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The BD PhaSeal™ Optima system is an airtight and leakproof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The BD PhaSeal™ Optima system also prevents microbial ingress for up to 168 hours.

BD PhaSeal™ Optima Closed System Transfer Devices (CSTD) are sterile, single use closed system drug transfer devices intended for the reconstitution and transfer of antineoplastic or other hazardous drugs in the healthcare setting. The BD PhaSeal™ Optima system is comprised of four devices—Protector, Injector, Connector, and Infusion Adapter.

The closed transfer of liquid drugs takes place through a double membrane utilizing self-sealing elastomeric membranes that are tightly fitted together through the collet-style fitting on each of the BD PhaSeal™ Optima system devices. During use, the single lumen cannula of the Injector perforates the double membranes for the transfer of liquids. When the cannula is retracted, the membranes seal to prevent the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing the individual and environmental exposure to drug vapor, aerosols, leaks and spills. The BD PhaSeal™ Optima system prevents microbial ingress for up to 168 hours. Performance of the self-sealing membrane has been substantiated for up to 10 penetrations.

The BD PhaSeal™ Optima Connecting Set (C83-O) is a sterile, single patient use sterile device that enables the administration of non-hazardous and hazardous parenteral drugs when used with the devices that have the compatible mating component - the BD PhaSeal™ Optima Spike Set and/or Connector. The BD PhaSeal™ Optima Connecting Set will be utilized by healthcare workers who administer parenteral hazardous drugs.

The BD PhaSeal™ Optima Spike Set (C180-O) is a sterile, single patient use sterile bag access device that enables the preparation and administration of non-hazardous and hazardous parenteral drugs when used with devices that have the compatible mating component - the BD PhaSeal™ Optima Injector and/or Connecting Set. The BD PhaSeal™ Optima Spike Set will be utilized by healthcare workers who prepare and administer parenteral hazardous drugs.

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The BD Phoenix Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacterales and Non-Enterobacterales and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus, and Streptococcus.

This premarket notification is for the BD Phoenix Automated Microbiology System with Eravacycline at a concentration of 0.125-2 µg/mL. Testing is indicated for Enterobacterales as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).

The BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) has demonstrated acceptable performance with the following organisms:

Enterobacterales (Citrobacter amalonaticus, Citrobacter braakii, Citrobacter farmeri, Citrobacter freundii, Citrobacter koseri, Citrobacter youngae, Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, and Klebsiella pneumoniae)

This submission is for addition of Eravacycline (0.125-2 µg/mL) to the BD Phoenix™ ID/AST or AST only panels. The ID portion of the ID/AST combination panel was not subject to review in this submission.

The Phoenix AST method is a broth-based microdilution test. The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells containing dried reagents. The ID/AST combination panel includes an ID side (51 wells) with dried substrates for bacterial identification and an AST side (85 wells). The AST panel contains a wide range of two-fold doubling dilution concentrations of antimicrobial agents and growth and fluorescent controls at appropriate well locations. The AST panel does not include wells for isolate identification.

The Phoenix System utilizes a redox indicator for the detection of organism growth in the presence of an antimicrobial agent. The organism to be tested must be a pure culture and be preliminarily identified as Gram-positive or Gram-negative. Colonies are then suspended in ID broth and equated to a 0.5 McFarland suspension using a nephelometer device. A further dilution is made into AST broth (a cation-adjusted formulation of Mueller-Hinton broth containing 0.010% Tween 80), to which the redox-buffered oxidation-reduction AST indicator solution is added producing a blue color in the wells. The concentration of organisms in the final AST broth suspension is approximately 5 X 10⁵ CFU/mL.

The Phoenix AST Broth is poured into the inoculation port of the AST panel and the inoculum flows into the panel, filling panel wells. Polyethylene caps are applied to seal the inoculation ports. An air admittance port is located in the panel lid to ensure adequate oxygen tension in the panel for the duration of the test. Inoculated panels are barcode scanned and loaded into the BD Phoenix Automated Microbiology System instrument where panels are continuously incubated at 35 °C ± 1 °C.

Continuous measurements of changes to the indicator as well as bacterial turbidity are used in the determination of bacterial growth. The instrument takes readings every 20 minutes. Organisms growing in the presence of a given antimicrobial agent reduce the indicator (changing it to a pink color). This signals organism growth and resistance to that antimicrobial agent. Organisms killed or inhibited by the antimicrobial agent do not cause reduction of the indicator and therefore do not produce a color change. The Phoenix instrument reads and records the results of the antimicrobial tests contained in the panel and interprets the reactions (based on the organism identification) to give a minimal inhibitory concentration (MIC) value and category interpretations (susceptible, intermediate, resistant, or not susceptible). AST results are available within 16 hours.

This is an auto read result; no manual readings are possible with this system.

Additional comments concerning specific organism/antimicrobial combinations are provided from the software-driven expert system (BDXpert), using rules derived from CLSI documentation and/or the FDA-approved drug labeling.

Here's a breakdown of the acceptance criteria and the study details for the BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL), based on the provided FDA 510(k) clearance letter:

1. Table of Acceptance Criteria and Reported Device Performance

Note on VMEs: A very major error (VME) occurs when a resistant isolate is categorized as susceptible by the device. This is a critical error as it can lead to inappropriate treatment. The FDA's acceptable rate for adjusted VMEs is typically ≤ 1.5%. The device exceeded this threshold for combined clinical and challenge isolates with manual inoculation, and for challenge isolates with manual inoculation, which required specific cautionary statements and recommendations for confirmatory testing in the product labeling.

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

• Clinical Isolates: 785 isolates (626 fresh, 159 stock)
  • Provenance: "three U.S. sites" (presumably clinical laboratories in the US). The exact country of origin for the isolates themselves is not specified beyond "U.S. sites."
  • Retrospective/Prospective: Not explicitly stated, but "fresh" and "stock" isolates suggest a mix, likely collected over time (retrospective component for stock, and potentially prospective for fresh if collected specifically for the study, or recent retrospective).
• Challenge Isolates: 84 isolates (stock isolates with known resistance mechanisms).
  • Provenance: "Additional stock challenge isolates were tested at each study site." (three U.S. sites, as mentioned for clinical testing).
  • Retrospective/Prospective: Retrospective (stock isolates).
• Reproducibility Isolates: 12 on-scale isolates.
• Quality Control Isolates: E. coli ATCC 25922 and P. aeruginosa ATCC 27853 (standard ATCC strains).

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

The ground truth for the test set (both clinical and challenge isolates) was established using the CLSI frozen broth microdilution reference panel, prepared according to CLSI M07 guidelines. This is a standardized laboratory method, not reliant on individual human experts in the same way, for example, a radiology image interpretation study would be. Therefore, the concept of "number of experts" and their "qualifications" doesn't directly apply in this context. The "expert" in this case is the CLSI standard method itself, which is developed by committees of microbiology experts.

4. Adjudication Method for the Test Set

Not applicable in the traditional sense of multiple human readers or a consensus process. The reference method (CLSI frozen broth microdilution) serves as the "gold standard" or ground truth. Discrepancies between the device and the reference method were analyzed for Essential Agreement (EA) and Category Agreement (CA). Further analysis and "adjustments" for major and very major errors were based on whether the MIC values of the errors fell within essential agreement (i.e., within one doubling dilution of the reference method).

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation (e.g., radiologists reading images) to compare the performance of human readers with and without AI assistance. The BD Phoenix system is an automated platform for antimicrobial susceptibility testing, where human interpretation of results is minimal once the system produces MIC values and interpretations.

6. Standalone Performance Study

Yes, a standalone performance study was done. The entire study described, which compares the BD Phoenix Automated Microbiology System's results directly against the CLSI frozen broth microdilution reference method, represents the standalone performance of the algorithm/device without human-in-the-loop performance influencing the primary results. The system automatically reads and interprets the results.

7. Type of Ground Truth Used

The type of ground truth used was a reference method, specifically the CLSI frozen broth microdilution reference panel prepared according to CLSI M07 guidelines. This is considered the "gold standard" for antimicrobial susceptibility testing.

8. Sample Size for the Training Set

The document does not explicitly mention a separate training set or its sample size. This is common for predicate-based 510(k) submissions, where the focus is on demonstrating substantial equivalence to a legally marketed predicate device, and the "training" of the internal device algorithms might have occurred during its initial development or earlier predicate clearances. The performance data presented here are for validation and comparison against the reference method.

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

As no specific training set is mentioned, the method for establishing its ground truth is also not described. If the device uses machine learning, its initial development and training would typically involve large datasets with ground truth established by expert-reviewed reference methods. However, this clearance focuses on the validation of a specific addition (Eravacycline) to an already established system.

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The BD Plastipak™ Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.

The BD Plastipak™ Syringe is a three-piece, single use, sterile, hypodermic syringe with a 6% (Luer) male connector in 20 mL and 50 mL eccentric luer slip tip configurations. The BD Plastipak™ Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The syringe barrel incorporates a male 6% (Luer) connector which is connectable to a compatible female 6% (Luer) connector. The BD Plastipak™ Syringe is provided sterile by Ethylene Oxide Gas (ETO) sterilization method.

The provided text is a 510(k) Clearance Letter for a medical device (BD Plastipak™ Syringe). It details the device's characteristics, intended use, and comparison to a predicate device. However, it does not describe an AI/ML-driven medical device or a study involving human readers or expert consensus for ground truth establishment.

The document discusses bench performance testing and biocompatibility tests for a physical device (syringe), not a software or AI-based diagnostic tool. Therefore, many of the requested criteria (like sample size for test/training set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types) are not applicable to this specific submission.

Despite the irrelevance of some questions to the provided document, I will structure the answer based on the questions asked, indicating "Not Applicable" or providing the information that is present in the document.

Here's an analysis of the provided 510(k) clearance letter in the context of the requested information about acceptance criteria and study data:

This 510(k) clearance letter pertains to a physical medical device, the BD Plastipak™ Syringe, not an AI/ML-driven diagnostic or image analysis tool. As such, many of the typical acceptance criteria and study methodologies applicable to AI models (e.g., ground truth established by experts, MRMC studies, training/test set sizes for algorithms, human reader improvement with AI assistance) are not relevant or described in this document.

The "study" referenced in the document primarily consists of non-clinical performance and biocompatibility testing to demonstrate the substantial equivalence of the new syringe (with a changed barrel resin) to a previously cleared predicate syringe.

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "The subject device met all the predetermined acceptance criteria for the above listed performance and biocompatibility tests." However, it does not explicitly list the quantitative acceptance criteria or the specific numerical performance results for each test. It only lists the tests performed and the standards they adhere to.

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

• Sample Size for Test Set: Not specified in the provided document. The tests are "bench performance testing" on various syringe units.
• Data Provenance: Not specified, but generally, bench testing for physical devices is conducted in a controlled lab environment by the manufacturer. It is non-clinical.
• Retrospective or Prospective: Not applicable for this type of physical device testing.

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

• Not Applicable. Ground truth for this physical device testing is established through standardized laboratory test methods and measurements against international or internal specifications, not by human experts interpreting clinical data.

4. Adjudication Method for the Test Set

• Not Applicable. (See point 3)

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. This is not an AI/ML device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or is relevant.

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

• No. This is not an AI/ML device. Therefore, no standalone algorithm performance was assessed. The performance tests are for the physical syringe itself.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on measurements against established engineering specifications and international standards (e.g., ISO, ASTM, USP) for physical and material properties (e.g., force, leakage, volume accuracy, biocompatibility reactions). It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device. There is no concept of a "training set" in the context of the reported non-clinical bench testing for a physical syringe.

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

• Not Applicable. (See point 8)

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The BD Veritor™ System for SARS-CoV-2 is a chromatographic digital immunoassay for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (i.e., symptomatic). The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the BD Veritor™ System for SARS-CoV-2 and followed up with a molecular test.

A negative test result is presumptive and does not preclude SARS-CoV-2 infection; it is recommended these results be confirmed by a molecular SARS-CoV-2 assay.

Positive results do not rule out co-infection with other bacteria or viruses and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Performance characteristics for SARS-CoV-2 were established between April 2024 and August 2024 when SARS-CoV-2 Omicron was the predominant SARS-CoV-2 variant in circulation. Performance characteristics may vary with newly emerging SARS-CoV-2 virus variants.

The BD Veritor™ System for SARS-CoV-2 is a rapid (approximately 15 minutes) chromatographic digital immunoassay for the direct detection of the presence or absence of SARS-CoV-2 antigens in anterior nasal swab specimens taken from patients with signs and symptoms of upper respiratory infection (i.e., symptomatic) who are suspected of COVID-19 by their healthcare provider. The test is intended for use with an opto-electronic interpretation instrument, the BD Veritor™ Plus Analyzer Instrument and is not interpreted visually.

• When specimens are processed and added to the test device, SARS‑CoV‑2 antigens present in the specimen bind to biotinylated antibodies and antibodies conjugated to detector particles in the test strip.
• The biotinylated antibody‑antigen‑conjugate complexes migrate across the test strip to the reaction area and are captured by a line of streptavidin bound on the membrane.
• A positive result is determined by the BD Veritor™ Plus Analyzer when antigen‑conjugate is deposited at the Test "T" position and a control conjugate is deposited at the Control "C" position on the assay device.
• The instrument analyzes and corrects for non‑specific binding and detects positives not recognized by the unaided eye to provide an objective result.

Procedures to evaluate test devices depend on the BD Veritor™ Plus Analyzer workflow configuration chosen. In Analyze Now mode, the instrument evaluates assay devices after manual timing of their development. In Walk Away mode, devices are inserted immediately after application of the specimen, and timing of assay development and analysis is automated. Additionally, connection of a BD Veritor™ Plus Analyzer to a printer or IT system is possible if desired. Additional result documentation capabilities are possible with the integration of a BD Veritor™ barcode scanning enabled module.

The Analyzer uses a proprietary algorithm that subtracts the nonspecific signal at the negative control line from the signal present at the test line. If the resultant test line signal is above a preselected cutoff, the specimen is scored as positive. If the resultant test line signal is below or equal to the cutoff, the specimen is scored as negative. Use of the active negative control feature allows the BD Veritor™ Plus Analyzer to correctly interpret test results that cannot be scored visually because the human eye is unable to accurately perform the subtraction of the nonspecific signal. The Analyzer measures the amount of light reflected from various zones along the assay strip. The measurement of the assay background zone is an important factor during the test interpretation as the reflectance value is compared to that of the control and test zones.

The provided FDA 510(k) clearance letter and summary describe the BD Veritor System for SARS-CoV-2. Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets in the document. However, based on the clinical study results and FDA clearance, the implicit acceptance criteria for clinical performance are related to the confidence intervals for Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA). The reported device performance is presented below:

Note: The document does not explicitly state numerical acceptance thresholds for PPA and NPA (e.g., "PPA must be > 80%"). Therefore, the "Implicit Acceptance Criteria" are inferred from the demonstrated performance and the fact that the device received clearance. The FDA typically evaluates these metrics within acceptable ranges for diagnostic tests.

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

• Sample Size for Test Set: 1,032 direct anterior nasal swabs.
• Data Provenance: The samples were prospectively collected from individual symptomatic patients across 15 geographically diverse areas across the United States between April and August 2024.

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

The document does not specify the number of experts used to establish the ground truth. The ground truth was established by an FDA-cleared SARS-CoV-2 RT-PCR test. For the false positive/negative re-testing, it broadly states "a second RT-PCR method," implying multiple tests might have been performed to confirm results without specifying expert involvement in interpreting these specific results beyond the RT-PCR outcome itself.

4. Adjudication Method for the Test Set

The primary ground truth for the clinical study was established by an FDA-cleared SARS-CoV-2 RT-PCR test without explicit mention of expert adjudication for every case. However, there was a form of adjudication for discordant results:

• False Positive Adjudication: The three BD Veritor System for SARS-CoV-2 false positive results were retested with a second RT-PCR method and were confirmed negative. This suggests a method where initial discrepancies against the reference method were independently verified.
• False Negative Adjudication: The 23 BD Veritor System for SARS-CoV-2 false negative results were retested with a second RT-PCR method in which 14 were confirmed positive and 9 were negative.

This indicates a process of re-testing or confirmation for discordant results, which serves as a form of adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance (or similar comparative effectiveness of human readers with vs. without the device) was not explicitly mentioned or described in the provided document. The BD Veritor System for SARS-CoV-2 uses an instrument (BD Veritor™ Plus Analyzer) for interpretation, replacing visual interpretation with an automated read. The comparison is between the device's performance and a reference RT-PCR, not between human readers with and without assistance from the device.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was done. The entire clinical performance study (Table 9 and 11) is a standalone study, as it evaluates the performance of the BD Veritor System for SARS-CoV-2 (algorithm/device only) compared to a reference RT-PCR without human interpretation of the lateral flow assay itself. The BD Veritor™ Plus Analyzer instrument is explicitly stated to read and interpret the results, and the device "is not interpreted visually."

7. Type of Ground Truth Used

The ground truth used for the clinical study was an FDA-cleared SARS-CoV-2 RT-PCR test (molecular test results).

8. Sample Size for the Training Set

The document does not specify a sample size for a training set. This submission is for a device, and the analytical and clinical studies described are for validation of the device's performance, not for developing or training an AI/ML algorithm in the context of a typical AI/ML development pipeline. The device uses a "proprietary algorithm" for signal subtraction and interpretation, but it's not presented as a machine learning model that requires a distinct training set in the typical sense.

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

Since no specific training set and its ground truth establishment are discussed in the context of AI/ML model training, this information is not applicable/provided based on the document. The "proprietary algorithm" for the instrument is described in terms of processing reflectance data and applying a preselected cutoff, and its development process (including any data used for internal calibration or parameter setting) is not detailed here.

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The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacterales and Non-Enterobacterales and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus, and Streptococcus.

This premarket notification is for the BD Phoenix Automated Microbiology System with Imipenem-relebactam at a concentration of 0.0625/4-16/4 µg/mL. Testing is indicated for Acinetobacter calcoaceticus-baumannii complex, Enterobacterales, and Pseudomonas aeruginosa, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).

The BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) has demonstrated acceptable performance with the following organisms:

• Acinetobacter calcoaceticus-baumannii complex
• Enterobacterales (Citrobacter amalonaticus, Citrobacter braakii, Citrobacter farmeri, Citrobacter freundii, Citrobacter koseri, Citrobacter youngae, Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, and Serratia marcescens)
• Pseudomonas aeruginosa

The Phoenix AST method is a broth-based microdilution test. The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells containing dried reagents. The ID/AST combination panel includes an ID side (51 wells) with dried substrates for bacterial identification and an AST side (85 wells). The AST panel contains a wide range of two-fold doubling dilution concentrations of antimicrobial agents and growth and fluorescent controls at appropriate well locations. The AST panel does not include wells for isolate identification.

The Phoenix System utilizes a redox indicator for the detection of organism growth in the presence of an antimicrobial agent. The organism to be tested must be a pure culture and be preliminarily identified as Gram-positive or Gram-negative. Colonies are then suspended in ID broth and equated to a 0.5 McFarland suspension using a nephelometer device. A further dilution is made into AST broth (a cation-adjusted formulation of Mueller-Hinton broth containing 0.010% Tween 80), to which the redox-buffered oxidation-reduction AST indicator solution is added producing a blue color in the wells. The concentration of organisms in the final AST broth suspension is approximately 5 X 10^5 CFU/mL.

The Phoenix AST Broth is poured into the inoculation port of the AST panel and the inoculum flows into the panel, filling panel wells. Polyethylene caps are applied to seal the inoculation ports. An air admittance port is located in the panel lid to ensure adequate oxygen tension in the panel for the duration of the test. Inoculated panels are barcode scanned and loaded into the BD Phoenix Automated Microbiology System instrument where panels are continuously incubated at 35 °C ± 1 °C.

Continuous measurements of changes to the indicator as well as bacterial turbidity are used in the determination of bacterial growth. The instrument takes readings every 20 minutes. Organisms growing in the presence of a given antimicrobial agent reduce the indicator (changing it to a pink color). This signals organism growth and resistance to that antimicrobial agent. Organisms killed or inhibited by the antimicrobial agent do not cause reduction of the indicator and therefore do not produce a color change. The Phoenix instrument reads and records the results of the antimicrobial tests contained in the panel and interprets the reactions (based on the organism identification) to give a minimal inhibitory concentration (MIC) value and category interpretations (susceptible, intermediate, resistant, or not susceptible). AST results are available within 16 hours. This is an auto read result; no manual readings are possible with this system.

Additional comments concerning specific organism/antimicrobial combinations are provided from the software-driven expert system (BDXpert), using rules derived from CLSI documentation and/or the FDA-approved drug labeling.

The provided FDA 510(k) clearance letter describes the acceptance criteria and the study that proves the BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) device meets those criteria for Antimicrobial Susceptibility Testing (AST).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criteria for AST devices are related to Essential Agreement (EA) and Category Agreement (CA) with a reference method. The study aims to demonstrate that the device's performance is substantially equivalent to the established reference method.

Note: The document mentions "The performance of the BD Phoenix Imipenem-relebactam met the combined acceptance criteria for all tested organisms, with overall EA and CA rates greater than 90%." This implicitly sets the 90% for EA and CA as the acceptance threshold.

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

• Clinical Isolates (Test Set):

  • Total: 1,111 isolates (862 fresh, 249 stock)
  • Organisms:
    • Acinetobacter baumannii/calcoaceticus complex (83 isolates)
    • Citrobacter freundii (21 isolates)
    • Citrobacter species (9 isolates)
    • Citrobacter koseri (26 isolates)
    • Enterobacter cloacae (60 isolates)
    • Escherichia coli (359 isolates)
    • Klebsiella aerogenes (58 isolates)
    • Klebsiella oxytoca (47 isolates)
    • Klebsiella pneumoniae (198 isolates)
    • Pseudomonas aeruginosa (176 isolates)
    • Serratia marcescens (74 isolates)
  • Provenance: Conducted at three U.S. clinical sites. Data consists of fresh and stock isolates, implying a mix of retrospective (stock) and prospective (fresh) collection.

• Challenge Isolates (Test Set):

  • Total: 85 isolates (these are specific strains with known resistance mechanisms)
  • Organisms:
    • Acinetobacter baumannii (7 isolates)
    • Citrobacter freundii (2 isolates)
    • Citrobacter koseri (2 isolates)
    • Enterobacter cloacae (12 isolates)
    • Escherichia coli (19 isolates)
    • Klebsiella aerogenes (4 isolates)
    • Klebsiella pneumoniae (24 isolates)
    • Pseudomonas aeruginosa (15 isolates)
  • Provenance: Tested at "each study site" (implying the same three U.S. clinical sites as for clinical isolates). These are typically retrospective isolates chosen to challenge the system.

• Reproducibility Isolates:

  • Total: 15 on-scale isolates (tested in triplicate over three days at three sites, for 405 data points).
  • Organisms: Enterobacter cloacae (2), Escherichia coli (5), Klebsiella aerogenes (1), Klebsiella pneumoniae (3) and Pseudomonas aeruginosa (4).
  • Provenance: Conducted at three clinical sites (for manual method) and three internal BD sites (for Phoenix AP instrument).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of medical device (automated microbiology system for AST) does not typically involve human experts to establish "ground truth" in the same way an imaging AI might.

• Ground Truth Establishment: The ground truth for antimicrobial susceptibility testing is established by a reference method, specifically the CLSI frozen broth microdilution reference panel, prepared according to CLSI M07 guidelines. This is a standardized, laboratory-based method, not dependent on expert visual interpretation.
• No "experts" in the human-reader sense are described as establishing ground truth for the test set. The expertise lies in adherence to CLSI standards and methodologies.

4. Adjudication Method for the Test Set

• No human adjudication method (e.g., 2+1, 3+1) is mentioned or applicable for this type of device.
• The comparison is directly between the result from the BD Phoenix system and the CLSI frozen broth microdilution reference panel. Discrepancies are categorized as minor, major, or very major based on established AST definitions (Essential Agreement and Category Agreement).

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

• No, an MRMC study was NOT done. This type of study is relevant for diagnostic imaging interpretation devices where human reader performance is a key metric. For an automated microbiology system, the comparison is to a "gold standard" laboratory method (CLSI microdilution), not to human interpretation or human improvement with AI assistance.

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

• Yes, this is essentially a standalone (algorithm only) performance study. The BD Phoenix system is an automated device that reads and interprets the results without human subjective input in the interpretative step. The "human-in-the-loop" aspects are limited to initial inoculum preparation (though automated options are also available and validated) and loading the panel, not interpreting the results. The comparison is the device's output (MIC and category) against the reference method.

7. The Type of Ground Truth Used

• The ground truth used is the CLSI frozen broth microdilution reference panel, which serves as the gold standard reference method for antimicrobial susceptibility testing.

8. The Sample Size for the Training Set

• The document does not explicitly state a separate "training set" sample size. For this type of automated system, which uses a growth-based detection principle rather than a machine learning model trained on large datasets of examples, the concept of a distinct "training set" in the modern AI sense is typically not applicable.
• The system's "training" or development would involve extensive internal R&D, algorithm refinement, and validation using proprietary data over time, which precedes a 510(k) submission. The data provided in the 510(k) is for the validation/test set to demonstrate performance.

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

• As a conventional, growth-based automated system rather than a machine learning device, there isn't a "training set" with ground truth established in the sense of human labeling or annotation.
• The system operates based on predefined biochemical reactions and growth kinetics, and its algorithms are built upon established microbiological principles and CLSI guidelines. Any internal development and testing would likewise use CLSI reference methods to establish expected outcomes for algorithm development and calibration.

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The BD Phoenix Automated Microbiology System is intended for the in vitro rapid identification (ID) and the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-positive bacteria from pure culture belonging to the genera Staphylococcus, other gram positive cocci and gram positive bacilli and of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Non-Enterobacteriaceae.

BD Phoenix is an automated system for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically relevant bacterial isolates. The BD Phoenix System utilizes a redox indicator to detect organism growth in the presence of an antimicrobial agent. Measurements of changes to the indicator as well as bacterial turbidity are used in the determination of bacterial growth. Each AST panel configuration contains several antimicrobial agents with a wide range of two-fold doubling dilution concentrations. The Phoenix instrument reads and records of the antimicrobial tests contained in the panel and interprets the reactions (based on the organism identification) to give a minimal inhibitory concentration (MIC) value and category interpretations (susceptible, intermediate, resistant, or not susceptible).

The BDXpert™ System is a rule-based software tool that provides expert advice based on organism ID and AST results obtained by broth micro-dilution on the BD Phoenix Instruments. BDXpert rule development is based on published information available through standards organizations, current scientific literature, and FDA's STIC; custom rules may be user defined if desired. The BDXpert System rule logic is applied to the susceptible, intermediate, and resistant (SIR) result, which is based on the breakpoint table and interpretation rule set included either in the BDXpert System on the standalone Phoenix instruments or through the BDXpert System on the connected BD EpiCenter™ data management system (EpiCenter) or BD Synapsys™ Informatics Solution (Synapsys). The resulting instrument report contains information such as: MIC interpretation, BDXpert rules, special messaging, resistance markers, etc. The expert results can then be sent to the Laboratory Information System (LIS).

Synapsys is a browser-based software platform operating in the clinical lab setting, offering secure connectivity and data storage, integrated workflows, and analytics tools. Synapsys consists of software servers operating the application and database, securely networked through a facility IT infrastructure to diagnostic instrumentation, external healthcare IT systems such as the LIS, and browser-enabled client devices for operating the system. Synapsys connects BD lab automation and diagnostic instruments to a common database and provides a single user interface to integrate laboratory workflows. Synapsys provides bi-directional communication with BD Phoenix and is able to process ID and AST results received from a BD Phoenix instrument. The system will automatically associate a known organism ID result, regardless of source, to any ID/AST or AST only Phoenix panel(s) that have the same accession/isolate number and lack an organism ID.

While the provided text describes an FDA 510(k) premarket notification for the BD Phoenix™ Automated Microbiology System, it does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria and the study that proves the device meets them.

The document primarily focuses on:

• Regulatory clearance: The FDA's determination of substantial equivalence to a predicate device.
• Device description: How the BD Phoenix system works for identification (ID) and antimicrobial susceptibility testing (AST).
• Comparison to predicate: Highlighting similarities and differences, particularly in data management connectivity (Synapsys vs. EpiCenter).
• General compliance: Mentioning adherence to standards like ISO 13485, IEC 62304, and ISO 14971, and FDA guidance on software functions.

Missing Information:

The document explicitly states under "V. Performance Characteristics (if/when applicable)": "Performance testing was conducted to verify compliance with specified design requirements... Software verification and validation activities demonstrate that BD Phoenix Instrument connected to Synapsys will perform as intended when used in accordance with device labeling." However, it does not provide the results of these performance tests, nor does it detail the specific acceptance criteria or the methodology of the study that generated those results.

Therefore, I cannot populate the table or answer the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement based solely on the provided text. This type of detailed performance data is typically found in the full 510(k) submission, which is more extensive than this summary letter.

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The BD Vaginal Panel is an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacteria associated with bacterial vaginosis (qualitative results reported based on detection and quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and/or Trichomonas vaginalis. The test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA from:

• · Bacterial vaginosis (BV) markers (Individual markers are not reported)
  • o Lactobacillus spp. (L. crispatus and L. jensenii)
  • o Gardnerella vaginalis
  • o Atopobium vaginae
  • o Bacterial Vaginosis Associated Bacteria-2 (BVAB-2)
  • o Megasphaera-1
• · Vulvovaginal candidiasis (VVC) markers (Markers are reported in the following groups)

o Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis)

• o Candida glabrata
• o Candida krusei
• · Trichomonas vaginalis (TV)

The assay may be used to detect DNA associated with BV, VVC, and TV, or a subset of these conditions per clinician order, in vaginal swab specimens collected from patients who are symptomatic for vaginitis/vaginosis. The BD Vaginal Panel is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis.

The BD Vaginal Panel is available for use with the BD MAX™ System or the BD COR™ System.

The BD MAX™ Vaginal Panel performed on the BD MAX™ System is an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacterial vaginosis (qualitative results reported based on detection and of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and/or Trichomonas vaginalis. The test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA from:

• · Bacterial vaginosis markers (Individual markers not reported)
  • o Lactobacillus spp. (L. crispatus and L. jensenii)
  • o Gardnerella vaginalis
  • o Atopobium vaginae
  • o Bacterial Vaginosis Associated Bacteria-2 (BVAB-2)
  • o Megasphaera-1
• · Vulvovaginal candidiasis (VVC) markers (markers are reported in the following groups)
  • o Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C.dubliniensis)
  • o Candida glabrata
  • o Candida krusei
• • Trichomonas vaginalis (TV)

The assay may be used to detect BV, VVC, and/or TV, or a subset of these conditions per clinician order, in vaginal swab specimens collected from patients who are symptomatic for vaginitis/vaginosis. The BD MAX™ Vaginal is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis.

The BD Vaginal Panel is an automated, qualitative in vitro diagnostic test for bacterial vaginosis markers. Candida species associated with vulyovaginal candidiasis, and Trichomonas vaginalis. From a single specimen, a vaginal swab collected from a patient who is symptomatic for vaginitis or vaginosis, the test provides qualitative (positive) results for the presence of the following conditions and/or organisms:

• Bacterial vaginosis (based on detection of Lactobacillus spp. (L. crispatus and L. . jensenii), Gardnerella vaginalis, Atopobium vaginae, Bacterial Vaginosis Associated Bacteria-2, and Megasphaera-1)
• Candida spp. (C. albicans, c. tropicalis, C. parapsilosis, and C. dubliniensis) .
• Candida glabrata ●
• Candida krusei ●
• Trichomonas vaginalis ●

The BD Vaginal Panel is available for use with the BD MAX™ System or the BD COR™ System under the trade names BD MAX™ Vaginal Panel and BD Vaginal Panel, respectively. The assay previously provided results for all five targets for every specimen run, regardless of whether the ordering clinician desires evaluation of all reported conditions. After clearance of this 510(k) submission, BD will release updates to the BD MAX™ and BD COR ™ software to allow users the versatility to mask results, per specimen, based on the order received from the clinician. This change allows a laboratory to use the BD Vaginal Panel to test a specimen for an individual target group (BV, VVC, or TV) or any two of the three targeted conditions, in addition to the current configuration that reports all three conditions simultaneously.

The provided text describes a 510(k) premarket notification for the BD Vaginal Panel, an in vitro diagnostic test. While the document details the device's intended use, technological principles, and comparison to a predicate device, it does not contain specific acceptance criteria and detailed study results in the format usually provided for device performance evaluation against such criteria. Instead, it states that "The clinical utility of the Vaginal Panel is unchanged from the clinical utility described in DEN160001" and that enabling a subset of results to be masked "has no clinical impact," implying that performance data was previously established and still applies.

Therefore, I cannot extract a table of acceptance criteria and reported device performance from the provided text, nor can I provide specific details on sample sizes, ground truth establishment, or expert involvement for the test set.

However, I can describe the basis for the claim of continued performance and what typically would be found in a complete submission to address these points.

Based on the provided text, here's what can be inferred and what information is missing:

Inferred Information Regarding Acceptance Criteria and Study to Prove Device Meets Them:

The core of the argument for "acceptance" in this submission (K243725) is that the changes to the BD Vaginal Panel (specifically, the ability to mask results for certain conditions based on clinician order) do not impact the analytical or clinical performance that was already established for the predicate device (BD Vaginal Panel, referenced by DEN160001, K191957, K201017, K223653).

The text states:

• "The clinical utility of the Vaginal Panel is unchanged from the clinical utility described in DEN160001."
• "BD has determined that introducing the capability to order a subset of the conditions evaluated by the Vaginal Panel while masking the results for those conditions that are not ordered has no clinical impact."
• "Enabling the assay to report results for only a subset of the conditions does not change the specimen type, the test conditions, or the logic that is used to determine whether a specimen is positive or negative for the associated condition: conditions that are not ordered are simply not reported to the user."
• "Therefore, analytical and clinical performance of the assays is not impacted."

This implies that the previous submissions (DEN160001, K191957, K201017, K223653) would contain the detailed study data that established the acceptance criteria and demonstrated the device's performance against them. The current submission is a modification where the manufacturer asserts that the modification does not alter the already proven performance.

Unavailable Information from the Provided Text:

Since this submission argues "no impact" on performance rather than providing new performance data, the following specific details are not present in the provided document:

1. A table of acceptance criteria and the reported device performance: This information would be in the predicate device's summary (e.g., DEN160001). The current submission leverages the established performance.
2. Sample sizes used for the test set and the data provenance: Not provided for this submission's changes, as it relies on previous data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided for this submission's changes.
4. Adjudication method for the test set: Not provided for this submission's changes.
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 is a molecular diagnostic test, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is described as an "automated qualitative in vitro diagnostic test," meaning its performance is its standalone performance without continuous human interpretation of raw data. The "human-in-the-loop" aspect here is the clinician receiving the final positive/negative result. The change highlighted in this 510(k) is masking results, not altering the fundamental detection algorithm.
7. The type of ground truth used: Not explicitly stated for this submission's changes, but for molecular diagnostics, ground truth typically involves a combination of clinical diagnosis, other laboratory methods (e.g., microscopy, culture, or other validated molecular assays), and sometimes expert clinical assessment.
8. The sample size for the training set: Not applicable as this is not an AI/ML device that requires a separate "training set" in that context. The "training" in molecular diagnostics refers to assay development and optimization, which isn't sample-size driven in the same way.
9. How the ground truth for the training set was established: See point 8.

Summary of what is present in the document relevant to the assertion of continued performance:

The basis of acceptance for this 510(k) submission (K243725) is that the modifications to the BD Vaginal Panel (specifically, the software update to allow result masking) do not compromise the established performance of the predicate device. The detailed performance data, acceptance criteria, study designs, and ground truth methodologies would be found in the original and subsequent predicate device submissions (DEN160001, K191957, K201017, K223653). The current submission serves to inform the FDA that a software change introducing result masking does not require new efficacy studies because it does not alter the underlying test's analytical or clinical capability to detect the specified targets.

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The PowerGlide Pro™ Midline Catheter is inserted into a patient's vascular system for short-term use (< 30 days) to sample blood or administer fluids intravenously. These catheters may be used for adult and pediatric patients, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerGlide Pro™ Midline Catheter is suitable for use with power injectors.

Bard Access Systems, Inc.'s PowerGlide Pro™ Midline Catheter is a sterile, single use device designed to provide access to the patient's vascular system. The device is intended for short term use (< 30 days) to sample blood and administer fluids intravenously. The device consists of an introducer needle with a passive safety mechanism, guidewire, and single lumen, radiopaque, body-softening polyurethane catheter rated for power injection.

Midline catheters, including the PowerGlide Pro, may be considered in patients with difficult IV access as clinically indicated.

The provided FDA 510(k) clearance letter for the PowerGlide Pro™ Midline Catheter specifies that no new performance tests, including verification and validation activities, were conducted because the modifications were limited to labeling updates (specifically, changes to the Indications for Use and associated Instructions for Use/labeling), with no changes to the device's design, materials, performance, or risk profile.

Therefore, based on the provided document, the typical information requested for acceptance criteria and study details (such as sample size, provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details) is not available as no new studies were deemed necessary due to the nature of the submission. The acceptance criteria essentially rely on the previously established performance of the legally marketed predicate device (K162377), which the subject device is substantially equivalent to.

However, I can extract the comparison table that highlights the differences between the subject device and the predicate device, which implicitly states that the performance criteria for the subject device are considered to be the same as the predicate device due to the lack of design or performance changes.

Here's a summary based on the provided document, addressing the points where information is available or where the document indicates why it's not applicable:

1. A Table of Acceptance Criteria and the Reported Device Performance

Since no new performance studies were conducted for this 510(k) submission, there are no new specific acceptance criteria or reported device performance metrics beyond those previously established for the predicate device. The document explicitly states:

"The results of the risk analysis determined that no verification or validation activities were required because the subject device modifications to the Indications for use and resulting modifications to the instructions for use and labeling do not include any changes to the design, materials, performance, or risk profile of the cited predicate device. Therefore, it is not necessary to conduct additional performance tests including verification and validation."

The "reported device performance" would therefore implicitly be identical to the predicate device, K162377, for all functional aspects. The acceptance criteria for this submission were that the labeling changes do not introduce new questions of safety or effectiveness and do not introduce any new or significantly modified risks. The document claims this was met for each change.

Summary of Device Comparison (Implicit Acceptance of Predicate Performance)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No new test set was used as no new performance studies were conducted.

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)
Not applicable. No new test set required ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set required 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 device is a medical catheter and does not involve AI assistance or human reader interpretation for its function.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No new ground truth was established for this submission. The substantial equivalence is based on the predicate device's established safety and effectiveness.

8. The sample size for the training set
Not applicable. No training set was used as no new algorithm or performance study was conducted.

9. How the ground truth for the training set was established
Not applicable. No training set was used.

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The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, and Streptococcus, This premarket notification is for the BD Phoenix™ Automated Microbiology System with Ciprofloxacin at a concentration of 0.0156-4 ug/mL. Ciprofloxacin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobial agent.

This submission is for a range extension of a single antimicrobial cleared for use on BD Phoenix ID/AST or AST only panels. The ID portion of the ID/AST combination panel was not subject to review in this submission.

The Phoenix AST method is a broth-based microdilution test. The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells containing dried reagents. The ID/AST combination panel includes an ID side (51 wells) with dried substrates for bacterial identification and an AST side (85 wells). The AST panel contains a wide range of two-fold doubling dilution concentrations of antimicrobial agents and growth and fluorescent controls at appropriate well locations. The AST panel does not include wells for isolate identification.

The Phoenix System utilizes a redox indicator for the detection of organism growth in the presence of an antimicrobial agent. The organism to be tested must be a pure culture and be preliminarily identified as Gram-positive or Gram-negative. Colonies are then suspended in ID broth and equated to a 0.5 McFarland suspension using a nephelometer device. A further dilution is made into AST broth (a cation-adjusted formulation of Mueller-Hinton broth containing 0.010% Tween 80), to which the redox-buffered oxidation-reduction AST indicator solution is added producing a blue color in the wells. The concentration of organisms in the final AST broth suspension is approximately 5 X 105 CFU/mL.

The Phoenix AST Broth is poured into the inoculation port of the AST panel and the inoculum flows into the panel, filling panel wells. Polyethylene caps are applied to seal the inoculation ports. An air admittance port is located in the panel lid to ensure adequate oxygen tension in the panel for the duration of the test. Inoculated panels are barcode scanned and loaded into the BD Phoenix Automated Microbiology System instrument where panels are continuously incubated at 35 ℃ ± 1 ℃.

Continuous measurements of changes to the indicator as well as bacterial turbidity are used in the determination of bacterial growth. The instrument takes readings every 20 minutes. Organisms growing in the presence of a given antimicrobial agent reduce the indicator (changing it to a pink color). This signals organism growth and resistance to that antimicrobial agent. Organisms killed or inhibited by the antimicrobial agent do not cause reduction of the indicator and therefore do not produce a color change. The Phoenix instrument reads and records the results of the antimicrobial tests contained in the panel and interprets the reactions (based on the organism identification) to give a minimal inhibitory concentration (MIC) value and category interpretations (susceptible, intermediate, resistant, or not susceptible). AST results are available within 16 hours. This is an auto read result; no manual readings are possible with this system.

Additional comments concerning specific organism/antimicrobial combinations are provided from the software-driven expert system (BDXpert), using rules derived from CLSI documentation and/or the FDA-approved drug labeling.

The BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.0156-4 ug/mL) is an antimicrobial susceptibility testing system. The provided text describes the performance characteristics of this device, particularly for Salmonella species, and the study conducted to demonstrate its performance against acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

(Note: The document states "The BD Phoenix Ciprofloxacin performance met the acceptance criteria for Salmonella with overall EA and CA greater than 90%." The specific numerical acceptance criteria for Min, Maj, Vmj are usually found in the referenced guidance documents but are not explicitly detailed as numerical percentages in the provided text for the device itself, other than the observed performance.)

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

• Clinical Isolates: 47 (fresh: 7 (14.9%), stock: 40 (85.1%))
  • Organisms: Salmonella species (43 isolates), Salmonella enterica ssp. enterica serovar Typhi (4).
  • Provenance: "Clinical testing was conducted at three U.S. sites." (Suggests prospective and retrospective clinical data from U.S. sources).
• Challenge Isolates: 82 stock isolates
  • Organisms: Salmonella species (79), Salmonella enterica ssp. enterica serovar Typhi (3).
  • Provenance: "Additional stock challenge isolates were tested at each study site." (Implying laboratory-controlled challenge strains, likely geographically diverse or from culture collections, but no specific country of origin is mentioned beyond "U.S. sites" for the clinical part which also conducted challenge testing).
• Reproducibility Study Isolates: 14 isolates of non-fastidious Gram-negative organisms (including Pseudomonas aeruginosa (1), Salmonella enterica ssp. enterica serovar Paratyphi A (1), and Salmonella species (11)).

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

The ground truth was established using the CLSI frozen broth microdilution reference panel, prepared according to CLSI M07 guidelines. This is a standardized laboratory reference method, implicitly implying experts in microbiology and antimicrobial susceptibility testing were involved in its execution and interpretation, rather than individual "experts" reviewing each case for a ground truth panel. The document does not specify the number or qualifications of "experts" as individuals but relies on the standardized, recognized reference method.

4. Adjudication Method for the Test Set:

Not applicable in the typical sense of expert adjudication for diagnostic imaging or similar devices. The ground truth is determined by a universally accepted reference laboratory method (CLSI frozen broth microdilution). The comparison involves measuring agreement between the device and this reference method.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study focuses on the standalone performance of the automated system against a reference method, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance:

Yes, a standalone performance study was conducted. The "BD Phoenix Automated Microbiology System" is an automated device, and its performance was evaluated against a reference method (CLSI frozen broth microdilution) without human intervention in the MIC determination or category interpretation on the device side. The reported Essential Agreement (EA) and Category Agreement (CA) metrics represent this standalone algorithmic performance.

7. Type of Ground Truth Used:

The ground truth used was expert consensus methodology/reference standard, specifically the CLSI frozen broth microdilution reference panel prepared according to CLSI M07 guidelines. This is the gold standard for antimicrobial susceptibility testing.

8. Sample Size for the Training Set:

The document does not explicitly state the sample size for a training set. This type of device (AST system) is typically developed and validated against extensive datasets during its initial creation and subsequent range extensions. However, the provided text describes the validation/test set used for this specific premarket notification (47 clinical isolates and 82 challenge isolates for Salmonella). This suggests a re-evaluation of performance based on updated breakpoints rather than a new algorithm development requiring a separate training set description in this 510(k) summary.

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

As no explicit training set sample size is provided, the method for establishing its ground truth is also not detailed. However, if a training phase was involved in the initial development of the BD Phoenix system, it would have traditionally relied on similar reference methodologies like CLSI broth microdilution to establish accurate MIC values and corresponding susceptibility categories.

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