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Sulopenem SPM 2 μg is an in vitro semi-quantitative method for antimicrobial susceptibility of clinical isolates tested on agar media using overnight incubation.

The Sulopenem SPM 2 μg is intended to determine susceptibility of Enterobacterales to sulopenem, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). Sulopenem at concentrations of 2 μg should be interpreted at 16-18 hours of incubation.

The Sulopenem SPM 2 μg demonstrated acceptable performance with the following organisms:

Enterobacterales (Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Klebsiella aerogenes, Klebsiella oxytoca, Proteus vulgaris, Providencia alcalifaciens, and Providencia stuartii).

Not Found

This FDA 510(k) clearance letter details the clearance of an Antimicrobial Susceptibility Test Disc, not an AI/ML medical device. Therefore, the information typically requested in an AI/ML device acceptance criteria and study section (such as human-in-the-loop performance, expert consensus on ground truth, training set details, or MRMC studies) is not applicable and is not present in the provided text.

The information from the letter describes a Sulopenem SPM 2 µg Antimicrobial Susceptibility Test Disc, a device used in vitro to determine the susceptibility of Enterobacterales to sulopenem. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance standards and validation studies required for such an in vitro diagnostic (IVD) device.

Based on the provided text, here's what can be extracted and what cannot:

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

The document states: "The Sulopenem SPM 2 µg demonstrated acceptable performance with the following organisms: Enterobacterales (Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Klebsiella aerogenes, Klebsiella oxytoca, Proteus vulgaris, Providencia alcalifaciens, and Providencia stuartii)."

However, the specific quantitative acceptance criteria (e.g., minimum essential agreement, categorical agreement percentages) and the reported performance values (e.g., actual percentages of agreement achieved) are not detailed in this clearance letter. These would typically be found in the more comprehensive 510(k) submission summary or review memorandum, which is not provided here.

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

The letter does not specify the sample size (number of isolates tested) used for the performance evaluation or the data provenance (e.g., country of origin, retrospective/prospective nature of the isolate collection).

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

This is not applicable as the "ground truth" for an antimicrobial susceptibility test is typically established by a reference method (e.g., broth microdilution or agar dilution) performed by trained laboratory personnel following standardized protocols, not by expert consensus in the way it is for imaging AI.

4. Adjudication method for the test set

Not applicable in the context of an AST device.

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

Not applicable. MRMC studies are relevant for imaging AI devices that assist human readers. This is an in vitro diagnostic disc.

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

Not applicable. This device is a physical disc; its "standalone performance" refers to its accuracy against a reference method. The letter confirms "acceptable performance" but does not detail the specific study methodology.

7. The type of ground truth used

The ground truth for antimicrobial susceptibility testing is typically established by comparing the device's results (zone of inhibition for a disc) to a gold standard reference method, such as broth microdilution or agar dilution, which determine the Minimum Inhibitory Concentration (MIC). The letter references the "FDA Susceptibility Test Interpretive Criteria (STIC)," implying these are the standards used for interpretation against a reference method. The letter also specifies "clinical isolates," indicating the testing was performed on real-world samples.

8. The sample size for the training set

This concept (training set) is typically associated with AI/Machine Learning models, not with a physical antimicrobial susceptibility test disc. Therefore, no "training set" or its size is mentioned.

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

Not applicable for the same reason as point 8.

In summary, based only on the provided FDA 510(k) clearance letter:

The letter confirms the Sulopenem SPM 2 µg Antimicrobial Susceptibility Test Disc has demonstrated "acceptable performance" for determining susceptibility of specific Enterobacterales (listed in the document) to sulopenem, according to FDA Susceptibility Test Interpretive Criteria (STIC) when interpreted at 16-18 hours of incubation. However, the specific quantitative results of the performance study and the details of the study methodology (like exact sample sizes, and the precise nature of the "acceptable performance" criteria in terms of agreement percentages) are not disclosed in this high-level clearance summary. These details would be contained within the full 510(k) submission.

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HardyDisk AST disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacterales, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Candida spp., Haemophilus spp., Neisseria gonorrhoeae, Neisseria meningitidis and Streptococcus spp., including Streptococcus pneumoniae.

Use of HardyDisk AST Gepotidacin 10μg (GEP10) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales, Staphylococcus saprophyticus, and Enterococcus faecalis to gepotidacin, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).

HardyDisk AST Gepotidacin at concentration 10μg demonstrated acceptable performance to determine the zone diameter (mm) of gepotidacin against the following microorganisms:

Enterobacterales (Citrobacter freundii complex, Escherichia coli, Klebsiella pneumoniae, Citrobacter koseri, Klebsiella aerogenes, Klebsiella oxytoca/Raoultella ornithinolytica, Morganella morganii, Proteus mirabilis, Providencia rettgeri)
Enterococcus faecalis
Staphylococcus saprophyticus

Not Found

The provided FDA 510(k) clearance letter is for the HardyDisk AST Gepotidacin 10µg (GEP10), an Antimicrobial Susceptibility Test Disc. This document primarily focuses on the regulatory clearance of a medical device and its intended use, rather than a detailed study report of an AI/ML powered device.

Therefore, the information traditionally sought for acceptance criteria and study proving performance for AI/ML devices (such as sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not present in this type of FDA clearance letter for a non-AI/ML antimicrobial susceptibility test disk.

The provided document describes:

• Device Name: HardyDisk AST Gepotidacin 10µg (GEP10)
• Intended Use: Semi-quantitative in vitro susceptibility testing by the agar diffusion (Kirby-Bauer) method.
• Acceptable Performance Demonstrated For: Determining the zone diameter (mm) of gepotidacin against specific microorganisms (Enterobacterales, Staphylococcus saprophyticus, and Enterococcus faecalis).

Since this is a traditional in vitro diagnostic device (an antimicrobial susceptibility test disk), its "acceptance criteria" relate to its ability to accurately determine susceptibility based on zone diameters, which is typically validated through comparison to a reference method (e.g., broth microdilution) and established interpretive criteria (STIC). The performance metrics would involve agreement rates (Essential Agreement and Categorical Agreement) with the reference method.

Based on the provided text, I cannot extract the specific details requested regarding study methodology, sample sizes, expert involvement, and ground truth establishment in the context of an AI/ML device. The letter only states that the device "demonstrated acceptable performance."

To answer your request, I will indicate where the information would typically be found in a study report for an AI/ML device and then explain why it's not present in this specific document.

Hypothetical Description of Acceptance Criteria and Study (if this were an AI/ML device, as requested by the prompt, but adapted to the limited information for this non-AI/ML device):

Given that the provided document is a 510(k) clearance letter for an Antimicrobial Susceptibility Test Disc (a traditional IVD, not an AI/ML device), the detailed study information typically associated with AI/ML algorithm validation (e.g., number of experts, adjudication methods, MRMC studies) is not included in this type of regulatory correspondence.

However, for a non-AI/ML device like an AST disk, "acceptance criteria" and "proof of meeting criteria" would typically involve demonstrating:

1. Essential Agreement (EA): The percentage of isolates for which the test device's zone diameter measurement is within a certain agreement range (e.g., ±3 mm) of the reference method's MIC or zone diameter.
2. Categorical Agreement (CA): The percentage of isolates for which the test device's interpretive result (Susceptible, Intermediate, Resistant) matches the reference method's interpretive result based on established breakpoints.
3. Very Major Errors (VME): False Susceptible (device says susceptible, reference says resistant).
4. Major Errors (ME): False Resistant (device says resistant, reference says susceptible).
5. Minor Errors (mE): Device says intermediate, but reference says susceptible or resistant, or vice versa.

The "study that proves the device meets the acceptance criteria" for an AST disk typically involves:

• Testing a large number of clinical isolates representing the target organisms (e.g., Enterobacterales, Staphylococcus saprophyticus, Enterococcus faecalis).
• Comparing the zone diameters and interpretive results of the HardyDisk AST Gepotidacin 10µg (GEP10) against an FDA-recognized reference method (e.g., broth microdilution or agar dilution) for gepotidacin.
• Analyzing the EA, CA, VME, ME, and mE rates according to FDA guidance for AST devices.

Since this is NOT an AI/ML device, many of the requested fields (e.g., MRMC studies, number of experts for ground truth beyond standard AST expert review) are not applicable.

Addressing Your Specific Questions based on the Provided Document:

Here's how the provided information aligns (or doesn't align) with your specific questions:

1. A table of acceptance criteria and the reported device performance:
   • Acceptance Criteria (Generalized for AST): For AST devices, typical acceptance criteria involve high rates of Essential Agreement and Categorical Agreement (e.g., >90%), and low rates of Major Errors and Very Major Errors (e.g.,

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Liofilchem Antibiotic Discs are a semi-quantitative agar diffusion method for in vitro determination of antimicrobial susceptibility of clinical isolates tested on agar media after overnight incubation.

The Ceftobiprole BPR 5 µg Disc is intended to determine susceptibility of Enterobacterales and Staphylococcus aureus to ceftobiprole, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). Ceftobiprole at concentrations of 5 μg should be interpreted at 16-18 hours of incubation.

The Ceftobiprole BPR 5 µg Disc demonstrated acceptable performance with the following organisms:

• Enterobacterales (Escherichia coli and Klebsiella pneumoniae)
• Staphylococcus aureus (includes methicillin resistant isolates)

Not Found

Based on the provided FDA 510(k) Clearance Letter, the device in question is a "Ceftobiprole BPR 5 µg Disc." This is an Antimicrobial Susceptibility Test (AST) disc, not a medical imaging or AI-driven diagnostic device. Therefore, the acceptance criteria and study design elements typically associated with AI/ML-based devices (such as MRMC studies, multi-reader consensus, training/test sets for AI, pixel-level ground truth, etc.) are not applicable in this context.

The 510(k) letter discusses the substantial equivalence of this AST disc to legally marketed predicate devices. The "study" proving the device meets acceptance criteria for an AST disc involves demonstrating its performance in determining antimicrobial susceptibility for specific organisms, as recognized by FDA Susceptibility Test Interpretive Criteria (STIC).

Here's how to interpret the provided information in the context of an AST disc:

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

For an AST disc, "acceptance criteria" typically refer to the agreement of the new device's zone diameters or interpretations (Susceptible, Intermediate, Resistant) with a reference method (e.g., broth microdilution or another FDA-cleared AST method) and demonstrating acceptable categorical agreement (CA) and essential agreement (EA) rates, as well as addressing very major errors (VME), major errors (ME), and minor errors (mE). The specific numerical targets for these metrics are not provided in this 510(k) letter but are standard for AST device clearance.

The letter states:

• Enterobacterales (Escherichia coli and Klebsiella pneumoniae)
• Staphylococcus aureus (includes methicillin resistant isolates)"

While specific percentages for CA, EA, VME, ME, mE are not in this letter, "acceptable performance" implies these standard metrics were met as per FDA guidance for AST devices. |

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

• Sample Size for Test Set: The 510(k) letter does not specify the number of isolates (sample size) used for the performance testing. For AST devices, this would typically be a pre-defined number of clinical isolates, often including a challenge set (e.g., resistant strains).
• Data Provenance: The letter doesn't directly state the country of origin or if the study was retrospective or prospective. For AST studies, the isolates are usually collected from various clinical sources to ensure representativeness. They are often cultivated and tested prospectively in a lab setting.

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

• For an AST disc, the "ground truth" is not established by human experts in the same way it is for image interpretation. Instead, the ground truth is established by a reference method, typically a CLSI-standardized broth microdilution method or another FDA-cleared AST system, using precisely controlled laboratory conditions.
• The "experts" involved would be trained microbiologists and laboratory technicians who perform these standardized susceptibility tests accurately. Their qualification lies in their adherence to CLSI (Clinical and Laboratory Standards Institute) guidelines and good laboratory practices. The number of such individuals is not specified and is less relevant than the accuracy and standardization of the reference method itself.

4. Adjudication method for the test set:

• Adjudication methods (e.g., 2+1, 3+1) are for subjective interpretations, primarily in medical imaging. For AST, the interpretations are quantitative (zone diameters) and then categorically assigned based on established breakpoints. There is no "adjudication" in the sense of multiple experts independently reviewing and then resolving discrepancies. The results from the test disc are compared directly to the results from the reference method.

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

• No, an MRMC comparative effectiveness study was not done. MRMC studies are for evaluating human reader performance, often with and without AI assistance, especially in radiology. This is not applicable to an antimicrobial susceptibility test disc, which is a laboratory diagnostic tool that provides a direct measurement for interpretation.

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

• This concept is also not applicable. The "device" is a physical disc that produces a zone of inhibition. A human (trained lab personnel) measures this zone and interprets it based on established criteria. There is no "algorithm" in the AI sense that performs a standalone diagnosis without human involvement. The interpretation is human-in-the-loop, though it's rule-based rather than expert opinion-based as in image reading.

7. The type of ground truth used:

• The ground truth for an AST disc is typically established by comparison to a CLSI-standardized reference method, such as broth microdilution or agar dilution, or an existing FDA-cleared AST system with well-defined performance characteristics. The relevant outcome data is the in vitro susceptibility phenotype of the bacterial isolate. It is not expert consensus, pathology, or direct patient outcomes in this context, but rather highly controlled laboratory measurements.

8. The sample size for the training set:

• For an AST disk like this, there isn't a "training set" in the AI/ML sense. The "training" of the device is through its precise manufacturing to consistently release the specified antimicrobial concentration and create reproducible inhibition zones. The "training data" for setting interpretive criteria (breakpoints) involves extensive in vitro testing of many strains, correlation with clinical outcomes, and pharmacokinetic/pharmacodynamic (PK/PD) studies, which often span decades of research. The 510(k) letter doesn't provide details on this broader historical "training" data.

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

• As above, for an AST disc, the concept of a "training set" and "ground truth" establishment for it, as understood in AI/ML, doesn't directly apply. The establishment of ground truth for setting the specific concentration of the disc (5 µg) and the interpretive breakpoints (STIC) is a highly complex process within clinical microbiology. It involves:
  • Extensive in vitro susceptibility testing: Using reference methods like broth microdilution against thousands of bacterial isolates to determine the minimal inhibitory concentrations (MICs).
  • Pharmacokinetic/Pharmacodynamic (PK/PD) studies: To understand drug concentrations in the body and how they relate to the MICs needed to inhibit bacterial growth.
  • Clinical Efficacy Data: Correlation between in vitro susceptibility results and patient outcomes in clinical trials (though these trials are usually for the drug itself, not the disc).
  • Expert Consensus and Regulatory Body Review: Committees (like CLSI and FDA) review all the available data to establish and officially recognize Susceptibility Test Interpretive Criteria (STIC) or breakpoints.

In summary, the information in the 510(k) letter pertains to an Antimicrobial Susceptibility Test Disc, which follows a different regulatory and validation pathway than AI/ML-driven diagnostic devices. The details requested primarily apply to AI-based systems.

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Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, these discs are intended to determine susceptibility against microorganisms for which specific drugs have been shown to be active both clinically and in vitro.

The Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 is intended to determine susceptibility of Enterobacterales to Aztreonam/Avibactam, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). The Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 demonstrated acceptable performance to determine susceptibility to Aztreonam/Avibactam against the following microorganisms:

Enterobacterales (Citrobacter freundii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Klebsiella oxytoca, Serratia marcescens, and Proteus mirabilis)

Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50

The provided FDA 510(k) clearance letter pertains to an Antimicrobial Susceptibility Test Disc (ASTD), specifically the "Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50". This type of device is a diagnostic tool used in microbiology laboratories to determine how effective certain antimicrobials are against specific microbial infections.

The information typically requested for AI/ML-based medical devices (such as acceptance criteria, ground truth establishment for training/test sets, sample sizes, MRMC studies, etc.) is not directly applicable to this type of traditional in vitro diagnostic device (IVD).

Here's why and what can be extracted from the document:

• Nature of the Device: The Aztreonam/Avibactam Disc is a physical disc impregnated with antimicrobial agents. Its "performance" refers to its ability to accurately measure the zone of inhibition (a clear area around the disk where bacteria do not grow), which then correlates to the susceptibility or resistance of the microorganism to the antibiotic. It's not an AI/ML algorithm that interprets or processes complex images or data in an automated way.
• Acceptance Criteria for ASTDs: For ASTDs, acceptance criteria typically involve demonstrating a high degree of correlation between the zone diameters produced by the disc and the Minimum Inhibitory Concentration (MIC) values obtained by a reference method (e.g., broth microdilution). This often involves:
  • Essential Agreement (EA): The percentage of isolates for which the disc test and the reference method produce results that categorize the isolate into the same interpretive category (Susceptible, Intermediate, Resistant).
  • Category Agreement (CA): A stricter measure, where both the zone diameter and MIC fall within defined ranges for a specific category.
  • Major Discrepancies (MD): When the disc test indicates Susceptible, but the reference method indicates Resistant.
  • Very Major Discrepancies (VMD): When the disc test indicates Resistant, but the reference method indicates Susceptible.
  • Minor Discrepancies (mD): Discrepancies between Intermediate and Susceptible/Resistant categories.
    The FDA expects these discrepancy rates to be below certain thresholds (e.g., VMD

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HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacterales, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Candida spp., Haemophilus spp., Neisseria gonorrhoeae, Neisseria meningitidis and Streptococcus spp., including Streptococcus pneumoniae.

Use of HardyDisk AST Aztreonam/Avibactam 30/20μg (AZA50) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales to Aztreonam/Avibactam, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).

HardyDisk AST Aztreonam/Avibactam at concentration 30/20μg demonstrated acceptable performance to determine the zone diameter (mm) of Aztreonam/Avibactam against the following microorganisms:

Enterobacterales (Citrobacter freundii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Klebsiella oxytoca, Serratia marcescens, Citrobacter koseri, Enterobacter spp., Klebsiella aerogenes, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Raoultella ornithinolytica, and Serratia spp.)

Not Found

Based on the provided FDA 510(k) clearance letter, the device in question is the "HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)", an antimicrobial susceptibility test disc. It describes the device's indications for use and states that it "demonstrated acceptable performance to determine the zone diameter (mm) of Aztreonam/Avibactam against" a list of Enterobacterales.

However, the provided document is an FDA 510(k) clearance letter and an "Indications for Use" form. Crucially, it does NOT contain the detailed performance study information, acceptance criteria, sample sizes, ground truth establishment methods, or expert details that you've asked for.

The letter confirms clearance based on "acceptable performance," but the specifics of how that performance was evaluated and what the acceptance criteria were are typically found in the full 510(k) submission, not in this clearance letter itself.

Therefore, I cannot provide the requested information from the given text. The text only states that the device demonstrated "acceptable performance." To answer your questions, I would need access to the actual performance study report that was part of the 510(k) submission.

To reiterate, the provided document does NOT contain the information needed to answer the questions about acceptance criteria and the study that proves the device meets them.

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HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacterales, Staphylococus spp., Acinetobacter spp., Listeria monocytogenes, Enterocccus spp., and by modified procedures, Candida spp., Neisseria gonorrhoeae, Neisseria meningitidis and Streptococcus spp., including Streptococcus pneumoniae.

Use of HardyDisk™ AST Cefiderocol 30μg (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of microorganisms to Cefiderocol.

HardyDisk™ AST Cefiderocol at concentration 30μg can be used to determine the zone diameter (mm) of Cefiderocol against the following microorganisms.

Active both in vitro and clinical infections against: Gram-negative bacteria Escherichia coli Enterobacter cloacae complex Proteus mirabilis Pseudomonas aeruginosa Acinetobacter baumannii complex Klebsiella pneumoniae Serratia marcescens

Active in vitro against: Gram-negative bacteria Citrobacter freundii complex Citrobacter koseri Klebsiella aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia rettgeri

HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens.

This document, K241060, is a 510(k) premarket notification for the HardyDisk AST Cefiderocol 30μg (FDC30), an antimicrobial susceptibility test disc. It describes the device's indications for use and states that it has been determined substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain information about the acceptance criteria or the study that proves the device meets those criteria.

The document is a clearance letter from the FDA, confirming the substantial equivalence of the device. It outlines regulatory requirements and general controls but does not include the technical study report, validation data, or specific performance metrics (like sensitivity, specificity, accuracy, etc.) that would be necessary to answer your questions regarding acceptance criteria and study details.

Therefore, I cannot provide the requested information from this document. To answer your questions, I would need access to the actual study report or the detailed premarket submission data that was reviewed by the FDA, which is not part of this clearance letter.

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Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. Used in a diagnostic workflow to and clinicians in determining potential treatment options for patients suspected of having a microbial infection, these discs are intended to determine susceptibility against microorganisms for which specific drugs have been shown to be active both clinically and in vitro.

The Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 can be used to determine susceptibility to Rezafungin against the following fungi for which Rezafungin has been shown to be active both clinically and in vitro:

Candida albicans
Candida glabrata
Candida parapsilosis
Candida tropicalis

Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing.

This document is an FDA clearance letter for a medical device called "Thermo Scientific Oxoid Rezafungin Disc (5 ug) RZF5". It does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter simply states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It also outlines the regulatory obligations for the manufacturer.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device

Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. Used in a diagnostic workflow to and clinicians in determining potential treatment options for patients suspected of having a microbial infection, these discs are intended to determine susceptibility against microorganisms for which specific drugs have been shown to be active both clinically and in vitro.

The Thermo Scientific Oxoid Sulbactam Disc (10/10 ug) SUD20 can be used to determine susceptibility to Sulbactam/Durlobactam against the following bacteria for which Sulbactam has been shown to be active both clinically and in vitro:

Acinetobacter-baumannii calcoaceticus complex

Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 ug) SUD20

The provided FDA letter and "Indications for Use" document do not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving the device meets them. This type of information is typically found in the 510(k) summary or the full 510(k) submission, neither of which is present in the provided text.

However, I can extract what is available and indicate where information is missing.

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

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

The provided document does not contain specific acceptance criteria or reported device performance metrics such as sensitivity, specificity, accuracy, or zone diameter interpretive criteria. It only describes the intended use of the device.

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

This information is not present in the provided text.

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

This information is not present in the provided text. The device is an antimicrobial susceptibility test disc, so the ground truth would likely refer to established microbiological methods, not expert human interpretation in the way, for example, a radiology AI device would use.

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

This information is not present in the provided text.

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

The device is an antimicrobial susceptibility test disc, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device.

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

The device itself is a physical disc used in a laboratory procedure. It is not an algorithm. The "performance" refers to the accuracy of the disc's susceptibility determination against established reference methods. While it operates "standalone" in the sense that its results are read directly, it's not an algorithm in the typical AI sense. The study would test the disc's performance in determining susceptibility against reference methods.

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

For antimicrobial susceptibility testing, the ground truth is typically established by reference methods such as broth microdilution (BMD) or agar dilution, performed according to recognized standards (e.g., Clinical and Laboratory Standards Institute (CLSI) guidelines). The provided document does not explicitly state the ground truth method, but this is the standard for such devices.

8. The sample size for the training set

The concept of a "training set" is usually associated with machine learning or AI models. This device is a physical antimicrobial susceptibility test disc. Therefore, there isn't a "training set" in the conventional AI sense. The development of such discs involves extensive laboratory testing and formulation, but not a dataset to train an algorithm.

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

As explained above, the concept of a "training set" and associated ground truth establishment for a training set is not applicable to this type of device.

Summary of Device and Indication from the Text:

• Device Name: Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 ug) SUD20
• Regulation Number: 21 CFR 866.1620
• Regulation Name: Antimicrobial susceptibility test disc
• Intended Use: To determine susceptibility to Sulbactam/Durlobactam against Acinetobacter baumannii-calcoaceticus complex using the semi-quantitative agar diffusion test method for in vitro susceptibility testing. This assists clinicians in determining potential treatment options for patients with microbial infections.
• Type of Use: Prescription Use.

To get the detailed information you are seeking, you would typically need to review the full 510(k) summary (K232276) available on the FDA's website, which often includes details about the analytical studies performed to demonstrate substantial equivalence.

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HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffision test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacterales, Staphylococcus spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Candidas spp., Neisseria gonorrhoeae, Neisseria meningitidis and Streptococcus spp., including Streptococcus pneumoniae.

Use of HardyDisk™ AST Sulbactam 10/10ug (SUD20) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of microorganisms to Sulbactam.

HardyDisk™ AST Sulbactam/Durlobactam at concentration 10/10ug can be used to determine the zone diameter (mm) of Sulbactam/Durlobactam against the following microorganisms for which Sulbactam has been shown to be active both clinically and in vitro: Acinetobacter baumannii-calcoaceticus complex (ABC).

HardyDisk™ AST Sulbactam/Durlobactam 10/10μg (SUD20)

I am sorry, but the provided text does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter and an Indications for Use statement for the HardyDisk™ AST Sulbactam/Durlobactam 10/10µg (SUD20).

While it mentions the device's purpose (antimicrobial susceptibility testing) and the microorganisms it tests against, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample size for test sets or data provenance.
• Information on experts used to establish ground truth or adjudication methods.
• Any mention of a multi-reader, multi-case (MRMC) comparative effectiveness study.
• Information about standalone algorithm performance.
• The type of ground truth used (beyond implying susceptibility testing).
• Sample size for the training set or how its ground truth was established.

This document confirms the device's clearance and intended use but does not delve into the underlying performance studies and acceptance criteria details that would typically be found in a more comprehensive submission summary or clinical study report.

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BD BBL Sensi-Disc Antimicrobial Susceptibility Test (AST) Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing.

BD BBL Sensi-Disc Lefamulin Disc 20 µg (LMU-20) can be used to determine susceptibility to Lefamulin against the following bacteria, as described in the FDA-approved package insert for this antimicrobial agent.

Active in vitro and in Clinical Infections Against: Gram-positive Bacteria Streptococcus pneumoniae Staphylococcus aureus (methicillin-susceptible isolates)

Gram-negative Bacteria Haemophilus influenzae

The BD BBL Sensi-Disc Lefamulin 20 µg (LMU-20) device is a 6 mm disc prepared by impregnating high quality absorbent paper with accurately determined amounts of Lefamulin. Discs are clearly marked on both sides with the code LMU-20. The code designates the agent Lefamulin (LMU) and the drug content (20 ug).

BD BBL Sensi-Disc Antimicrobial Susceptibility Test Discs are furnished in cartridges containing 50 discs each. The last disc in each cartridge is marked "X" and contains the drug as coded. BD BBL Sensi-Disc Antimicrobial Susceptibility Test Discs can be dispensed using a BD BBL Sensi-Disc Dispenser.

The provided document is a 510(k) Summary for the BD BBL Sensi-Disc Lefamulin 20µg (LMU-20), an antimicrobial susceptibility test disc. It details the device's intended use, performance characteristics, and comparison to a predicate device. However, it does not describe a study involving an AI/machine learning device or human readers. The acceptance criteria and performance data provided relate to the reproducibility and comparative performance of an antimicrobial susceptibility disc, which is a physical diagnostic tool for laboratory use, not a digital AI-based diagnostic system.

Therefore, many of the requested elements for describing the acceptance criteria and the study for an AI device (e.g., number of experts for ground truth, adjudication methods, MRMC studies, training set details) are not applicable to this document.

I will extract the relevant information regarding acceptance criteria and performance as presented for this specific device.

Device: BD BBL Sensi-Disc Lefamulin 20µg (LMU-20)
Device Type: Antimicrobial Susceptibility Test Disc (not an AI/machine learning device)
Purpose of Study: To demonstrate substantial equivalence to a legally marketed predicate device (HardyDisk AST Lefamulin 20µg (LMU20)) for determining antimicrobial susceptibility to Lefamulin.

Below is the information extracted and adapted based on the provided document, acknowledging that it is not for an AI device.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes two main performance studies: Reproducibility and Method Comparison (Clinical and Challenge). The acceptance criteria for these are typically implied as meeting certain percentages of agreement or being within accepted ranges.

• Total Isolates Tested: 336
• Category Agreement (CA): 98.5% (331/336)
• Very Major Errors (VMJ): 4 (adjusted potential VMJ error rate is 0% due to measurement differences)
• Major Errors (MAJ): 1 |
  | Specific Organisms: | | |
  | Haemophilus influenzae | | Combined CA: 96.4% (108/112); VMJ: 3, MAJ: 1 |
  | Staphylococcus aureus (methicillin-susceptible isolates) | | Combined CA: 100.0% (112/112); VMJ: 0, MAJ: 0 |
  | Streptococcus pneumoniae | | Combined CA: 99.1% (111/112); VMJ: 1, MAJ: 0 |

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

• Reproducibility Study:

  • Sample Size: 15 organisms (5 Haemophilus influenzae, 5 Staphylococcus aureus, 5 Streptococcus pneumoniae), tested in triplicate with two disc lots on three separate days.
  • Data Points: 270 data points (15 organisms x 2 disc lots x 3 days x 3 independent readers).
  • Provenance: Conducted at one external site (country of origin not specified, but the applicant and regulatory body are US-based). The study appears to be prospective in nature for generating the performance data.

• Method Comparison Study (Clinical and Challenge):

  • Clinical Isolates: 270 isolates (90 Haemophilus influenzae, 90 Staphylococcus aureus (methicillin-susceptible), and 90 Streptococcus pneumoniae).
  • Challenge Isolates: 66 isolates (22 Haemophilus influenzae, 22 Staphylococcus aureus (methicillin-susceptible), and 22 Streptococcus pneumoniae).
  • Total Isolates: 336 (Clinical + Challenge).
  • Data Provenance: Performed at one U.S. site. The isolates likely represent a collection of retrospective or prospectively acquired clinical and challenge strains.

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

This section is not applicable as the document describes a traditional antimicrobial susceptibility test disc, not an AI/machine learning device requiring expert review for image-based ground truth. The "ground truth" for this device would be the established zone diameter readings from the predicate device and the reference standard MIC (Minimum Inhibitory Concentration) method, interpreted against recognized susceptibility interpretive criteria (e.g., CLSI, FDA STIC).

• Reproducibility: Results were visually read by three independent readers. Their specific qualifications are not detailed, but generally, operators in such settings are trained laboratory personnel.
• Method Comparison: Three independent operators participated in reading of test results. Their specific qualifications are not detailed.

4. Adjudication Method for the Test Set

This is not explicitly detailed for defining the "ground truth" as it is typically understood in AI studies (e.g., in cases of disagreement among experts).

• For reproducibility, readings from three independent readers were compared against a "modal or median" zone diameter value.
• For method comparison, the "ground truth" or reference for comparison was the FDA-cleared predicate disk's results and the MIC reference method. Discrepancies (errors) were simply reported without mentioning an explicit adjudication process beyond the direct comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study (MRMC comparative effectiveness study comparing human readers with AI vs without AI assistance) is not applicable to this device. The device is a diagnostic disc, not an AI system.

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

Not applicable in the context of an AI algorithm. The device's performance is inherently linked to human interpretation of zone diameters. The performance stated in the table (e.g., Reproducibility, Category Agreement) reflects the device's performance when used by human operators.

7. The Type of Ground Truth Used

The "ground truth" for evaluating this device's performance is based on:

• Reference Method: Comparison against an FDA-cleared predicate device (HardyDisk AST Lefamulin 20µg (LMU20)) utilizing a standardized agar diffusion test procedure (Kirby-Bauer).
• Interpretive Criteria: Use of FDA-recognized susceptibility test interpretive criteria (e.g., from CLSI M100, FDA STIC website) which define susceptible, intermediate, and resistant categories based on zone diameters or MICs.
• MIC Results: Where errors occurred, the document mentions that potential VMJ errors were compared to "historical MIC results," implying an underlying MIC reference method for establishing the true susceptibility category.

8. The Sample Size for the Training Set

Not applicable. This is a physical diagnostic disc, not an AI model that requires a training set.

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

Not applicable. As above, there is no AI training set for this type of device.

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