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The Thermo Scientific Sensititre ARIS HiQ System is part of the Sensititre AST system and is an automated plate management device containing an incubator and embedded OptiRead module. The Thermo Scientific Sensititire ARIS HiO System is designed for use with the Themo Scientific Sensitities SWIN Software System. The ARIS HiQ and the SWIN system work together to read Sensititre (18-24 hr) susceptibility plates, generating minimum inhibitory concentration (MIC) and interpreting breakpoint (BP) results for non-fastidious microorganisms.

The Thermo Scientific Sensititre ARIS HiQ System is part of the Sensititre AST system and is an automated plate management device containing an incubator and embedded OptiRead module. The Thermo Scientific Sensititire ARIS HiO System is designed for use with the Themo Scientific Sensitities SWIN Software System. The ARIS HiQ and the SWIN system work together to read Sensititre (18-24 hr) susceptibility plates, generating minimum inhibitory concentration (MIC) and interpreting breakpoint (BP) results for non-fastidious microorganisms.

The provided text is a 510(k) clearance letter for the Thermo Scientific Sensititre ARIS HiQ System. It describes the device's indications for use but does not contain any information about the acceptance criteria, study design, or performance metrics that would be required to answer the questions about how the device meets acceptance criteria.

Specifically, the document does not provide any data or details regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, number of experts, adjudication methods for ground truth, or details about training and test sets.
3. Whether MRMC or standalone studies were conducted, or details about ground truth establishment.

Therefore,Based on the provided document, I cannot answer the questions about the acceptance criteria and the study that proves the device meets those criteria.

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The Thermo Scientific Sensititre ARIS HiQ System is part of the Sensititre AST system and is an automated plate management device containing an incubator and embedded OptiRead module. The Thermo Scientific Sensititre ARIS HiQ System is designed for use with the Thermo Scientific Sensititre SWIN Software System. The ARIS HiQ and the SWIN system work together to read Sensititre (18-24 hr) susceptibility plates, generating minimum inhibitory concentration (MIC) and interpreting breakpoint (BP) results for non-fastidious microorganisms.

The Thermo Scientific Sensititre ARIS HiQ System is part of the Sensititre AST system and is an automated plate management device containing an incubator and embedded OptiRead module. The Thermo Scientific Sensititre ARIS HiQ System is designed for use with the Thermo Scientific Sensititre SWIN Software System. The ARIS HiQ and the SWIN system work together to read Sensititre (18-24 hr) susceptibility plates, generating minimum inhibitory concentration (MIC) and interpreting breakpoint (BP) results for non-fastidious microorganisms.

The provided FDA clearance letter for the Thermo Scientific Sensititre ARIS HiQ System (K191914) does not contain the detailed information required to answer your questions regarding acceptance criteria and performance study specifics.

The document is a standard FDA 510(k) clearance letter, which primarily confirms that the device is substantially equivalent to a legally marketed predicate device. It briefly describes the device's intended use (automated plate management, incubator, OptiRead module for reading Sensititre susceptibility plates, generating MIC and interpreting breakpoint results for non-fastidious microorganisms) and regulatory classification.

It does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for test or training sets.
3. Information on multi-reader multi-case (MRMC) studies or standalone algorithm performance.

To obtain this information, one would typically need to refer to:

• The full 510(k) submission document itself, if it were publicly available with performance study details.
• Performance study reports provided by the manufacturer to the FDA.
• Clinical trial summaries or publications if the device involved such studies.

Therefore, based solely on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets those criteria. The information is simply not present in this FDA clearance letter.

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The Sensititre® OptiRead™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.

The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram negative organisms.

The Sensititre OptiRead is used to read fluorescence values from the Sensititre MIC or BP Susceptibility Test System for non-fastidious Gram negative organisms. The plate reading on the OptiRead is initiated via SWIN software and the fluorescence values from the OptiRead are then transferred back to the SWIN software where the results are generated.

The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.

This document is a 510(k) clearance letter for the Sensititre® OptiRead™, an antimicrobial susceptibility test powder reader. It does not contain the detailed study information required to answer your questions. The letter simply states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
2. Sample sizes used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present.
4. Adjudication method: This information is not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This information is not present.
6. If a standalone performance study was done: This information is not present.
7. The type of ground truth used: This information is not present.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

The document focuses on the regulatory clearance and the device's indications for use, not the specifics of its validation studies.

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The Sensititre® OptiRead™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.

The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram positive cocci to include Staphylococcus spp., Enterococcus spp., Streptococcus pneumoniae and, other Streptococcus spp.

This 510(k) is for the addition of: "Sensititre® OptiRead™"

The Sensititre OptiRead is used to read fluorescence values from the Sensititre MIC or BP Susceptibility Test System for non-fastidious and fastidious Gram positive cocci. The plate reading on the OptiRead is initiated via SWIN software and the fluorescence values from the OptiRead are then transferred back to the SWIN software where the results are generated.

The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.

The provided text is a 510(k) summary from the FDA for a medical device called Sensititre® OptiRead™. It discusses the regulatory approval, but it does not contain the specific detailed information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a more extensive 510(k) submission.

Here's a breakdown of why I cannot fulfill your request based solely on the provided text, and what kind of information would be needed:

• This document is a regulatory approval letter, not a study report. It confirms that the device has been found substantially equivalent to a predicate device, allowing it to be marketed. It does not detail the technical performance studies in depth.

To answer your request comprehensively, I would need a different type of document, such as:

• The full 510(k) submission: This would contain the study protocols, results, and acceptance criteria.
• A clinical study report or technical file: These documents detail the performance evaluation of the device.

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

What I can infer from the provided text, which hints at the device's function and purpose, is:

• Device Name: Sensititre® OptiRead™
• Intended Use: To be used with the Sensititre® MIC or BP Susceptibility Test System. It is a fluorescence-based detection instrument used to read Sensititre® MIC or BP Susceptibility plates for clinical susceptibility testing of non-fastidious Gram positive cocci (Staphylococcus spp., Enterococcus spp., Streptococcus pneumoniae, and other Streptococcus spp.). Results are transferred to SWIN software for generation.
• Regulatory Clearance: K103532, cleared on August 26, 2011.

To illustrate what you would generally expect to find if the information were present, here's how a hypothetical response might look if the data were available in the document:

Hypothetical Response (if the information were available in the document):

1. Table of Acceptance Criteria and Reported Device Performance

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The MicroScan® MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 -24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually. Alternatively, the panels can be incubated in and read by the MicroScan® WalkAway System, according to the Package insert.

This particular submission is for the addition of the antimicrobial agent Linezolid, at concentrations of 0.12 to 16 ug/mL, to the test panel.

The organisms which may be used for Linezolid susceptibility testing in this panel are:

Streptococcus pneumoniae including multi-drug resistant strains

Streptococcus pyogenes

Streptococcus agalactiae

Viridans group streptococci

MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of . aerobic streptococci, including Streptococcus pneumoniae.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 µl Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB), after inoculation of the broth with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Alternatively, the panel can be incubated in and read by the MicroScan® WalkAway System.

Here's an analysis of the acceptance criteria and study detailed in the provided documents, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "fresh and stock Efficacy isolates and stock Challenge strains" for the external evaluation. However, it does not explicitly state the specific number of isolates or strains used for either the efficacy or challenge testing.

• Data Provenance: The study was an "external evaluation," implying it was conducted outside of the manufacturer's immediate control but within a regulated framework, comparing the device to a CLSI frozen Reference panel. The document does not specify the country of origin but implies a standard reference method commonly used in the US (CLSI). It is a retrospective evaluation as it uses established isolates.

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

• The document states that "Challenge strains were compared to Expected Results determined prior to the evaluation." This implies that the "Expected Results" serve as the ground truth for the challenge strains.
• The number of experts and their specific qualifications are not mentioned in the provided text. The ground truth for the reference panel itself is implicitly a consensus from standard methodologies (CLSI).

4. Adjudication Method for the Test Set

• The document implies a direct comparison of the MicroScan MICroSTREP plus Panel's performance against a CLSI frozen Reference panel.
• For challenge strains, performance was compared to "Expected Results."
• No specific multi-reader adjudication method (e.g., 2+1, 3+1) is described for the test set. The comparison is against established reference values.

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

• No, an MRMC comparative effectiveness study involving human readers is not described in these documents. The study focuses on the performance of the automated/semi-automated AST system against a reference method. The document mentions reproducibility testing with different read methods (manual and WalkAway™ instrument), but this refers to the device's consistency, not the improvement of human readers with AI assistance.

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

• Yes, a standalone performance study was done. The device itself (MicroScan MICroSTREP plus Panels) is assessed for its ability to determine antimicrobial susceptibility. The "manual" read method mentioned in reproducibility testing still refers to reading the panel results, not a human interpretation divorced from the device's output. The "WalkAway™ instrument" automatically reads the panel, which is a standalone function of the device system.

7. The Type of Ground Truth Used

• The primary ground truth used is a CLSI frozen Reference Panel. For challenge strains, "Expected Results" determined prior to the evaluation were used, which would also be based on established reference methods. This falls under expert consensus derived from standardized laboratory procedures.

8. The Sample Size for the Training Set

• The document does not provide information on the sample size used for the training set. The focus is on the performance evaluation of the device as submitted. This type of device (AST panel) typically relies on biochemical principles and established MIC ranges, rather than deep learning models that require distinct training sets in the same way an AI image analysis algorithm would.

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

• Given that the document does not mention a distinct "training set" in the context of machine learning, the question of how its ground truth was established is not applicable. The device's development would be based on established microbiological principles for determining MICs, where the "ground truth" is defined by standard reference methods like those outlined by CLSI.

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The MicroScan® MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually. Alternatively, the panels can be incubated in and read by the MicroScan® WalkAway System, according to the Package Insert.

This particular submission is for the addition of the antimicrobial Moxifloxacin at concentrations of 0.03 to 8 ug/ml to the test panel.

The organisms which may be used for Moxifloxacin susceptibility testing in this panel are:

Streptococcus pneumoniae (including penicillin resistant strains) Streptococcus pyogenes Streptoccocus agalactiae Streptococcus constellatus Streptococcus anginosus Viridans group streptococci

MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 µl Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB), after inoculation of the broth with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Alternatively, the panel can be incubated in and read by the MicroScan® WalkAway System.

Here's a breakdown of the acceptance criteria and study information for the MicroScan® MICroSTREP plus® Panels with Moxifloxacin, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as a single number of isolates. However, the study mentions:
  • "fresh and stock Efficacy isolates"
  • "stock Challenge strains"
  • The overall Essential Agreement of 97.3% for Moxifloxacin suggests a substantial number of isolates were tested to achieve this agreement rate across different concentrations.
• Data Provenance: Not explicitly stated (e.g., country of origin). The data is retrospective, as it compares the performance of the device to an established CLSI frozen Reference Panel.

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

• The ground truth for the test set was not established by individual experts in this context. Instead, it was established by a CLSI frozen Reference Panel. This panel itself represents a consensus standard for antimicrobial susceptibility testing, implying that its development and validation involved a panel of experts in microbiology and antimicrobial susceptibility. No specific number or qualifications of experts are given for the initial establishment of the CLSI reference method.

4. Adjudication Method for the Test Set

• No explicit adjudication method (like 2+1 or 3+1) is described. The comparison was directly between the MicroScan MICroSTREP plus Panel and the CLSI frozen Reference Panel. For challenge strains, the method was comparison to "Expected Results determined prior to the evaluation," which implies pre-defined reference values.

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

• No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This study focuses on the agreement between the device and a reference method, not on human reader performance with or without AI assistance. While the panel can be read manually or by the MicroScan® WalkAway System, the study primarily evaluates the device's accuracy against the CLSI reference.

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

• Yes, a standalone study was done. The "MicroScan® MICroSTREP plus® Panel" itself is the "algorithm/device" being tested. Its performance (Essential Agreement) was compared directly to the CLSI frozen Reference Panel, representing its standalone accuracy. While it can be read manually, the core evaluation confirms the performance of the panel itself.

7. The Type of Ground Truth Used

• The primary ground truth used was a CLSI frozen Reference Panel. For "Challenge strains," the ground truth was "Expected Results determined prior to the evaluation," which would have been established using a recognized reference method, likely aligned with CLSI standards. This is a form of expert consensus standard in microbiology.

8. The Sample Size for the Training Set

• The document does not provide information on a "training set" in the context of machine learning or AI development. This device is an antimicrobial susceptibility test panel, which operates based on biochemical reactions and defined dilutions, not a machine learning algorithm that requires a separate training set. Its "development" would involve optimizing dilutions and components to match reference methods.

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

• As there is no explicit "training set" described for a machine learning model, this question is not applicable to the information provided. The "ground truth" for the device's development would be established through established microbiological reference methods (like CLSI standards), but this is not a separate training set as understood in AI/ML contexts.

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The MicroScan® Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. After inoculation, panels are incubated for 16 - 20 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for the addition of the antimicrobial Doripenem at concentrations of 0.008 to 32 mcg/ml to the test panel.

The gram-negative organisms which may be used for Doripenem susceptibility testing in this panel are:

Acinetobacter baumanii Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa

MicroScan Dried Gram-Negative MIC/Combo Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 16-20 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

The acceptance criteria related to the performance of the MicroScan Dried Gram-Negative MIC/Combo Panels with Doripenem, as described in the provided text, is primarily focused on Essential Agreement with a CLSI frozen Reference Panel.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implicitly suggests that "acceptable" reproducibility and quality control are also part of the acceptance criteria, as their successful demonstration is highlighted.

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

• The document states: "The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains."
• It does not specify the exact total sample size for the test set (number of isolates or tests).
• The data provenance is not explicitly stated in terms of country of origin. Given Siemens Healthcare Diagnostics is the manufacturer and the FDA is the regulatory body, it is likely the study was conducted to meet US regulatory requirements, potentially using data gathered in the US or under US-standardized conditions.
• The study appears to be retrospective for the challenge strains (compared to "Expected Results determined prior to the evaluation"), and could be a mix for efficacy isolates (fresh isolates might involve prospective collection, while stock isolates are typically retrospective).

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

• The document does not provide any information on the number of experts used or their qualifications for establishing the ground truth.

4. Adjudication Method for the Test Set

• The document does not describe any adjudication method. It states that challenge strains were "compared to Expected Results determined prior to the evaluation," and the Dried Gram-Negative Panel's performance was compared with a CLSI frozen Reference panel. This suggests the reference panel results or pre-determined expected results served as the "ground truth" rather than an adjudicated expert consensus.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is focused on the performance of the automated AST system (MicroScan panels) against a reference method, not on human readers' improvement with or without AI assistance. The device is for automated antimicrobial susceptibility testing, not assistive AI for human interpretation.

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

• Yes, a standalone performance evaluation was done. The study directly compares the MicroScan Dried Gram-Negative MIC/Combo Panel's results to a CLSI frozen Reference panel. This is an evaluation of the device's (algorithm's) performance independent of human interpretation or intervention, except for initial setup and reading of the MICs, which can be automated (via autoSCAN® -4 and WalkAway® instruments) or visual.

7. The Type of Ground Truth Used

• The ground truth used was a CLSI frozen Reference Panel. For challenge strains, "Expected Results determined prior to the evaluation" also served as a form of ground truth. This is a standardized, recognized reference method for antimicrobial susceptibility testing.

8. The Sample Size for the Training Set

• The document does not provide any information about a separate training set or its sample size. The focus is on the performance of the device against a reference standard in an external evaluation. This is typical for AST device validations, where the system is "trained" during its development phase using various isolates, but the submission documentation primarily describes the validation (test set) performance.

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

• As no information about a training set is provided, there is no information on how its ground truth was established.

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The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive cocci. After inoculation, panels are incubated for 16 - 24 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

The MicroScan Cefoxitin Screen is intended to determine the susceptibility of staphylococci to the penicillinase stable beta-lactams.

This particular submission is for the addition of the antimicrobial test the Cefoxitin Screen, at a concentration of 4 mcg/ml, to the test panel.

The gram-positive organisms which may be used for Cefoxitin Screen susceptibility testing in this panel are:

Staphylococcus aureus Staphylococcus lugdunensis

MicroScan Dried Gram-Positive MIC/Combo Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive cocci.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 16-20 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states the device's performance metrics but implies the acceptance criteria by stating that the "Cefoxitin Screen demonstrated acceptable performance" when compared to the reference methods and that its performance was "substantially equivalent" as defined by FDA guidance documents. Exact numerical acceptance thresholds are not provided in this summary.

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

The document refers to "external design validation (Clinical Trial) was conducted with fresh and stock Efficacy isolates and stock Challenge strains." However, the specific sample size for the test set is not provided.

Regarding data provenance:

• Country of Origin: Not specified.
• Retrospective or Prospective: The use of "fresh and stock Efficacy isolates and stock Challenge strains" suggests a combination. "Fresh" isolates could imply prospective collection, while "stock" isolates typically refer to retrospective or archived samples.

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

This information is not provided in the summary. The ground truth was established by comparing the device's performance against two reference methods (CLSI cefoxitin disk diffusion and mecA PCR) and to "Expected Results" for challenge strains, but it doesn't mention expert review of the test set itself.

4. Adjudication Method for the Test Set

This information is not provided in the summary. The ground truth was established by reference methods and expected results, not through an explicit adjudication process described in the text.

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

A MRMC comparative effectiveness study was not performed according to this summary. The study is evaluating the performance of an automated susceptibility test system against reference methods, not human readers.

6. Standalone (i.e. algorithm only without human-in-the loop performance) Study

Yes, a standalone study was performed. The "MicroScan® Dried Gram-Positive MIC/Combo Panels" is an automated system designed for determining antimicrobial susceptibility. Its performance was evaluated directly against reference standards (CLSI cefoxitin disk diffusion and mecA PCR) and against "Expected Results" for challenge strains, indicating an algorithm-only evaluation without human-in-the-loop performance being part of this PAI.

7. Type of Ground Truth Used

The ground truth was established primarily using:

• Reference Methods: CLSI cefoxitin disk diffusion test.
• Molecular Test: mecA PCR.
• Expected Results: For stock Challenge strains, determined prior to evaluation.

8. Sample Size for the Training Set

The sample size for the training set is not explicitly provided in the summary. The summary describes the test set and evaluation but does not detail the training process or dataset.

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

This information is not provided in the summary. As the training set size isn't mentioned, the method for establishing its ground truth is also absent.

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The MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive enterococci and staphylococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35℃ +/- 1℃, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial Streptomycin Synergy Screen, at a concentration of 1000 ug/ml, for enterococci, to the test panel.

The gram-positive organisms which may be used for Streptomycin Synergy Screen susceptibility testing in this panel are:

Enterococcus species

MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels, utilizing both the MicroScan® Rapid Fluorogenic Identification and Dried Overnight Antimicrobial Susceptibility Testing (AST) technologies, are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive enterococci and staphylococci.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. Various antimicrobial agents are diluted in water, buffer, or minute concentrations of broth, to concentrations bridging the range of clinical interest. Panels are rehydrated with Synergies plus"" Pos Broth, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® SI, or equivalent, System, for 4.5 -18 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

Here's a breakdown of the acceptance criteria and study information for the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Streptomycin Synergy Screen, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Information

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

• Test Set Description: The external validation was conducted with "fresh and stock Efficacy isolates and stock Challenge strains."
• Sample Size: The exact numerical sample size for the test set is not specified in the provided text.
• Data Provenance: The text does not explicitly state the country of origin. It indicates "external validation," which could imply data collected from various geographical locations or a specific external site. The study seems to be prospective in nature for the "fresh" isolates, and potentially retrospective for the "stock" isolates and challenge strains.

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

• The text does not specify the number of experts or their qualifications used to establish the ground truth for the test set.

4. Adjudication method for the test set:

• The text does not describe any specific adjudication method used for the test set. It mentions "Challenge strains were compared to Expected Results determined prior to the evaluation," implying a pre-defined ground truth for these strains, but not an adjudication process for discrepancies.

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

• No, an MRMC comparative effectiveness study was not done. This device (antimicrobial susceptibility test panel) is a diagnostic assay, not an AI-assisted reading tool for human interpretation of images or other complex data.

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

• Yes, it was a standalone performance study. The device is designed to provide quantitative and/or qualitative antimicrobial agent susceptibility directly by determining the lowest antimicrobial concentration showing inhibition of growth after incubation. While human intervention is involved in preparing the inoculum and reading (or setting up an instrument to read), the core performance measurement (Categorical Agreement) is against a reference method. The text mentions "the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth," and this reading can be done by the WalkAway® SI system or equivalent, indicating an automated or semi-automated standalone nature for the reading part.

7. The type of ground truth used:

• The ground truth was established by a frozen Reference Panel. For the challenge strains, "Expected Results" were determined prior to the evaluation, which would likely be derived from a validated reference method.

8. The sample size for the training set:

• The text does not mention a training set sample size. This type of device (a diagnostic panel) typically undergoes R&D and validation but not in the same "training set" manner as machine learning algorithms.

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

• As a training set is not explicitly mentioned or applicable in the traditional sense for this type of device, the method for establishing its ground truth is not described. The "frozen Reference Panel" is used for validation/testing, not for training.

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To determine bacterial antimicrobial agent susceptibility

The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read visually according to the Package Insert. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument.

This particular submission is for the addition of instrument read capability of the antimicrobial Clarithromycin, at concentrations of 0.06 - 2 mcg/ml on the MicroScan MICroSTREP plus® Panel.

The organisms which may be used for Clarithromycin susceptibility testing on this panel are:

Streptococcus pneumoniae
Streptococcus pyogenes
Streptococcus agalactiae
Streptococci (Groups C, F, G)
viridans group streptococci

The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 – 24 hours at 35°C +/-1 ℃ in a non-CO2 incubator, and read according to the Package Insert.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 µl Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: MicroScan MICroSTREP plus® Panel with Clarithromycin (0.06 – 2 mcg/ml)
Intended Use: To determine bacterial antimicrobial agent susceptibility, specifically for Clarithromycin against aerobic streptococci, including Streptococcus pneumoniae. This submission focuses on adding instrument-read capability using the MicroScan® WalkAway instrument.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "acceptable performance with an overall Essential Agreement of 98.6%". The "acceptable" for reproducibility, precision, and QC implies these were also acceptance criteria, though no numerical thresholds are given in the provided text.

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

• Sample Size (Test Set): Not explicitly stated. The document mentions "external evaluation was conducted with stock and CDC Challenge strains," but the specific number of strains or isolates tested is not provided.
• Data Provenance: The study was an "external evaluation." While the specific country is not mentioned, the manufacturer (Dade Behring Inc.) is based in the USA, and the FDA submission is to the US regulatory body, suggesting the evaluation would align with US standards and likely involve US-based laboratories or strains. The data appears to be prospective in nature, as it was designed to "confirm the acceptability of the proposed instrument read method" by comparing it to "Expected Results determined before the evaluation."

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

This information is not provided in the given text. The "Expected Result" is mentioned as the comparator, and it was "generated on a CLSI frozen Reference Panel," but the human involvement in establishing these "Expected Results" or "ground truth" is not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the given text. While an "Expected Result" was used, the method by which this ground truth was confirmed or adjudicated (e.g., beyond the CLSI reference panel itself) is not described.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is focused on the performance of the instrument-read method for antimicrobial susceptibility testing, comparing it to an "expected result" from a reference method, not on human reader performance with or without AI assistance.

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

Yes, a standalone performance study was done. The entire premise of the submission is to demonstrate the performance of the MicroScan® WalkAway instrument (an automated system, essentially an algorithm/device only) in reading the MICroSTREP plus® Panel with Clarithromycin. It compares the "instrument read results" to a predefined "Expected Result," implying an algorithm-only evaluation. The primary comparison is the instrument reading versus the CLSI frozen Reference Panel, which serves as the independent standard. The original method was "manually read by observing the lowest antimicrobial concentration showing inhibition of growth," but the study explicitly focuses on the "addition of instrument read capability."

7. The Type of Ground Truth Used

The ground truth used was based on an "Expected Result generated on a CLSI frozen Reference Panel." This indicates a well-established, standardized reference method, likely involving expert consensus and adherence to Clinical and Laboratory Standards Institute (CLSI) guidelines, which are recognized standards for antimicrobial susceptibility testing.

8. The Sample Size for the Training Set

The document does not provide information regarding a distinct "training set." The study described is an "external evaluation" conducted to confirm acceptability, implying a validation or test set. For an AST system, the "training" analogous to machine learning often happens during the initial development and optimization of the instrument's reading algorithms, using various characterized strains and concentration ranges. This information is typically proprietary and not part of the 510(k) summary for a post-development validation.

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

As no specific training set is mentioned in the context of this 510(k) summary, the method for establishing its ground truth is not described. If "training" implicitly refers to the initial development of the instrument's reading capabilities, it would have involved a similar process as the ground truth for the test set, likely using CLSI reference methods and expert interpretation to teach the instrument to accurately "read" MIC values.

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