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PASCO MIC AND MIC/ID PANELS are used for quantitatively measuring the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms.

This 510(k) notification is for the addition of the antimicrobial Telithromycin at concentrations of 0.015 - 4 mcg/ml to Pasco Panels. Telithromycin has been shown to be active in vitro against most isolates of the following microorganisms; as described in the FDA-approved package insert for this antimicrobic.

Active In Vitro and in Clinical Infectious Against:

Aerobic Gram-positive microorganisms

Staphylococcus aureus (methicillin and erythromycin susceptible isolates only)

Pasco MIC and MIC/ID panels are used for quantitatively measuring the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms. Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco microdilution panels and the panels are then frozen. Panels are thawed prior to inoculation with the test organisms, incubated the traditional 16-24 hours and panels are then observed for visible growth or color changes as described in the package insert.

The lowest concentration of each antimicrobial agent with no apparent visible growth of the test organism is recorded as the minimum inhibitory concentration (MIC). Changes in and production of specific metabolites from growth in biochemical substrates are interpreted as described in the package insert for conventional tubed media.

The provided text describes the 510(k) summary for the Pasco MIC and MIC/ID Panels, specifically for the addition of Telithromycin. 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:

Note: While a numerical acceptance criterion for Essential Agreement is not explicitly stated, the FDA typically looks for very high agreement (often >90-95%) for antimicrobial susceptibility tests to be deemed substantially equivalent. The 100% reported performance clearly meets such an implied high standard.

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

• Sample Size: 207 challenge and clinical Staphylococcus aureus isolates were tested.
• Data Provenance: Not explicitly stated as a country of origin. The data is from a "multi-site" study (three test sites). The methodology involved "challenge strains, fresh clinical isolates, stock clinical isolates and QC strains," indicating a mix of laboratory curated strains and real-world clinical samples. The study is prospective in the sense that these tests were performed specifically for the 510(k) submission using the device and reference methodology concurrently.

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

• This information is not provided in the given text. The ground truth (reference methodology) is implied to be established by the "reference methodology," but the human expert involvement in reading or interpreting these reference results, or setting up the "challenge strains," is not detailed.

4. Adjudication Method for the Test Set:

• This information is not provided in the given text. It is usual for AST studies to compare the device's results against a well-established reference method, often without explicit expert adjudication of discrepancies, as the reference method itself is considered the gold standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• No, this was not an MRMC comparative effectiveness study. This device is an Antimicrobial Susceptibility Test (AST) panel, which provides quantitative measurements (Minimum Inhibitory Concentration - MIC) of bacterial susceptibility to antibiotics. It is not an AI-assisted diagnostic tool that helps human readers interpret images or complex data in the traditional sense of an MRMC study. Therefore, the concept of "human readers improving with AI vs. without AI assistance" does not apply here.

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

• The Pasco MIC and MIC/ID Panels are standalone devices in that they provide results (MIC values and biochemical identifications) based on the growth patterns and color changes in the microdilution wells. While human observation and interpretation of these changes are required, the "algorithm" that determines susceptibility is inherent in the design and formulation of the wells (e.g., specific concentrations of antimicrobials). The results are directly read from the panel after incubation. The study compares the device's output to a reference methodology, which is a standalone performance comparison.

7. The Type of Ground Truth Used:

• The ground truth was established by "reference methodology." While not explicitly detailed, for AST devices, this typically refers to a standardized laboratory method, such as broth microdilution or agar dilution, performed according to guidelines from organizations like the Clinical and Laboratory Standards Institute (CLSI) or NCCLS (as cited in the text). This is a well-established and accepted laboratory standard for determining MIC values.

8. The Sample Size for the Training Set:

• This information is not applicable/provided in the context of this device. The Pasco MIC and MIC/ID Panels are not machine learning or AI-based devices that require a "training set" in the computational sense. Their performance is based on chemical and biological reactions, and their development would involve iterative design and testing rather than algorithm training.

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

• This information is not applicable as there is no "training set" in the context of a machine learning algorithm. The device's underlying principles are based on established microbiology and pharmacology.

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Pasco MIC and MIC/ID panels are used for quantitatively measuring the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms.

This 510(k) notification is for the addition of the antimicrobial Telithromycin at concentrations of 0.015 - 4 mcg/ml to Pasco Panels for use in testing Streptococcus pneumoniae and Streptococcus spp. other than Streptococcus pneumoniae. Telithromycin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic.

Active In Vitro and in Clinical Infectious Against:

Aerobic gram-positive microorganisms

Streptococcus pneumoniae (including multi-drug resistant isolates (MDRSP))

Active In Vitro but their clinical significance is unknown:

Aerobic gram-positive microorganisms

Streptococcus pyogenes (erythromycin susceptible isolates only) Streptococci (Lancefield groups C and G) Viridans group streptococci

Pasco Panels are used for quantitatively measuring the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms. Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco microdilution panels and the panels are then frozen. Panels are thawed prior to use, inoculated with the test organisms, incubated the traditional 16-24 hours and panels are then observed for visible growth or color changes as described in the package insert.

The lowest concentration of each antimicrobial agent with no apparent visible growth of the test organism is recorded as the minimum inhibitory concentration (MIC). Changes in pH and production of specific metabolites from growth in biochemical substrates are interpreted as described in the package insert for conventional tubed media.

The provided 510(k) summary describes the acceptance criteria and study results for the Pasco MIC and MIC/ID Panels for Telithromycin.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 570 challenge and clinical Streptococcus pneumoniae and Streptococcus spp. other than S. pneumoniae strains.
• Data Provenance: The data included "challenge strains, fresh clinical isolates, stock clinical isolates and QC strains." Testing was conducted at "three test sites." The specific country of origin is not explicitly stated, but given the submission to the FDA, it is highly likely to be U.S.-based or follow U.S. regulatory guidelines for data collection. The use of "fresh clinical isolates" suggests a prospective component, alongside "stock clinical isolates" which could be considered retrospective if they were banked prior to the study design.

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

The document does not specify the number of experts used or their qualifications for establishing the ground truth. For antimicrobial susceptibility testing, the "ground truth" is typically established by a reference methodology performed by trained laboratory personnel, rather than expert clinicians or radiologists.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method. In AST studies, ground truth is usually determined by established reference methodologies (e.g., broth microdilution according to CLSI/NCCLS guidelines) and confirmed by quality control strains, rather than an expert consensus adjudication process. The comparison is directly between the new device's results and the reference method's results.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is more common for diagnostic imaging devices where human interpretation is a key component. The Pasco MIC and MIC/ID Panels are automated or semi-automated devices for reading antimicrobial susceptibility, and the "readers" are the devices themselves or laboratory technicians following standardized procedures, not typically "human readers" in the sense of a MRMC study.

6. Standalone Performance Study

Yes, a standalone performance study was done. The entire study describes the performance of the Pasco MIC and MIC/ID Panels (the algorithm/device) against a reference methodology without human interpretation influencing the measurement of MICs. The "Essential Agreement" and "Category Agreement" metrics, along with error rates, reproducibility, and QC endpoints, are all measures of the device's standalone performance.

7. Type of Ground Truth Used

The ground truth used was established by reference methodology. The text states: "Challenge strains, fresh clinical isolates, stock clinical isolates and QC strains were tested concurrently using both Pasco methodology and reference methodology...". For AST, reference methodology typically refers to a standardized method like broth microdilution as defined by clinical and laboratory standards organizations (e.g., NCCLS/CLSI).

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size or discuss how the device was trained. For AST devices like these, particularly older ones, the "training" equivalent often involves calibrating the instrument/methodology to match established reference methods and NCCLS (now CLSI) guidelines, rather than machine learning on a distinct training dataset. The development and validation process would involve internal testing and optimization before the formal pre-market notification study.

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

As no separate training set is explicitly mentioned or detailed as being used in the context of device "training" (as understood in modern AI/ML terms), the document does not provide information on how ground truth for such a set might have been established. Any internal development and calibration would have also relied on established reference methods and QC strains.

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Pasco MIC and MIC/ID panels are used for quantitatively measuring the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms.

This 510(k) notification is for the addition of the antimicrobial Daptomycin at concentrations of 0.06 - 8 mcg/ml to Pasco Panels for use in testing Streptococcus spp. other than S. pneumoniae. Daptomycin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic.

Active In Vitro and in Clinical Infectious Against:

Aerobic Gram-positive microorganisms Streptococcus agalactiae Streptococcus dysgalactiae subsp. equisimilis Streptococcus pyogenes

PASCO MIC and MIC/ID PANELS are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement or category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms. Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco microdilution panels and the panels are then frozen. Panels are thawed prior to the addition of organisms, incubated the traditional 16-24 hours and panels are then observed for visible growth or color changes as described in the package insert.

The lowest concentration of each antimicrobial agent with no apparent visible growth of the test organism is recorded as the minimum inhibitory concentration (MIC). Changes in pH and production of specific metabolites from growth in biochemical substrates are interpreted as described in the package insert for conventional tubed media.

The Pasco MIC and MIC/ID Panels are antimicrobial susceptibility test systems. The 510(k) notification (K041214) is specifically for the addition of the antimicrobial Daptomycin at concentrations of 0.06 - 8 mcg/ml to these panels for testing Streptococcus spp. other than S. pneumoniae.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: 348 challenge and clinical Streptococcus spp.
• Data Provenance: The isolates included "challenge strains, fresh clinical isolates, stock clinical isolates and QC strains." The text does not specify the country of origin but implies a multi-site study ("Testing was conducted at three test sites"). It's a retrospective analysis of collected strains for the challenge and stock isolates, but also includes "fresh clinical isolates" which suggests a prospective component as well.

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

• The document does not specify the number of experts or their qualifications. The ground truth appears to be established by comparison to a "reference methodology" rather than expert opinion on individual cases.

4. Adjudication Method for the Test Set:

• The document does not describe an adjudication method. The evaluation relies on direct comparison to a reference methodology.

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 study was NOT done. This device is an automated antimicrobial susceptibility test system, not an AI-assisted diagnostic tool that involves human readers interpreting images or data with and without AI assistance. The performance is assessed against a "reference methodology."

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

• Yes, this is essentially a standalone (algorithm/device only) performance evaluation. The Pasco MIC and MIC/ID panels are designed to automatically determine the MIC or qualitative category results. The performance is compared directly to a "reference methodology," indicating the device's inherent accuracy in measuring susceptibility. While human technicians operate the panels, the "reading" of the results (visible growth or color changes, and interpretation of MIC or biochemical identification) is standardized and intrinsic to the device's methodology rather than subjective human interpretation being aided by an algorithm.

7. The Type of Ground Truth Used:

• The ground truth was established by a reference methodology. The document states, "Challenge strains, fresh clinical isolates, stock clinical isolates and QC strains were tested concurrently using both Pasco methodology and reference methodology..." This refers to a recognized, established method for determining antimicrobial susceptibility, implicitly considered the "gold standard" for this type of testing.

8. The Sample Size for the Training Set:

• The document does not provide information on a specific training set size. Antimicrobial susceptibility testing devices like this typically do not involve a "training set" in the machine learning sense. Instead, they are developed based on established microbiological principles and validated against reference methods using a test set (as described in point 2).

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

• As there is no mention of a traditional "training set" for a machine learning model, this question is not applicable in the context of this device's development and validation as described. The ground truth for the validation/test set was established by a "reference methodology" (as described in point 7).

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Pasco MIC and MIC/ID panels are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement of category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms.

This 5.10(k) notification is for the antimicrobial Daptomycin at concentrations of 0.06 - 8 mcg/ml to Pasco Panels. Daptomycin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic.

Active In Vitro and in Clinical Infectious Against:

Aerobic Gram-positive microorganisms

Enterococcus faecalis (vancomycin-susceptible strains only) Staphylococcus aureus (including methicillin-resistant strains)

Active In Vitro but their clinical significance is unknown

Aerobic Gram-positive microorganisms

Enterococcus faecalis (vancomycin-resistant strains) Enterococcus faecium (including vancomycin-resistant strains) Staphylococcus epidermidis (including methicillin-resistant strains) Staphylococcus haemolyticus

Pasco Panels are used for quantitatively measuring the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms. Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco microdilution panels and the panels are then frozen. Panels are thawed prior to use, inoculated with the test organisms, incubated the traditional 16-24 hours and panels are then observed for visible growth or color changes as described in the package insert.

The lowest concentration of each antimicrobial agent with no apparent visible growth of the test organism is recorded as the minimum inhibitory concentration (MIC). Changes in pH and production of specific metabolites from growth in biochemical substrates are interpreted as described in the package insert for conventional tubed media.

The provided document describes the acceptance criteria and the study conducted for the Pasco MIC and MIC/ID Panels with the inclusion of Daptomycin.

Acceptance Criteria and Reported Device Performance

Study Information

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

   • Test Set Size: 413 challenge and clinical Staphylococcus spp. and 365 challenge and clinical Enterococcus spp. (Total = 778 isolates).
   • Data Provenance: The document states "Challenge strains, fresh clinical isolates, stock clinical isolates and OC strains were tested concurrently". It also mentions "Testing was conducted at three test sites." The country of origin is not explicitly stated. The nature of "fresh clinical isolates" and "stock clinical isolates" suggests a mix of retrospective and prospective data. "Challenge strains" and "OC strains" are likely laboratory-derived.

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

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified.
   • The ground truth was established by "reference methodology." While the document doesn't detail who performs this or their qualifications, it implies a standard, established method, likely overseen by qualified laboratory personnel.

3. Adjudication method for the test set:

   • Not applicable as the study compares the device's results against a "reference methodology" rather than relying on multiple expert readings for ground truth establishment.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an Antimicrobial Susceptibility Test (AST) system, which typically provides objective measurements (MIC values) rather than interpretation requiring human readers in the same way an imaging AI would. This study focuses on the agreement of the device with a reference method, not on human interpretive improvement with AI assistance.

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

   • Yes, this was a standalone study. The device (Pasco MIC and MIC/ID Panels) is a diagnostic test system that produces a result (MIC values). The study assessed the performance of this system ("Pasco methodology") independently against a "reference methodology." There is no mention of a human-in-the-loop component for the device's primary function or for the evaluation.

6. The type of ground truth used:

   • The ground truth was established using reference methodology. For Antimicrobial Susceptibility Testing, this typically involves a standardized, validated laboratory method (e.g., agar dilution or broth microdilution following CLSI/NCCLS guidelines) that is considered the gold standard for determining MIC values.

7. The sample size for the training set:

   • The document does not explicitly mention a "training set" in the context of an algorithm or AI. This study is for a traditional diagnostic panel, not an AI-driven device that requires training. The described isolates are for the "test set" or samples used for validation.

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

   • As there is no mention of a "training set" for an algorithm, this question is not applicable. For the isolates used in the performance study, the ground truth was established by "reference methodology" as described in point 6.

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PASCO MIC AND MIC/ID PANELS are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement or category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms. This 510(k) notification is for the addition of the antimicrobial Gemifloxacin at concentrations of 0.015 - 4 mcg/ml to Pasco Panels. Gemifloxacin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic. Active In Vitro and in Clinical Infectious Against: Aerobic Gram-negative microorganisms Klebsiella pneumoniae Active In Vitro but their clinical significance is unknown Aerobic Gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only) Aerobic Gram-negative microorganisms Acinetobacter lwoffi Klebsiella oxytoca Proteus vulgaris

Pasco Panels are used for quantitatively measuring the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms. Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco microdilution panels and the panels are then frozen. Panels are thawed prior to use, inoculated with the test organisms, incubated the traditional 16-24 hours and panels are then observed for visible growth or color changes as described in the package insert. The lowest concentration of each antimicrobial agent with no apparent visible growth of the test organism is recorded as the minimum inhibitory concentration (MIC). Changes in pH and production of specific metabolites from growth in biochemical substrates are interpreted as described in the package insert for conventional tubed media.

The information provided describes the acceptance criteria and the study conducted for the Pasco MIC and MIC/ID Panels with the addition of Gemifloxacin.

Here's the breakdown as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical acceptance criteria (e.g., a precise percentage for EA or CA) are not explicitly stated in the provided text. However, "acceptable" and the absence of major/very major errors imply that the reported performance met the pre-defined thresholds for regulatory approval.

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

• Sample Size (Test Set): 615 isolates (challenge and clinical Enterobacteriaceae and Acinetobacter sp.)
• Data Provenance: The isolates included "challenge strains, fresh clinical isolates, stock clinical isolates and QC strains." The study was conducted at "three test sites." The text does not specify the country of origin but implies a multi-site clinical evaluation. It is a prospective or concurrent evaluation as it compares the Pasco methodology to a reference methodology.

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

• This information is not provided in the given text. The ground truth (reference methodology) is mentioned, but details about the experts involved in establishing it are absent.

4. Adjudication Method for the Test Set

• This information is not provided in the given text.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as the device is an automated antimicrobial susceptibility test panel, not an interpretive imaging device requiring human readers.

6. Standalone Performance

• Yes, a standalone (algorithm only) performance was done. The device's performance (Essential Agreement, Category Agreement, etc.) was directly compared against a reference methodology without human intervention in the interpretation of the core MIC values.

7. Type of Ground Truth Used

• The ground truth used was established by a "reference methodology". The text doesn't specify the exact nature of this reference methodology (e.g., specific manual dilution methods, another FDA-approved AST system, etc.), but it is implied to be a gold standard for antimicrobial susceptibility testing.

8. Sample Size for the Training Set

• This information is not provided in the given text. The document focuses on the validation of the device, not its development or training phase.

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

• This information is not provided in the given text, as details on the training set are absent.

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PASCO MIC AND MIC/ID PANELS are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement or category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms. This 510(k) notification is for the addition of the antimicrobial Linezolid at concentrations of 0.25 - 8 mcg/ml to Pasco Panels. Linezolid has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic. Active In Vitro and in Clinical Infectious Against: Aerobic Gram-positive microorganisms Enterococcus faecium (vancomycin-resistant strains only) Staphylococcus aureus (including methicillin-resistant strains) Active In Vitro but their clinical significance is unknown Aerobic Gram-positive microorganisms Enterococcus faecalis (including vancomycin-resistant strains) Enterococcus faecium (vancomycin-susceptible strains) Staphylococcus epidermidis (including methicillin-resistant strains) Staphylococcus haemolyticus

Pasco Panels are used for quantitatively measuring the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms. Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco microdilution panels and the panels are then frozen. Panels are thawed prior to use, inoculated with the test organisms, incubated the traditional 16-24 hours and panels are then observed for visible growth or color changes as described in the package insert. The lowest concentration of each antimicrobial agent with no apparent visible growth of the test organism is recorded as the minimum inhibitory concentration (MIC). Changes in pH and production of specific metabolites from growth in biochemical substrates are interpreted as described in the package insert for conventional tubed media.

Here's an analysis of the provided 510(k) summary regarding the PASCO MIC and MIC/ID Panels for Linezolid, structured to address your specific questions:

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

The document doesn't explicitly state quantitative acceptance criteria in a dedicated section. However, based on the conclusions and terminology used, the implicit acceptance criteria for this type of device (Antimicrobial Susceptibility Test) are high levels of "Essential Agreement" (EA) and "Category Agreement" (CA), and the absence of "very major," "major," or "minor" errors. Reproducibility is also a key criterion.

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

• Sample Size for Test Set:
  • 413 challenge and clinical Staphylococcus spp.
  • 365 challenge and clinical Enterococcus spp.
  • For reproducibility testing: 10 organisms at each of 3 sites, tested in triplicate on 3 separate days (10 organisms * 3 sites * 3 days * 3 replicates = 270 individual tests for reproducibility).
• Data Provenance:
  • The data includes "Challenge strains, fresh clinical isolates, stock clinical isolates and QC strains."
  • Testing was conducted at "three test sites."
  • The document does not specify the country of origin, but given the FDA submission, it's presumed to be within the US or compliant with US regulatory standards.
  • The study appears to be prospective for the clinical isolates, as they were tested concurrently with both the Pasco methodology and reference methodology. Stock and challenge strains would also be part of a prospectively planned study.

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

This information is not provided in the summary. For Antimicrobial Susceptibility Testing (AST) devices, the ground truth is typically established by a recognized reference method (e.g., broth microdilution or agar dilution as per CLSI/NCCLS standards) rather than individual expert adjudication of results. The document states, "Challenge strains, fresh clinical isolates, stock clinical isolates and QC strains were tested concurrently using both Pasco methodology and reference methodology." The reference methodology serves as the ground truth.

4. Adjudication method for the test set

There was no human adjudication described for the test set results in the way one might see for imaging or pathology studies. Instead, the device's results were directly compared against a "reference methodology." The agreement percentages (EA, CA) and error rates (VM, M, m) indicate a direct comparison and calculation rather than an adjudicated consensus.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices where human reading is involved and the device provides assistance (e.g., AI in radiology). The Pasco device automates the measurement of MIC and identification, and the comparison is between the device and a reference method, not human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

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

Yes, a standalone performance evaluation was conducted. The Pasco device, described as giving specific quantitative MIC values and biochemical identification, is itself the "algorithm" or automated system. The reported performance metrics (EA, CA, error rates, reproducibility) are for the device's output compared to a reference standard, without human intervention in the interpretation of the device's primary output. The "human-in-the-loop" here would be laboratory personnel performing the setup and reading of the reference methodology and interpreting the final results for patient care, but the device's performance itself is standalone.

7. The type of ground truth used

The ground truth used was a reference methodology for antimicrobial susceptibility testing. The document states, "Challenge strains, fresh clinical isolates, stock clinical isolates and QC strains were tested concurrently using both Pasco methodology and reference methodology". For AST, the reference method (e.g., broth microdilution as per CLSI standards) is the gold standard for determining MICs.

8. The sample size for the training set

The document does not specify a separate training set or its sample size. This type of 510(k) submission for a diagnostic device usually focuses on verification and validation (V&V) testing (what you've termed the "test set") against a known standard. Device development (which might involve 'training' in a broad sense, especially for pattern recognition or instrument calibration) is usually internal to the manufacturer and not explicitly detailed as a 'training set' in the 510(k) summary in the same way an AI/ML model's training set would be.

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

Since a separate "training set" with ground truth establishment is not mentioned for this type of device submission, this question is not applicable based on the provided information. The ground truth for the test set (reference methodology) is detailed above.

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PASCO MIC AND MIC/ID PANELS are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement or category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms.

This 510(k) notification is for the antimicrobial Ertapenem at concentrations of 0.03 - 32 mcg/ml to Pasco Panels. Ertapenem has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic.

Active In Vitro and in Clinical Infectious Against:

Aerobic Gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only)

Aerobic Gram-negative microorganisms Escherichia coli Klebsiella pneumoniae

Active In Vitro but their clinical significance is unknown

Aerobic Gram-negative microorganisms

Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Klebsiella oxytoca (excluding ESBL producing strains) Morganella morganii Proteus mirabilis Proteus vulgaris Serratia marcescens

Pasco Panels are used for quantitatively measuring the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms. Varving concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco microdilution panels and the panels are then frozen. Panels are thawed prior to use, inoculated with the test organisms, incubated the traditional 16-24 hours and panels are then observed for visible growth or color changes as described in the package insert.

The lowest concentration of each antimicrobial agent with no apparent visible growth of the test organism is recorded as the minimum inhibitory concentration (MIC). Changes in pH and production of specific metabolites from growth in biochemical substrates are interpreted as described in the package insert for conventional tubed media.

1. Acceptance Criteria and Reported Device Performance:

Note: The acceptance criteria for Essential Agreement (EA) and Category Agreement (CA) are implicitly derived from the context of "acceptable" and the high percentages reported, aligning with typical AST performance standards. The document explicitly states "Category Agreement (CA) was acceptable at 99.4% with 5 random minor discrepancies, all of which were within EA." and "No major (M) or very major (VM) errors were observed" for Enterobacteriaceae, indicating these are key performance indicators for acceptance.

2. Sample Size and Data Provenance for Test Set:

• Sample Size:
  • Staphylococci spp.: 410 challenge and clinical strains
  • Enterobacteriaceae: 574 challenge and clinical strains
  • QC organisms: 10 organisms for reproducibility testing across 3 sites, each tested in triplicate on 3 separate days. (Total 90 tests per site for reproducibility).
• Data Provenance: The study used "challenge strains, fresh clinical isolates, stock clinical isolates and QC strains." The data was collected at "three test sites." The specific country of origin is not mentioned, but the submission is to the U.S. FDA, implying relevance to the U.S. market. The use of "fresh clinical isolates" suggests prospective collection for those samples, while "stock clinical isolates" implies a mix of retrospective and potentially prospective uses. "Challenge strains" and "QC strains" are typically laboratory-maintained strains.

3. Number and Qualifications of Experts for Ground Truth:

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, for antimicrobial susceptibility testing, the "reference methodology" (presumably a standard such as broth microdilution or agar dilution as per NCCLS guidelines) serves as the ground truth. This reference methodology is typically performed by trained microbiologists or laboratory personnel following established protocols.

4. Adjudication Method for Test Set:

The document does not describe an explicit adjudication method (like 2+1 or 3+1). The "reference methodology" is considered the standard against which the Pasco panels are compared. Discrepancies are reported (e.g., 5 random minor discrepancies for Enterobacteriaceae), and the agreement (Essential and Category) is calculated based on direct comparison to the reference method. There's no indication of a separate expert review or adjudication process for conflicting results between the test device and the reference method, beyond standard laboratory quality control.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is more common in diagnostic imaging where human readers interpret results with and without AI assistance. This submission describes an in vitro diagnostic device (Antimicrobial Susceptibility Test) where the output is typically an objective measurement (MIC) or category (S/I/R), not an interpretation that varies significantly between human readers in the same way an imaging study would. The study focuses on comparing the device's performance against a reference laboratory method.

6. Standalone Performance Study:

Yes, a standalone study was done. The document describes the performance of the Pasco MIC and MIC/ID Panels directly against a "reference methodology." The results for Essential Agreement, Category Agreement, and reproducibility are reported for the device itself, without human-in-the-loop assistance for interpretation beyond reading the visible growth or color changes as per the package insert instructions.

7. Type of Ground Truth Used:

The ground truth used was the reference methodology for antimicrobial susceptibility testing. The text states: "Challenge strains, fresh clinical isolates, stock clinical isolates and QC strains were tested concurrently using both Pasco methodology and reference methodology..." This implies a standard, accepted laboratory method (e.g., broth microdilution or agar dilution as per NCCLS guidelines) as the gold standard for determining the true MIC and susceptibility category.

8. Sample Size for the Training Set:

The document does not specify a separate training set sample size or clearly delineate it from the test set. For in vitro diagnostic devices like AST panels, the "training set" in the context of an algorithm or AI is not typically applicable in the same way as for imaging devices. The "training" for such devices often involves optimizing the panel design, reagent concentrations, and interpretation rules during product development, which is usually done on a larger, internal set of diverse isolates, but this is not reported as a separate "training set" in the 510(k) summary. The clinical testing described primarily serves as validation (test set).

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

As no distinct "training set" is explicitly mentioned, the method for establishing its ground truth is not detailed. However, if any internal development or optimization involved using ground truth, it would almost certainly have been established using similar reference methodology as described for the validation (test set).

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PASCO MIC AND MIC/ID PANELS are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement or category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms.

This 510(k) notification is for the addition of the antimicrobial Moxifloxacin at concentrations of 0.015 - 8 mcg/ml to Pasco Panels. Moxifloxacin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic.

Active In Vitro and in Clinical Infectious Against:

Aerobic Gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only)

Aerobic Gram-negative microorganisms Klebsiella pneumoniae

Active In Vitro but their clinical significance is unknown

Aerobic Gram-positive microorganisms Staphylococcus epidermidis (methicillin-susceptible strains only)

Aerobic Gram-negative microorganisms Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Proteus mirabilis

Pasco Panels are used for quantitatively measuring the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a batterv of antimicrobial agents and determining the biochemical identification of those organisms. Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco microdilution panels and the panels are then frozen. Panels are thawed prior to use, inoculated with the test organisms, incubated the traditional 16-24 hours and panels are then observed for visible growth or color changes as described in the package insert.

The lowest concentration of each antimicrobial agent with no apparent visible growth of the test organism is recorded as the minimum inhibitory concentration (MIC). Changes in pH and production of specific metabolites from growth in biochemical substrates are interpreted as described in the package insert for conventional tubed media.

Here's a breakdown of the acceptance criteria and study details for the Pasco MIC and MIC/ID Panels based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Staphylococci spp.: 410 (challenge and clinical isolates)
  • Enterobacteriaceae: 574 (challenge and clinical isolates)
  • Reproducibility testing: 10 organisms at each of the three sites, tested on three separate days in triplicate.
  • QC organisms: S. aureus ATCC 29213, E. faecalis ATCC 29212, E. coli ATCC 25922, and P. aeruginosa ATCC 27853.
• Data Provenance: The document states "Challenge strains, fresh clinical isolates, stock clinical isolates and QC strains were tested concurrently." It does not specify the country of origin, but given the FDA 510(k) submission, it's highly likely to be U.S.-based or from regions with comparable clinical practices. It implies a mix of prospective (fresh clinical isolates) and retrospective (stock clinical isolates, challenge strains) data for the performance evaluation.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts or their qualifications used to establish the ground truth. For Antimicrobial Susceptibility Testing (AST) devices, the "reference methodology" (e.g., broth microdilution or agar dilution as defined by CLSI/NCCLS standards) is typically considered the ground truth, and its results are interpreted by trained laboratory personnel, not necessarily "experts" in the context of a panel review.

4. Adjudication Method for the Test Set

No explicit adjudication method (like 2+1, 3+1) is mentioned. For AST devices, the ground truth is established by the reference method, and the test device's results are compared directly to this reference. Discrepancies are categorized (major, very major, minor) based on established criteria for AST performance studies.

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

No MRMC comparative effectiveness study was done, nor is it applicable in this context. This device is an automated or semi-automated diagnostic test (Antimicrobial Susceptibility Test panel), not an imaging or interpretation aid for human readers. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" does not apply.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was clearly done. The Pasco MIC and MIC/ID Panels are designed to provide quantitative or qualitative antimicrobial susceptibility results directly. The "Pasco methodology" results were compared directly against "reference methodology," demonstrating its performance in isolation, without human intervention for result interpretation beyond reading the panel itself.

7. Type of Ground Truth Used

The ground truth was established using reference methodology, specifically comparing results from the Pasco panels with those obtained through a recognized "reference methodology" for antimicrobial susceptibility testing. This reference method is the accepted standard against which new AST devices are evaluated.

8. Sample Size for the Training Set

The document does not specify a separate "training set" or its size. In the context of a 510(k) for an AST panel, manufacturers develop the panel and its interpretation criteria. The provided data (challenge, clinical, and QC strains) is the "test set" used to demonstrate performance against the reference method for regulatory clearance. It's not a machine learning model that requires a distinct training and testing set in the same way an AI algorithm would.

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

As there's no explicitly defined "training set" for an AI model, this question is not fully applicable. However, the methods used to establish ground truth for the performance evaluation were "reference methodology," meaning established, standard laboratory procedures for determining antimicrobial susceptibility, such as broth microdilution, which yield the Minimum Inhibitory Concentration (MIC) values considered the gold standard.

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PASCO MIC AND MIC/ID PANELS are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement or category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms.

This 510(k) notification is for the addition of the antimicrobial Gatifloxacin at concentrations of 0.03 - 8 mcg/ml to Pasco Panels. Gatifloxacin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic.

Active In Vitro and in Clinical Infectious Against:

Aerobic Gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only) Aerobic Gram-negative microorganisms Escherichia coli Klebsiella pneumoniae Proteus mirabilis

Active In Vitro but their clinical significance is unknown

Aerobic Gram-positive microorganisms Staphylococcus saprophyticus

Aerobic Gram-negative microorganisms Acinetobacter lwoffii Citrobacter koseri Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Klebsiella oxytoca Morganella morganii Proteus vulgaris

Pasco Panels are used for quantitatively measuring the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms. Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco microdilution panels and the panels are then frozen. Panels are thawed prior to use, inoculated with the test organisms, incubated the traditional 16-24 hours and panels are then observed for visible growth or color changes as described in the package insert.

The lowest concentration of each antimicrobial agent with no apparent visible growth of the test organism is recorded as the minimum inhibitory concentration (MIC). Changes in pH and production of specific metabolites from growth in biochemical substrates are interpreted as described in the package insert for conventional tubed media.

This document describes the regulatory submission for the Pasco MIC and MIC/ID Panels, specifically for the inclusion of the antimicrobial Gatifloxacin. The study's purpose is to demonstrate substantial equivalence to previously cleared devices.

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

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

• Test Set Sample Size:
  • Nonfastidious gram-positive organisms: 410
  • Gram-negative organisms: 615
  • Reproducibility testing: 10 organisms (tested in triplicate over 3 days at each of 3 sites, total 90 tests per site for reproducibility and 270 total tests across all sites)
• Data Provenance: The document does not specify the country of origin. It indicates that "Challenge strains, fresh clinical isolates, stock clinical isolates and QC strains were tested concurrently." The testing was conducted at "three test sites." The type of study is prospective, as it involves concurrent testing of "fresh clinical isolates" and "challenge strains."

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)

The document does not provide information on the number or qualifications of experts used to establish the ground truth. The "reference methodology" is used as the comparator, which typically implies established laboratory practices and expert interpretation but specific details are not provided.

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

The document does not describe an explicit adjudication method. The comparison is made against "reference methodology," and errors (major, very major, minor) are reported based on this comparison. It does not mention multiple readers or 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on a standalone device's performance (antimicrobial susceptibility test panel) against a reference method, not on human reader performance with or without AI assistance. This device is not an AI-powered diagnostic tool.

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

Yes, a standalone study was done. The "Pasco MIC and MIC/ID Panels" are a device for quantitatively measuring antimicrobial susceptibility. The performance metrics (Essential Agreement, Category Agreement, reproducibility) are reported for the device itself against a "reference methodology." While human observation is involved in reading the panels (visible growth or color changes), the evaluation is of the device's accuracy in determining MIC values compared to the reference, not human performance using the device.

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

The ground truth was established by "reference methodology" for antimicrobial susceptibility testing. This typically refers to established and validated laboratory methods for determining Minimum Inhibitory Concentrations (MICs), often following guidelines from organizations like the Clinical and Laboratory Standards Institute (CLSI) or its predecessors (like NCCLS, mentioned in the document). The specific nature of this "reference methodology" is not detailed but is implied to be a standard, accepted laboratory procedure.

8. The sample size for the training set

This document does not describe a "training set" as it would for a machine learning or AI model. The study is a traditional device validation comparing the Pasco panels to a reference method, not a development of an algorithm that requires a separate training phase.

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

Not applicable, as there is no "training set" in the context of this device validation study.

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