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hemoFISH Masterpanel is a qualitative nucleic acid hybridization assay performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system that demonstrates the presence of organisms as determined by Gram stain and is intended for the identification of the following species / families:

Gram-positive: Staphylococcus spp., Staphylococcus aureus, Streptococcus spp.
Gram-negative: Enterobacteriaceae, Escherichia coli, Klebsiella pneumoniae

The hemoFISH Masterpanel is indicated as an aid in the diagnosis of bacteremia and results should be used in conjunction with other clinical and laboratory findings. Positive hemoFISH Masterpanel results do not rule out coinfection with organisms not included in the hemoFISH Masterpanel is not intended to monitor treatment for bacteremia.

Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and epidemiological typing, to identify organisms in the blood culture that are not identified by the hemoFISH Masterpanel, and for species determination of Staphylococcus spp., Streptococcus spp., and Enterobacteriaceae that are not identified by the hemoFISH Masterpanel.

The hemoFISH Masterpanel identifies bacteria within 30 minutes directly from positive blood cultures.

The methodology is based on classical fluorescence in-situ hybridization (FISH) combined with the usage of fluorescently labeled molecular beacons.

A solution of fluorescently labeled molecular DNA beacons is dispensed on fixed and perforated cells prepared from a blood culture. The hybridization is carried out at 52°C for 10 minutes. Submerging the slide into a bath containing a stop solution ceases the reaction. Adding a drop of Mounting Medium to each field prevents fading of fluorescence. After applying a cover slip, the slide is ready for examination using fluorescence microscopy.

The hemoFISH Masterpanel is a qualitative nucleic acid hybridization assay designed for the rapid identification of specific bacterial species/families directly from positive blood culture samples. It utilizes fluorescence in-situ hybridization (FISH) with molecular DNA probes.

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

1. Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list "acceptance criteria" in a separate table with specific numerical thresholds for sensitivity and specificity that the device must meet. Instead, it presents the results of its performance studies, implying that these results are considered acceptable for substantial equivalence.

However, based on the "Performance Characteristics" section, we can infer the de-facto acceptance criteria by examining the reported performance and the overall conclusion of substantial equivalence. The key performance metrics are Sensitivity (Positive Agreement) and Specificity (Negative Agreement) against routine laboratory methods.

Here's a table summarizing the reported device performance, which the FDA implicitly accepted as meeting the criteria for substantial equivalence:

Table 1: Reported Device Performance (Monomicrobial Cultures, Prospective and Spiked Samples Combined)

Note: The numbers in parentheses for each target agent represent the number of samples identified as such by the "Routine Identification" (ground truth).

2. Sample Size and Data Provenance

• Test Set Sample Size:

  • Clinical Studies (Monomicrobial): 609 prospective blood culture bottles + 61 in-house spiked (monomicrobial) blood culture bottles = 670 monomicrobial blood cultures (combined in Table 3).
  • Clinical Studies (Polymicrobial): 55 polymicrobial prospective blood culture bottles (analyzed separately in Table 4).
  • Analytical Inclusivity: 120 representative reference strains.
  • Analytical Specificity: 215 strains representing clinical relevant species and/or species selected based on sequence similarities.
  • Limit of Detection (LoD): Not specified for the number of strains, but "≥19/20 replicates (≥95%) were positive at 10^3 CFU/mL" for each tested species.
  • Reproducibility: 90 tests per strain (3 slides/strain tested by 2 different operators on 2 x five consecutive days).

• Data Provenance: The document does not explicitly state the country of origin for the clinical data. It mentions "3 clinical laboratory studies." Given the submitter's location (Düsseldorf, Germany), it's highly probable that the clinical studies were conducted in Germany or Europe, though this is not confirmed. The data appears to be prospective for the main clinical method comparison study, with additional in-house spiked samples (retrospective/controlled laboratory setting).

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts or their qualifications involved in establishing the ground truth for the clinical test set. The ground truth for the clinical studies was established by "routine laboratory methods" (e.g., culture, biochemical tests, mass spectrometry, or other conventional microbiology methods), which are presumed to be performed by qualified laboratory personnel following established protocols.

4. Adjudication Method for the Test Set

The document does not mention any specific adjudication method (e.g., 2+1, 3+1) for discordant results between the hemoFISH Masterpanel and the routine laboratory methods. The "routine identification" is presented as the reference standard.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a diagnostic assay, and the performance evaluation focused on its agreement with standard laboratory identification methods, not on how human readers (e.g., clinicians or microbiologists) improve their diagnostic performance with or without AI assistance. The interpretation of the device results is "Visual by fluorescence microscopy" and is a direct output from the assay, not an interpretation by a human of an AI output.

6. Standalone (Algorithm Only) Performance

The study primarily evaluates the standalone performance of the hemoFISH Masterpanel assay. The "visual by fluorescence microscopy" interpretation refers to a direct reading of the assay's output, not an algorithm's output. There isn't an "algorithm only without human-in-the-loop performance" in the typical sense of AI-driven image analysis. The device itself performs the detection (hybridization and fluorescence), and the "visual" part is the human reading the output. This is a traditional IVD, not an AI/ML-driven device in the sense of image interpretation.

7. Type of Ground Truth Used

The primary ground truth used for the clinical studies was "routine identification" based on standard laboratory methods, which typically involve microbial culture and subsequent identification techniques (e.g., Gram stain, biochemical tests, mass spectrometry, gene sequencing).

For analytical studies:

• Analytical Inclusivity/Specificity: Determined using "representative reference strains" with known identities.
• LoD: Spiked blood culture bottles with known reference strains.

8. Sample Size for the Training Set

The document does not specify an explicit "training set" sample size in the context of machine learning. As a traditional IVD (fluorescence in-situ hybridization assay), this device does not typically undergo a "training" phase like an AI/ML model. The design and validation of the probes (the core "method" of the device) are based on molecular biology principles and analytical testing, not iterative learning from a large dataset.

9. How Ground Truth for the Training Set Was Established

Since there is no "training set" in the context of machine learning for this traditional IVD, the concept of establishing ground truth for a training set does not apply. The development of the hemoFISH Masterpanel involved designing specific DNA probes to target ribosomal RNA sequences of the target organisms. The "ground truth" during this development (analogous to a training phase) would have involved:

• Bioinformatics: In silico analysis of ribosomal RNA sequences to design highly specific and inclusive probes.
• Analytical validation: Testing probe performance against a wide range of known bacterial strains (as mentioned in the Analytical Inclusivity and Specificity sections) to confirm their binding specificity and sensitivity. These analytical studies are part of the device development and validation, not a separate "training set" as understood in AI/ML.

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The provided document is a 510(k) clearance letter from the FDA for the "Gram-Negative QuickFISH™ BC Blood Culture Identification Kit." This letter grants market clearance based on substantial equivalence to a predicate device, but it does not contain the detailed study information, acceptance criteria, or performance data typically found in the 510(k) submission itself.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, ground truth methods), or the specifics of standalone or MRMC studies from this document.

To answer your questions, I would need access to the actual 510(k) submission for K123418, which would include the clinical and analytical study reports.

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GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli, and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa on smears from positive blood cultures containing Gramnegative rods observed on Gram stain.

Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.

The GNR Traffic Light PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli, and/or K, pneumoniae, and/or P. aeruginosa bacteremia.

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This document is a 510(k) clearance letter for the AdvanDX GNR Traffic Light PNA FISH Identification Kit. It does not contain the detailed study information required to answer your request.

The letter acknowledges the substantial equivalence determination for the device based on a premarket notification. It outlines the regulatory classification, general controls, and responsibilities of the manufacturer. However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
• Details on multi-reader multi-case (MRMC) studies or standalone performance.
• The type of ground truth used, or sample sizes and ground truth establishment methods for a training set.

To obtain this information, you would typically need to refer to the original 510(k) submission document (K101558) itself, which would contain the validation study details.

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E. colilP. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods.

The E. coliIP. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.

Subculturing of positive blood cultures is necessary for susceptibility testing and/or differentiation of mixed growth.

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This document is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain the detailed study results, acceptance criteria, or performance metrics typically found in a clinical study report or a summary of safety and effectiveness.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be gathered and what cannot:

Information NOT available in the provided text:

• A table of acceptance criteria and the reported device performance: This document is the clearance letter, not the study report.
• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not present.
• 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): Not present.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable as this is not an AI-assisted device for human readers; it's a diagnostic test for identifying bacteria.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a laboratory assay, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
• The sample size for the training set: Not present.
• How the ground truth for the training set was established: Not present.

Information that can be extracted or inferred:

1. Device Name: E. coli/P. aeruginosa PNA Fish™
2. Indications for Use (from the document):
   • E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods.
   • The E. coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.
   • Subculturing of positive blood cultures is necessary for susceptibility testing and/or differentiation of mixed growth.
3. Regulatory Class: Class I
4. Product Codes: JSS
5. Regulatory Regulation Number: 21 CFR §866.2660
6. Regulatory Regulation Name: Microorganism differentiation and identification device.

To obtain the detailed study information, one would typically need to consult the complete 510(k) submission summary, which is often publicly available on the FDA's website, or directly request it from the manufacturer. The provided document is merely the FDA's clearance letter stating that the device is substantially equivalent to a predicate device.

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EK/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and/or Klebsiella pneumoniae and Pseudomonas aeruginosa on smears made from positive blood cultures containing Gram-negative rods. The test does not distinguish between E. coli and K. pneumoniae. Further testing is needed to differentiate E. coli and K. pneumoniae.

Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.

The EK/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or K. pneumoniae and P. aeruginosa bacteremia.

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The provided document is a 510(k) clearance letter from the FDA for the AdvanDx EK/P. aeruginosa PNA FISH device. It confirms the device's substantial equivalence to a legally marketed predicate device. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about sample sizes, ground truth establishment, or expert qualifications.

The letter primarily focuses on:

• Device Name: AdvanDx EK/P. aeruginosa PNA FISH
• Regulation Number/Name: 21 CFR 866.2660, Microorganism differentiation and identification device
• Regulatory Class: Class I
• Product Code: JSS, JSZ
• Indications for Use: Multicolor, qualitative nucleic acid hybridization assay for identification of Escherichia coli and/or Klebsiella pneumoniae and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods. It also states that the test does not distinguish between E. coli and K. pneumoniae and serves as an aid in diagnosis.

To answer your specific questions, one would need access to the actual 510(k) submission or the study report that was cited in the submission. The information requested falls under the detailed performance data and clinical evidence typically presented in such submissions, which are not part of this clearance letter.

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EK/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli /Klebsiella pneumoniae and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods. The test does not distinguish between E. coli and K. pneumoniae. Further testing is needed to differentiate E. coli and K. pneumoniae. The EK/P. aeruginosa PNA FISH assay is indicated for use in conjunction with positive blood subcultures as an aid in the identification of E. coli/K. pneumoniae, and/or P. aeruginosa.

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This document is a 510(k) clearance letter from the FDA for a device called EK/P. aeruginosa PNA FISH. It does not contain the detailed study information required to answer the prompt thoroughly.

Here's why and what's missing:

The provided text informs AdvanDx, Inc. that their device EK/P. aeruginosa PNA FISH has received 510(k) clearance. It specifies the regulation number, name, class, and product code. It also includes the indications for use.

Crucially, it does not include the results of any clinical studies, performance data, or detailed acceptance criteria. A 510(k) clearance letter acknowledges substantial equivalence to a predicate device, but the supporting data for that claim is typically found in the 510(k) submission itself, not the clearance letter.

Therefore,Based on the provided FDA 510(k) clearance letter for the EK/P. aeruginosa PNA FISH device, the following information regarding acceptance criteria and supporting studies cannot be extracted:

1. Table of acceptance criteria and reported device performance: This document only states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not present the specific acceptance criteria or the performance metrics of the new device.
2. Sample size used for the test set and data provenance: No details are provided about the test set size, nor where the data originated (country, retrospective/prospective).
3. Number of experts used to establish ground truth and their qualifications: The document does not discuss the methodology of ground truth establishment for any studies.
4. Adjudication method for the test set: There is no mention of adjudication methods.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: The document does not describe any MRMC studies or human-in-the-loop performance.
6. Standalone (algorithm only) performance study: This document does not describe standalone performance. The device is a "qualitative nucleic acid hybridization assay," implying it's a lab-based test, not a standalone algorithm in the typical sense of AI imaging.
7. Type of ground truth used: No information is given about how ground truth was established for any study (e.g., pathology, outcomes data, expert consensus).
8. Sample size for the training set: There is no mention of a training set, as this is a diagnostic assay, not an AI/ML device in the context of the prompt's typical questions.
9. How the ground truth for the training set was established: No information is available for a training set.

Summary of available information from the document:

• Device Name: EK/P. aeruginosa PNA FISH
• Intended Use: Qualitative nucleic acid hybridization assay for identification of Escherichia coli / Klebsiella pneumoniae and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods.
• Regulatory Status: 510(k) clearance, found substantially equivalent to predicate devices.
• Key Indication Note: The test does not distinguish between E. coli and K. pneumoniae; further testing is needed. It is indicated for use in conjunction with positive blood subcultures.

To answer your prompt comprehensively, one would need to access the full 510(k) submission documentation, which would contain the detailed study reports and performance data.

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E. colilP. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods. The E. colifP. aeruginosa PNA FISH assay is indicated for use in conjunction with positive blood subcultures as an aid in the identification of E.coli and/or P. aeruginosa.

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Here's an analysis of the provided text regarding the E. coli/P. aeruginosa PNA FISH Culture Identification Kit, focusing on the acceptance criteria and study details:

Unfortunately, the provided text is a 510(k) clearance letter from the FDA and does not contain the specific details of the acceptance criteria nor the study results that proved the device met those criteria. The letter acknowledges that a 510(k) premarket notification was submitted and reviewed, determining the device is "substantially equivalent" to legally marketed predicate devices. This means that AdvanDx Inc. provided data demonstrating safety and effectiveness, likely including performance studies, but those study details are not present in this document.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer many of your specific questions about the study design.

However, based on the context of FDA device clearance and the nature of an "Identification Kit," I can infer some general aspects and what kind of information would typically be found in the actual study reports.

Based on the provided document, I cannot answer the following questions as the information is not present:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set
• Data provenance (country of origin, retrospective/prospective)
• Number of experts used to establish ground truth for the test set
• Qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
• If a standalone (algorithm only) performance was done (as this is a lab kit, not an AI algorithm)
• The type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

What can be inferred or stated from the provided document:

• Device Name: E. coli/P. aeruginosa PNA FISH Culture Identification Kit
• Intended Use: "identification of Escherichia coli and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods. The E. coli/P. aeruginosa PNA FISH assay is indicated for use in conjunction with positive blood subcultures as an aid in the identification of E.coli and/or P. aeruginosa."
• Regulatory Class: Class I (indicated by the 510(k) process and the lack of mention of Special Controls or PMA). This generally means a lower regulatory burden and often substantial equivalence is based on comparisons to well-established predicate devices.
• Nature of the Device: It's a "qualitative nucleic acid hybridization assay." This means it likely uses probes (PNA FISH - Peptide Nucleic Acid Fluorescent In Situ Hybridization) to bind to specific RNA sequences of the target bacteria (E. coli and P. aeruginosa) within a sample, and the binding is detected qualitatively (e.g., presence/absence of fluorescence under a microscope).

Hypothetical Information (what would typically be found in the supporting 510(k) submission but is not in this letter):

For a device like this, the acceptance criteria would most likely revolve around:

• Sensitivity: The ability of the test to correctly identify E. coli or P. aeruginosa when they are present in the sample.
• Specificity: The ability of the test to correctly identify when E. coli or P. aeruginosa are not present (i.e., not cross-reacting with other common blood culture pathogens).
• Accuracy: Overall agreement with a gold standard method.
• Reproducibility/Repeatability: Consistency of results when tested multiple times under the same or varying conditions.

The study would typically involve:

• Test Set: A collection of positive blood culture samples (either contrived or clinical) known to contain E. coli, P. aeruginosa, other Gram-negative rods, or other bacteria/no bacteria.
• Ground Truth: For a microbiology identification kit, the ground truth would almost certainly be established by culture and biochemical identification methods (e.g., Vitek, API, or 16S rRNA gene sequencing) performed by trained microbiologists. This is the "gold standard" for bacterial identification. Pathology or outcomes data would not be relevant here.
• Standalone Performance: For a diagnostic kit, the performance is almost always "standalone" – the kit itself processes the sample and gives a result. There isn't typically an "algorithm only" or a "human-in-the-loop" aspect in the same way there would be for an AI imaging device. Human interpretation might be involved in reading a fluorescent signal under a microscope, but the "performance" is tied to the chemical reaction of the kit.
• Training Set: While not explicitly mentioned, during the development of such an assay, "training" might involve optimizing probe design, hybridization conditions, and interpretation criteria using a smaller set of known positive and negative samples before large-scale validation. The ground truth for this would also be established by culture.

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