounds with Pseudomonas aeruginosa at bacterial loads ≥ 104 CFU/g.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Performance Testing: Retrospective analysis of data from 350 patients.
The study evaluated the effectiveness of MolecuLight i:X to identify wounds with Pseudomonas aeruginosa at bacterial loads ≥ 104 CFU/g based on sensitivity, specificity, PPV, NPV, and likelihood ratio.
Results for Cyan fluorescence in the detection of Pseudomonas aeruginosa at Species Specific Levels ≥ 104 CFU/g (n=32 positive, n=318 negative):
Sensitivity: 43.75% (95% CI: 26.26, 62.34)
Specificity: 94.97% (95% CI: 91.96, 97.10)
PPV: 46.67% (95% CI: 28.34, 65.67) - computed for study prevalence of 9.14%
NPV: 94.38% (95% CI: 91.26, 96.63) - computed for study prevalence of 9.14%
Likelihood Ratio: 8.70 (95% CI: 4.69, 16.14)
Additional analysis presented diagnostic parameters for:
- Fluorescence in the Detection of Pseudomonas aeruginosa at Species Specific Levels ≥ 104 CFU/g (Table 3)
- Cyan FL: Post.Test.Risk (PPV) 0.467 (0.283, 0.657), Likelihood Ratio 8.695
- Red FL: Post.Test.Risk (PPV) 0.088 (0.049, 0.143), Likelihood Ratio 0.959
- Red or Cyan FL: Post.Test.Risk (PPV) 0.143 (0.095, 0.204), Likelihood Ratio 1.656
- Fluorescence in the Detection of Total Bacterial Load (TBL) at Levels ≥ 104 CFU/g (Table 4)
- Cyan FL: Post.Test.Risk (PPV) 0.967 (0.828, 0.999), Likelihood Ratio 6.366
- Red FL: Post.Test.Risk (PPV) 0.956 (0.911, 0.982), Likelihood Ratio 4.767
- Red or Cyan FL: Post.Test.Risk (PPV) 0.960 (0.919, 0.984), Likelihood Ratio 5.268
- Fluorescence in the Detection of Wounds with Total Bacterial Load (TBL) at Levels ≥ 104 CFU/g negative for Pseudomonas aeruginosa (Table 5)
- Cyan FL: Post.Test.Risk (PPV) 0.938 (0.698, 0.998), Likelihood Ratio 3.706
- Red FL: Post.Test.Risk (PPV) 0.952 (0.903, 0.980), Likelihood Ratio 4.871
- Red or Cyan FL: Post.Test.Risk (PPV) 0.953 (0.906, 0.981), Likelihood Ratio 5.047
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity, Specificity, PPV, NPV, Likelihood Ratio
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
MolecuLight i:X (K191371)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4550 Autofluorescence detection device for general surgery and dermatological use.
(a)
Identification. An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.(b)
Classification. Class II (special controls). The special controls for this device are:(1) In vivo testing under anticipated conditions of use must characterize the ability of the device to detect autofluorescent signals from tissues or structures consistent with the indications for use.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Performance testing must demonstrate the sterility of patient-contacting components of the device.
(6) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(7) Performance testing must demonstrate laser and light safety for eye, tissue, and skin.
(8) Labeling must include the following:
(i) Instructions for use;
(ii) The detection performance characteristics of the device when used as intended; and
(iii) A shelf life for any sterile components.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 22, 2021
MolecuLight Inc. Jordan John Director, Quality Assurance & Regulatory Affairs Suite 700, 425 University Avenue Toronto, Ontario M5G 1T6 Canada
Re: K210882
Trade/Device Name: MolecuLight I:X Regulation Number: 21 CFR 878.4550 Regulation Name: Autofluorescence Detection Device For General Surgery And Dermatological Use Regulatory Class: Class II Product Code: QJF, FXN Dated: March 24, 2021 Received: March 25, 2021
Dear Jordan John:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name
MolecuLight i:X
Indications for Use (Describe)
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.
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 (iii) 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.
Type of Use (Select one or both, as applicable)
□ Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)
□ Over-The-Counter Use (21 CFR 801
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *
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3
510(k) SUMMARY
MolecuLight i:X
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
MolecuLight Inc. Suite 700, 425 University Avenue Toronto, ON, Canada M5G 1T6 Phone: 647-362-4684 Contact Person: Jordan John
Date Prepared: June 22, 2021
Name of Device
MolecuLight i:X
Device Classification and Product Code
Autofluorescence detection device, 21 CFR 878.4550, Class II, QJF Tape, Camera, Surqical, 21 CFR 878.4160, Class I, FXN
Predicate Devices
MolecuLight i:X (K191371)
Indications for Use
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 (iii) 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 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.
4
Device Description
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.
Comparison of Intended Use, Indications for Use and Technological Characteristics with the Predicate Device
The intended use and technological characteristics of the subject MolecuLight i:X are identical to the previously cleared MolecuLight i:X. The only difference between the subject and predicate device is an additional statement in the device's labeling clarifying the relationship between the presence of a cyan fluorescence signature and the increased likelihood that wound contains Pseudomonas aeruqinosa. This statement does not change the indications for use of the device, and does not raise any new questions of safety or efficacy. The statement is supported by additional analysis of the clinical study reported in support of K191371.
| | SUBJECT DEVICE
MolecuLight i:X | Predicate Device
MolecuLight i:X (K191371) |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | MolecuLight i:X | MolecuLight i:X |
| Manufacturer | MolecuLight Inc. | MolecuLight Inc. |
| 510(k) Number | - | K191371 |
| Regulatory Class | Class II | Class II |
| Regulation
Number | QJF | QJF |
| Product
Classification | 21 CFR 878.4550 | 21 CFR 878.4550 |
| Classification
Name | Autofluorescence detection device
for general surgery and
dermatological use | Autofluorescence detection device
for general surgery and
dermatological use |
| Intended Use | Intended for general surgery and
dermatological use as an adjunct
tool that uses autofluorescence to
detect tissues or structures. This
device is not intended to provide a
diagnosis. | Intended for general surgery and
dermatological use as an adjunct
tool that uses autofluorescence to
detect tissues or structures. This
device is not intended to provide a
diagnosis. |
| Indications for
Use | 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 | 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 |
| Table 1: Comparison of Technological Characteristics for Fluorescence Imaging | ||
|---|---|---|
5
| (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 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. | (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 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. | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Labelled relationship between Cyan fluorescence and Pseudomonas aeruginosa | Yes | No |
| Target Organ | Wounds | Wounds |
| Patient Population | Adult patients | Adult patients |
| Operating Modes | Standard and fluorescence imaging, video and image capture | Standard and fluorescence imaging, video and image capture |
| Excitation Light | 405 nm light emitted from light emitting diodes (LED)s | 405 nm light emitted from light emitting diodes (LED)s |
| Laser Power Density | N/A | N/A |
| Infrared LED | N/A | N/A |
| White LED | N/A | N/A |
| Emission Wavelength | 500-545 nm and 600-665 nm | 500-545 nm and 600-665 nm |
| Contrast agent | Not required - autofluorescent target | Not required - autofluorescent target |
| Working Distance | 8-12 cm | 8-12 cm |
| Resolution (focal plane) | 5 megapixels | 5 megapixels |
| Magnification | N/A | N/A |
| Camera Bit Depth | 8 bits | 8 bits |
| Image Size (Pixels) | 1136 x 640 pixels | 1136 x 640 pixels |
| Image Format | JPEG | JPEG |
| Video Format | MOV | MOV |
| Software Operating System (OS) | Apple iOS 9.3.5 | Apple iOS 9.3.5 |
| Compatibility Measurement Functionality | Wound length, width, and area measurements | Wound length, width, and area measurements |
| Power Supply | Battery and Wall | Battery and Wall |
| Display | Handheld device; no remote display | Handheld device; no remote display |
| Patient Contacting Materials | Non-patient contacting device (held 8-12 cm from skin) | Non-patient contacting device (held 8-12 cm from skin) |
| Sterility | Used non-sterile | Used non-sterile |
| Electrical Safety | Compliance to IEC 60601-1 | Compliance to IEC 60601-1 |
| Mechanical Safety | Compliance to IEC 60601-1 | Compliance to IEC 60601-1 |
| Chemical Safety | No chemical delivered or used as part of the system | No chemical delivered or used as part of the system |
| Standards with which the Device Complies | IEC 60601-1-2
IEC 60601-1
IEC 60601-2-57
IEC 62471 | IEC 60601-1-2
IEC 60601-1
IEC 60601-2-57
IEC 62471 |
6
In summary, the modified MolecuLight i:X with the additional labeling statement is substantially equivalent to the legally marketed MolecuLight i:X. The intended use of the i:X device is the same as the predicate, and there are no differences in technological characteristics. 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. Thus, the MolecuLight i:X is substantially equivalent to the previously cleared MolecuLight i:X.
Non-Clinical Testing
No non-clinical performance testing was performed for this 510(k) submission.
Clinical Performance Testing
Data from 350 patients were retrospectively analyzed to evaluate the effectiveness of MolecuLight i:X to identify wounds with Pseudomonas aeruginosa at bacterial loads ≥ 104 CFU/g based on sensitivity, specificity, PPV, NPV, and likelihood ratio.
7
Table 2: Cyan Fluorescence in the Detection of Pseudomonas aeruginosa at Species Specific Levels ≥ 104 CFU/q
| Fluorescence
Signature | Sensitivity
(95% CI)ª
n=32 | Specificity
(95% CI)ª
n=318 | PPVb
(95% CI)ª
n=30 | NPVb
(95% CI)ª
n=320 | Likelihood
Ratio
(95% CI)
N=30 |
|---------------------------|----------------------------------|-----------------------------------|-----------------------------|-----------------------------|-----------------------------------------|
| Cyan | 43.75%
(26.26,
62.34) | 94.97%
(91.96,
97.10) | 46.67%
(28.34,
65.67) | 94.38%
(91.26,
96.63) | 8.70
(4.69, 16.14) |
o aTwo-sided 95% Clopper Pearson Confidence Intervals.
o bThe PPV and NPV are computed for the study prevalence of 9.14%.
-
o Likelihood ratio is the probability of a wound with Pseudomonas aeruginosa at Species Specific Levels ≥ 104 CFU/q being positive for cyan fluorescence divided by the probability of a wound that does not have Pseudomonas aeruginosa at Specific Levels ≥ 104 CFU/q being positive for cyan fluorescence.
Detailed retrospective analysis included assessment for the presence of any i:X fluorescence signature (red and/or cyan), presence of cyan fluorescence, presence of red fluorescence, and total bacterial load (TBL; CFU/g; sum of all species). Results for three separate analyses of the diagnostic parameters are presented below: -
Fluorescence in the Detection of Pseudomonas aeruginosa at Species Specific Levels ≥ i. 104 CFU/g
-
Fluorescence in the Detection of Total Bacterial Load (TBL) at Levels ≥ 104 CFU/g ii.
-
iii. Fluorescence in the Detection Total Bacterial Load (TBL) at Levels ≥ 104 CFU/g in Absence of Pseudomonas aeruginosa
| Test | Post.Test.Risk (PPV) | Likelihood | ||||
|---|---|---|---|---|---|---|
| Output | Pa.High | Pa.Low | Post.Test.Risk | Lower | ||
| Confidence | ||||||
| Limit | Upper | |||||
| Confidence | ||||||
| Limit | Ratio | |||||
| Cyan FL | 14 | 16 | 0.467 | 0.283 | 0.657 | 8.695 |
| Red FL | 14 | 145 | 0.088 | 0.049 | 0.143 | 0.959 |
| Red or | ||||||
| Cyan FL | 25 | 150 | 0.143 | 0.095 | 0.204 | 1.656 |
| Total | 32 | 318 | 0.091 | 0.063 | 0.127 | 1.000 |
Table 3: Cyan, Red, and Cyan or Red Fluorescence in the Detection of Pseudomonas aeruginosa at Species Specific Levels ≥ 104 CFU/g
8
Table 4: Cyan, Red, and Cyan or Red Fluorescence in the Detection of Total Bacterial Load (TBL) at Levels ≥ 104 CFU/g
| Post.Test.Risk (PPV) | ||||||
|---|---|---|---|---|---|---|
| Test | ||||||
| Output | TBL.High | TBL.Low | Post.Test.Risk | Lower | ||
| Confidence | ||||||
| Limit | Upper | |||||
| Confidence | ||||||
| Limit | Likelihood | |||||
| Ratio | ||||||
| Cyan FL | 29 | 1 | 0.967 | 0.828 | 0.999 | 6.366 |
| Red FL | 152 | 7 | 0.956 | 0.911 | 0.982 | 4.767 |
| Red or | ||||||
| Cyan FL | 168 | 7 | 0.960 | 0.919 | 0.984 | 5.268 |
| Total | 287 | 63 | 0.820 | 0.776 | 0.859 | 1.000 |
Table 5: Cyan, Red, and Cyan or Red Fluorescence in the Detection of Wounds with Total Bacterial Load (TBL) at Levels ≥ 104 CFU/g negative for Pseudomonas aeruginosa
| Test
Output | TBL
(Absent
PA).High | TBL
(Absent
PA).Low | Post.Test.Risk (PPV) | | | Likelihood
Ratio |
|----------------------|----------------------------|---------------------------|----------------------|------------------------------|------------------------------|---------------------|
| | | | Post.Test.Risk | Lower
Confidence
Limit | Upper
Confidence
Limit | |
| Cyan
FL | 15 | 1 | 0.938 | 0.698 | 0.998 | 3.706 |
| Red FL | 138 | 7 | 0.952 | 0.903 | 0.980 | 4.871 |
| Red or
Cyan
FL | 143 | 7 | 0.953 | 0.906 | 0.981 | 5.047 |
| Total | 255 | 63 | 0.802 | 0.754 | 0.844 | 1.000 |
Conclusion
The modified MolecuLight i:X is substantially equivalent to the cleared MolecuLight i:X.