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The provided FDA letter (K211672) is for an Antimicrobial Susceptibility Test Powder (MTS Piperacillin-tazobactam). This type of device is used to determine the susceptibility of microorganisms to antimicrobial agents, which is crucial for guiding antibiotic treatment. The information provided in the FDA letter and its attachments does not typically contain the detailed performance study information common for AI/ML-based medical devices or imaging analysis software.

Therefore, many of the specific details requested in your prompt (e.g., sample size for training set, number of experts for ground truth, MRMC study effect size, AI assistance) are not applicable (N/A) to this specific device/submission type, as it is a microbiology culture-based test, not an AI/ML device.

However, I can extract the relevant information regarding the acceptance criteria and performance as typically presented for such devices.

Here's the summary based on the provided documents:

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

For Antimicrobial Susceptibility Testing (AST) devices like this, acceptance criteria typically involve demonstrating substantial equivalence to a predicate device and achieving acceptable Essential Agreement (EA) and Category Agreement (CA) with a reference method (e.g., CLSI broth microdilution). The acceptance criteria often align with FDA guidance for AST devices.

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VITEK®2 Gram Negative Piperacillin/Tazobactam is designed for antimicrobial susceptibility testing of Acinetobacter baumanii. Escherichia coli. Klebsiella pneumoniae. Pseudomonas aeruginosa, Citrobacter koseri, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, and Salmonella enterica. It is intended for use with the VITEK® 2 and VITEK® 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology. The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK 2 COMPACT has a manual filling and sealing operation. The VITEK 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cvcle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.

This document describes the regulatory submission for the VITEK® 2 Gram Negative Piperacillin/Tazobactam system, specifically a Special 510(k) for a device modification related to updated breakpoints for Pseudomonas aeruginosa. The provided text details the device's intended use and performance without explicitly laying out acceptance criteria in a table format common for AI/ML device clearances. However, by analyzing the "Special 510(k) Summary" section, we can infer the acceptance criteria and performance as presented for this specific modification.

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

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

Based on the information provided, the primary performance metric reported for this modification is Category Agreement.

Note: The document specifies that the performance is evaluated against the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, Issued Feb. 5, 2003. This guidance outlines the specific criteria for Category Agreement (CA), Essential Agreement (EA), and overall acceptable performance for AST systems.

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

The document does not explicitly state the sample size (number of isolates) used for the test set. It mentions that "The data are representative of performance on both the VITEK 2 and VITEK 2 COMPACT instrument platforms." No specific information about the country of origin or whether the data was retrospective or prospective is provided. The focus of this specific submission is on the re-evaluation of performance due to a breakpoint change for a single organism (Pseudomonas aeruginosa).

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

The ground truth is established by the CLSI broth microdilution reference method. This is a standardized laboratory method for determining antimicrobial susceptibility, not typically requiring expert human interpretation beyond standard laboratory procedures and quality control. Therefore, the concept of "experts" in the context of ground truth establishment, as it applies to AI/ML devices requiring human labeling, is not relevant here.

4. Adjudication method for the test set

Not applicable. The ground truth is a laboratory reference method (CLSI broth microdilution), not a subjective human interpretation requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

Not applicable. This is an antimicrobial susceptibility test system, not an imaging device requiring human reader interpretation or AI-assistance for diagnosis. The device generates MIC values and interpretive categories (Susceptible, Intermediate, Resistant).

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

The VITEK 2 system automatically performs the test and generates results. The reported performance (92.3% Category Agreement) is the standalone performance of the device against the reference method. There isn't a "human-in-the-loop" component in the direct interpretation of the raw data from the device to produce the MIC and categorical result.

7. The type of ground truth used

The ground truth used is the CLSI broth microdilution reference method. This is a gold-standard laboratory method for determining minimum inhibitory concentrations (MICs) of antimicrobials, which then dictate the interpretive category (susceptible, intermediate, resistant).

8. The sample size for the training set

The document does not provide details on a distinct "training set" or its sample size. The VITEK 2 system operates based on established principles of growth detection and comparison to provide MICs. The original development and "training" (calibration) would have been part of the predicate device's clearance (K113200). This submission is a modification to update the interpretation when a new breakpoint for a specific organism is applied, not a new AI model requiring a separate training phase.

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

As in point 8, the concept of a "training set" for an AI/ML model is not directly applicable in the same way for this type of device. The original calibration and validation of the VITEK 2 system, which would serve a similar purpose to "training," would have established its internal algorithms and growth detection parameters. This would have involved extensive testing against the CLSI broth microdilution reference method with a large collection of isolates. The current modification focuses on applying a new interpretive breakpoint, not retraining the core measurement algorithm.

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The Piper GO-IO® Intraosseous Infusion System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adult and pediatric patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

The Piper GO-IO® Intraosseous Infusion System provides clinicians and emergency personnel with access to the intraosseous space for resuscitation and lifesaving fluid delivery for up to 24 hours. The Piper GO-IO® Intraosseous Infusion System consists of the following:

• a single use hypodermic needle (with needle safety cap), ●
• a powered or manual driver to assist with needle insertion, ●
• an extension set, and;
• an adhesive-backed securement dressing.

For insertions using the powered driver, the hypodermic needle hub that mates with a stylet connected to a drive adapter hub. The drive adapter hub includes a magnetic insert that attaches to the powered driver prior to needle insertion. The Piper GO-IO® Powered Driver is a hand-held, batterypowered device with a rechargeable lithium battery used to assist in the insertion of the subject device needle through the bone cortex. The assembly of the hypodermic needle and stylet with connected drive adapter hub is referred to as the needle set.

For insertions using the manual driver, the needle and the needle hub mate with a stylet in the same way as the needle set that is used with the powered driver, except the stylet is integrated into the handle of the manual driver instead of a drive adaptor hub (i.e. the manual driver needle assembly does not include a drive adapter hub).

The stylet was designed to include a passive safety feature to protect the placer from sharps injury. After the needle is inserted, the stylet is separated from the needle and needle hub. Upon separation of the stylet from the needle hub, the passive safety feature is released onto the stylet tip and can be safely discarded into a sharps container. Following needle insertion, the securement dressing can be applied to secure the needle hub to the skin. An extension set is available for access to the needle hub to support fluid exchange.

The subject device Piper GO-IO® Intraosseous Infusion System will be offered in needle set (for use with the powered driver) and manual driver needle kit configurations. Each kit configuration will include a securement dressing and an extension set.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details various performance tests conducted on the Piper GO-IO® Intraosseous Infusion System. For most entries, the "acceptance criteria" are implied by the standard followed (e.g., ISO 9626:2016 for Needle Outer Diameter) and the "reported device performance" is stated as "met all predetermined acceptance criteria" within the "Summary of Substantial Equivalence" section. Specific quantitative acceptance criteria or detailed performance results are not provided in this document for individual tests.

Therefore, a table cannot be constructed with explicit quantitative acceptance criteria and reported device performance for each test. However, a summary table indicating the tests performed and the general outcome can be presented:

2. Sample Size for Test Set and Data Provenance

The document does not provide specific sample sizes for the test sets (e.g., number of needles, drivers, or tests performed on each). The provenance of the data is not specified; it refers to "performance tests completed on the subject device system" and implies the data was generated internally as part of the regulatory submission. There is no information regarding country of origin or whether the studies were retrospective or prospective beyond the stated date of preparation of the summary (November 8, 2019).

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable. The device is a medical instrument (intraosseous infusion system), and the performance testing described is engineering and biological in nature, evaluating physical and material properties, and adherence to established standards. It does not involve diagnostic interpretation or human reader performance that would require experts to establish ground truth in the context of image analysis or similar AI/algorithm-driven tasks.

4. Adjudication Method for Test Set

This information is not applicable, as the performance tests are objective engineering and biological assessments against established standards, not subjective interpretations requiring adjudication.

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

No MRMC comparative effectiveness study was done. The document describes premarket notification for a medical device, which typically involves demonstrating substantial equivalence to a predicate device through engineering, biocompatibility, and performance testing, rather than comparative effectiveness studies with human readers and AI.

6. Standalone (Algorithm Only) Performance Study

No standalone (algorithm only) performance study was done. The device is a physical medical instrument, not an AI or software algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance tests outlined in the document is established by adherence to recognized international and national standards (e.g., ISO, ASTM, FDA guidance, USP) and internal protocols. These standards define the methods, parameters, and acceptable ranges for various tests related to material properties, mechanical performance, electrical safety, biocompatibility, and sterilization.

8. Sample Size for Training Set

This information is not applicable. The device is a hardware medical device, not an AI or machine learning model that requires a training set.

9. How Ground Truth for Training Set Was Established

This information is not applicable, as there is no training set for a hardware medical device.

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ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in ug/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation.

Piperacillin/Tazobactam has been shown to be active against the Gram-negative aerobic microorganisms listed below according to the FDA label for this antimicrobial agent.

ETEST® P/T can be used to determine the MIC of Piperacillin/Tazobactam against the following microorganisms:

Active both in vitro and in clinical infections: Acinetobacter baumannii Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa

In vitro data are available for the following microorganisms, but clinical significance is unknown:

Citrobacter koseri Morganella morganii Proteus mirabilis Proteus vulgaris Serratia marcescens Providencia stuartii Providencia rettgeri Salmonella enterica

ETEST® is a thin, inert and non-porous plastic strip carrying on one side the MIC reading scale in ug/mL, and on the other side a predefined antibiotic gradient.

When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip.

ETEST® Piperacillin/Tazobactam contains a range of piperacillin from 0.016 to 256 ug/mL, overlaid with a fixed concentration of 4 ug/mL of tazobactam.

This document describes the performance of the ETEST® Piperacillin/Tazobactam (P/T) device in determining antimicrobial susceptibility.

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

Note: The document references the "FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, issued on August 28, 2009" and "CLSI M100-S28 January 2018," which would contain the specific acceptance criteria for Essential Agreement and Category Agreement. The reported performance is directly quoted from Table 1.

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

• Sample Size (Test Set):
  • Enterobacteriaceae: The performance data for Enterobacteriaceae includes: E. coli (168), K. pneumoniae (190), C. koseri (46), M. morganii (41), P. mirabilis (41), P. vulgaris (31), S. marcescens (47), P. stuartii (36), P. rettgeri (28), and S. enterica (31). The total number of unique isolates for Enterobacteriaceae is the sum of these values: 168 + 190 + 46 + 41 + 41 + 31 + 47 + 36 + 28 + 31 = 659 isolates.
  • P. aeruginosa and Acinetobacter spp.: Specific numbers for these categories are not provided beyond the overall performance percentages.
  • The study utilized "fresh and stock clinical isolates, as well as a set of challenge strains." This implies a diverse collection of organisms.
• Data Provenance: The document does not explicitly state the country of origin. It indicates "External evaluations were conducted with fresh and stock clinical isolates, as well as a set of challenge strains." This suggests a retrospective and potentially prospective collection of real-world clinical isolates for the test set.

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 method (CLSI broth microdilution) is a standardized laboratory procedure, not typically relying on expert interpretation in the same way an imaging study would.

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

This information is not applicable for this type of device and study. The ground truth (broth microdilution) is a quantitative laboratory measurement, not subject to subjective expert interpretation requiring 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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an Antimicrobial Susceptibility Test (AST) system, which provides quantitative MIC values and categorical interpretations (Susceptible, Intermediate, Resistant). It is not an AI-assisted diagnostic imaging or interpretation tool for human readers.

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

The study assessed the standalone performance of the ETEST® Piperacillin/Tazobactam device. The device itself (the strip and its resulting inhibition ellipse) generates the result, which is then read by a trained user to determine the MIC. While a human reads the strip, the performance metrics (Essential Agreement, Category Agreement) refer to the accuracy of the device's output compared to the reference method, essentially evaluating the "algorithm only" in generating the gradient and inhibition pattern. The document mentions optional inoculator and ETEST® strip applicator, but clarifies that "swabs were used for plate inoculation/streaking and forceps were used for ETEST® strip application" in the clinical studies, indicating manual procedures for the setup, but the core measurement is from the device.

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

The ground truth used was the CLSI M07-A11 January 2018 broth microdilution reference method. This is a recognized standard laboratory method for determining antimicrobial susceptibility.

8. The sample size for the training set:

The document does not explicitly mention a training set sample size. For AST devices, performance studies typically focus on an independent test set compared to a reference method. While there's a development process for the ETEST® strip formulation, the submitted data pertains to its validation against established standards, not a machine learning model's training.

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

As no explicit training set is mentioned in the context of machine learning, the question of how its ground truth was established is not applicable here. The "development" of the ETEST® device would have involved ensuring the stability and accuracy of the antibiotic gradient, but this is a manufacturing/chemistry process, not a data-driven model training process with ground truth labels.

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The 5 FR DL Piper PICC Catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and prolonged exposure to intraluminal solutions containing up to 70% ethanol. The maximum recommended infusion rate is 5mL/sec for power injection of contrast media.

The 5 French (FR) Dual Lumen (DL) Piper PICC is a single use peripherally inserted central catheter made from a specially-formulated medical grade polyurethane material.

The Piper PICC is designed to perform infusion, intravenous therapy, blood sampling and power injection of contrast media, and is compatible with intraluminal solutions containing up to 70% ethanol. The maximum recommended infusion rate is 5 mL/sec.

The Piper PICC is a 5 French catheter with two 18-gauge lumens and will be provided with 55cm of effective length. The catheter has a reverse-tapered design. The catheter is inserted peripherally by the clinician and is trimmable to fit different patient sizes. It is inserted with a Seldinger or modified-Seldinger technique with compatibility to guidewires up to 0.019" in outer diameter. The catheter distal tip is positioned in the lower 1/3 of the Superior Vena Cava (SVC). The effective length of the catheter including the distal end is radiopaque, which allows for catheter tip visualization.

The Piper PICC catheter includes an extruded polyurethane catheter shaft molded to an injection molded polyurethane hub with extruded extension legs molded to luer-lock fittings, which provide attachments for IV administration. The junction has suture wings to allow for securement to the patient. Clamps are attached to both extension legs on the catheter.

The distal end of the catheter shaft is a dual lumen symmetrical D-shape design that does not differ in material from the remainder of the shaft. With the exception of the reverse-tapered section of the shaft, the distal end is also dimensionally identical to the remainder of the shaft.

The proximal end of the catheter consists of two power injectable extension legs, which each have a luer lock style connection depicting gage size, thumb clamp, ID tag. The catheter has an average priming volume is 0.61 mL

The Piper PICC is packaged in a catheter only kit and provided sterile to the end user. There are no additional components in the kit.

The provided text describes a 510(k) submission for a medical device, the 5 FR DL Piper PICC, and details the non-clinical performance testing conducted to demonstrate its substantial equivalence to a predicate device. This submission focuses on the safety and performance aspects rather than a study on diagnostic accuracy or AI performance. Therefore, many of the requested categories related to AI studies, ground truth, and expert evaluation are not applicable or cannot be extracted from this document.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "The 5 FR DL Piper PICC met all of the predetermined acceptance criteria derived from the standards and guidance listed above." It lists the standards and guidance used, and all the tests performed. However, it does not provide a specific table detailing each acceptance criterion and the quantitative reported device performance for each test. It only gives a general statement that all criteria were met.

A list of guidelines and standards employed:

• Guidance on Premarket Notification [510(k)] Submission for Short- Term and Long-Term Intravascular Catheter, March 16, 1995
• Design Control Guidance for Medical Device Manufacturers, March 11, 1997
• ISO 10555-1: 2013, Sterile, single-use intravascular catheters, Part 1: General requirements
• ISO 10555-3: 2013, Intravascular catheters--Sterile and single-use catheters, Part 3: Central venous catheters
• ISO 594-1: 1986, Conical fittings with 6% luer taper for syringes, needles and certain other medical equipment - Part 1: General Requirements
• ISO 594-2: 1998, Conical fittings with 6% luer taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings
• ASTM F640-79 (reapproved 2000): 2012, Standard Test Methods for Radiopacity of Plastics for Medical Use
• ISO 11135:2014, Medical Devices Validation and Routine Control of Ethylene Oxide Sterilization
• ISO 11607-1: 2006, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
• ISO 11607-1 AMD 1: 2014, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
• ISO 10993-7: 2008. Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals
• ANSI/AAMI ST72:2011, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
• FDA Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers, 2010
• ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for externally communicating, blood contacting, permanent devices and FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
• ISO 14971:2007, Medical Devices – Risk Management for Medical Devices.

List of tests performed:

• Dimensional Analysis
• Ink Permanence
• Radiopacity
• Leak Testing
• Extension Leg Leak w/ Clamp
• Pump Flow
• Priming Volume
• Gravity Flow
• Kink Diameter
• Catheter Collapse
• Tip Stability
• Suture Wing Integrity
• Assembly Tensile
• Shaft Tensile
• Catheter Elongation
• Catheter Modulus
• Catheter Fatigue
• Power Injection
• Assembly Burst
• Extension Leg Burst
• ISO Luer Gauging
• ISO Luer Testing
• Sterilization
• Packaging Validation
• Residuals. EO and ECH
• Pyrogenicity Bacterial Endotoxin Test (LAL)
• Cytotoxicity
• Sensitization
• Irritation/Intracutaneous Reactivity
• Acute Systemic Toxicity
• Material Mediated Pyrogenicity
• Hemolysis (indirect/direct)
• Complement Activation
• Partial Thromboplastin Time
• Sheep Thrombogenicity
• Implantation 13 weeks
• Chemical Characterization
• Subacute/ Sub-chronic Toxicity
• Genotoxicity
• Chronic Toxicity
• Carcinogenicity

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

The document does not explicitly state the sample sizes for each specific test mentioned (e.g., how many catheters were tested for leak testing, power injection, etc.). The study is a non-clinical performance evaluation, likely involving bench testing and some in-vivo animal testing (sheep thrombogenicity, 13-week implantation). No human patient data is mentioned; thus, data provenance in terms of country of origin is not applicable for this type of testing, nor is the retrospective/prospective nature as it's a verification and validation study.

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

Not applicable. This is a non-clinical device performance study, not an AI diagnostic study requiring expert ground truth for interpretation of images or patient data.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical device performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Reader Improvement with AI vs Without AI Assistance

Not applicable. This document describes the performance testing of a physical medical device (PICC catheter), not an AI-powered diagnostic tool. No human-in-the-loop study with AI assistance was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Not applicable. This document is for a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device, in essence, is established by adherence to the performance requirements outlined in the referenced national and international standards (e.g., ISO, ASTM, FDA Guidance). The tests performed (e.g., dimensional analysis, leak testing, tensile strength, biocompatibility, sterilization validation) are designed to objectively verify that the device meets these pre-defined engineering and safety specifications. No pathology, outcomes data, or expert consensus in the diagnostic sense is mentioned as ground truth.

For thrombogenicity evaluations, a legally marketed comparative device (LMCD), the Bard 5F Dual Lumen PowerPICC, was used as a reference for in vivo thrombogenicity evaluations to meet ISO 10993-4 requirements. This served as a comparative benchmark rather than a "ground truth" derived from patient outcomes or pathology.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable. There is no training set for a physical medical device.

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VITEK® 2 Gram Negative Piperacillin/tazobactam is designed for antimicrobial susceptibility testing of gram-negative organisms and is intended for use with the VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 Gram Negative Piperacillin/tazobactam is a quantitative test. Piperacillin/ tazobactam has been shown to be active against most strains of the organisms listed below according to the FDA label for the antimicrobial.

Active in vitro and in clinical infections Klebsiella pneumoniae Acinetobacter baumanii Escherichia coli Pseudomonas aeruginosa

Active in vitro but their clinical significance is uknown:

Proteus vulgaris

Providencia rettgeri

Providencia stuartii

Citrobacter koseri Morqanella morganii Proteus mirabilis

Salmonella enterica Serratia marcescens

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

VITEK® 2 Gram Negative Piperacillin/Tazobactam is designed for antimicrobial susceptibility testing of Acinetobacter baumanii, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Citrobacter koseri, Morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Salmonella enterica and Serratia marcescens. It is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mod/ml. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK 2 Compact has a manual filling and sealing operation. The VITEK 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.

Here's an analysis of the acceptance criteria and the study that demonstrates the device meets these criteria, based on the provided text:

Device Name: VITEK® 2 Gram Negative Piperacillin/Tazobactam (≤ 4 - ≥ 128 µg/ml)

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated as a numerical value for the test set. The document mentions "fresh and stock clinical isolates" were used.
• Data Provenance: The study was an "external evaluation" designed to confirm performance by comparing it with the CLSI broth microdilution reference method. The text does not specify the country of origin of the data or whether it was retrospective or prospective.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set:

• Not explicitly stated. The ground truth method (CLSI broth microdilution) is a standardized laboratory method, so expert adjudication in the traditional sense (e.g., radiologists reviewing images) is not applicable here.

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 device is an automated antimicrobial susceptibility test system, not an imaging device requiring human reader interpretation in the context of AI assistance. The performance is assessed against a reference laboratory method.

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

• Yes, the core of the study is a standalone performance evaluation. The VITEK® 2 system is an automated device designed to determine antimicrobial susceptibility. Its performance (Essential Agreement, Category Agreement) is directly compared to a reference method (CLSI broth microdilution), which represents its "standalone" diagnostic accuracy without human intervention in the susceptibility determination process itself.

7. The Type of Ground Truth Used:

• The ground truth used was the CLSI broth microdilution reference method. This is considered the gold standard for determining minimum inhibitory concentrations (MICs) of antimicrobials.

8. The Sample Size for the Training Set:

• The document does not provide information regarding a separate training set. The VITEK 2 system's underlying algorithm for determining MICs and interpretive categories would have been developed and validated previously, and this submission focuses on the performance of a specific antimicrobial-device combination (Piperacillin/Tazobactam on the VITEK 2 AST-GN card) against a reference method. It's possible the "training" (development) of the MIC interpretation algorithms for the VITEK 2 system happened prior to this specific submission, and this study is a validation for a new antimicrobial.

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

• Since no specific training set for this particular antimicrobial validation is mentioned, the method for establishing its ground truth is also not specified. However, for the underlying VITEK 2 system's development, it would have involved extensive testing against reference methods like CLSI broth microdilution.

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The BD Phoenix™ Automated Microbiology System is intended for the rapid identification and in vitro antimicrobial susceptibility testing of isolates from pure culture of most aerobic and facultative anaerobic Gram-negative and Gram- positive bacteria of human origin.

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 Enterobacteriaceae and Non-Enterobacteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus and Streptococcus.

This premarket notification is for Piperacillin at concentrations of 2-128 µg/mL to Gram-negative ID/AST or AST only Phoenix panels with the removal of the limitations for Proteus mirabilis, Providencia species and Stenotrophomonas maltophilia. Piperacillin 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.

The BD Phoenix Automated Microbiology System (Phoenix System) is an automated system for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically relevant bacterial isolates. The system includes the following components:

• BD Phocnix instrument and software. .
• BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents . for AST determinations.
• BD Phoenix ID Broth used for performing ID tests and preparing AST Broth inoculum. .
• BD Phoenix AST Broth used for performing AST tests only. .
• BD Phoenix AST Indicator solution added to the AST Broth to aid in bacterial growth . determination.

The Phoenix AST method is a broth based microdilution test. The Phoenix system utilizes a redox indicator for the detection of 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 panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells containing dried reagents. Organisms for susceptibility testing must be a pure culture and preliminarily identified as a Gram-negative or Gram-positive isolate. Phoenix panels are inoculated with a specified organism density and placed in the instrument.

The instrument houses the panels where they are continuously incubated at a nominal temperature of 35°C. The instrument takes readings of the panels every 20 minutes. The readings are interpreted to give an identification of the isolate, minimum inhibitory concentration (MIC) values and category interpretations, S, I, or R (sensitive, intermediate, or resistant).

Here's a breakdown of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Device Performance

The core of the acceptance criteria for this device, a susceptibility testing system, revolves around two key metrics: Essential Agreement (EA) and Category Agreement (CA). These are standard in antimicrobial susceptibility testing (AST) device evaluations. The reported performance for Piperacillin for Gram-Negative Organisms is included in the table.

Note on Reported Performance: The provided table (Table 1) under "Performance of BD Phoenix System for Gram-Negative Organisms by Drug" is highly unreadable and appears to be corrupted or poorly formatted. Therefore, the specific numerical values for EA and CA for Piperacillin are not extractable from the provided text. However, the text explicitly states that the study results demonstrate substantially equivalent performance and that reproducibility was greater than 90% for intra-site and greater than 95% for inter-site, suggesting that the EA and CA likely met or exceeded the generally accepted >= 90% threshold for AST devices.

Study Details

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

   • Sample Size: Not explicitly stated in terms of a specific number for the test set. The study tested "Clinical, stock and challenge isolates."
   • Data Provenance: "across multiple geographically diverse sites across the United States." The study included both "Clinical isolates" (likely prospective, collected during routine clinical practice) and "stock and challenge isolates" (retrospective, from laboratory collections or spiked for specific testing).

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

   • The ground truth for the clinical isolates was established by the CLSI reference broth microdilution method. This is a laboratory standard method, not typically performed or interpreted by individual "experts" in the context of radiologists or pathologists. The CLSI method itself is the "expert" reference standard.
   • For "Challenge set isolates," results were compared to "expected results," which would have been pre-determined by an established method or expert consensus for those specific strains. No specific number or qualification of experts is mentioned.

3. Adjudication Method for the Test Set:

   • Not applicable as the ground truth was established by the CLSI reference broth microdilution method for clinical isolates and "expected results" for challenge isolates. These are objective laboratory methods; there is no mention of human adjudication for discrepancies between methods.

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

   • No, an MRMC comparative effectiveness study was not conducted. This study focuses on comparing the automated device's performance against a reference laboratory method, not on human reader performance with or without AI assistance.

5. Standalone Performance (Algorithm Only Without Human-in-the-loop Performance):

   • Yes, this was a standalone performance study. The BD Phoenix™ Automated Microbiology System is an automated device, and its performance was evaluated directly against a reference method (CLSI broth microdilution). Humans prepare the samples and load the panels, but the determination of MIC values and categorical interpretations is performed solely by the instrument's algorithm.

6. Type of Ground Truth Used:

   • For clinical isolates: CLSI reference broth microdilution method. This is a gold standard laboratory method for antimicrobial susceptibility testing.
   • For challenge set isolates: Expected results. These are pre-defined results for known strains, typically established through rigorous characterization using reference methods.

7. Sample Size for the Training Set:

   • The document does not explicitly state a sample size for a "training set." The BD Phoenix system is a commercial product, and the mechanism for internal algorithm development (training) is not detailed in this 510(k) summary, which focuses on validation data for a specific antimicrobial agent addition. The clinical studies described are for validation, not training.

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

   • As no explicit "training set" is mentioned in the context of this 510(k) summary, how its ground truth was established is not provided. The summary focuses on the validation of the device for a new antimicrobial agent using existing reference methods as the ground truth for validation.

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VITEK® 2 Gram Negative Piperacillin is designed for antimicrobial susceptibility testing of gramnegative organisms and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 Gram Negative Piperacillin is a quantitative test. Piperacillin has been shown to be active against most strains of the organisms listed below according to the FDA label for the antirocrobial.

Active in vitro and in clinical infections

Acinetobacter species Enterobacter species Escherichia coli Klebsiella species

Morganella morganii Providencia rettgeri Proteus mirabilis Proteus vulgaris

Pseudomonas aeruginosa Serratia species

Active in vitro but their clinical significance is uknown: Burkholderia cepacia Citrobacter koseri (formerly C. diversus)

Citrobacter freundii Pseudomonas fluorescens

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilii, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MC) microdilution methodology.

The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK 2 Compact has a manual filling and sealing operation. The VITEK 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.

Here's a breakdown of the acceptance criteria and study details for the VITEK® 2 Gram Negative Piperacillin device, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: Not explicitly stated as a number of isolates. The document mentions "fresh and stock clinical isolates and stock challenge strains."
   • Data Provenance: Not explicitly stated, but it was an "external evaluation," implying data was collected outside of bioMérieux's internal development environment. The country of origin is not specified. It included both "fresh and stock clinical isolates," indicating a mix of prospective and retrospective (archived) clinical data.

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

   • Not specified. The ground truth method (CLSI broth microdilution) is a standardized laboratory method rather than expert consensus on individual cases.

3. Adjudication Method for the Test Set:

   • Not applicable. The ground truth was established by the CLSI broth microdilution reference method, which is an objective measurement, not requiring human adjudication of differing interpretations.

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

   • No, an MRMC study was not done. This device is an automated in vitro diagnostic (IVD) system for antimicrobial susceptibility testing, not a device intended for direct human interpretation or improvement of human reader performance. The study compared the device's performance to a reference laboratory method.

5. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

   • Yes, this was a standalone performance study. The VITEK® 2 system is an automated device, and its performance was evaluated against the CLSI reference method to determine its accuracy without human intervention other than sample preparation and loading.

6. The Type of Ground Truth Used:

   • Expert Consensus: No
   • Pathology: No
   • Outcomes Data: No
   • Other: CLSI broth microdilution reference method. This is a universally accepted standardized laboratory procedure for determining minimum inhibitory concentrations (MICs) of antimicrobial agents.

7. The Sample Size for the Training Set:

   • Not applicable/Not mentioned. The document describes a validation study for a device. For a traditional in vitro diagnostic, the "training set" concept (as in machine learning) is generally not applied in the same way. The device's underlying methodology is based on established microbiological principles, and its performance is validated using a test set against a gold standard.

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

   • Not applicable/Not mentioned (see point 7).

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The BD Phoenix™ Automated Microbiology System is intended for the rapid identification and in vitro antimicrobial susceptibility testing of isolates from pure culture of most aerobic and facultative anaerobic Gram-negative and Gram-positive bacteria of human origin.

This premarket notification is for the addition of the antimicrobial agent piperacillin-tazobactam at concentrations of 1/4-128/4 ug/mL to Gram Positive ID/AST or AST only Phoenix panels. Piperacillin-tazobactam 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.

Active In Vitro and in Clinical Infections Against:
Staphylococcus aureus (excluding methicillin and oxacillin-resistant isolates)

Active In Vitro Against:
Enterococcus faecalis (ampicillin or penicillin-susceptible isolates only) Staphylococcus epidermidis (excluding methicillin and oxacillin-reistant isolates)

The BD Phoenix Automated Microbiology System (Phoenix System) is an automated system for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically relevant bacterial isolates. The system includes the following components:

• BD Phoenix instrument and software. .
• BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents t or AST determinations.
• BD Phoenix ID Broth used for performing ID tests and preparing AST Broth inoculum. .
• BD Phoenix AST Broth used for performing AST tests only. .
• BD Phoenix AST Indicator solution added to the AST Broth to aid in bacterial growth . determination.

The Phoenix AST method is a broth based microdilution test. The Phoenix system utilizes a redox indicator for the detection of 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 panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells containing dried reagents. Organisms for susceptibility testing must be a pure culture and preliminarily identified as a Gram-negative or Gram-positive isolate. Phoenix panels are inoculated with a specified organism density and placed in the instrument.

The instrument houses the panels where they are continuously incubated at a nominal temperature of 35°C. The instrument takes readings of the panels every 20 minutes. The readings are interpreted to give an identification of the isolate, minimum inhibitory concentration (MIC) values and category interpretations, S, I, or R (sensitive, intermediate, or resistant).

Here's a summary of the acceptance criteria and study details for the BD Phoenix™ Automated Microbiology System for piperacillin-tazobactam:

1. Acceptance Criteria and Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: "1949" isolates were tested for the Piperacillin-tazobactam drug. The text also mentions a "panel of Gram-positive isolates" for reproducibility studies, but a specific number for that panel isn't provided beyond discussing the clinical and challenge isolates.
• Data Provenance: Clinical, stock, and challenge isolates were tested across multiple geographically diverse sites across the United States. This indicates a mix of retrospective (stock and some clinical) and prospective (new clinical isolates) data collection.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• The document does not explicitly state the number of experts used to establish ground truth.
• It refers to "CLSI reference broth microdilution method" and "expected results" for challenge isolates as the ground truth. While these methods are performed by trained personnel, the document doesn't detail the qualifications of individuals performing these reference methods for this specific study.

4. Adjudication Method (Test Set)

• The document does not describe an adjudication method for disagreements between the device and the reference method or discrepancies amongst multiple expert readers. The comparison is directly between the Phoenix System's results and the CLSI reference method or expected results.

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

• No MRMC comparative effectiveness study was done. This study focuses on the performance of the automated system against a reference method, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was done. The entire study describes the performance of the BD Phoenix™ Automated Microbiology System (an algorithm-driven automated device) in determining antimicrobial susceptibility. It compares the device's output directly to the CLSI reference broth microdilution method.

7. Type of Ground Truth Used

• Clinical Isolates: The ground truth for clinical isolates was the CLSI reference broth microdilution method.
• Challenge Isolates: The ground truth for challenge isolates was their expected results.

8. Sample Size for the Training Set

• The document does not explicitly state the sample size for a training set. This is a 510(k) submission focusing on substantial equivalence testing of a specific antimicrobial agent for an already established system. The underlying algorithms would have been developed and trained using data prior to this specific submission.

9. How Ground Truth for the Training Set Was Established

• The document does not provide details on how the ground truth for any training set was established. As mentioned above, this submission concerns the addition of a new antimicrobial agent to an existing system, rather than the initial development and training of the system's core algorithms.

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