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BD BACTEC Myco/F Lytic culture medium when used with the BD BACTEC fluorescent series instruments is a nonselective culture medium to be used as an adjunct to aerobic blood culture media for the qualitative culture and recovery of mycobacteria, yeast and fungi from blood. This medium may also be used for the culture of sterile body fluids when veast or fungi are suspected.

BD BACTEC Myco/F Lytic culture medium is a Middlebrook 7H9 and Brain Heart Infusion broth formulation for the recovery of mycobacteria from blood specimens, and yeast and fungi from blood and sterile body fluids. Specific modifications were made to enhance the growth and recovery of mycobacteria, yeast and fungi. These modifications include ferric ammonium citrate to provide an iron source for specific strains of mycobacteria and fungi, the addition of saponin as a blood lysing agent, and the addition of specific proteins and sugars to provide nutritional supplements. Each vial contains a sensor which can detect decreases in oxygen concentration in the vial resulting from microorganism metabolism and growth. The sensor is monitored by the BD BACTEC fluorescent series instrument for increasing fluorescence, which is due to the decrease in oxygen. A positive determination indicates the presumptive presence of viable microorganisms in the vial.

BD BACTEC Myco/F Lytic Culture Vials are supplied in a carton containing 50 vials. It is a nonsterile product.

This document is a 510(k) Substantial Equivalence Determination Decision Summary for the BD BACTEC Myco/F Lytic Culture Vials (plastic). It evaluates the device's performance against a predicate device (BD BACTEC Myco/F Lytic Culture Vials (glass)) to determine if it is substantially equivalent. The studies described are analytical performance comparisons rather than clinical trials with human subjects for diagnostic accuracy.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a bulleted or numbered list with corresponding reported performance values within a formal table. Instead, it presents performance data for the modified (plastic) device compared to the predicate (glass) device across various analytical parameters. The implicit acceptance criteria appear to be substantial equivalence, meaning the performance of the new plastic vial is "equivalent to or better than" the predicate glass vial.

Here's a synthesized table based on the provided data, comparing the plastic device's performance to the predicate:

Table: Summary of Device Performance Compared to Predicate (Implicit Acceptance Criteria: Equivalent to or Better)

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

The studies described are analytical performance studies performed in a laboratory setting, rather than clinical studies with patient samples. The samples used are seeded samples (i.e., known microorganisms inoculated into blood or sterile body fluid).

• Test Set (Seeded Samples):
  • Reproducibility: Not explicitly stated as a separate "test set" size, but involved testing across three lots of media with varying blood/SBF volumes and inoculum levels.
  • Microbial Detection Limit (MDL) - Blood:
    • Sample Size: 414 paired vials (plastic vs. glass). 2 pairs discarded due to contamination, resulting in 412 paired vials. (23 organisms x 3 lots x 3 blood vol x 2 inoculum levels x 1 instrument).
    • Data Provenance: This is in vitro analytical data obtained from controlled laboratory experiments, not from human patients or a specific country of origin.
  • Microbial Detection Limit (MDL) - Sterile Body Fluid (SBF):
    • Sample Size: 264 paired vials (plastic vs. glass). (3 organisms x 3 lots x 4 SBF volumes x 2 inoculum levels x 1 instrument x 2 SBF types) + (5 organisms x 3 lots x 4 SBF volumes x 2 inoculum levels x 1 instrument x 1 SBF type).
    • Data Provenance: In vitro analytical data.
  • Delayed Entry in blood (Mycobacteria):
    • Sample Size: Not explicitly stated as a total paired set number, but involved 8 strains of mycobacterium. Total number of vials for each delay condition (e.g., 72/72 for no delay, 70/70 for 12h @ 20-25C, etc.) is provided in Table 7. Each test used 3 lots and 1, 3, or 5 mL human blood.
    • Data Provenance: In vitro analytical data using human blood matrix.
  • Percent Recovery (Detection) - Blood (10-100 CFU/vial):
    • Sample Size: 207 paired sets (plastic vs. glass). (23 organisms x 3 lots x 3 blood volumes x 1 instrument).
    • Data Provenance: In vitro analytical data using blood matrix.
  • Percent Recovery (Detection) - SBF (10-100 CFU/vial):
    • Sample Size: 132 paired sets (plastic vs. glass). (3 organisms x 3 lots x 4 SBF volumes x 1 inoculum level x 1 instrument x 2 SBF types) + (5 organisms x 3 lots x 4 SBF volumes x 1 inoculum level x 1 instrument x 1 SBF type).
    • Data Provenance: In vitro analytical data using SBF matrix.
  • False Positive Rate - Blood:
    • Sample Size: 144 paired sets initially, 143 after contamination exclusion. (8 vials x 3 blood volumes x 3 lots x 2 instruments).
    • Data Provenance: In vitro analytical data using fresh blood.
  • False Positive Rate - SBF:
    • Sample Size: 432 paired sets initially, 425/424 after contamination exclusions. (8 vials x 3 SBF volumes x 3 lots x 2 instruments x 3 SBF types).
    • Data Provenance: In vitro analytical data using sterile body fluid.
  • False Negative Rate - Blood:
    • Sample Size: 619 combined paired sets from Recovery and MDL studies.
    • Data Provenance: In vitro analytical data.
  • False Negative Rate - SBF:
    • Sample Size: 396 combined paired sets from Recovery and MDL studies.
    • Data Provenance: In vitro analytical data.
  • Instrument Compatibility - Blood:
    • Sample Size: 54 paired sets for FX and 9050 each, 53 paired sets for FX-40 and 9240 each (total 214-216 paired sets for blood). (6 organisms x 3 blood volumes x 1 inoculum x 3 lots / 4 instruments).
    • Data Provenance: In vitro analytical data.
  • Instrument Compatibility - SBF:
    • Sample Size: 48 paired sets per instrument (total 192 paired sets for SBF). (4 organisms x 4 SBF volumes x 1 inoculum x 3 lots / 4 instruments).
    • Data Provenance: In vitro analytical data.

All data described is retrospective in the sense that it was collected as part of a pre-market submission process, likely after the plastic vial formulation was developed. It is not prospective clinical data from patient studies. The data provenance is internal laboratory studies, not patient data from a specific country.

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

The ground truth for these analytical studies is based on controlled, seeded experiments where the presence and identity of the microorganisms are known.

• The "ground truth" is the known inoculum (CFU/vial) of specific ATCC strains or clinical isolates of mycobacteria, yeast, and fungi.
• Detection by instruments (BD BACTEC fluorescent series instruments) is validated against the known presence/absence of these seeded organisms and further confirmed by subculture for discordant results (e.g., false positives/negatives), which is a standard microbiological method.
• No human experts (like radiologists) are mentioned or typically involved in establishing ground truth for in vitro diagnostic (IVD) culture media performance studies. The ground truth is intrinsically tied to the experimental design – what was precisely inoculated and subsequently confirmed by laboratory methods.

4. Adjudication Method for the Test Set

Adjudication, in the context of IVD performance, would typically involve resolving discrepancies between a device's result and a reference method/truth.

• For these studies, the primary comparison is the Time-to-Detection (TTD) and Percent Recovery of the plastic vial versus the glass predicate vial against the known seeded inoculum.
• For false positive/negative rates, discrepancies between instrument reads and definitive culture (subculture) results are identified. The report explicitly mentions how these were defined:
  • False Positive: "instrument positive but subculture negative."
  • False Negative: "instrument-negative at the end of protocol yet contains viable organisms upon subculturing onto appropriate culture media."
• There's no mention of a multi-observer or consensus-based adjudication process as one would see in image interpretation studies. The "adjudication" is inherent in the design of comparing instrument readouts to known inputs and standard microbiological subculture confirmation.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.

• MRMC studies are typically performed for medical imaging devices where human readers interpret images, and the AI's impact on their performance is evaluated.
• This submission concerns an in vitro diagnostic culture medium, which is an automated system for microbial growth detection. The "reader" is the BD BACTEC fluorescent series instrument, not a human.
• Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here. The comparison is between two different types of culture vials (plastic vs. glass), both processed by the same automated instruments.

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

Yes, in essence, standalone performance was evaluated.

• The device being assessed is the BD BACTEC Myco/F Lytic Culture Vial (plastic), which operates when placed into the BD BACTEC fluorescent series instruments.
• The performance metrics (TTD, Percent Recovery, False Positive/Negative rates) are generated by the instrument's automated detection algorithm based on the changes in fluorescence caused by microbial growth in the vial.
• Humans are involved in inoculating the vials and performing subcultures for confirmation, but the "performance" described is the direct, automated output of the integrated vial-instrument system. It is not an "AI" in the sense of an image interpretation algorithm, but an automated detection system where the organism's metabolism directly causes a measurable signal change detected by the instrument's programming (analogous to an algorithm).

7. The Type of Ground Truth Used

The ground truth used primarily in these analytical studies is an expert-determined, controlled, seeded panel.

• This involves known strains of mycobacteria, yeast, and fungi (e.g., ATCC strains and clinical isolates) at specified inoculum levels (CFU/vial).
• For discordant results (e.g., instrument negative but suspected positive), subculture onto appropriate culture media plates was used to confirm the presence of viable organisms, acting as a definitive microbiological reference method for the seeded content.
• It does not utilize pathology reports (which are for tissue diagnosis) or outcomes data (which would be clinical outcomes in patients).

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" or "training data" in the conventional machine learning sense.

• This is an IVD device validation, not an AI/ML software validation.
• The comparison is between a new device (plastic vial) and a predicate device (glass vial), demonstrating substantial equivalence based on a series of analytical performance studies.
• The "training" of the instrument's underlying detection algorithm (which interprets the fluorescent signals) would have occurred during its initial development and prior regulatory submissions (e.g., for K970333, K970512 for the predicate device). The current submission focuses on demonstrating that the change in vial material (plastic vs. glass) does not adversely affect this established performance.

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

As noted above, there is no explicitly defined "training set" for the vial in the context of this submission. The ground truth for the instrument's core detection capabilities would have been established historically during its development. This would also involve known, quantifiable microbial cultures and their characteristic growth patterns and metabolic activity in the media over time, likely confirmed by standard agar plate cultures or other gold standard microbiological methods.

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BD BACTEC™ Plus Aerobic/F Culture Vials are used in a qualitative procedure for the aerobic culture and recovery of microorganisms (bacteria and yeast) from blood. The principal use of this medium is with the BD BACTECTM fluorescent series instruments.

The BD BACTECTM Plus Aerobic/F Culture Vials contain a bacterial growth medium intended for use in the qualitative culture and recovery of aerobic microorganisms (bacteria and yeast) from blood. It has been designed for blood volumes of three (3) to ten (10) milliliters and is used specifically with the BD BACTEC™ fluorescent-series instruments in monitoring of clinical blood specimens for the presence of microorganisms.

BD BACTECTM Plus Aerobic/F Culture Vials are supplied in a carton containing 50 vials. It is a nonsterile product.

This document describes the performance assessment of the BD BACTEC™ Plus Aerobic/F Culture Vials, a modified device, against a predicate device (K113558) to establish substantial equivalence.

Here's a breakdown of the acceptance criteria and study details:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state quantitative acceptance criteria in a dedicated table format with precise thresholds. Instead, it describes comparative "acceptance criteria" through statements of "no statistically relevant difference" or "no significant differences" between the modified and predicate devices for various analytical performance metrics.

However, based on the study findings, we can infer the implicit acceptance criteria:

2. Sample sized used for the test set and the data provenance:

• Sample Size (Test Set):

  • Instrument Time to Detection & Percent Recovery:
    • For 44 organisms at 10-100 CFU/vial: 264 vials per device (3 lots x 2 blood volumes x 44 organisms).
    • For 15 organisms at 0-1 and 1-10 CFU/vial: 45 vials per device per inoculum level per blood volume on BACTEC™ FX, totaling 90 vials per device for these specific conditions.
    • Total vials for TTD/Recovery: Approximately 444 vials per device (264 + 90 + 90).
  • False Negative Rate: "115 instrument negative vials (57 in the modified device and 58 in the predicate device)" out of the 444 total vials from the TTD/Recovery study that were instrument negative.
  • False Positive Rate: 120 vials per device (3 lots x 8 replicates x 5 blood volumes).
  • Instrument Compatibility:
    • BACTEC™ FX and FX40: 264 paired sets per instrument (total 528 paired sets).
    • BACTEC™ 9240 and 9050: 96 paired sets per instrument (total 192 paired sets).
  • Resin Performance: 314 antibiotic/organism combinations per lot per device. With 3 lots per device, this amounts to 942 vials per device. Overall, 1884 vials for this study.

• Data Provenance: The studies were retrospective analytical performance studies, comparing a modified device to a previously cleared predicate device. The information does not specify the country of origin of the data, but given it's an FDA submission for a Becton, Dickinson and Company product, it is likely based on studies conducted in the US or in compliance with US regulatory standards. The testing involved controlled laboratory conditions using spiked (inoculated) blood samples, not clinical patient samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This study is an analytical performance study for a microbial growth monitor. The "ground truth" for the test set (i.e., whether growth occurred and what the TTD was) was established by:

• Direct Inoculation: Precise quantities (CFU/vial) of known bacterial and yeast organisms were inoculated into the vials.
• Instrument Detection: The BD BACTEC™ fluorescent series instruments automatically detect and log growth (CO2 production) as part of their function.
• Terminal Subculture: For vials that remained negative, a terminal subculture was performed to confirm the absence of viable microorganisms.

Therefore, this type of study does not rely on human experts to "establish ground truth" in the way a diagnostic imaging study might require radiologists. The ground truth is determined by the experimental design (known inoculum) and the objective readings of the instrument, verified by standard microbiological techniques (subculture).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. As described above, the ground truth is established by controlled inoculation and objective instrument readings/terminal subculture, not by human interpretation or adjudication.

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:

Not applicable. This is an analytical performance study of a microbial growth medium and instrument system, not a clinical study involving human readers interpreting diagnostic images or data with or without AI assistance. The device is not an AI-powered system that assists human readers.

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

The device (BD BACTEC™ Plus Aerobic/F Culture Vials) is a component of an automated system (BD BACTEC™ fluorescent series instruments). The performance evaluated in this submission is effectively the "standalone" performance of the altered vial formulation within the automated BACTEC™ system, without direct human intervention in the detection process itself. Human involvement comes in collecting blood, inoculating vials, and interpreting the instrument's final positive/negative results. The study inherently assesses the algorithm (instrument's detection logic) as part of the overall system performance.

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

The ground truth used was controlled laboratory inoculation with known quantities of specific microorganisms, followed by objective instrument detection (fluorescence changes indicating CO2 production) and confirmation by terminal microbiological subculture for negative vials. This is a highly controlled "gold standard" for analytical performance in microbiology.

8. The sample size for the training set:

Not applicable. This is an analytical performance study comparing a modified in vitro diagnostic device component to a predicate device. It does not involve a "training set" in the context of machine learning model development. The study design is focused on demonstrating functional equivalence through empirical testing.

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

Not applicable, as there was no training set in the context of machine learning.

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The BACT/ALERT® MP Reagent System consists of the BACT/ALERT® MP culture bottle with a removable closure used in conjunction with the BACT/ALERT® MP Antimicrobial Supplement and the BACT/ALERT® MP Nutrient Supplement. The BACT/ALERT® MP Reagent System is designed for use with BACT/ALERT® 3D Mycobacteria Detection Systems for recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested/decontaminated clinical specimens.

BACT/ALERT® MP Reagent System consists of three reagents: BACT/ALERT® MP Culture Bottle, the BACT/ALERT® MP Antimicrobial Supplement and the BACT/ALERT® MP Nutrient Supplement.

The provided text describes the performance characteristics of the BACT/ALERT® MP Reagent System, comparing it to a predicate device (BACT/ALERT® MP Culture Bottle) for the recovery and detection of mycobacteria.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a table format with pass/fail thresholds. However, it presents the performance of the new device and the predicate device, implying that the new device aims to be equivalent or superior, particularly in Time To Detection. The study demonstrates that the new device has increased sensitivity and specificity and a faster time to detection for certain mycobacteria species.

For the purpose of this response, I will interpret the performance metrics presented as the "reported device performance" and infer that the device meets implied acceptance criteria by being equivalent or better than the predicate.

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

• Clinical Performance Studies (for Sensitivity, Specificity, Recovery Rates):

  • Sample Size: 1,488 specimens obtained from 1,162 patients.
  • Data Provenance: Prospective clinical study conducted at 3 different sites. The document does not specify the country of origin, but generally, FDA submissions involve studies conducted in or for the US market, potentially with multi-national sites.

• Analytical Performance Studies (LoD, Growth Performance, Precision, Reproducibility):

  • Sample Size: Varies by study (e.g., LoD specified as lowest inoculum level with >95% recovery, Growth Performance at high and low inoculum levels, Precision on a minimum of 3 lots over 12 days, Reproducibility with 5 organisms at low and high concentrations in two matrices). Specific total sample numbers for these analytical studies are not given, but generally involve laboratory-controlled experiments.
  • Data Provenance: In-house seeded studies and tests at clinical trial sites (for reproducibility). The specific country of origin is not mentioned for these internal studies.

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

This information is not provided in the document. The ground truth for clinical samples appears to be established by laboratory results using both the test and predicate devices, and primary solid medium culture ("a sample has a positive patient infected status when one of the BACT/ALERT® MP (REF 419744 or 259797) subcultures is positive, or the primary solid medium is positive"). This implies a laboratory-based gold standard rather than expert clinical consensus or adjudication on imaging, for example.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

The document does not describe an adjudication method involving multiple human readers or a specific consensus process for reviewing diagnostic results in the test set. The ground truth seems to be determined by a combination of positive results from subcultures of both the test and predicate devices, and primary solid medium culture. This is a laboratory-based ground truth, not one requiring human expert adjudication.

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:

This device is a microbial growth monitor and not an AI-powered diagnostic imaging tool or a system that requires human "readers" in the context of an MRMC study. Therefore, an MRMC comparative effectiveness study, as typically understood for AI-assisted image interpretation, was not performed and is not applicable here. The comparison is between two laboratory systems (the new device vs. the predicate).

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

The device (BACT/ALERT® MP Reagent System) is an automated system for detecting microbial growth. Its performance is inherently standalone in the sense that the instrument provides the detection signal without continuous human intervention for interpretation in the same way an AI algorithm for image analysis would. The "algorithm" here is the system's ability to detect CO2 production. The study evaluates the performance of this system directly.

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

The ground truth for the clinical performance studies (sensitivity, specificity, recovery) in the document is defined as follows:

• Positive Patient Infected Status: "A sample has a positive patient infected status when one of the BACT/ALERT® MP (REF 419744 or 259797) subcultures is positive, or the primary solid medium is positive."
• Negative Patient Infected Status: "A sample has a negative patient infected status when both BACT/ALERT® MP (REF 419744 and 259797) subcultures are negative and the primary solid media is negative (i.e. there is no growth of mycobacteria)."

This is a laboratory-based and culture-confirmed ground truth, relying on the isolation and identification of mycobacteria from subcultures and primary solid media.

8. The sample size for the training set:

The document does not mention a training set because this is a medical device for in-vitro diagnostics based on chemical reactions and optical detection, not typically a machine learning or AI algorithm that requires a separate training set. The "formulation changes" and "analytical performance studies" represent the development and validation of the reagent system itself.

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

As no training set is mentioned or applicable in the context of this device's type, there is no information on how ground truth for a training set was established.

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BacT/ALERT® FA Plus Culture Bottles are used with BacT/ALERT® Microbial Detection Systems in qualitative procedures for recovery and detection of aerobic microorganisms (bacteria and yeast) from blood and other normally sterile body fluids.

BacT/ALERT® PF Plus Culture Bottles are used with BacT/ALERT® Microbial Detection Systems in qualitative procedures for recovery and detection of aerobic microorganisms (bacteria and yeast) from blood.

The BacT/ALERT® Microbial Detection Systems 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 test sample, carbon dioxide is produced as the microorganisms 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 lighter color results in an increase of reflectance units monitored by the system. Bottle reflectance is monitored and recorded by the instrument every 10 minutes.

BacT/ALERT® Microbial Detection Systems are used to determine if microorganisms are present in blood or other normally sterile body fluid samples taken from a patient suspected of having bacteremia/fungemia. The BacT/ALERT® Systems and culture bottles provide both a microbial detection system and a culture medium with suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and other normally sterile body fluid infections. An inoculated bottle is placed into the instrument where it is incubated and continuously monitored for the presence of microorqanisms that will grow in the BacT/ALERT® FA Plus or PF Plus Culture Bottle (The BacT/ALERT® PF Plus Culture Bottle provides for detection of microorganisms when a small volume of blood is available.).

The provided text describes the performance characteristics of the BacT/ALERT® FA Plus and BacT/ALERT® PF Plus culture bottles, which are microbial detection systems. The study aims to demonstrate the equivalency of a modified formulation of these devices to their predicate devices.

Here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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BD BACTEC Peds Plus™F culture vials (enriched Soybean-Casein Digest broth with CO2) are for aerobic blood cultures. Principal use is with the BD BACTEC fluorescent series instruments for the qualitative culture and recovery of aerobic microorganisms (mainly bacteria and yeast) from pediatric and non-pediatric blood specimens which are generally less than 3 mL in volume.

The sample to be tested is inoculated into one or more vials which are inserted into the BD BACTEC fluorescent series instrument for incubation and periodic reading. Each vial contains a chemical sensor which can detect increases in CO2 produced by the growth of microorganisms. The sensor's fluorescence measurement is detected at regular intervals to determine the change in CO2 present in the system. A positive reading indicates the presumptive presence of viable microorganisms in the vial. BD BACTEC Peds Plus™F culture vial detection is limited to microorganisms that will grow in a particular type of medium.

The document describes the analytical performance criteria and the study conducted for the BD BACTEC™ Peds Plus™/F Culture Vials.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

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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.

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.

Here's a breakdown of the BacT/ALERT VIRTUO Bacterial Detection System's acceptance criteria and study proving its performance, based on the provided FDA 510(k) Summary.

This device is not an AI/ML device in the modern sense (e.g., using deep learning for diagnostic imaging), but rather an automated system that uses embedded algorithms to detect microbial growth. Therefore, some of the requested information regarding AI/ML-specific concepts (like MRMC studies, training set details for complex models) might not be directly applicable or detailed in the provided document. The study performed is a comparative clinical study against a predicate device.

Device Name: BacT/ALERT® VIRTUO™ Microbial Detection System

Device Description: 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. It utilizes a colorimetric sensor and reflected light to monitor CO2 production as an indicator of microbial growth. Its detection algorithms are proprietary to the system.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state the "acceptance criteria" for performance as a numerical threshold (e.g., "sensitivity must be > X%"). Instead, it demonstrates substantial equivalence to the predicate device (BacT/ALERT® 3D Microbial Detection System) by comparing their performance head-to-head. The key performance metric assessed is the "Ratio of True Positives" and its 95% Confidence Interval (CI), with the implicit acceptance being that the performance of the VIRTUO is comparable to the established predicate device, and the false positive/negative rates are within acceptable limits.

Performance Goal: Demonstrate substantial equivalence to the BacT/ALERT® 3D Microbial Detection System in detecting microbial growth.

Note on CI for PF Plus (Blood): The document explicitly states "Since the confidence interval contains a negative, the interval does not provide a meaningful interpretation" due to extremely low positive counts for this specific category. However, the 1:1 ratio of detected positives itself implies equivalence for the limited positive cases observed.

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

• Test Set (Clinical Evaluation):

  • Total Bottle Pairs Tested (Clinical Samples): 5862 bottle pairs (one VIRTUO bottle and one BTA3D bottle per patient sample).
  • Detailed Sample Sizes per Category:
    • BacT/ALERT FA Plus (Blood): 1057 (compliant)
    • BacT/ALERT FN Plus (Blood): 912 (compliant)
    • BacT/ALERT PF Plus (Blood): 161 (compliant)
    • Low Fill BacT/ALERT FA Plus (Blood): 379 (compliant)
    • BacT/ALERT SA (Blood): 780 (compliant)
    • BacT/ALERT SN (Blood): 830 (compliant)
    • BacT/ALERT FA Plus (SBF): 374
    • BacT/ALERT FN Plus (SBF): 437
    • BacT/ALERT PF Plus (SBF): 77
    • BacT/ALERT SA (SBF): 81
    • BacT/ALERT SN (SBF): 81
  • Data Provenance: "External performance evaluations were conducted at eight external clinical sites." The document does not specify the country of origin, but given the FDA submission, it is typically either US-based or multi-national with significant US participation. The data is prospective as it involves clinical evaluation performed specifically for the 510(k) submission.

• Control Sample Size:

  • 1490 positive controls
  • 1486 negative controls
  • Total controls: 2976

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. However, for a device detecting microbial growth, the "ground truth" for positive culture would typically be established by standard microbiological laboratory procedures:

• Positive Culture: Visual detection of growth indicators (e.g., turbidity, gas production, or color change) in the culture bottle, followed by subculture onto agar plates and identification of microbial isolates using standard laboratory techniques (e.g., Gram stain, biochemical tests, mass spectrometry).
• Negative Culture: No growth detected after a specified incubation period, confirmed by terminal subculture on rich media.
• Clinical Determination (Significant/Contaminant/Unknown): This classification would typically be made by a qualified microbiologist or infectious disease physician, based on the identified organism, patient's clinical presentation, and other relevant factors.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

The document does not explicitly describe an adjudication method. For comparison studies of this nature, discrepancies between the investigational device and the predicate (or deviations from expected results) would generally be investigated by the clinical sites' microbiology laboratories to determine the definitive "ground truth" (e.g., re-subculture, review of patient charts).

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, an MRMC comparative effectiveness study was not done. This type of study (assessing human reader performance with and without AI assistance on diagnostic images) is not applicable to this device. The BacT/ALERT VIRTUO is an automated microbial detection system, not an imaging AI diagnostic aid for human readers. Its primary function is to automatically detect the presence of microbial growth, replacing or assisting a manual observation process, rather than augmenting a radiologist's interpretation of an image.

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

Yes, in essence, the primary performance evaluation measures the standalone performance of the BacT/ALERT VIRTUO system against the predicate BacT/ALERT 3D system. Both systems operate autonomously to detect microbial growth. The reported "True Positives," "False Positives," and "False Negatives" for VIRTUO directly reflect its algorithm-only performance in detecting growth from clinical samples, without human intervention required for the detection itself (humans are involved in loading bottles and interpreting the overall clinical significance, but not in the detection of growth by the device).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth was established by standard microbiological culture and identification methods, combined with a clinical review to classify isolates as "significant," "contaminant," or "unknown." This is essentially a definitive laboratory diagnosis of microbial presence and identity.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size in the context of typical AI/ML model development. The device uses "proprietary algorithms unique for BacT/ALERT VIRTUO," which implies embedded logic or rules rather than a dynamically trained machine learning model in the contemporary sense. The algorithms would have been developed and validated internally by the manufacturer using a combination of laboratory studies, simulated data, and potentially a distinct internal dataset. The data presented in the 510(k) is for the clinical validation (test set performance) of the final device.

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

Given that this is not a modern AI/ML device with a distinct training phase documented for public review, the methods for establishing ground truth for any internal algorithm development ("training") would also implicitly rely on controlled laboratory studies and established microbiological techniques to generate data on microbial growth, CO2 production kinetics, and associated reflectance changes. This would involve inoculating bottles with known strains and concentrations of microorganisms and observing their growth characteristics under various conditions.

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BD BACTECT™ Standard/10 Aerobic/F culture vials (enriched Soybean-Casein Digest broth with CO2) are for aerobic blood cultures. Principal use is with the BD BACTEC fluorescent series instruments for the qualitative culture and recovery of aerobic microorganisms (bacteria and yeast) from blood.

The sample to be tested is inoculated into one or more vials which are inserted into the BD BACTEC fluorescent series instrument for incubation and periodic reading. Each vial contains a chemical sensor which can detect increases in CO2 produced by the growth of microorganisms. The sensor is monitored by the instrument every ten minutes for an increase in its fluorescence, which is proportional to the amount of CO2 present. A positive reading indicates the presumptive presence of viable microorganisms in the vial. Detection is limited to microorganisms that will grow in a particular type of medium.

The provided document describes the BD BACTEC™ Standard/10 Aerobic/F Culture Vials (plastic version). The device is a culture vial for aerobic blood cultures, intended for use with BD BACTEC fluorescent series instruments for qualitative detection of microorganisms (bacteria and yeast) in blood. The study presented aims to demonstrate that the plastic version of the culture vial is substantially equivalent to the predicate device (glass version).

Here's an analysis of the acceptance criteria and study details based on the provided text, focusing on the comparisons between the modified (plastic) device and the predicate (glass) device:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It describes analytical studies comparing the modified device to a predicate device.

• Instrument Time to Detection: 682 paired sets recovered organisms in both devices.
• Percent Recovery: 984 paired sets.
• Microbial Detection Limit: 360 paired sets.
• False Positive Rate: 240 paired sets (comprised of 40 bottles from each of 3 lots).
• False Negative Rate: 91 paired sets that were instrument negative.

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

The document does not provide any information regarding the number or qualifications of experts used to establish ground truth. The studies described are laboratory-based comparisons of detection capabilities, not evaluations of human interpretation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method involving human interpretation. The "ground truth" (or reference standard) in these studies appears to be based on whether microorganisms were successfully grown and detected, or confirmed by terminal subculture in the case of false negatives.

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. This device is a culture vial designed for automated detection by an instrument, not an AI-assisted diagnostic tool that requires human reader interpretation.

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

The performance described in the document is effectively "standalone" in terms of the device's ability to detect microbial growth. The BD BACTEC fluorescent series instruments are automated systems that detect increases in CO2 produced by microorganisms. The studies evaluate the performance of the modified culture vial within this automated system, essentially demonstrating the algorithm (instrument's detection mechanism) only performance as it relates to the culture media. There is no human intervention in the detection process itself once the vials are loaded into the instrument.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the analytical studies appears to be based on:

• Presence of microbial growth: Confirmed by instrument detection and/or terminal subculture for definitive growth determination.
• Known inoculum levels: For studies like Microbial Detection Limit and implied for Time to Detection and Percent Recovery, predefined organism concentrations are used to challenge the system.

8. The Sample Size for the Training Set

The document does not mention any "training set." The studies described are analytical performance evaluations of a medical device, not a machine learning model that requires a training phase.

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

Not applicable, as there is no mention of a training set or machine learning model.

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BD BACTECTM Standard Anaerobic/F culture vials (prereduced enriched Soybean-Casein Digest broth with CO2) are for anaerobic blood cultures. Principal use is with the BD BACTEC fluorescent series instruments for the qualitative culture and recovery of anaerobic microorganisms from blood.

The sample to be tested is inoculated into one or more vials which are inserted into the BD BACTEC fluorescent series instrument for incubation and periodic reading. Each vial contains a chemical sensor which can detect increases in CO2 produced by the growth of microorganisms. The sensor is monitored by the instrument every ten minutes for an increase in its fluorescence, which is proportional to the amount of CO2 present. A positive reading indicates the presumptive presence of viable microorganisms in the vial. Detection is limited to microorganisms that will grow in a particular type of medium.

The provided document describes the BD BACTEC™ Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial (modified device) and its substantial equivalence to the predicate device (glass vial). The studies performed are analytical and focus on the performance of the culture medium and vial characteristics.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for each test. Instead, it indicates that the modified device should perform "equivalently" or show "no relevant difference" compared to the predicate device. For the purpose of this table, "Acceptance Criteria" are inferred from the study conclusions.

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

The document describes analytical studies. The "test set" in this context refers to the samples used in these analytical performance studies.

• Instrument Time to Detection: 443 paired sets
• Percent Recovery: 528 paired sets
• Microbial Detection Limit: 312 paired sets
• False Positive Rate: 240 paired sets (40 from each of 3 lots)
• False Negative Rate: 70 paired sets

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of these analytical studies (e.g., inoculation with specific CFU levels), they are inherently prospective and controlled laboratory experiments. The origin of the human blood used for the false positive rate study is not specified beyond "fresh human blood."

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

This information is not provided in the document. The studies are analytical performance comparisons of a microbial growth medium, not diagnostic accuracy studies that rely on expert interpretation of results. The "ground truth" for these studies is typically defined by microbial culture techniques (e.g., presence/absence of growth, colony counts) rather than expert consensus on images or clinical classifications.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. These analytical studies focus on the objective measurement of microbial growth and detection by the instrument.

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

This information is not applicable. The device (BD BACTEC™ Standard Anaerobic/F Culture Vials) is a culture medium used with an automated instrument (BD BACTEC fluorescent series instruments) for detecting microbial growth in blood. It is not an AI-powered diagnostic device or an imaging device that involves human readers interpreting results with or without AI assistance. Therefore, an MRMC comparative effectiveness study involving human readers and AI is outside the scope of this device.

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

This information is not applicable in the context of an "algorithm only" device. The device itself is a culture vial (medium) that is used with an instrument. The instrument's algorithms detect growth. The studies evaluate the performance of the vial and medium in conjunction with the instrument, not an isolated algorithm. The "standalone" performance is essentially what the analytical studies describe – the ability of the combined system to detect growth.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for these analytical studies is based on microbiological culture and laboratory methods.

• Presence/absence of microbial growth: Confirmed by standard microbiological techniques (e.g., subculture to agar plates, colony identification).
• Time to detection (TTD): Objectively measured by the BACTEC instrument.
• Colony-forming units (CFU): Used to prepare inoculum levels for certain studies.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context presented. The document describes an analytical performance comparison study for a modified device against a predicate device. It does not mention any machine learning or AI components that would require a distinct "training set" in the conventional sense. The instrument's algorithms are assumed to be pre-existing and validated.

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

This information is not provided and is not applicable for the reasons stated in point 8.

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BD BACTEC Peds Plus™/F culture vials (enriched Soybean-Casein Digest broth with CO2) are for aerobic blood cultures. Principal use is with the BACTEC fluorescent series instruments for the qualitative culture and recovery of aerobic microorganisms (mainly bacteria and yeast) from pediatric and non-pediatric blood specimens which are generally less than 5 mL in volume.

The sample to be tested is inoculated into one or more vials which are inserted into the BD BACTEC fluorescent series instrument for incubation and periodic reading. Each vial contains a chemical sensor which can detect increases in CO2 produced by the growth of microorganisms. The sensor is monitored by the instrument every ten minutes for an increase in its fluorescence, which is proportional to the amount of CO2 present. A positive reading indicates the presumptive presence of viable microorganisms in the vial. Detection is limited to microorganisms that will grow in a particular type of medium.

The document describes the BD BACTEC Peds Plus™/F Culture Vials (plastic), which is an aerobic blood culture medium. It compares this modified device to its predicate, the BD BACTEC Peds Plus/F medium (glass). The purpose of the studies is to demonstrate that the modified device performs equivalently to the predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative format for each performance metric. Instead, it aims to demonstrate equivalence or non-inferiority to the predicate device. The reported performance is generally framed as "no statistically significant difference" or "performs equivalently."

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

• Instrument Time to Detection: 473 paired sets (positive in both devices).
• Percent Recovery: 1344 paired sets.
• Microbial Detection Limit: 360 inoculated cultures (196 grew and detected in both).
• False Positive Rate: 288 paired sets (96 bottles from each of 3 lots).
• False Negative Rate: 83 paired sets (end-of-protocol negative in both), and other sets where only one device detected (129 predicate-only, 146 modified-only).
• Antimicrobial Neutralization Capability: 51 paired sets.
• Reproducibility: Tested across three lots (implied using subsets of the TTD and Percent Recovery data).

Data Provenance: The document does not specify the country of origin. The studies appear to be prospective analytical studies conducted in a laboratory setting, involving the inoculation of culture media with specific microorganisms and human blood.

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

This information is not provided in the document. The studies described are analytical performance studies of a culture medium, not diagnostic studies involving interpretation by human experts. The "ground truth" for these tests (e.g., presence/absence of microbial growth, CFU counts) would have been established through standard microbiology laboratory techniques (e.g., subculture, plate counts) rather than expert consensus on diagnostic images or clinical data.

4. Adjudication Method for the Test Set

This information is not applicable/provided. As mentioned above, these are analytical performance studies where the outcome is objectively measured (e.g., instrument detection of CO2, colony counts from subcultures), not subjective interpretations requiring adjudication by human experts.

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

No, an MRMC comparative effectiveness study was not done. The device is a culture medium, and the studies assess its analytical performance (e.g., time to detection, recovery rates) directly from instrument readings and laboratory methods, not human reader performance with or without AI assistance.

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

Yes, the studies reflect standalone performance of the device in conjunction with the BACTEC fluorescent series instruments. The instrument automatically detects growth based on CO2 production. Human intervention would be for initial sample loading, result interpretation (positive/negative), and subsequent microbiological workup, but the "detection" itself is algorithmic. The document states: "The sensor is monitored by the instrument every ten minutes for an increase in its fluorescence, which is proportional to the amount of CO2 present. A positive reading indicates the presumptive presence of viable microorganisms in the vial." This describes the standalone algorithmic detection by the instrument.

7. The Type of Ground Truth Used

The ground truth used for these analytical studies includes:

• Microbiological Culture and Growth: The presence or absence of viable microorganisms, confirmed by growth in culture or subculture, and typically quantified by plate counts (e.g., CFU per vial shown in the Microbial Detection Limit section).
• Instrument Readings: The BACTEC fluorescent series instruments provide quantitative data on CO2 production and time to detection.
• Terminal Subculture: Used to confirm true positive/negative status where the instrument did not detect growth, particularly for false negative assessments.

8. The Sample Size for the Training Set

This information is not provided as this is not an AI/ML device that requires a distinct "training set" in the conventional sense. The device is a culture medium where performance is evaluated through a series of analytical experiments with known microbial inocula and clinical samples (human blood). There is no "training phase" for an algorithm in the context of this product.

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

Not applicable as there is no training set for an AI/ML algorithm involved with this device. The product is a physical culture medium, and its performance is evaluated against established microbiological methods and instrument readings as ground truth.

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The BD BACTEC™ Plus Anaerobic/F medium is used in a qualitative procedure for the anaerobic culture and recovery of microorganisms (bacteria) from blood. The principal use of this medium is with the BD BACTEC fluorescent series instruments.

The sample to be tested is inoculated into one or more vials which are inserted into the BD BACTEC fluorescent series instrument for incubation and periodic reading. Each vial contains a chemical sensor which can detect increases in CO2 produced by the growth of microorganisms. The sensor is monitored by the instrument every ten minutes for an increase in its fluorescence, which is proportional to the amount of CO2 present. A positive reading indicates the presumptive presence of viable microorganisms in the vial. Detection is limited to microorganisms that will grow in a particular type of medium.

The provided text describes a 510(k) premarket notification for a medical device called the "BD BACTEC Plus Anaerobic/F (plastic)" medium. This device is an anaerobic blood culture medium used with BD BACTEC fluorescent series instruments for the qualitative culture and recovery of microorganisms from blood. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, the "BD BACTEC Plus Anaerobic/F" medium (glass bottle).

The acceptance criteria for this type of device are primarily tied to demonstrating equivalent performance to a legally marketed predicate device across several analytical performance metrics. The study described is a series of analytical studies comparing the new plastic bottle device to the predicate glass bottle device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are not explicitly stated as numerical targets in a table format within the document. Instead, the studies aim to demonstrate "equivalent performance" or that differences are "minimal" or "detectable but favoring the new device" compared to the predicate. The performance is reported in terms of comparison to the predicate device.

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