Search Results

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 Cefiderocol 30μg (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii complex and Stenotrophomonas maltophilia to cefiderocol, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).

HardyDisk AST Cefiderocol at concentration 30μg demonstrated acceptable performance to determine the zone diameter (mm) of cefiderocol against the following microorganisms:

• Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, and Serratia marcescens)
• Pseudomonas aeruginosa
• Acinetobacter baumannii complex
• Stenotrophomonas maltophilia

Not Found

N/A

Ask a specific question about this device

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., <3% for VME, <1.5% for ME).
   • Reported Device Performance: The document only states: "HardyDisk AST Gepotidacin at concentration 10μg demonstrated acceptable performance to determine the zone diameter (mm) of gepotidacin against the following microorganisms: Enterobacterales (...), Enterococcus faecalis, Staphylococcus saprophyticus." No specific performance metrics (e.g., actual EA, CA, VME, ME percentages) are provided in this clearance letter.

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

   • Sample Size: Not specified in the provided text. For AST devices, typically hundreds to thousands of isolates are tested.
   • Data Provenance: Not specified. For AST devices, data typically comes from clinical laboratories, often across multiple sites and potentially involving retrospective and prospective collections of isolates, or challenge sets from culture collections.

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

   • Not applicable in the AI/ML sense. For an AST device, the "ground truth" is established by a reference method (e.g., FDA-recognized broth microdilution or agar dilution standard). The interpretation of these reference method results against established Susceptibility Test Interpretive Criteria (STIC) provides the "true" susceptibility. While experts (e.g., clinical microbiologists, laboratory technicians) perform and interpret these reference tests, it's not the "expert consensus" model seen in AI/ML imaging studies.

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

   • Not applicable. Adjudication is typically for resolving discrepancies among human readers or ground truth establishment in complex interpretations. For AST, the reference method provides a definitive result.

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

   • Not applicable. This device is an AST disk, not an AI/ML assistant for human readers.

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

   • Applicable in a different context. The "standalone performance" of this device would be its ability to produce accurate zone diameters and susceptibility interpretations independently when used by a trained laboratory professional according to its validated procedure (i.e., its performance in relation to the reference standard). The letter states it demonstrated "acceptable performance."

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

   • Reference Method: The ground truth for AST devices is established by an FDA-recognized reference antimicrobial susceptibility testing method (e.g., broth microdilution, agar dilution) with results interpreted using FDA-recognized Susceptibility Test Interpretive Criteria (STIC) for gepotidacin.

8. The sample size for the training set:

   • Not applicable. This is a physical test disk, not a machine learning model that undergoes training in the AI/ML sense. Its "performance" is inherent to its manufacturing and chemical properties and is validated, not "trained."

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

   • Not applicable. (See point 8).

In summary, the provided FDA clearance letter is for a traditional diagnostic device and therefore does not contain the detailed study methodology information typically associated with AI/ML device clearances. The "acceptable performance" mentioned refers to the device meeting the established regulatory requirements for AST disk clearance, which involves comparison to a gold standard reference method.

Ask a specific question about this device

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.

Ask a specific question about this device

Hardy Diagnostics' Viral Transport Medium (VTM) is intended for the collection and transport of clinical specimens for the preservation of viral agents influenza A, Influenza B, Adenovirus, and Echovirus from the collection site to the testing laboratory. Hardy Diagnostics' VTM is a culture-based media that is intended to be used in standard laboratory procedures for virus culture and diagnostic assays that utilize stable recoverable infectious viral particles.

Hardy Diagnostics' Viral Transport Medium (VTM) is a non-propagating culture-based transport media used for the collection and transport of specimens suspected of containing viruses including Influenza A, Influenza B, Adenovirus, and Echovirus for downstream laboratory test methods. The VTM includes a screw-cap polypropylene tube with skirted conical bottom containing 3mL of transport medium. VTM tubes can be supplied alone, or in a kit format with a mini-tip flocked swab in a sterile peel-pouch. Hardy Diagnostics' VTM is not claimed to be sterile nor is it intended to be sterilized by the end user. Hardy Diagnostics' VTM vials are single use devices.

The product is supplied in multiple configurations described in more detail in table 1 below: tubes alone, or in a kit format with a swab.

The provided text is a 510(k) Premarket Notification summary for a Viral Transport Medium (VTM), a Class I device. It describes the design, intended use, and studies conducted to demonstrate its substantial equivalence to a predicate device.

It's important to note that this document is not for an AI/ML-based medical device. Therefore, many of the requested elements for describing the acceptance criteria and study that proves an AI device meets acceptance criteria (such as MRMC studies, ground truth establishment by experts, and training set details) are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding the device's performance studies and acceptance criteria as provided for this specific product, which focuses on viral recovery performance and shelf-life stability.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance for Viral Transport Medium (VTM)

The studies presented focus on demonstrating the VTM's ability to preserve viral agents over time and under various storage conditions.

1. Table of Acceptance Criteria and Reported Device Performance

For Viral Recovery Performance:

*The note states that -92.24% for Influenza A at 24 hours (20-25°C) was "Considered acceptable because subsequent timepoints, i.e., 48 h time point showed < 90% increase." This implies a tolerance for transient excursions if the overall trend at later, crucial time points remains within the acceptance range.

For Shelf-life Stability:

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

• Viral Recovery Study: "A minimum of three lots of Viral Transport Medium" were inoculated with known virus concentrations. Aliquots of each lot were pulled at 0, 24, and 48 hours, serially diluted, and inoculated in triplicate into susceptible host cell lines.
• Shelf-life Stability Study: "Three lots of VTM were assessed qualitatively at each time point."
• Data Provenance: The studies appear to be prospective laboratory studies conducted by Hardy Diagnostics. The document does not specify the country of origin of the data beyond being part of a US FDA submission. The "pooled negative clinical matrix" suggests human-derived samples were used as the base, but the testing itself was laboratory-controlled.

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

• Not applicable in the context of an AI/ML device. For this VTM, the "ground truth" (or reference standard) for viral recovery was established by laboratory measurements of viral titer (TCID50/mL) using the Reed-Muench method, which is a quantitative, objective measure. There's no indication of human expert consensus building for the "ground truth" in this type of product.

4. Adjudication Method for the Test Set

• Not applicable. This is not an AI/ML device requiring human adjudication of performance. The performance was determined by quantitative laboratory assays.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• Not applicable. This is not an AI/ML device, and no human reader studies (MRMC or otherwise) would be relevant for evaluating its performance.

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

• Not applicable. This is a physical transport medium, not an algorithm. Its performance is inherent in its chemical composition and ability to preserve viral viability.

7. The Type of Ground Truth Used

• For Viral Recovery Performance: The ground truth was laboratory-derived viral titers (TCID50/mL) determined at baseline (T=0 hours) using the Reed-Muench method, which serves as the reference for percentage change calculations.
• For Shelf-life Stability: The ground truth for functional and physical characteristics included quantitative measurements (pH, fill volume) and qualitative assessments (appearance, growth/no growth for contamination) against predetermined specifications.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

• Not applicable. As there is no training set for this device, a ground truth for it was not established.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby- Bauer). 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 Rezafungin 5ug (RZF5) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of microorganisms to Rezafungin.

HardyDisk™ AST Rezafungin at concentration 5ug can be used to determine the zone diameter (mm) of Rezafungin against the following microorganisms for which Rezafungin has been shown to be active both clinically and in vitro. Candida albicans, Candida glabrata, Candida parapsilosis, and Candida tropicalis.

Not Found

This is a 510(k) premarket notification for a medical device called HardyDisk™ AST Rezafungin 5ug (RZF5), which is an antimicrobial susceptibility test disc. The document states that the FDA has reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices.

The acceptance criteria and study information are not directly about an AI/ML device, but rather about an antimicrobial susceptibility test. Therefore, many of the requested points, such as those related to AI assistance, human readers, experts, and adjudication methods, are not applicable.

Here's the relevant information that can be extracted from the provided text, adapted for the context of an antimicrobial susceptibility test:

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

The document does not explicitly provide a table of acceptance criteria and reported device performance. It states that the device "can be used to determine the zone diameter (mm) of Rezafungin against the following microorganisms for which Rezafungin has been shown to be active both clinically and in vitro. Candida albicans, Candida glabrata, Candida parapsilosis, and Candida tropicalis."

To determine the device's performance, one would typically compare the zone diameters obtained using the HardyDisk™ AST Rezafungin 5ug (RZF5) with a reference method (e.g., broth microdilution method) and evaluate criteria such as essential agreement (EA) and categorical agreement (CA). These specific performance metrics and their acceptance thresholds are not detailed in this particular document.

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

This information is not provided in the given text. For an antimicrobial susceptibility test, the sample size would refer to the number of bacterial or fungal isolates tested, and provenance would include details about where these isolates were obtained and if the study was prospective or retrospective.

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 applicable in the traditional sense for an antimicrobial susceptibility test. The "ground truth" for AST is typically established by a reference method (e.g., CLSI broth microdilution) rather than expert consensus on images.

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

This information is not applicable for an antimicrobial susceptibility test in the context of expert adjudication. Adjudication typically applies to ambiguous cases requiring human interpretation.

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

This information is not applicable as this is not an AI-assisted device and does not involve human readers interpreting cases.

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

This information is not applicable as this is not an AI/ML algorithm-based device.

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

For an antimicrobial susceptibility test, the "ground truth" for determining susceptibility or resistance of a microorganism to an antimicrobial agent is typically established by reference methods, such as the broth microdilution method according to a recognized standard (e.g., Clinical and Laboratory Standards Institute (CLSI) guidelines). This is inferred from the nature of the device, although not explicitly stated in the document.

8. The sample size for the training set

This information is not applicable as this is not an AI/ML algorithm-based device that undergoes training.

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

This information is not applicable as this is not an AI/ML algorithm-based device that undergoes training.

Ask a specific question about this device

Not Found

Not Found

This is a clearance letter for an Antimicrobial Susceptibility Test Disc (HardyDisk AST Cefiderocol 30ug). This type of device does not involve AI/ML. As such, the requested information (acceptance criteria, study details, human reader performance, ground truth, training set information) is not applicable.

Ask a specific question about this device

Not Found

Not Found

The provided text is an FDA clearance letter for a medical device (HardyDisk AST Lefamulin 20μg). It does not contain information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth establishment, or any of the specific technical details requested in the prompt.

Therefore, I cannot fulfill the request using only the provided text. To answer your questions, I would need a different document, such as a study report, 510(k) summary, or a more detailed technical description of the device's performance characteristics.

Ask a specific question about this device

Not Found

Not Found

This FDA document is a 510(k) clearance letter for an antimicrobial susceptibility test disc. It does not contain the kind of detailed information typically found in a study report for AI/ML-based medical devices regarding acceptance criteria, performance tables, sample sizes, ground truth establishment, or expert adjudication.

Therefore, I cannot extract the requested information from the provided text. The document confirms that the HardyDisk AST Imipenem/relebactam 10/25ug (IMR 10/25) device, a physical test disc, has been found substantially equivalent to a predicate device. It does not describe a study involving an algorithm or AI.

Ask a specific question about this device