(270 days)
K903505/A2
Not Found
No
The description mentions "algorithms" embedded in firmware/software for interpreting readings, but there is no mention of AI, ML, or any learning process. The performance studies compare it to a predicate device and focus on standard metrics like false positive/negative rates, not metrics typically associated with AI/ML model evaluation.
No.
This device is an in-vitro diagnostic system designed to detect microbial growth from blood and other sterile body fluids, not to provide therapeutic treatment.
Yes
The device is an automated microbial test system that detects microorganism growth, which is used to diagnose infections from blood and other sterile body fluids.
No
The device description clearly outlines hardware components including an incubator, agitation mechanism, robotic apparatus, and a tactile graphical interface. While it utilizes software and firmware for monitoring and interpretation, it is fundamentally a hardware system with integrated software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "microbial test system" for the "detection of aerobic microorganism growth from blood and other normally sterile body fluids." This is a diagnostic purpose performed on samples taken from the body.
- Device Description: The description details how the system works by monitoring changes in culture medium due to microbial metabolism (CO2 production). This is a classic method used in in vitro diagnostics to identify the presence of microorganisms in a sample.
- Anatomical Site: The samples tested are "Blood and other normally sterile body fluids," which are biological specimens.
- Performance Studies: The performance studies involve testing clinical samples and controls to evaluate the system's ability to detect microbial growth, which is a key aspect of validating an IVD.
- Predicate Device: The predicate device is also a "Microbial Detection System," further indicating the diagnostic nature of this type of device.
All these factors align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
BacT/ALERT® VIRTUO(TM) Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic microorganism growth from blood and other normally sterile body fluids.
Product codes (comma separated list FDA assigned to the subject device)
MDB
Device Description
The VIRTUO Instrument is the next generation of the bioMerieux BacT/ALERT Microbial Detection System. This blood culture instrument consists of an incubator, agitation mechanism, robotic apparatus for automated loading and unloading of bottles and a tactile graphical interface. The VIRTUO is used in conjunction with existing, commercialized BacT/ALERT reagent bottles for clinical use (BacT/ALERT SA, SN, FA Plus, FN Plus and PF Plus culture bottles).
The VIRTUO system utilizes a colorimetric sensor and reflected light to monitor the presence and production of carbon dioxide (CO2) dissolved in the culture medium. If microorganisms are present in the inoculated sample, carbon dioxide is produced as the organisms metabolize the substrates in the culture medium. When growth of the microorganisms produces CO2, the color of the gas-permeable sensor installed in the bottom of each culture bottle changes from blue-green to yellow. The color change results in an increase of reflectance units monitored by the system. The VIRTUO optically monitors the reflectance of each bottle over time and will store and interpret readings against algorithms, which are embedded in the firmware and/or software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Blood and other normally sterile body fluids
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
External performance evaluations were conducted at eight external clinical sites. The evaluation included testing of blood & sterile body fluids using the BacT/ALERT SA, SN, FA Plus, PF Plus and FN Plus culture bottles with the VIRTUO and 3D Systems.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The BacT/ALERT VIRTUO Microbial Detection System demonstrated substantially equivalent performance when compared with the BacT/ALERT 3D Microbial Detection System.
When all 5862 bottle pairs tested are considered, false positive rates were 0.09% (5/5862) and 0.19% (11/5862) for VIRTUO and BTA3D, respectively. False negative rates were 0.38% (22/5862) and 0.38% (22/5862) for VIRTUO and BTA3D, respectively, While the algorithm on VIRTUO is new and has some differences compared to that of the BTA3D, these results for VIRTUO and BTA3D demonstrate an equivalent ability of the two systems to detect and recover organisms in BacT/ALERT bottles and demonstrate the efficacy of the VIRTUO Detection algorithm. The yields of microorganisms are similar between VIRTUO and BTA3D.
There were 1490 positive controls tested on VIRTUO for all sites combined. Of those, 1487 (99.8%) were signaled positive by VIRTUO. There were 1486 negative controls tested for all sites combined. Of those, 1486 (100%) were signaled negative by VIRTUO. Of the total of 2976 controls tested over the course of the clinical trial, VIRTUO gave the expected result for 2973/2976 (99.9%) of the controls.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
False positive rates: 0.09% (VIRTUO), 0.19% (BTA3D)
False negative rates: 0.38% (VIRTUO), 0.38% (BTA3D)
Positive control detection rate: 99.8% (VIRTUO)
Negative control detection rate: 100% (VIRTUO)
Overall control accuracy: 99.9% (VIRTUO)
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.
BacT/ALERT® 3D Microbial Detection System (K903505/A2)
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
§ 866.2560 Microbial growth monitor.
(a)
Identification. A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I. With the exception of automated blood culturing system devices that are used in testing for bacteria, fungi, and other microorganisms in blood and other normally sterile body fluids, this device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 28, 2017
BIOMERIEUX, INC. JOLYN TENLLADO DIRECTOR GLOBAL REGULATORY AFFAIRS MICROBIOLOGY 595 ANGLUM RD. HAZELWOOD MO 63042
Re: K161816
Trade/Device Name: BacT/ALERT® VIRTUO™ Microbial Detection System Regulation Number: 21 CFR 866.2560 Regulation Name: Microbial growth monitor Regulatory Class: I Product Code: MDB Dated: February 21, 2017 Received: February 23, 2017
Dear Ms. Tenllado:
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. 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.
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ribhi Shawar -A
For Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
1.5 - Indications for Use (FDA FORM 3881)
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) Unknown at time of 510(k) Submission
Device Name BacT/ALERT® VIRTUO(TM) Microbial Detection System
Indications for Use (Describe)
BacT/ALERT® VIRTUO(TM) Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic microorganism growth from blood and other normally sterile body fluids.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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
B.
C.
Image /page/3/Picture/1 description: The image shows the logo for bioMérieux. The logo consists of the company name in a sans-serif font, with a stylized graphic above it. The graphic is a circle with lines on the left side, and a curved line that goes through the circle.
510(k) SUMMARY
BacT/ALERT® VIRTUO™ Microbial Detection System
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Jolyn Tenllado |
| Director, Global Regulatory Affairs Microbiology | |
| Phone Number: | 314-731-8386 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | June 30, 2016 |
| Device Name: | |
| Formal/Trade Name: | BacT/ALERT® VIRTUO™ Microbial Detection |
| System | |
| Classification Name: | 21 CFR 866.2560, Microbial Growth Monitor |
| Common Name: | BacT/ALERT® VIRTUO™; VIRTUO™ |
| Predicate Device: | BacT/ALERT® 3D Microbial Detection System |
| (K903505/A2) |
D. 510(k) Summary:
Intended Use:
BacT/ALERT® VIRTUO™ Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids.
Device Description:
The VIRTUO Instrument is the next generation of the bioMerieux BacT/ALERT Microbial Detection System. This blood culture instrument consists of an incubator, agitation mechanism, robotic apparatus for automated loading and unloading of bottles and a tactile graphical interface. The VIRTUO is used in conjunction with existing, commercialized BacT/ALERT reagent bottles for clinical use (BacT/ALERT SA, SN, FA Plus, FN Plus and PF Plus culture bottles).
Page 001 - 1.10-1
bioMérieux, Inc. Phone: 314/731-8500 800/638-4835 595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Fax: 314/731-8700
4
The VIRTUO system utilizes a colorimetric sensor and reflected light to monitor the presence and production of carbon dioxide (CO2) dissolved in the culture medium. If microorganisms are present in the inoculated sample, carbon dioxide is produced as the organisms metabolize the substrates in the culture medium. When growth of the microorganisms produces CO2, the color of the gas-permeable sensor installed in the bottom of each culture bottle changes from blue-green to yellow. The color change results in an increase of reflectance units monitored by the system. The VIRTUO optically monitors the reflectance of each bottle over time and will store and interpret readings against algorithms, which are embedded in the firmware and/or software.
| | New Device:
BacT/ALERT VIRTUO | Predicate Device:
BacT/ALERT 3D |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | The BacT/ALERT® VIRTUOTM
Microbial Detection System is
an automated microbial test
system capable of incubating,
agitating, and continuously
monitoring for the detection of
aerobic, facultative, and
anaerobic microorganism
growth from blood and other
normally sterile body fluids.
Note: The intial release of the
system will not include detection
of Mycobacterium species
growth from clinical specimens. | The BacT/ALERT® 3D Microbial
Detection System is a totally
automated test system capable
of incubating, agitating, and
continuously monitoring aerobic
and anaerobic media inoculated
with patient specimens
suspected of having bacteremia,
fungemia, and/or
mycobacteremia (Clinical Use) |
| Reagent | For use with the BacT/ALERT
SA, SN, FA Plus, PF Plus and
FN Plus culture bottles (Clinical
Use) | For use with the BacT/ALERT
SA, SN, FA, PF, FN, MP, FA
Plus, FN Plus, PF Plus (Clinical
Use) |
| Detection Method
for Microbial
Growth | Reflectance change of
colorimetric sensor over time to
measure metabolic reactants | Reflectance change of
colorimetric sensor over time to
measure metabolic reactants |
| Incubation &
Agitation | Electrically heated forced air
convection incubation.
Continuous 12.5° from
horizontal sinusoidal rocking of
reagent & sample @50-60
cycles/minute. | Electrically heated forced air
convection incubation.
Continuous 12.5° from
horizontal sinusoidal rocking of
reagent & sample @50-60
cycles/minute. |
| Colorimetric
Optics | LED emitter with 634nm peak
wavelength and 17nm
bandwidth/photodiode detector.
Four point graduated grey scale
optical calibration. | LED emitter with 634nm peak
wavelength and 17nm
bandwidth/photodiode detector.
Four point graduated grey scale
optical calibration. |
| Differences | | |
| Detection
algorithms | Proprietary algorithms unique
for BacT/ALERT VIRTUO | Proprietary algorithms unique
for BacT/ALERT 3D |
| Capacity | 108-6912 bottles | 240-1440 bottles |
| Bottle Loading | Automated loading of bottles
placed on conveyor (up to 40 at
a time) with bottle label
scanning, measuring of sample | Customer scans bottle labels
and loads the bottle into a bottle
cell of an open drawer, one
bottle at a time |
| Table 1: Similarities & Differences Between BacT/ALERT Microbial Detection Systems | |
|---|---|
| ------------------------------------------------------------------------------------ | -- |
5
Section 1.10
| | volume & loading via robotic
arm into open incubator cell with
appropriate agitation. Customer
can manually load bottles if
automation features are not
operable | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Remote
Customer Access | Internal (customer site) network
access | Unavailable |
Performance Characteristics:
The BacT/ALERT VIRTUO Microbial Detection System demonstrated substantially equivalent performance when compared with the BacT/ALERT 3D Microbial Detection System. This 510(k) Premarket Notification presents data in support of the BacT/ALERT VIRTUO. External performance evaluations were conducted at eight external clinical sites. The evaluation included testing of blood & sterile body fluids using the BacT/ALERT SA, SN, FA Plus, PF Plus and FN Plus culture bottles with the VIRTUO and 3D Systems.
The following tables compare results of the BacT/ALERT VIRTUO to BacT/ALERT 3D blood cultures for all compliant blood culture bottles that yielded any number of isolates on subculture.
| Clinical Determination | VIRTUO True
Positives | % of VIRTUO True
Positives in
Population | BTA3D True
Positives | % of BTA3D True
Positives in
Population | Ratio of True
Positives | 95% CI
(LCL, UCL) |
|------------------------|--------------------------|------------------------------------------------|-------------------------|-----------------------------------------------|----------------------------|----------------------|
| Significant | 64 | 6.1 (64/1057) | 66 | 6.2 (66/1057) | 0.970 | 0.821,
1.119 |
| Contaminant | 7 | 0.7 (7/1057) | 11 | 1.0 (11/1057) | 0.636 | |
| Unknown | 2 | 0.2 (2/1057) | 2 | 0.2 (2/1057) | 1.000 | |
| Total | 73 | 6.9 (73/1057) | 79 | 7.5 (79/1057) | 0.924 | 0.766,
1.082 |
| BacT/ALERT FA Plus: Blood - Compliant -- Single and Multiple Isolates |
|---|
| ----------------------------------------------------------------------- |
BacT/ALERT FN Plus: Blood - Compliant - Single and Multiple Isolates
| Clinical Determination | VIRTUO
True
Positives | % of VIRTUO True
Positives in
Population | BTA3D
True
Positives | % of BTA3D True
Positives in
Population | Ratio of
True
Positives | 95% CI
(LCL,
UCL) |
|------------------------|-----------------------------|------------------------------------------------|----------------------------|-----------------------------------------------|-------------------------------|-------------------------|
| Significant | 47 | 5.2 (47/912) | 48 | 5.3 (48/912) | 0.979 | 0.823,
1.135 |
| Contaminant | 13 | 1.4 (13/912) | 10 | 1.1 (10/912) | 1.300 | |
| Unknown | 0 | 0.0 (0/912) | 0 | 0.0 (0/912) | - | |
| Total | 60 | 6.6 (60/912) | 58 | 6.4 (58/912) | 1.034 | 0.852,
1.216 |
6
| BacT/ALERT PF Plus: Blood - Compliant - Single and Multiple Isolates | |||
|---|---|---|---|
| Clinical Determination | VIRTUO
True
Positives | % of VIRTUO True
Positives in
Population | BTA3D True
Positives | % of BTA3D True
Positives in
Population | Ratio of True
Positives | 95% CI
(LCL, UCL) |
|------------------------|-----------------------------|------------------------------------------------|-------------------------|-----------------------------------------------|----------------------------|----------------------|
| Significant | 1 | 0.6 (1/161) | 1 | 0.6 (1/161) | 1.000 | -1.772,
3.772* |
| Contaminant | 0 | 0.0 (0/161) | 0 | 0.0 (0/161) | - | |
| Unknown | 0 | 0.0 (0/161) | 0 | 0.0 (0/161) | - | |
| Total | 1 | 0.6 (1/161) | 1 | 0.6 (1/161) | 1.000 | -1.772,
3.772* |
*Since the confidence interval contains a negative, the interval does not pe interval does not provide a meaningful interpretation.
Low Fill BacT/ALERT FA Plus: Blood – Compliant – Single and Multiple Isolates
| Clinical Determination | VIRTUO
True
Positives | % of VIRTUO True
Positives in
Population | BTA3D True
Positives | % of BTA3D True
Positives in
Population | Ratio of True
Positives | 95% CI
(LCL,
UCL) |
|------------------------|-----------------------------|------------------------------------------------|-------------------------|-----------------------------------------------|----------------------------|-------------------------|
| Significant | 28 | 7.4 (28/379) | 29 | 7.7 (29/379) | 0.966 | 0.790,
1.142 |
| Contaminant | 4 | 1.1 (4/379) | 3 | 0.8 (3/379) | 1.333 | |
| Unknown | 1 | 0.3 (1/379) | 0 | 0.0 (0/379) | - | |
| Total | 33 | 8.7 (33/379) | 32 | 8.4 (32/379) | 1.031 | 0.790,
1.272 |
BacT/ALERT SA: Blood Culture – Compliant – Single and Multiple Isolates
| Clinical Determination | VIRTUO
True
Positives | % of VIRTUO True
Positives in
Population | BTA3D True
Positives | % of BTA3D True
Positives in
Population | Ratio of True
Positives | 95% CI
(LCL, UCL) |
|------------------------|-----------------------------|------------------------------------------------|-------------------------|-----------------------------------------------|----------------------------|----------------------|
| Significant | 40 | 5.1 (40/780) | 39 | 5.0 (39/780) | 1.026 | 0.857,
1.195 |
| Contaminant | 4 | 0.5 (4/780) | 10 | 1.3 (10/780) | 0.400 | |
| Unknown | 2 | 0.3 (2/780) | 1 | 0.1 (1/780) | 2.000 | |
| Total | 46 | 5.9 (46/780) | 50 | 6.4 (50/780) | 0.920 | 0.736,
1.104 |
7
| Clinical Determination | VIRTUO
True
Positives | % of VIRTUO True
Positives in
Population | BTA3D True
Positives | % of BTA3D True
Positives in
Population | Ratio of True
Positives | 95% CI
(LCL, UCL) |
|------------------------|-----------------------------|------------------------------------------------|-------------------------|-----------------------------------------------|----------------------------|----------------------|
| Significant | 32 | 3.9 (32/830) | 30 | 3.6 (30/830) | 1.067 | 0.797,
1.337 |
| Contaminant | 1 | 0.1 (1/830) | 4 | 0.5 (4/830) | 0.250 | |
| Unknown | 1 | 0.1 (1/830) | 0 | 0.0 (0/830) | - | |
| Total | 34 | 4.1 (34/830) | 34 | 4.1 (34/830) | 1.000 | 0.730,
1.270 |
BacT/ALERT SN: Blood – Compliant – Single and Multiple Isolates
The following tables compare results of the BacT/ALERT VIRTUO to BacT/ALERT 3D sterile body fluid cultures that yielded single or multiple isolates on subculture.
| Clinical Determination | VIRTUO
True
Positives | % of VIRTUO True
Positives in
Population | BTA3D True
Positives | % of BTA3D True
Positives in
Population | Ratio of True
Positives | 95% CI
(LCL, UCL) |
|------------------------|-----------------------------|------------------------------------------------|-------------------------|-----------------------------------------------|----------------------------|----------------------|
| Significant | 42 | 11.2 (42/374) | 42 | 11.2 (42/374) | 1.000 | 0.852,
1.148 |
| Contaminant | 8 | 2.1 (8/374) | 6 | 1.6 (6/374) | 1.333 | |
| Unknown | 5 | 1.3 (5/374) | 4 | 1.1 (4/374) | 1.250 | |
| Total | 55 | 14.7 (55/374) | 52 | 13.9 (52/374) | 1.058 | 0.864,
1.252 |
BacT/ALERT FA Plus: SBF - Single and Multiple Isolates
BacT/ALERT FN Plus: SBF - Single and Multiple Isolates
| | VIRTUO
True
Positives | % of VIRTUO True
Positives in
Population | BTA3D True
Positives | % of BTA3D True
Positives in
Population | Ratio of True
Positives | 95% CI
(LCL, UCL) |
|------------------------|-----------------------------|------------------------------------------------|-------------------------|-----------------------------------------------|----------------------------|----------------------|
| Clinical Determination | | | | | | |
| Significant | 39 | 8.9 (39/437) | 38 | 8.7 (38/437) | 1.026 | 0.838,
1.214 |
| Contaminant | 9 | 2.1 (9/437) | 8 | 1.8 (8/437) | 1.125 | |
| Unknown | 4 | 0.9 (4/437) | 6 | 1.4 (6/437) | 0.667 | |
| Total | 52 | 11.9 (52/437) | 52 | 11.9 (52/437) | 1.000 | 0.794,
1.206 |
8
| Clinical Determination | VIRTUO
True
Positives | % of VIRTUO True
Positives in
Population | BTA3D True
Positives | % of BTA3D True
Positives in
Population | Ratio of True
Positives | 95% CI
(LCL,
UCL) |
|------------------------|-----------------------------|------------------------------------------------|-------------------------|-----------------------------------------------|----------------------------|-------------------------|
| Significant | 14 | 18.2 (14/77) | 15 | 19.5 (15/77) | 0.933 | 0.807,
1.059 |
| Contaminant | 0 | 0.0 (0/77) | 2 | 2.6 (2/77) | 0.000 | |
| Unknown | 1 | 1.3 (1/77) | 0 | 0.0 (0/77) | - | |
| Total | 15 | 19.5 (15/77) | 17 | 22.1 (17/77) | 0.882 | 0.665,
1.099 |
BacT/ALERT SA: Sterile Body Fluids - Single and Multiple Isolates
BacT/ALERT SN: Sterile Body Fluids - Single and Multiple Isolates
| Clinical Determination | VIRTUO True Positives | % of VIRTUO True Positives in Population | BTA3D True Positives | % of BTA3D True Positives in Population | Ratio of True Positives | 95% CI (LCL, UCL) |
|---|---|---|---|---|---|---|
| Significant | 17 | 21.0 (17/81) | 17 | 21.0 (17/81) | 1.000 | 0.837, |
| 1.163 | ||||||
| Contaminant | 1 | 1.2 (1/81) | 1 | 1.2 (1/81) | 1.000 | |
| Unknown | 1 | 1.2 (1/81) | 0 | 0.0 (0/81) | - | |
| Total | 19 | 23.5 (19/81) | 18 | 22.2 (18/81) | 1.056 | 0.806, |
| 1.306 |
9
Section 1.10
When all 5862 bottle pairs tested are considered, false positive rates were 0.09% (5/5862) and 0.19% (11/5862) for VIRTUO and BTA3D, respectively. False negative rates were 0.38% (22/5862) and 0.38% (22/5862) for VIRTUO and BTA3D, respectively, While the algorithm on VIRTUO is new and has some differences compared to that of the BTA3D, these results for VIRTUO and BTA3D demonstrate an equivalent ability of the two systems to detect and recover organisms in BacT/ALERT bottles and demonstrate the efficacy of the VIRTUO Detection algorithm. The yields of microorganisms are similar between VIRTUO and BTA3D.
There were 1490 positive controls tested on VIRTUO for all sites combined. Of those, 1487 (99.8%) were signaled positive by VIRTUO. There were 1486 negative controls tested for all sites combined. Of those, 1486 (100%) were signaled negative by VIRTUO. Of the total of 2976 controls tested over the course of the clinical trial, VIRTUO gave the expected result for 2973/2976 (99.9%) of the controls.
Page 001 - 1.10-2