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BD MAX™ Enteric Bacterial Panel
The BD MAX™ Enteric Bacterial Panel performed on the BD MAX™ System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. The BD MAX™ Enterial Panel detects nucleic acids from:

• · Salmonella spp.
• · Campylobacter spp. (jejuni and coli)
• · Shigella spp. / Enteroinvasive E. coli (EIEC)
  · Shiga toxin 1 (stxl ) / Shiga toxin 2 (stx2) genes (found in Shiga toxin-producing E. coli [STEC]) as well as Shigella dysenteriae, which can possess a Shiga toxin gene (stx) that is identical to the stx1 gene of STEC.
  Testing is performed on unpreserved soft to diartheal stool specimens or Cary-Blair preserved stool specimens from symptomatic patients with suspected acute gastroenteritis or colitis. The test is performed directly on the specimen, utilizing real-time polymerase chain reaction (PCR) for the amplification of SpaO, a Campylobacter specific tuf gene sequence, ipaH and strilstr2. The test utilizes fluorogenic sequence-specific hybridization of the amplified DNA.
  This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of Salmonella, Shigella/EIEC, Campylobacter and Shiga toxinproducing E. coli (STEC) infections. Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with other organisms that are not detected by this test and may not be the sole or definitive cause of patient illness. Negative results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or noninfectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

BD MAX™ Extended Enteric Bacterial Panel
The BD MAX™ Extended Enteric Bacterial Panel performed on the BD MAX™ System, is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. It is used in conjunction with the BD MAX™ Enteric Bacterial Panel as an optional Master Mix. The BD MAX™ Extended Enteric Bacterial Panel detects nucleic acids from:

• Plesiomonas shigelloides
• · Vibrio (V. vulnificus, V. parahaemolyticus, and V. cholerae)
• · Enterotoxigenic Escherichia coli (ETEC) heat-labile enterotoxin (LT)/ heat-stable enterotoxin (ST) genes
• Yersinia enterocolitica
  Testing is performed on unpreserved soft to diar preserved stool specimens from symptomatic patients with suspected acute gastroenteritis or colitis. The test is performed directly on the specimen, utilizing real-time polymerase chain reaction (PCR) for the amplification of relevant gene target DNA. The test utilizes fluorogenic genespecific hybridization probes for the detection of the amplified DNA.
  This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of Plesiomonas shigelloides, Vibrio (V. vulnificus, V. parahaemolyticus, and V. cholerae) Enterotoxigenic Escherichia coli (ETEC) LT/ST and Yersinia enterocolitica infections. Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient decisions. Positive results do not rule out co-infection with other organisms that are not detected by this test and may not be the sole or definitive cause of patient illness. Negative results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

The BD MAX™ Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel assays along with the BD MAX System are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, and extraction reagents. The instrument automates sample preparation including target lysis. DNA extraction and concentration, reagent rehydration, target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX™ System software automatically interprets test results. For the BD MAXTM Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel, a test result may be called as POS, NEG or UNR (Unresolved) based on the amplification status of the targets and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX™ System failure.

This document describes the performance evaluation of the BD MAX™ Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel when used with the BD FecalSwab™ Collection, Transport and Preservation System. The primary goal of the studies was to demonstrate substantial equivalence to the existing Cary-Blair Para-Pak® specimen collection method.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria varied across the different studies. For the user variability study, specific percentage targets were set. For the clinical evaluation, the performance was presented as Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to the Cary-Blair method.

User Variability Study Acceptance Criteria and Performance:

Clinical Evaluation Performance (FecalSwab™ vs. Cary-Blair):

*Note on Plesiomonas shigelloides retrospective PPA: The low PPA (33.3%) is due to a very small sample size of positive specimens (3 total, with only 1 detected by FecalSwab). The contrived specimen data shows 100% PPA for this pathogen.

2. Sample Size for the Test Set and Data Provenance

• Limiting Dilution LoD Study:

  • Test Set Sample Size: For each organism and each collection type (FecalSwab and Para-Pak®), 24 replicates were tested per concentration level. For Plesiomonas shigelloides, Y. enterocolitica, V. parahaemolyticus, and E. coli ETEC, one non-reportable sample in the Para-Pak® group for Conc 1 resulted in 23 replicates.
  • Data Provenance: Not explicitly stated, but likely laboratory-prepared samples.

• User Variability Study:

  • Test Set Sample Size: 12 negative samples (6 users x 2 samples), 36 low-positive samples (6 users x 2 samples x 3 panel members), and 12 moderate-positive samples (6 users x 2 samples x 1 panel member).
  • Data Provenance: Laboratory-prepared FecalSwab specimens.

• Clinical Evaluation:

  • Test Set Sample Size: 618 prospective specimens and 295 retrospective specimens were initially enrolled (Total 913). After exclusions, the final data analysis included 897 compliant subjects.
  • Data Provenance:
    • Country of Origin: Not explicitly stated, but collected from "eight (8) geographically diverse clinical centers" which typically implies within the United States for FDA submissions.
    • Retrospective/Prospective: Both. 618 prospective specimens and 295 retrospective specimens.

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

For these in vitro diagnostic assays, the "ground truth" for the clinical evaluation is based on the results from the predicate device (Cary-Blair Para-Pak® preserved stool samples tested with the BD MAX™ Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel). No human "experts" like radiologists are mentioned for establishing ground truth in this context; instead, it relies on an established laboratory method.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method in the sense of expert review for discrepancies between the FecalSwab and Cary-Blair results. The comparison is a direct statistical agreement between the two methods (FecalSwab vs. Cary-Blair). For contrived specimens, the ground truth was "expected results," implying a predefined status based on specimen preparation.

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

No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) test, not an AI imaging or diagnostic algorithm that humans would interpret in a multi-reader, multi-case setting. The evaluation focuses on the analytical and clinical performance of the assay itself.

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

Yes, the device (BD MAX™ System with the assay panels) operates in a standalone manner. The test is "automated" and produces qualitative results (POS, NEG, UNR) directly. No human interpretation of the assay results is detailed as part of the core performance, other than the system software interpreting the results.

7. The Type of Ground Truth Used

• Limiting Dilution LoD Study: The ground truth was based on the known concentration of serially diluted organisms spiked into negative stool.
• User Variability Study: The ground truth was based on the known status (negative, low-positive, moderate-positive) of laboratory-prepared panel members.
• Clinical Evaluation: The ground truth for comparing the FecalSwab™ system was the results obtained from the predicate device method (Cary-Blair Para-Pak® preserved stool samples tested with the BD MAX™ Enteric Bacterial Panel and BD MAX™ Extended Enteric Bacterial Panel). For the additional contrived specimens, the ground truth was the "expected results" (known positive or negative status of the prepared specimens).

8. The Sample Size for the Training Set

The provided text describes performance evaluation studies for substantial equivalence, focusing on validating the FecalSwab collection method. It does not mention a "training set" in the context of machine learning or AI development. The BD MAX™ assays are PCR-based in vitro diagnostic tests, which typically do not involve machine learning training sets in the same way an AI algorithm might. Their "training" or development would involve optimizing primers, probes, and reaction conditions through laboratory experiments.

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

As no "training set" in the AI sense is explicitly mentioned or relevant for this type of IVD device, this question is not applicable. The development of the assay's ability to detect specific nucleic acids relies on molecular biology principles and analytical validation, not statistical training on labeled data in the way an AI model is trained.

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The Micronics PanNAT STEC Test is a qualitative, in vitro nucleic acid amplification-based tor the simultaneous detection and identification of the stx1 and stx2 Shiga toxin genes and the O-antigen gene cluster of E.coli O157 (fc/). Testing is performed in a unitized cartridge on the PanNAT System on soft to diarrheal unpreserved or Cary-Blair preserved stool specimens from individuals with signs and symptoms of gastrointestinal infection. The PanNAT STEC Test is intended for use, in conjunction with clinical presentation, laboratory findings and epidemiological risk factors, as an aid in detection of specific Shiga-toxin expressing strains of E. coli ("STEC") from patients with diarrhea.

The results of this test should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Positive PanNAT STEC Test results do not rule out the potential for coinfection with other pathogens that are not detected by this device and may not be indicative of the sole or definitive cause of patient illness. Negative PanNAT STEC Test results in the context of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

The PanNAT System consists of the instrument with onboard software and 9-inch touchscreen used to process PanNAT STEC Test cartridges. The instrument automates all steps of the assay after sample addition to the test cartridge and insertion into the instrument; including DNA purification, nucleic acid amplification and detection of the target nucleic acid sequences using qualitative real-time PCR.

The system is a portable device that is powered by an external mains supply with a voltage range of 100-240VAC and a frequency range of 50-60 Hz. An onboard battery is included to provide power to the instrument for up to one hour in the event that mains power supply is interrupted. The instrument includes a pneumatic subsystem, a thermal control unit, fluorescent optical detectors, and software needed to process a test cartridge,

The PanNAT STEC Test cartridge is a unique, single use, disposable device in which all test reagents and controls are incorporated and all steps of the assay are performed. The PanNAT STEC Test cartridge uses a PanNAT Sample Transfer Pack accessory that contains a flocked swab, a prefilled Sample Buffer Tube and an Adaptor Cap.

There are three integrated controls for the PanNAT STEC Test: an endogenous human DNA internal process control that is coextracted and coamplified with the target nucleic acids, a negative control, and a positive control. These controls are performed automatically and do not require any action from the operator. External quality controls for the PanNAT STEC Test are also commercially available. Alternatively, laboratories may prepare their own controls.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

The document describes the PanNAT STEC Test, a qualitative, in vitro nucleic acid amplification-based test for detecting stx1, stx2 Shiga toxin genes, and the E.coli O157 O-antigen gene cluster.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or percentage format next to performance metrics. However, the results presented in the analytical and clinical performance studies implicitly serve as the demonstration of the device's ability to meet expected performance standards for diagnostic assays. I will summarize the key performance metrics from the studies provided.

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

Test Set for Reproducibility:

• Sample Size: 773 observations overall from 90 panel members (10 for each of 9 panel members evaluated in triplicate over 6+ days at each of 3 sites). Specific counts per panel member vary from 82 to 88.
• Data Provenance: The study was conducted at three sites (2 external and 1 internal). This suggests a mix of internal testing and external validation, likely within the US given the FDA submission. The data appears to be prospective in the sense of being generated specifically for the study under controlled conditions (testing coded panel members).

Test Set for Clinical Performance:

• Prospective Specimens:
  • Sample Size: 1331 prospective specimens enrolled, 1301 evaluated after initial exclusions, and 1280 (1184 Cary-Blair preserved and 96 unpreserved) qualified for agreement analysis.
  • Data Provenance: Collected at six clinical sites. Specimens were from pediatric and adult patients as part of routine patient care. This is prospective regional data.
• Retrospective Specimens:
  • Sample Size: 114 specimens initially enrolled, leading to 103 evaluable results.
  • Data Provenance: Frozen, retrospective samples. Likely collected from a broader range of past cases. This is retrospective data.
• Contrived Specimens:
  • Sample Size: 16 contrived specimens.
  • Data Provenance: Unpreserved, spiked with enumerated stocks of specific E. coli strains and tested at clinical sites. These are contrived samples.

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

The document does not explicitly state the "number of experts" or their specific qualifications (e.g., "radiologist with 10 years of experience") for establishing the ground truth.

• For Reproducibility: The ground truth was established by the composition of the coded 9-member panel, which consisted of E. coli strains with known analyte presence (stx1, stx2, O157) at low or moderate concentrations, or negative for all. This is a defined ground truth based on strain characteristics.
• For Analytical Reactivity, Specificity, Interference: The ground truth for these studies was based on the known characteristics of the microbial strains, viruses, yeast, parasites, and interfering substances used in the experiments.
• For Clinical Performance:
  • Prospective study: The ground truth was established using "standard of care testing (comparator method)" which included "an immunoassay for detection of Shiga toxins 1 and 2 following enrichment culture, and a SMAC plate for presumptive detection of O157, confirmed by latex agglutination and biochemical analysis."
  • Discordant analysis: Performed by an "independent molecular reference laboratory" using "alternative PCR and bidirectional (BDS) sequencing methods." This implies expert molecular biologists or laboratory staff established the final ground truth for discrepant cases.
  • Retrospective study: The ground truth was established by "alternative PCR (nested)/bidirectional sequencing." This also implies expert molecular biologists or laboratory staff.
  • The document doesn't specify the exact number of experts or their years of experience for these reference methods.

4. Adjudication Method for the Test Set

• For Reproducibility and Analytical Studies: No explicit "adjudication method" beyond the inherent known characteristics of the panel members and strains. For the quantitative results in reproducibility, only valid results were used for mean/SD/CV calculation.
• For Clinical Performance:
  • Prospective study: A discordant analysis was performed on discrepant samples by an independent molecular reference laboratory. This serves as an adjudication method, where the reference method's result is used to resolve discrepancies between the device and the initial standard of care comparator.
  • Retrospective study: The comparator method itself was an "alternative PCR (nested)/bidirectional sequencing," which acted as the reference standard, therefore, no separate adjudication process is described for this stage beyond the initial testing.

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

No, an MRMC comparative effectiveness study was not done.

This device is a diagnostic test (nucleic acid amplification-based assay) for pathogen detection, not an imaging device or one that relies on human interpretation for its primary output. Therefore, measuring "how much human readers improve with AI vs without AI assistance" is not applicable to this type of device. The study evaluates the device's performance against comparator methods and predefined ground truths, not assistance to human interpretation.

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 performance evaluation described focuses on the PanNAT STEC Test system (instrument and cartridges) operating autonomously after sample loading. The "PanNAT System automates all steps of the assay after sample addition to the test cartridge and insertion into the instrument." The results are displayed on the screen and stored in the instrument database. There is no human interpretation or human-in-the-loop component in the detection and reporting of results for this assay. The human interaction is limited to preparing and loading the sample.

7. The Type of Ground Truth Used

• Analytical Studies (Reproducibility, LoD, Reactivity, Specificity, Interference, Carryover):
  • Defined Ground Truth: Known concentrations of specific bacterial strains, or known presence/absence of target analytes in well-characterized cultures, viruses, yeast, parasites, and chemical substances.
• Clinical Performance Studies (Prospective and Retrospective):
  • Prospective: Initial ground truth established by "standard of care testing" (immunoassay + SMAC/latex agglutination/biochemical). Discrepant results were then adjudicated by an "independent molecular reference laboratory" using "alternative PCR and bidirectional (BDS) sequencing methods."
  • Retrospective: Ground truth established by "alternative PCR (nested)/bidirectional sequencing."
  • Contrived: Defined ground truth based on spiking known concentrations of specific strains into negative matrix.

8. The Sample Size for the Training Set

The document describes no separate "training set" in the context of an AI/ML algorithm that would undergo a distinct training phase. This device is a real-time PCR assay, not a machine learning model that is "trained" on data in the traditional sense. The data presented are for performance validation of the established PCR assay.

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

As noted above, there is no explicit "training set" for an AI/ML algorithm. The ground truth for the analytical studies and clinical studies (which act as validation data) was established as described in section 7.

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The Great Basin Stool Bacterial Pathogens Panel is a multiplexed, qualitative test for the detection and identification of DNA targets of enteric bacterial pathogens. The Stool Bacterial Pathogens Panel detects nucleic acids from:

• · Campylobacter (C. coli/C. jejuni)
• · Salmonella
• · Shiga toxin 1 (stx1)
• Shiga toxin 2 (stx2)
• · Escherichia coli serotype 0157
• Shigella

Shiga toxin genes are found in Shiga toxin-producing strains of E. coli (STEC/EHEC/VTEC) and Shigella dysenteriae. The E. coli O157 test result is only reported if a Shiga toxin gene (stx1 and/or stx2) is also detected.

The Stool Bacterial Pathogens Panel is performed directly from Cary Blair or C&S Medium preserved stool specimens from symptomatic patients with suspected acute gastroenteritis, or colitis and is performed on the Portrait™ Analyzer.

The test is intended for use as an aid in the diagnosis of gastrointestinal illness in conjunction with clinical and epidemiological information; however, it is not to be used to monitor these infection . Positive results do not rule out co-infection with other organisms and may not be the definitive cause of patient illness. Negative test results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test, or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease. Concomitant culture is necessary if organism recovery or further typing of bacterial agents is desired.

The Great Basin Stool Bacterial Pathogens Panel on the PA500 Portrait™ System utilizes automated, hot-start PCR amplification technology to amplify specific nucleic acid sequences that are then detected using hybridization probes immobilized on a modified silicon chip surface, in a single-use, self-contained test cartridge.

An aliquot of the specimen (stool preserved in stool transport media) is first processed using the Sample Preparation Device (SPD). An aliquot of the eluate obtained from the SPD is loaded into the sample port of the SBPP Test Cartridge.

Genomic DNA is extracted from microbial cells and diluted to reduce potential inhibitors of the PCR. During the PCR process, biotin-labeled primers direct the amplification of specific nucleic acid sequences within a conserved region for identification of: a bacterial sample processing control (SPC), Campylobacter coli/Campylobacter jejuni, Salmonella spp., Shiga toxin 1, Shiqa toxin 2, and E. coli serotype 0157.

Following PCR, biotin-labeled, amplified target DNA sequences are hybridized to sequence specific probes immobilized on the silicon chip surface, and incubated with antibody conjugated to the horseradish peroxidase enzyme (HRP). The unbound conjugate is washed away, and tetramethylbenzidine (TMB) is added to produce a colored precipitate at the location of the probe/target sequence complex. The resulting signal is detected by the automated Portrait™ Optical Reader within the PA500 Portrait™ Analyzer System. The SPC undergoes the same extraction, amplification, and detection steps as the sample in order to inhibitory substances, as well as process inefficiency due to instrument or reagent failure. No operator intervention is required once the sample is loaded into the sample port, and the Stool Bacterial Pathogens Panel cartridge is loaded into the Portrait™ Analyzer.

The PA500 Portrait™ Analyzer System is a fully automated system that includes: the Portrait™ Analyzer, single-use Stool Bacterial Pathogen Panel Cartridges, and the Portrait™ Data Analysis Software Program. The Portrait™ System is designed to perform automated sample preparation, PCR, and optical chip-based detection with integrated data analysis in less than two hours.

This detailed document outlines the performance characteristics of the Great Basin Stool Bacterial Pathogens Panel (SBPP). While it does not include AI-specific performance criteria, it provides a comprehensive overview of the device's analytical and clinical validation, which are analogous to acceptance criteria and study data for traditional medical devices. I will extract the relevant information and present it in the requested format, interpreting "acceptance criteria" as the performance benchmarks demonstrated in the studies and "device performance" as the results achieved.

For AI-specific questions (Adjudication method, MRMC, Standalone performance, Training set details), the document does not contain this information as it pertains to a nucleic acid-based assay and not an AI/ML-driven device. I will explicitly state "Not applicable" for these points.

Acceptance Criteria and Device Performance for Great Basin Stool Bacterial Pathogens Panel

1. Table of Acceptance Criteria and the Reported Device Performance

Since this is a diagnostic assay and not an AI-driven image analysis tool, the acceptance criteria are based on analytical and clinical performance metrics. The document describes several studies (Analytical Sensitivity, Analytical Reactivity, Analytical Specificity, Competitive Inhibition, Interfering Substances, Microbial Interference, Carry-over/Cross Contamination, Reproducibility, Specimen Stability, and Clinical Studies).

For simplicity and relevance to a typical "acceptance criteria" table for a diagnostic device, I will focus on the key performance indicators from the reproducibility and clinical studies. The implicit "acceptance criteria" are the demonstrated performance percentages, often with 95% confidence intervals where available.

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

• Clinical Test Sets:

  • Prospective Study (Fresh Samples): 1479 samples included in the analysis (1506 collected, 24 excluded). Collected from four external, geographically-diverse U.S. clinical study sites (Midwest, Northeast, Southwest and West) from July 2016 to November 2016. These were excess remnants of preserved stool samples. Prospective data.
  • Frozen Retrospective Sample Study: 150 frozen archived de-identified specimens initially (for the general panel), with specific numbers for each analyte:
    • Salmonella: 206 samples
    • Shiga Toxin 1: 206 samples
    • Shiga Toxin 2: 206 samples
    • E. coli O157: 48 samples
    • Shigella: 206 samples
      These were de-identified specimens previously characterized (historical result). Retrospective data.
  • Selected Fresh Positive Salmonella Samples Study: 28 additional fresh samples. Collected from Intermountain Healthcare (IMC) in Salt Lake City, UT. Prospective data.

• Analytical Test Sets:

  • Analytical Sensitivity (LoD): 10 bacterial strains, serially diluted.
  • Analytical Reactivity (Inclusivity): 91 well-characterized bacterial strains, multiple replicates per strain (at least 3).
  • Analytical Specificity (Exclusivity): 100 non-target organisms (84 bacterial, 3 yeast, 3 parasites, 9 viruses) and human genomic DNA, multiple replicates per organism (minimum of 3).
  • Competitive Inhibition: 48 unique combinations of pathogens, each tested in triplicate.
  • Interfering Substances: 19 different substances, tested with 8 target organisms, minimum of 3 replicates per substance/organism combination.
  • Microbial Interference: 29 non-target organisms tested in presence of 8 target analytes, minimum of 3 replicates.
  • Carry-over/Cross Contamination: 40 high positive samples and 40 negative samples (total 80 tests).
  • Reproducibility: 7 different samples tested in triplicate over 5 non-consecutive days by 6 operators, across 3 sites (90-92 replicates per positive analyte, 450 replicates for negative).

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

The document describes the ground truth for clinical samples as "standard stool culture-based methods" and "standard of care method used at the institution (historical result)," further confirmed by "FDA cleared Nucleic Acid Amplification Test (NAAT)" for retrospective samples. The experts are implicitly the microbiologists and clinical laboratory personnel at the clinical sites performing these standard methods. No specific number or explicit qualifications (e.g., years of experience) for these "experts" are provided in the document, which is typical for diagnostic assay submissions relying on established clinical laboratory practices.

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

None described. The ground truth for the clinical studies relied on standard microbiological culture methods and FDA-cleared NAATs as reference methods. Discrepant results were investigated by further testing with other FDA-cleared NAATs (BioFire Film Array GI Panel or Nanosphere Verigene® EP test). This is a discrepant analysis approach, not an adjudication process by human experts re-interpreting initial data.

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

Not applicable. This device is a molecular diagnostic assay, not an AI-driven imaging or diagnostic tool intended for human-in-the-loop assistance.

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

Yes, the device operates as a standalone automated system. The entire analytical and clinical performance evaluation described in the document represents the standalone performance of the SBPP, as it integrates sample preparation, PCR, and detection with automated software interpreting results. It is an "algorithm only" in the sense of a laboratory assay's automated result interpretation, although not a machine learning algorithm.

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

The ground truth for the clinical studies was established primarily by:

• Standard stool culture-based methods (for prospective samples).
• Historical results from clinical sites using their standard of care methods, then confirmed by FDA cleared Nucleic Acid Amplification Tests (NAATs) (for frozen retrospective samples).
• Discrepant analysis was performed using other FDA-cleared NAATs (BioFire Film Array GI Panel or Nanosphere Verigene® EP test) for unconcordant results.

Thus, the ground truth is a combination of established microbiological standards and validated molecular diagnostic tests.

8. The sample size for the training set:

Not applicable. This is a nucleic acid-based diagnostic device, not an AI/ML device that requires a "training set" in the conventional sense. The development of the assay (primer/probe design, assay conditions) would be based on scientific knowledge and wet-lab experiments, not a machine learning training data set.

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

Not applicable. See point 8. The "ground truth" for developing the assay would be pure cultures of target and non-target organisms, along with their known biochemical and genetic characteristics, established through standard microbiology laboratory practices.

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The BD MAX™ Enteric Bacterial Panel performed on the BD MAX™ System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. The BD MAX Enteric Bacterial Panel detects nucleic acids from:

• Salmonella spp. .
• Campylobacter spp. (jejuni and coli) .
• Shigella spp. / Enteroinvasive E. coli (EIEC) .
• Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes (found in Shiga toxin-producing . E. coli [STEC]) as well as Shigella dysenteriae, which can possess a Shiga toxin gene (stx) that is identical to the stx1 gene of STEC.

Testing is performed on unoreserved soft to diarrheal stool specimens or Cary-Blair preserved stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis or colitis. The test is performed directly on the specimen, utilizing real-time polymerase chain reaction (PCR) for the amplification of SpaO, a Campylobacter specific tuf gene sequence, ipaH and stx1/stx2. The test utilizes fluorogenic sequence-specific hybridization probes for detection of the amplified DNA.

This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of Salmonella, Shigella/EIEC, Campylobacter and Shiga toxin-producing E. coli (STEC) infections. Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

The BD MAX™ System and the BD MAX™ Enteric Bacterial Panel are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges. master mixes, unitized reagent strips, extraction reagents, and sample buffer tubes. The instrument automates sample preparation including target lysis, DNA extraction and concentration, reagent rehydration, and target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX™ System software automatically interprets test result may be called as POS. NEG or UNR for each of the assay's targets, based on the amplification status of the target and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX™ System failure.

Here's a breakdown of the acceptance criteria and study details for the BD MAX™ Enteric Bacterial Panel, based on the provided document:

Acceptance Criteria and Device Performance

The document describes various analytical and clinical performance studies, each with inherent acceptance criteria demonstrated by the reported results. The explicit acceptance criteria are outlined in the "Precision" section for analytical performance. For clinical performance, the acceptance is implied by the achieved PPA (Positive Percent Agreement) and NPA (Negative Percent Agreement) values with corresponding confidence intervals.

Table of Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes both Analytical Performance and Clinical Performance studies.

Analytical Performance Studies

These studies evaluate the device's technical capabilities in detecting the target pathogens.

• Sample Size Used for the Test Set and Data Provenance:
  • Precision:
    • Within-laboratory: For each of 4 different target types (Shiga toxins, Campylobacter, Shigella, Salmonella), 4 sample categories (TN, HN, LP, MP) were tested in triplicate over 12 days, with 2 runs per day. This results in 72 replicates per category per target.
    • Site-to-Site Reproducibility: 3 clinical sites were provided with 10 panels, each with 12 tubes. Each site performed the study over 5 distinct days, with 2 panels tested per day by 2 technologists. This results in 90 replicates per category per target across all sites (though specific numbers vary slightly when looking at site-by-site data for positive/negative agreement).
    • Lot-to-Lot Reproducibility: Data from 5 days of an accuracy and precision study, using 12 panel members per lot, with two users for each of two lots, was used. This equates to 90 replicates per category per target across the lots.
  • Data Provenance: Not explicitly stated as real-world patient data. These appear to be spiked samples (engineered to be near LoD, etc.) into negative stool matrix. The origin of the negative stool matrix is stated as "from patients".
• Number of Experts and Qualifications for Ground Truth: Not applicable for analytical studies, as ground truth is established by spiked concentrations of known organisms.
• Adjudication Method: Not applicable for analytical studies.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. These are analytical studies of the device's performance, not comparative effectiveness of human readers with/without AI assistance.
• Standalone Performance: Yes, these studies evaluate the standalone performance of the BD MAX™ Enteric Bacterial Panel system.
• Type of Ground Truth Used: For precision and reproducibility, known concentrations of target strains were used (e.g., "5 CFU/mL" for HN, "≥1 and

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