Search Results

The Sensititre YeastOne Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for micafungin in the dilution range of 0.008-16 ug/mL for testing Candida spp. on The Sensitite YeastOne Susceptibility System. Micafungin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Candida albicans Candida glabrata Candida guilliermondi Candida krusei Candida parapsilosis Candida tropicalis

Not Found

I apologize, but the provided text from the FDA 510(k) clearance letter for "The Sensititre YeastOne Susceptibility System with Micafungin" does not contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets those criteria.

This document is a formal clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices. It covers:

• The trade/device name, regulation number, regulatory class, and product code.
• Confirmation of substantial equivalence.
• Information about general controls, special controls, the predetermined change control plan (PCCP), and other applicable regulations (Quality System, adverse event reporting, UDI Rule).
• Indications for Use of the device.

It specifically lacks the following information that would be necessary to address your request:

1. Acceptance criteria table and reported device performance: The letter does not describe specific performance metrics (e.g., accuracy, sensitivity, specificity) or the thresholds for acceptance (e.g., "required to be > X%").
2. Study details (sample size, data provenance, expert counts, adjudication, MRMC, standalone performance, ground truth type, training set details): The letter does not include any information about the design or results of the studies used to validate the device's performance. For an Antimicrobial Susceptibility Test (AST) system, performance is typically assessed by comparing its results (categorization into Susceptible, Intermediate, Resistant) against a reference method.

To obtain the information you're looking for, you would typically need to review the actual 510(k) submission summary publically available on the FDA website, or the relevant performance study reports and data that were provided by Thermo Fisher Scientific to the FDA for review. The clearance letter itself is a summary of the FDA's decision, not the underlying data or study methodology.

Ask a specific question about this device

VITEK 2 AST-Yeast Voriconazole is designed for antifungal susceptibility testing of Candida species 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 antifungal agents. VITEK 2 AST-Yeast Voriconazole is a quantitative test. Voriconazole has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antifungal.

Active in vitro and in clinical infections: Candida krusei Candida parapsilosis Candida tropicalis

The VITEK 2 Fungal Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.

The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique. The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique. Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain premeasured portions of a specific antibiotic combined with culture media. The bacterial or yeast isolate to be tested is diluted to a standardized concentration with 0.45-0.5% 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, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. 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.

VITEK® 2 AST-YS Voriconazole has the following concentrations in the card: 0.03125, 0.125, 0.25, 1, and 2 (equivalent standard method concentration by efficacy in ug/mL).

The provided FDA 510(k) summary describes the VITEK® 2 AST-Yeast Voriconazole device, which is an antimicrobial susceptibility test system.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria are implicitly derived from the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems and are presented through "Essential Agreement" (EA) and "Category Agreement" (CA) performance metrics, along with error rates. The table below summarizes the reported performance for each microorganism. The specific acceptance thresholds for EA and CA are not explicitly stated as numerical percentages (e.g., >90% EA, >90% CA) with the exception of the individual error types (VME, ME, mE) having specified maximum allowable percentages. However, it is implied that the presented results were deemed acceptable by the FDA.

Key Definitions:

• Essential Agreement (EA): Agreement between the MIC results of the test device and the reference method within plus or minus one doubling dilution.
• Category Agreement (CA): Agreement between the interpretive categories (Susceptible, Intermediate, Resistant) of the test device and the reference method.
• Very Major Error (VME): The test device reports susceptible, but the reference method reports resistant.
• Major Error (ME): The test device reports resistant, but the reference method reports susceptible.
• Minor Error (mE): Any other disagreement in interpretive category (e.g., susceptible vs. intermediate, resistant vs. intermediate).

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

The sample sizes for the test set (external evaluation) are provided for each microorganism:

• C. albicans: 257 isolates
• C. krusei: 76 isolates
• C. parapsilosis: 74 isolates
• C. tropicalis: 87 isolates

Data Provenance: The study conducted an "external evaluation" with "fresh and stock clinical isolates, as well as a set of challenge strains." The document does not specify the country of origin of the data nor explicitly state if it was retrospective or prospective. However, "fresh clinical isolates" typically implies a prospective collection, while "stock clinical isolates" could be either.

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

The ground truth was established by the "CLSI broth microdilution reference method." This is a standardized laboratory method, not reliant on human expert adjudication in the same way an imaging study would be. Therefore, the concept of "experts" and their qualifications as typically applied to visual diagnostic tasks (e.g., radiologists) is not directly applicable here. The ground truth method itself (CLSI broth microdilution) is the expert-defined standard.

4. Adjudication Method for the Test Set:

Not applicable in the human expert sense. The "adjudication method" for determining the ground truth in this context is the CLSI broth microdilution reference method, which serves as the gold standard for antimicrobial susceptibility testing. The device's results are compared directly against this established reference.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, often in conjunction with AI. The VITEK® 2 AST-Yeast Voriconazole is an automated in vitro diagnostic device for antimicrobial susceptibility testing; its performance is evaluated by comparing its automated output to a gold standard laboratory method, not by how it assists human readers.

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

Yes, a standalone performance evaluation was done. The VITEK® 2 AST-Yeast Voriconazole system is an automated device designed to determine antimicrobial susceptibility without human interpretation of the primary data once the sample is loaded. The performance metrics (Essential Agreement, Category Agreement, error rates) directly reflect the device's standalone capability compared to the reference method.

7. The Type of Ground Truth Used:

The ground truth used was the CLSI broth microdilution reference method, incubated for 24 hours (up to 48 hours for slowly growing isolates). This is a well-established and scientifically accepted standard in microbiology for determining minimum inhibitory concentrations (MICs) of antifungal agents.

8. The Sample Size for the Training Set:

The document does not explicitly state the sample size for the training set. The descriptions focus on the "external evaluation" (test set). For IVD devices like this, the 'training set' often corresponds to historical data, internal studies, and method development efforts that lead to the final algorithm and concentration ranges. Without further information, the exact size of the training set used to develop the VITEK® 2 AST-Yeast Voriconazole algorithm is not provided in this 510(k) summary.

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

Similar to the answer for point 8, the document does not explicitly describe how the ground truth for any potential training set was established. However, given that the final performance is benchmarked against the CLSI broth microdilution reference method, it is highly probable that any internal development or training data would also have used this or a similar established reference method to determine the true susceptibility of isolates.

Ask a specific question about this device

VITEK 2 AST-Yeast Anidulafungin is designed for antifungal susceptibility testing of Candida species 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 antifungal agents. VITEK 2 AST-Yeast Anidulafungin is a quantitative test. Anidulafungin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antifungal.

Active in vitro and in clinical infections: Candida albicans Candida glabrata Candida parapsilosis Candida tropicalis

In vitro data are available, but clinical significance is unknown: Candida guillermondii Candida krusei

The VITEK 2 Fungal Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.

The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh (1) and Gerlach(2). The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique (3).

Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain premeasured portions of a specific antibiotic combined with culture media. The bacterial or yeast isolate to be tested is diluted to a standardized concentration with 0.45 – 0.5% 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, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. 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.

VITEK® 2 AST-YS Anidulafungin has the following concentrations in the card: 0.0625, 0.125, 0.5, 2, and 8 (equivalent standard method concentration by efficacy in ug/mL).

Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text.

Device: VITEK 2 AST-Yeast Anidulafungin

Indications for Use: Antifungal susceptibility testing of Candida species (C. albicans, C. glabrata, C. parapsilosis, C. tropicalis, C. guilliermondii, C. krusei) as a laboratory aid in determining in vitro susceptibility to antifungal agents.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state the acceptance criteria in a separate table directly defining thresholds for Essential Agreement (EA), Category Agreement (CA), or error rates (VME, ME, mE) that the device must meet for approval. Instead, it presents the results of the performance study and implies that these results were deemed "acceptable" by the FDA. The performance is compared to 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 August 28, 2009)". This guidance document would contain the specific acceptance criteria.

However, based on the presented "Performance Overview" (Page 7) and the overall context of AST device approvals, typical acceptance criteria for Essential Agreement and Category Agreement are usually in the range of 90-95% or higher, with Very Major Error (VME) and Major Error (ME) rates usually being low (e.g.,

Ask a specific question about this device

The Sensitite YeastOne Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candido spp. This 510(k) is for Rezafungin in the dilution range of 0.008 - 8 ug/mL for testing Candida spp. on the Sensititer YeastOne Susceptibility System. Rezafungin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drup label: Candida albicans Candida glabrata Candida parapsilosis.

Not Found

The provided text is a 510(k) clearance letter for the Sensititre YeastOne Susceptibility System with Rezafungin. It does not contain the detailed study information required to answer your specific questions about acceptance criteria and study design. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not include the performance data, sample sizes, ground truth establishment, or expert details that would typically be found in a study report or a more comprehensive FDA review document.

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

Ask a specific question about this device

The Sensititre YeastOne Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for Fluconazole with new FDA breakpoints and indications for testing Candida spp. on the Sensititre YeastOne Susceptibility System. Fluconazole has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Candida albicans Candida glabrata Candida parapsilosis

The Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL

This document is a 510(k) clearance letter for the Sensititre YeastOne Susceptibility System with Fluconazole. It does not contain the detailed study information (acceptance criteria, device performance, sample sizes, expert qualifications, etc.) that you are requesting.

The letter primarily:

• Confirms that the device is substantially equivalent to a legally marketed predicate device.
• States the regulation number, regulation name, and product code.
• Outlines the general controls provisions of the Act that the manufacturer must comply with.
• Specifies the Indications for Use for the device, listing the Candida species against which Fluconazole has shown activity.

To obtain the information regarding acceptance criteria and the study proving the device meets those criteria, one would typically need to refer to the 510(k) summary or the full 510(k) submission for K221198, which are usually more detailed technical documents. These documents are often publicly available via the FDA's 510(k) database if they are submitted as non-confidential information.

Therefore, I cannot fulfill your request with the provided text. The document does not contain the requested information about device performance metrics, study design, or ground truth establishment.

Ask a specific question about this device

The Sensititre YeastOne Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for Caspofungin with new FDA breakpoints and indications for testing Candida spp. on the Sensititre YeastOne Susceptibility System. Caspofungin has been shown to be active both clinically and in viro against the following organisms according to the FDA drug label: Candida albicans Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis

Not Found

The provided text does NOT contain information about specific "acceptance criteria" for a device that uses AI/algorithm and a "study that proves the device meets the acceptance criteria". The document is an FDA 510(k) clearance letter for The Sensititre YeastOne Susceptibility System with Caspofungin.

This system is an in vitro diagnostic product for clinical susceptibility testing of Candida spp., which is a laboratory test to determine how effective an antifungal drug (Caspofungin) is against specific yeast organisms. It determines the minimum inhibitory concentration (MIC) rather than being an AI-driven image analysis or diagnostic device that relies on complex algorithms or human readers' interpretation of images.

Therefore, the requested information about AI model performance metrics, sample sizes for test/training sets, expert consensus, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this document. The clearance is based on the system's ability to accurately determine susceptibility to Caspofungin compared to a legally marketed predicate device.

To answer your request based on the provided text, I must state that the document does not contain the specific details you're looking for regarding AI device acceptance criteria and study data.

Ask a specific question about this device

Not Found

Not Found

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for a medical device (Sensititre YeastOne Susceptibility System with Voriconazole), but it does not include the specifics of the performance study.

The requested information such as a table of acceptance criteria, reported performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC study details, standalone performance, type of ground truth, and training set details are not present in this document.

While it mentions the device and its intended use, it does not delve into the scientific study details.

Ask a specific question about this device

VITEK® 2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Micafungin is a quantitative test 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 Yeast Micafungin has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antifungal.

Active in vitro and clinical infections:

• Candida albicans
• Candida glabrata Candida guilliermondii
• Candida krusei
• Candida parapsilosis
• Candida tropicalis

The VITEK @ 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 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 spp., S. pneumoniae, and clinically significant yeast.

VITEK® 2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Micafungin is a quantitative test 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 aqents.

The provided text describes a Special 510(k) Device Modification for the VITEK 2 AST-YS Micafungin, which involves changing the expected Quality Control (QC) range for the QC organism C. parapsilosis ATCC 22019. It focuses on the regulatory approval process rather than a detailed study comparing device performance against acceptance criteria in a clinical setting for diagnostic accuracy.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of algorithm performance or clinical utility are not applicable or not provided in this document. The focus of this document is a modification to a QC range, which ensures the reliability of the test itself, not its diagnostic accuracy in patients.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified. The document mentions a "completed CLSI M23 study" but does not provide details on the number of isolates or replicates used in this study to establish the new QC range.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Not Applicable. This document concerns a change in a QC range for an Antimicrobial Susceptibility Test (AST) device, not a diagnostic device where expert ground truth on patient samples would typically be established. The "ground truth" here is the established and validated range for a specific QC organism based on a standardized protocol (CLSI M23).

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

• Not Applicable. Adjudication methods are typically used in clinical studies involving interpretation of images or other subjective data by multiple readers. This document describes a QC range modification for an automated AST device, which relies on objective measurements.

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 is not an AI-assisted diagnostic device, nor does it involve human readers interpreting results in a MRMC study context.

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

• Partially Applicable. The VITEK 2 system is an automated AST device. The "algorithm" here refers to the system's ability to accurately determine susceptibility based on its internal processes and calibrated ranges. The document states that "Validation of the modified QC range and QC performance with the modified range has now been established," implying standalone performance verification for the device with the new QC range. However, no specific performance metrics (e.g., categorical agreement, essential agreement) of this standalone performance are provided in this summary.

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

• The "ground truth" for establishing the QC range is derived from standardized laboratory testing protocols (CLSI M23) using a reference QC organism (C. parapsilosis ATCC 22019). This involves multiple replications of testing under controlled conditions to determine the consistent susceptibility range of the QC organism to the antimicrobial agent (micafungin).

8. The sample size for the training set:

• Not Applicable / Not Provided. This document does not pertain to an algorithm that requires a "training set" in the context of machine learning or AI. The CLSI M23 study would involve a study set to establish the new range, but it's not a "training set" in the computational sense. The size of this study set is not specified.

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

• Not Applicable / Not Provided. As noted above, there's no "training set" in the computational sense. The "ground truth" for the QC range was established through a "completed CLSI M23 study" which provides a standardized methodology for determining acceptable QC ranges for AST devices.

In summary, this regulatory submission focuses on a modification to an existing device's quality control parameters, rather than a de novo clinical validation study of a diagnostic device's accuracy. The "study" mentioned is a "CLSI M23 study" that established a new expected QC range for a specific organism.

Ask a specific question about this device

VITEK® 2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Micafungin is a quantitative test 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 Yeast Micafungin has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antifungal.

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 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 spp., S. pneumoniae, and clinically significant yeast.

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

The isolate to be tested is diluted to a standardized concentration in 0.45 - 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 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 antimicrobial contained on the card.

Here's a breakdown of the acceptance criteria and study details for the VITEK® 2 AST-Yeast Micafungin device, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

• The document mentions "fresh and stock clinical isolates, as well as a set of challenge strains." However, the exact sample size (number of isolates or cases) used for the test set is not provided in the text.
• Data Provenance: The study involved an "external evaluation," implying data was collected from various sources, likely clinical laboratories. The country of origin is not specified, but the review is by the US FDA, suggesting data may be from the US or otherwise internationally relevant for US market approval. The data includes both retrospective (stock clinical isolates) and potentially prospective (fresh clinical isolates) components.

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

• Not applicable / Not explicitly stated. The ground truth was established by a reference method (CLSI broth microdilution), not by human expert consensus or interpretation of the device results.

4. Adjudication method for the test set:

• Not applicable. Since the ground truth was established by a reference method (CLSI broth microdilution), there was no need for expert adjudication of the ground truth for the test set. The device's results were directly compared to the reference method.

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

• No. This is an Antimicrobial Susceptibility Test (AST) device, an in vitro diagnostic (IVD) intended for automated measurement of MIC values. It is not an AI-assisted diagnostic imaging or interpretation device that would involve human readers or assess improvement with AI assistance.

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

• Yes. The VITEK® 2 AST-Yeast Micafungin system is an automated device designed to determine antifungal susceptibility. The study compared its performance directly against a reference method (CLSI broth microdilution), indicating a standalone performance evaluation of the device's algorithm and system.

7. The type of ground truth used:

• Reference method: The ground truth was established using the CLSI broth microdilution reference method, which is a widely accepted standard for antimicrobial susceptibility testing.

8. The sample size for the training set:

• Not provided. The document describes a performance evaluation of the device but does not detail the development or training of any underlying algorithms. It's possible the device uses pre-calibrated methods rather than a machine learning model that requires a distinct "training set" in the traditional sense, or this information was not deemed necessary for the 510(k) summary.

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

• Not applicable / Not provided. As the training set size is not given, the method for establishing its ground truth is also not described. If statistical methods are used for calibration, those would implicitly rely on data for which the ground truth (established by a reference method) is known.

Ask a specific question about this device

VITEK® 2 AST-YS Caspofungin is designed for antifungal susceptibility testing of Candida species 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 Yeast Caspofungin is a quantitative test. Caspofungin has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antifyingal.

Active in vitro and clinical infections: Candida albicans Candida glabrata Candida guilliermondii Candida krusei Candida parapsilosis Candida tropicalis

The VITEK @ 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System 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 spp., S. pneumoniae, and clinically significant yeast.

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

The isolate to be tested is diluted to a standardized concentration in 0.45 - 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 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 antimicrobial contained on the card.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical acceptance criteria for Essential Agreement and Category Agreement are often found in FDA guidance documents for AST systems, which are referenced (FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, issued August 28, 2009). While the document states that the device demonstrated "acceptable performance," it does not explicitly list the numerical thresholds from that guidance.

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

• Sample Size for Test Set: Not explicitly stated as a total number. The study utilized "fresh and stock clinical isolates, as well as a set of challenge strains." The document does not specify the exact number of isolates for each category or the total.
• Data Provenance: The document indicates the use of "clinical isolates" (both fresh and stock) and "challenge strains." The country of origin is not specified, but the context implies data collected for regulatory submission within the U.S.

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

• The document does not mention the use of experts to establish ground truth for the test set.
• Instead, the ground truth was established by a reference method: the CLSI broth microdilution reference method.

4. Adjudication Method for the Test Set

• None. The ground truth was established by comparison to a standardized reference method (CLSI broth microdilution), not through expert adjudication of images or clinical cases.

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

• No. An MRMC comparative effectiveness study was not conducted as this device is an automated in vitro diagnostic for antimicrobial susceptibility testing, not a system involving human readers interpreting clinical cases with or without AI assistance. The performance is compared to a reference laboratory method.

6. If a Standalone Performance Study Was Done

• Yes. The study described is a standalone performance evaluation of the VITEK® 2 AST-YS Caspofungin system. It compares the results generated by the VITEK® 2 system (algorithm-driven interpretation of growth patterns) directly against the CLSI broth microdilution reference method. This is an "algorithm only" type of performance study for a diagnostic device.

7. The Type of Ground Truth Used

• Reference Method (CLSI Broth Microdilution): The ground truth was established by the CLSI broth microdilution reference method, incubated at 24 hours.

8. The Sample Size for the Training Set

• The document does not specify a separate "training set" or its sample size. For in vitro diagnostic devices like this, the development likely involves internal studies and database building, but the submission specifically focuses on the external evaluation data as the primary validation.

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

• Since a training set is not explicitly mentioned or detailed in the document, how its ground truth was established is not provided. If a training set was used during the device's development, it would typically involve similar reference methods (like CLSI broth microdilution) to establish the correct susceptibility profiles the system is designed to learn from or emulate.

Ask a specific question about this device