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Qualitative culture and recovery of yeasts and fungi from blood

BACTEC Fungal Medium is a growth medium providing an aerobic environment for the detection of yeast and fungi. It has been designed for blood volumes of four to 10 mL, and is used specifically with BACTEC non-radiometric (NR) series instruments in the monitoring of clinical blood specimens for the presence of yeasts and fungi. BACTEC Fungal medium has a higher weight/volume concentration of dextrose and sucrose then the predicate device to enhance the recovery and CO2 production of yeast. Saponin was added to the BACTEC Fungal Medium as a lysing agent, and ferric ammonium citrate was added as a source of iron to stimulate recovery of fungi other than yeast. Resin was removed from this medium. Principles for detection of CO2 produced by microorganisms metabolizing blood culture medium nutrients are identical to the predicate device.

Here's a breakdown of the acceptance criteria and study details for the BACTEC® Fungal Medium, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly derived from the comparative study against predicate devices (BACTEC® PLUS 26 Culture Vials and ISOLATOR™ Microbial Tubes/ISOSTAT® Microbial System). The goal is to demonstrate that the BACTEC® Fungal Medium performs "as good or better than" or "equivalent to" these predicate devices for the recovery of yeasts and fungi from blood, particularly in terms of recovery rates and speed of detection.

Vs. IS System: Equivalent recovery of fungi, with the exception of Histoplasma capsulatum. (i.e., performance should not be significantly worse for most fungi). | Vs. BACTEC® PLUS 26:

• 68 fungi isolates total.
• 31 (45.6%) recovered in both media.
• 11 (16.2%) recovered in BACTEC® PLUS 26 only.
• 26 (38.2%) recovered in BACTEC® Fungal Medium only.
• **Recovery of all fungi combined and of Torulopsis glabrata was statistically significantly better (p

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The BBL® MGIT™ Mycobacteria Growth Indicator Tube and BBL® MGIT™ supplemented with BBL® MGIT™ OADC and BBL® MGIT™ supplemented with BBL® MGIT™ PANTA antibiotic mixture, is intended for the detection and recovery of mycobacteria from decontaminated clinical specimens (except urine) and sterile body fluids (except blood). Acceptable clinical specimen types are digested and decontaminated.

The BBL® MGIT™ Mycobacteria Growth Indicator Tube contains 4 mL of modified Middlebrook 7H9 Broth Base. The complete medium is supplemented with 0.5 mL OADC enrichment and 0.1 mL of PANTA antibiotic mixture, when necessary. The medium components are substances essential for the growth of mycobacteria. A fluorescent compound is embedded in the bottom of the BBL® MGIT™ tube which is sensitive to the presence of oxygen dissolved in the broth. Specimens are inoculated (0.5 mL) into the BBL® MGIT™ tube and incubated at the appropriate temperature. Tubes are read daily from the second day of inoculation. Actively respiring microorganisms consume the oxygen and allow the compound to fluoresce. Each inoculated BBL® MGIT™ tube is compared to the fluorescence Positive Control and Negative Control tube to assist in the interpretation of a positive signal from the BBL® MGIT™ tube. A BBL® MGIT™ tube which exhibits fluorescence comparable to the Positive Control tube is considered presumptively positive for growth.

The provided text describes the BBL® MGIT™ Mycobacteria Growth Indicator Tube, intended for the detection and recovery of mycobacteria from clinical specimens. The device relies on an oxygen-sensitive fluorescent sensor that detects oxygen consumption by actively respiring microorganisms.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity, specificity, or false positive rates. However, the study aims to show comparable performance to predicate devices. Therefore, the "acceptance criteria" appear to be implicit: the BBL® MGIT™ tubes should perform similarly to or better than the BACTEC® 460TB System and the BBL® SEPTI-CHEK® AFB Mycobacteria Culture System in terms of recovery rate and time to detection, while maintaining an acceptable false positive rate.

                               false positives relative to clinical impact) | 0.5%                            |

| Time-to-Detection | Comparable to predicate devices (not explicitly stated, but implies being efficient | 14.1 days (average for all mycobacteria) |
| Unrecovered Isolates | Minimally higher than predicate devices (with further recovery via recommended second medium) | 3.7% (isolates recovered by reference, but not MGIT) |
| Breakthrough Contamination Rate | Acceptably low | 9.7% |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: A combined total of 2801 clinical specimens were evaluated.
• Data Provenance:
  • Country of origin: Not explicitly mentioned, but the submitting company is Becton Dickinson Microbiology Systems, located in Sparks, MD, USA. It's highly probable the studies were conducted in the USA.
  • Retrospective or Prospective: Not explicitly stated. However, external evaluations are typically conducted prospectively to compare a new device against existing methods in real-world clinical settings. The description of "specimens were evaluated" and "isolates recovered during the study" suggests a prospective collection and testing over a period.

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)

The document does not specify the number of experts or their qualifications for establishing the ground truth. The ground truth was established by culture results from reference methods:

• BACTEC® 460TB System
• BBL® SEPTI-CHEK® AFB Mycobacteria Culture System
• Conventional solid agar media

Presumably, trained laboratory personnel followed standard protocols for these reference systems to determine the presence or absence of mycobacteria and to identify isolates.

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

The document does not describe an adjudication method involving human experts. The ground truth for mycobacterial presence was determined directly by the growth observed in the reference culture systems. If there was discordance between the BBL® MGIT™ and the reference, it was noted as an unrecovered isolate by the MGIT, not subjected to a separate expert adjudication process to determine a "true" positive or negative outside of the reference method's result.

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

• MRMC Study: No, this was not a multi-reader, multi-case (MRMC) comparative effectiveness study.
• AI (Artificial Intelligence): The BBL® MGIT™ device is a culture-based diagnostic system, not an AI-assisted diagnostic tool. Therefore, there's no discussion of AI assistance or its effect size on human readers. The growth detection is described as "Manual observation of fluorescence via excitation with longwave UV light."

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

The BBL® MGIT™ device itself is a standalone diagnostic tool in the sense that its detection mechanism (fluorescence) is independent of human interpretation for the initial signal. However, the final interpretation of a "presumptively positive" signal and subsequent identification of the mycobacteria would involve human intervention. The "manual observation of fluorescence" indicates human involvement in reading the fluorescence.

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

The ground truth used was culture-based detection and recovery of mycobacteria using established reference methods:

• BACTEC® 460TB System
• BBL® SEPTI-CHEK® AFB Mycobacteria Culture System
• Conventional solid agar media

The presence of mycobacteria, and their specific isolates, as determined by growth in one or more of these reference systems, formed the ground truth against which the BBL® MGIT™ performance was compared.

8. The sample size for the training set

The document does not specify a separate "training set" in the context of machine learning or AI models. This device is a culture medium system, not a software algorithm that requires training data in that sense. The "internal testing" mentioned likely involved R&D and optimization of the medium components and detection method, rather than training a predictive model.

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

As there was no explicit "training set" for an algorithm, the concept of establishing ground truth for it doesn't apply directly in this context. The "internal testing" would have relied on known mycobacterial strains and clinical samples where the presence/absence of mycobacteria was confirmed by standard laboratory methods.

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A non-radiometric automated blood culturing system which is designed for the monitoring and detection of clinical cultures of blood for the presence of microorganisms.

BACTEC® 9050 System is a non-radiometric automated blood culturing system. It has a capacity of 50 specimens, uses Positivity Algorithms by Media Type for culture analysis, has agitation on during testing, uses a Florescence Detector (LED) for detection optics, incubates at 35°C ± 1.5°C, has a protocol length of 4 to 7 Days, uses Florescent Series Media, tests specimens every 10 Minutes, uses Low Voltage DC power supplies, and displays 1 rack (Rotor). Its dimensions are 24"W x 28.5"H x 25.5"D.

Here's an analysis of the provided text, focusing on the acceptance criteria and study details:

Acceptance Criteria and Device Performance

The provided text focuses on demonstrating substantial equivalence to a predicate device rather than defining specific numerical acceptance criteria for a novel performance threshold. The core acceptance criterion appears to be that the BACTEC 9050 performs "equivalent" to the BACTEC 9240.

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Detection of mycobacteria in clinical respiratory specimens

BACTEC® 9000MB: 7H9 Middlebrook broth base with nutrient additives, Fluorescence sensor in silicon rubber base, Fluorescent detection of O₂ consumption by mycobacterial growth, On-board incubation at 37°C ± 1.5°C; internal instrument agitation every 10 minutes.

Here's a breakdown of the acceptance criteria and study information for the BACTEC® 9000MB, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text does not explicitly state "acceptance criteria" in a formal, quantifiable manner for overall device performance. Instead, it compares the BACTEC® 9000MB to other methods (BACTEC® 460TB and Conventional Media) across various technical specifications and time to detection.

However, based on the comparative tables, we can infer some key performance aspects of the BACTEC® 9000MB and frame them as its reported performance relative to the benchmarks. The "acceptance criteria" for this device would likely be implicitly tied to demonstrating comparable or improved performance over existing methods.

Important Note: The current document is a summary of safety and efficacy and focuses on describing the device and comparing its technical specifications and typical performance to other methods. It does not contain a dedicated section outlining pre-established, quantitative "acceptance criteria" that the device was then tested against in a formal study. The "acceptance" is implied by demonstrating a viable alternative with certain benefits (e.g., non-radiometric, faster than conventional).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given text.

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 information is not provided in the given text.

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

This information is not provided in the given text.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The BACTEC® 9000MB is a diagnostic instrument for detecting mycobacteria using fluorescence, not an AI-assisted image interpretation tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device.

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

Yes, a standalone study of the BACTEC® 9000MB performance was implicitly done. The document describes the technical specifications and "Time to detection (TTD)" of the device itself, comparing it directly to other methods (BACTEC® 460TB and Conventional Media), not human performance. The TTD of 11-15 days is a direct measurement of the device's performance.

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

The "ground truth" for the performance comparisons (e.g., Time to Detection) would have been established by confirming the presence or absence of mycobacterial growth. Given the nature of microbiology diagnostics, this would typically involve:

• Microbiological Culture Confirmation: Positive cultures on other standard media, possibly with further identification techniques.
• Microscopy: Observation of acid-fast bacilli (AFB) in smears.
• Clinical Outcomes/Patient Diagnosis (less likely for TTD, but relevant for overall efficacy): Correlation with the patient's clinical diagnosis of mycobacterial infection.

The text does not explicitly state the specific ground truth method used, but it would undeniably rely on established microbiological techniques for identifying mycobacteria.

8. The sample size for the training set

This information is not applicable as the BACTEC® 9000MB is a laboratory diagnostic instrument, not a machine learning algorithm that requires a "training set" in the context of AI. Its "training" is in its engineering and calibration.

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

This information is not applicable for the reasons stated above (not an AI algorithm).

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The QBC® AUTOREAD™ System provides a diagnostic hematology profile on venous or capillary blood: hematocrit, hemoglobin, MCHC, platelet count, white blood cell count, granulocyte count (% and number), and lymphocyte/monocyte count (% and number).

The QBC® AUTOREAD™ System includes an analyzer, power pack, printer, centrifuge, and test accessories. The system uses specially designed tubes known as the QBC® AccuTube. AccuTubes are filled with blood and centrifuged. The spun tube is placed in the QBC® AUTOREAD™ analyzer which provides a report.

The provided text describes a 510(k) summary for the QBC® AUTOREAD™ System, focusing on its equivalency to a predicate device. Here's an analysis of the acceptance criteria and the supporting study, based on the information given:

Acceptance Criteria and Reported Device Performance

The core of the acceptance criteria for this 510(k) submission is demonstrating equivalency to the predicate device and established methods for hematology parameters. The "reported device performance" is essentially the statistical measures (correlation coefficient, slope, intercept) derived from the equivalency studies.

Study Details

Regarding the study that proves the device meets the acceptance criteria:

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

   • Hematocrit and Hemoglobin equivalency study: 160 fresh EDTA whole blood samples.
   • Data Provenance: The study was conducted at "two hospital sites". No specific country of origin is mentioned, but the company address is in Sparks, Maryland, USA, suggesting the data is likely from the United States. The samples were "fresh EDTA whole blood samples," indicating they were retrospectively collected from patients.
   • Other Parameters (Platelets, WBC, Granulocytes, Lymphocytes/Monocytes): The sample size for these parameters is not explicitly stated, but it's implied to be the same set of samples or a comparable set used for the hematocrit and hemoglobin equivalency against the original QBC AccuTube.

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

   • This type of device (automated differential cell counter) does not typically rely on human expert consensus for "ground truth" in the same way as image-based diagnostics. The ground truth here is established by reference methods (e.g., spun microhematocrit method, impedance cell counter, or the established predicate device).
   • Therefore, the concept of "number of experts" and "qualifications" doesn't directly apply here for establishing the ground truth, as it's a quantitative measurement device.

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

   • No adjudication method is mentioned or relevant for this type of quantitative device study. Measurements are taken and compared directly to reference methods.

4. 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. This is not an MRMC comparative effectiveness study. It is a study to demonstrate the analytical equivalency of a diagnostic device to predicate devices and established reference methods. Human reader performance or AI assistance are not relevant to this type of submission.

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

   • Yes, effectively. The "device" in question is an automated system (QBC® AUTOREAD™ System) which includes an analyzer and algorithms to generate results. The studies described evaluate the performance of this system (including its modified algorithm) in a standalone capacity against reference methods and the predicate device. There is no human interpretation component being evaluated in these specific studies; it's the machine's output.

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

   • Reference Methods:
     • For Hematocrit: Spun microhematocrit method.
     • For Hemoglobin: Impedance cell counter method.
     • For all parameters (Hematocrit, Hemoglobin, Platelets, White Blood Cells, Granulocytes, Lymphocytes/Monocytes): The original QBC AccuTube read with the original QBC AUTOREAD algorithm (the predicate device).

7. The sample size for the training set:

   • The document does not explicitly mention a separate "training set" or its size. Since this is a 510(k) summary for a device with modified components (AccuTube and algorithms), the modifications were likely developed and refined using internal data, but the submission focuses on the validation or test data to demonstrate equivalency. It is possible that the algorithm adjustments were "trained" on some data, but this information is not provided in the summary.

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

   • Given the lack of information on a "training set," there's no detail on how ground truth for such a set would have been established. However, for internal development, it would typically involve comparing preliminary device results against similar reference methods as used in the validation studies.

Conclusion: The studies described successfully demonstrate the equivalency of the modified QBC® AUTOREAD™ System to established reference methods and its predicate device for the measured hematology parameters, addressing the implicit acceptance criteria for this 510(k) submission.

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A qualitative procedure for the culture and recovery of aerobic microorganisms (mainly bacteria and fungi) from pediatric and other blood specimens which are generally less than 3 mL in volume.

BACTEC PEDS PLUS medium is a bacterial growth medium providing an aerobic environment for the detection of bacteria and fungi. It has been designed for the recovery of microorganisms from pediatric and other blood specimens which are generally less than 3 mL in volume and is used specifically with the BACTEC NR ( non-radiometric )blood culture series instruments. Each glass vial of medium contains 20 mL of enriched Soybean-Casein Digest Broth with resins and CO2. If microorganisms are present in the test sample inoculated into the BACTEC vial, CO2 will be produced and liberated into the atmosphere when the organisms metabolize the substrates present in the vial. The instrument analyzes the vial head space gas for CO2 and, If a threshold level is exceeded, indicates that the vial is positive, i.e., that the test sample contains viable organisms.

Here's a breakdown of the acceptance criteria and study details for the BACTEC® PEDS PLUS™ Culture Vials, based on the provided text:

Acceptance Criteria and Reported Device Performance

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