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The QIAstat-Dx Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid real-time PCR based in vitro diagnostic test intended for use with the QIAstat-Dx Analyzer 1.0. The QIAstat-Dx ME Panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids from cerebrospinal fluid (CSF) specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis.

The following organisms are identified using the OlAstat-Dx ME Panel: Enterovirus, Escherichia coli K1, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitidis (encapsulated), Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, and Cryptococcus neoformans/gattii*.

The QIAstat-Dx ME Panel is indicated as an aid in the diagnosis of meningitis and/or encephalitis and results must be used in conjunction with other clinical, endemiological, and laboratory data. Results from the OlAstat-Dx ME Panel are not intended to be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with organisms not included in the QIAstat-Dx ME Panel. The agents detected may not be the definite cause of the disease. Negative results do not preclude central nervous system infection.

Not all agents of central nervous system infection are detected by this test and sensitivity in clinical use may differ from that described in the instructions for use.

The QIAstat-Dx ME Panel is not intended for testing specimens collected from indwelling central nervous system medical devices.

The QIAstat-Dx ME Panel is intended to be used in conjunction with standard of care culture for organism recovery, serotyping, and antimicrobial susceptibility testing.

*Cryptococcus neoformans and Cryptococcus gattii are not differentiated.

The QIAstat-Dx® Meningitis/Encephalitis (ME) Panel is part of the QIAstat-Dx Meningitis/Encephalitis system and works with the OIAstat-Dx Analyzer 1.0.

The QIAstat-Dx ME Panel is intended to be used with cerebrospinal fluid (CSF) specimens.

Once the cartridge has been inserted into the instrument, the test starts automatically and runs for approximately 80 minutes. When the test is finished, the cartridge is removed by the user and discarded. The OIAstat-Dx Analyzer 1.0 automatically interprets test results and displays a summary on the analyzer display screen. The results can be printed using a connected printer, if needed. The detected analytes are displayed in red. For other analytes tested, they are displayed in green if not detected or in gray if not applicable or invalid. The analyzer will report if an error occurs during processing, in which case the test will fail and no results will be provided (screen will show "FAIL").

QIAstat-Dx consists of single-test cartridges with pre-packaged reagents including both wet and dry chemistry necessary to perform the sample preparation, nucleic acid amplification and detection to be used in conjunction with the QIAstat-Dx Analyzer 1.0. All sample preparation and assay steps are performed within the cartridge, so the user does not need to manipulate any reagent during the test. This eliminates exposure of the user or the Analyzer to chemicals contained in the cartridge during the test and up to the disposal of used cartridges.

Within the cartridge, multiple steps are automatically performed in sequence by using pneumatic pressure and a multiport valve to transfer the sample and fluids via the Transfer Chamber (TC) to their intended destinations. Following the introduction of the sample from a disposable transfer pipette, the following assay steps occur automatically and sequentially:

• Resuspension of air-dried internal control and Proteinase K (ProtK) enzyme using . provided buffer and mixing with the liquid sample (IC Cavity and ProtK Cavity);
• Cell lysis using mechanical (rotation) and chemical (chaotropic and isotonic) ● means (lysis chamber):
• Membrane-based nucleic acid purification from Lysate by: ●
  • Mixing lysate with binding buffer and capturing on the membrane -(purification chamber);
  • First washing of membrane to remove bound proteins (purification chamber and waste chamber);
  • Second washing of membrane to leave only bound nucleic acids -(purification chamber and waste chamber);
  • Rinsing of Transfer Chamber (TC) using the rinsing buffer before introduction of the eluate (Transfer Chamber);
• Drying of membrane with bound nucleic acids with an air flow generated by a high flow vacuum pump (purification chamber); and
  • Elution of nucleic acids with elution buffer (purification chamber and TC);
• Mixing of the purified nucleic acid (eluate) with lyophilized "Master Mix" reagents ● (Dry chemistry container (DCC) and TC);
• Sequential transfer of defined aliquots of mixed eluate/Master Mix from the ● Transfer Chamber to each of eight Reaction Chambers containing the specified, airdried primers and probes;
• Within each Reaction Chamber, real-time, multiplex PCR ("rtPCR") testing is ● performed. Increase in fluorescence (indicative of detection of each target analyte) is detected directly within each Reaction Chamber; and
• The detected signal per fluorescent marker per Reaction Chamber is then used by the system software to generate the assay result.

The provided document is a 510(k) Summary for the QIAGEN GmbH QIAstat-Dx Meningitis/Encephalitis (ME) Panel. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria (i.e., predefined thresholds for sensitivity and specificity). However, it reports sensitivity (Positive Percent Agreement - PPA) and specificity (Negative Percent Agreement - NPA) values from its clinical performance study. The reported performance is implicitly the "met acceptance criteria" as the device received 510(k) clearance.

Here's a summary of the clinical performance for each pathogen from the prospective clinical study (Table 16), which represents the primary evidence for diagnostic performance:

Additionally, for contaminants that were confirmed by culture (fungal and bacterial), in table 19 and 20:

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

• Test Set (Clinical Performance Study):
  • Prospective Specimens: 1524 evaluable specimens.
    • 552 (36.2%) were frozen before testing.
    • 972 (63.8%) were tested fresh.
  • Archived Specimens: 41 evaluable archived specimens (from an initial 195 collected).
  • Contrived Specimens: Not specified as a "test set" in the context of clinical performance, but used to supplement for rare analytes.
    • Ranges from 79 to 96 samples per pathogen, tested at 2xLoD and 5xLoD (e.g., Cryptococcus neoformans/gattii had 79 samples). These were likely individual spiked samples.
• Data Provenance:
  • Country of Origin: 13 geographically diverse clinical sites across 4 countries (10 U.S. sites and 3 European sites).
  • Retrospective/Prospective: The study included both prospective (March 2022 to March 2023) and retrospective (archived) specimens.

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" used to establish ground truth or their specific qualifications (e.g., radiologist with X years of experience).

Instead, the ground truth for the clinical performance study was established using:

• An FDA-cleared molecular comparator method.
• Two validated end point PCRs followed by bidirectional sequencing (BDS) for Streptococcus pneumoniae and Streptococcus pyogenes.
• Standard of Care (SoC) testing, which varied across sites and included bacterial culture, Laboratory Developed PCR tests (LDT), FDA-cleared molecular methods, and Cryptococcus antigen screen and culture.
• Discrepancy investigations were conducted for discordant results, implying a review process, but details on who performed this review are not given.

4. Adjudication Method for the Test Set

The document mentions that discrepancies between the QIAstat-Dx ME Panel and the comparator methods were investigated. This implies an adjudication process was in place to determine the true positive/negative status for discordant results. However, the specific method (e.g., 2+1, 3+1, none) is not explicitly described. The footnotes in Table 16 (Clinical Performance) provide details on how some discordant cases were resolved (e.g., "no organisms were detected with resolution method PCR/BDS," "negative result was confirmed positive with SoC culture and LDT result was positive").

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This device is an in vitro diagnostic (IVD) test for nucleic acid detection, not an imaging AI device that assists human readers.

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

Yes, a standalone performance study was done. The entire clinical performance study (Prospective, Archived, and Contrived Specimens Testing) evaluates the performance of the QIAstat-Dx ME Panel (the algorithm/device) directly against comparator methods (other molecular tests, culture, PCR/BDS), without a human-in-the-loop component. The device generates results automatically, and its accuracy is assessed based on these outputs.

7. Type of Ground Truth Used

The ground truth for the clinical performance studies was established using a combination of:

• FDA-cleared molecular comparator method.
• Validated end point PCRs followed by bidirectional sequencing (BDS).
• Standard of Care (SoC) culture (for bacterial and fungal analytes).
• Laboratory-Developed PCR tests (LDT).
• Discrepancy investigations where discordant results were resolved using additional testing.

For the contrived specimens, the ground truth was known by design, as the samples were intentionally spiked with quantified strains.

8. Sample Size for the Training Set

The document does not provide details about a specific "training set" sample size for the QIAstat-Dx ME Panel. As an IVD based on real-time PCR, its "training" is typically in the form of analytical validation and optimization during its development, rather than machine learning model training with a distinct training dataset. The studies described are primarily for clinical performance validation, demonstrating the device's accuracy in a real-world setting.

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

Since a dedicated "training set" for a machine learning model is not described, the concept of establishing ground truth for it is not applicable here in the conventional sense of AI/ML. The analytical validation studies (Limit of Detection, Analytical Reactivity/Inclusivity, Analytical Specificity/Exclusivity, etc.) involved known concentrations and strains of pathogens (e.g., ATCC strains, commercial stocks) in artificial or negative clinical CSF. The "ground truth" for these analytical studies was based on the known composition and concentration of these prepared samples.

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The DiaSorin Molecular Simplexa™ VZV Direct assay is intended for use on the LIAISON® MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF) from patients signs and/or symptoms of meningitis and/or encephalitis. This test is intended as an aid in the diagnosis of VZV infections of the central nervous system (CNS).

Negative results do not preclude VZV infection and should not be used as the sole basis for treatment or other patient management decisions.

The assay is not intended for use as a donor screening test. The assay is for professional use only.

The Simplexa™ VZV Positive Control Pack is intended to be used as a control with the Simplexa™ VZV Direct kit.

This control is not intended for use with other assays or systems.

The Simplexa™ VZV Direct assay is a real-time polymerase chain reaction (PCR) system that enables the direct amplification and detection of VZV DNA from unprocessed cerebral spinal fluid (CSF) specimens without nucleic acid extraction. The system consists of the Simplexa™ VZV Direct assay, the LIAISON® MDX (with LIAISON® MDX Studio Software), the Direct Amplification Disc and associated accessories. In the Simplexa™ VZV Direct assay, fluorescent probes are used together with corresponding forward and reverse primers to amplify VZV and internal control targets. A well-conserved region of the VZV DNA polymerase gene is targeted to identify VZV DNA in the specimen. An internal control is used to detect PCR failure and/or inhibition.

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

Acceptance Criteria and Device Performance for Simplexa™ VZV Direct Assay

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" as a set of predefined thresholds. Instead, it presents performance metrics from various studies. Based on the provided clinical agreement study, the implicit acceptance criteria for clinical performance would likely be a high Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA). For analytical performance, the LoD is a key metric.

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

• Sample Size (Clinical):
  • Prospective Samples: 637 clinical samples.
  • Contrived Samples: 240 contrived VZV positive samples.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the submission is to the U.S. FDA by a company in Cypress, California, USA, and the testing was performed at "testing sites" and "DiaSorin Molecular, Cypress, CA", suggesting U.S.-based data.
  • Retrospective or Prospective: The study included both:
    • Prospective and prospectively banked collections from eight (8) collection sites (February 2018 to November 2018).
    • Contrived samples were used to supplement low prevalence true positive clinical samples.

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

Not applicable. This device is an in vitro diagnostic (IVD) based on molecular detection. Ground truth for diagnostic assays like this is typically established by comparative methods rather than expert human interpretation of images or other subjective data. No human "experts" were used to establish the ground truth in the sense of clinical decision-making from images.

4. Adjudication Method for the Test Set

Not applicable in the sense of expert human review (e.g., 2+1, 3+1). The ground truth for the clinical samples was established using a composite reference method:

• Two (2) validated real-time PCR assays.
• Followed by confirmation of positive PCR amplification products with bi-directional sequencing.
• Decision Rule: Samples were characterized as positive if one (1) or both PCR assays were positive AND confirmed by bi-directional sequencing. Samples were characterized as negative if both PCR assays were negative.

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

No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) designed for laboratory use to detect VZV DNA. Its performance is evaluated against reference methods, not against human readers (e.g., radiologists, pathologists). Therefore, improvement for human readers with AI assistance is not applicable in this context.

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

Yes, the primary performance studies presented focus on the standalone performance of the Simplexa™ VZV Direct assay. The "Clinical Agreement" section directly compares the Simplexa™ VZV Direct results to the composite reference method without explicit human intervention in the interpretation of the Simplexa™ VZV Direct results. The assay is an automated real-time PCR system.

7. Type of Ground Truth Used

The ground truth for the clinical agreement study was established using a composite reference method. This method involved:

• Two (2) validated real-time PCR assays.
• Confirmation of positive PCR amplification products with bi-directional sequencing.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI models. This device is an in vitro diagnostic (IVD) based on real-time PCR technology, which relies on molecular biology principles (primers and probes) rather than machine learning models that require distinct training and test sets. The assay design and optimization would involve internal development and validation, but not typically a "training set" in the AI sense.

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

Not applicable, as a "training set" for an AI model is not described or relevant for this type of molecular diagnostic device. The analytical characteristics and design of the PCR assay (e.g., primer and probe specificity) are established through various analytical studies (e.g., analytical sensitivity, specificity, cross-reactivity) rather than a ground-truthed training set for machine learning.

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The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray, FilmArray Torch systems. The FilmArray ME Panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids directly from cerebrospinal fluid (CSF) specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis. The following organisms are identified using the FilmArray ME Panel:

Bacteria:

• · Escherichia coli K 1
• · Haemophilus influenzae
• · Listeria monocytogenes
• · Neisseria meningitidis (encapsulated)
• · Streptococcus agalactiae
• Streptococcus pneumoniae

Viruses:

• · Cytomegalovirus
• · Enterovirus
• Herpes simplex virus 1
• Herpes simplex virus 2
• · Human herpesvirus 6
• Human parechovirus
• Varicella zoster virus

Yeast:

• · Cryptococcus neoformans/gattii
  The FilmArray ME Panel is indicated as an aid in the diagnosis of meningitis and/or encephalitis and results are meant to be used in conjunction with other clinical, epidemiological, and laboratory data. Results from the FilmArray ME Panel are not intended to be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with organisms not included in the agent detected may not be the definite cause of the disease. Negative results do not preclude central nervous system (CNS) infection. Not all agents of CNS infection are detected by this test and sensitivity in clinical use may differ from that described in the package insert.

The FilmArray ME Panel is not intended for testing of specimens collected from indwelling CNS medical devices.

The FilmArray ME Panel is intended to be used in conjunction with standard of care culture for organism recovery, serotyping, and antimicrobial susceptibility testing.

The FilmArray Meningitis/Encephalitis (ME) Panel is a multiplex nucleic acid test designed to be used with FilmArray systems. The FilmArray ME pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex PCR with DNA melt analysis. The FilmArray Meningitis/Encephalitis (ME) Panel simultaneously conducts 14 tests for the identification of potential CNS pathogens from CSF specimens obtained via lumbar puncture (Table 1). Results from the FilmArray ME Panel test are available within about one hour.

A test is initiated by loading Hydration Solution into one port of the FilmArray pouch and a CSF sample mixed with the provided Sample Buffer into the other port of the FilmArray ME pouch and placing it in the FilmArray Instrument. The pouch contains all of the reagents required for specimen testing and analysis in a freeze-dried format; the addition of Hydration Solution and Sample/Buffer Mix rehydrates the reagents. After the pouch is prepared, the FilmArray Software guides the user through the steps of placing the instrument, scanning the pouch barcode, entering the sample identification, and initiating the run.

The FilmArray instrument contains a coordinated system of inflatable bladders and seal points, which act on the pouch to control the movement of liquid between the pouch blisters. When a bladder is inflated over a reagent blister, it forces liquid from the blister into connecting channels. Alternatively, when a seal is placed over a connecting channel it acts as a valye to open or close a channel. In addition, electronically controlled pneumatic pistons are positioned over multiple plungers in order to deliver the rehydrated reagents into the blisters at the appropriate times. Two Peltier devices control heating and cooling of the pouch to drive the PCR reactions and the melt curve analysis.

Nucleic acid extraction occurs within the FilmArray pouch using mechanical and chemical lysis followed by purification using standard magnetic bead technology. After extracting and purifying nucleic acids from the unprocessed sample, a nested multiplex PCR is executed in two stages. During the first stage, a single, large volume, highly multiplexed reverse transcription PCR (rt-PCR) reaction is performed. The products from first stage PCR are then diluted and combined with a fresh, primer-free master mix and a fluorescent double stranded DNA binding dye (LC Green® Plus, BioFire Defense, LLC). The solution is then distributed to each well of the array. Array wells contain sets of primers designed specifically to amplify sequences internal to the PCR products generated during the first stage PCR reaction. The 21d stage PCR, or nested PCR, is performed in each well of the array. At the conclusion of the 21d stage PCR, the array is interrogated by melt curve analysis for the detection of signature amplicons denoting the presence of specific targets. A digital camera placed in front of the array captures fluorescent images of the PCR2 reactions and software interprets the data.

The FilmArray software automatically interprets the results of each DNA melt curve analysis and combines the data with the results of the internal pouch controls to provide a test result for each organism on the panel.

Here's the breakdown of the acceptance criteria and study information for the FilmArray Meningitis/Encephalitis (ME) Panel when used with the FilmArray Torch system, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a table format with specific thresholds. Instead, it describes performance in terms of reproducible detection at LoD (Limit of Detection) and agreement with expected negative results.

Note: The acceptance criteria in the "Implied" column are based on common industry practices for diagnostic assay performance and reproducibility, as the document doesn't provide explicit numerical targets directly labeled as "acceptance criteria."

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

• Sample Size: 30 replicates per analyte per system, tested on three complete FilmArray Torch systems, resulting in a total of 90 replicates per analyte.
• Data Provenance: The study involved contrived samples containing each FilmArray ME Panel analyte at low positive levels (1x LoD) and expected negative results. The document does not specify the country of origin, but given the submission to the FDA, it's likely the testing was conducted in the US. This was a prospective study, as samples were specifically prepared and tested to evaluate the new instrument.

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

The document does not mention the use of experts to establish ground truth for this particular study. The ground truth for the test set was established by the contrived nature of the samples, meaning the researchers intentionally prepared samples with known positive (at 1x LoD) and negative results.

4. Adjudication Method for the Test Set

Since the ground truth was established by preparing contrived samples with known concentrations (1x LoD) or known absence of analytes, there was no adjudication method described or necessary. The "ground truth" was inherent in the sample preparation.

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

No, an MRMC comparative effectiveness study was not done. This study focused on verifying the performance of the existing FilmArray ME Panel when used with a new instrument system (FilmArray Torch). It was not designed to assess human reader performance with or without AI assistance.

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

Yes, a standalone performance study was done. The described performance evaluation tests the FilmArray ME Panel (an in vitro diagnostic device with an automated test interpretation algorithm) on the FilmArray Torch system directly. The results are automatically interpreted by the FilmArray software, and the user "cannot access raw data," indicating an algorithm-only or standalone performance evaluation.

7. The Type of Ground Truth Used

The ground truth used was based on contrived samples with known positive (1x LoD) and negative results. This is a form of analytical truth established by precise sample preparation.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for the training set. This K160462 submission is for a special 510(k) to add a new instrument (FilmArray Torch) for an already cleared device (FilmArray ME Panel, cleared under DEN150013). Therefore, the reagent kit and its underlying algorithm were presumably developed and trained prior to this submission, and that information is not detailed here.

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

Similarly, the document does not describe how the ground truth for the training set was established. This information would have been part of the original 510(k) submission (DEN150013) for the FilmArray ME Panel itself, which is not provided in this excerpt.

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The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray and FilmArray 2.0 systems. The FilmArray ME Panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids directly from cerebrospinal fluid (CSF) specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis. The following organisms are identified using the FilmArray ME Panel:

Bacteria:
Escherichia coli K1 Haemophilus influenzae Listeria monocytogenes Neisseria meningitidis (encapsulated) Streptococcus agalactiae Streptococcus pneumoniae

Viruses: Cytomegalovirus Enterovirus Herpes simplex virus 1 Herpes simplex virus 2 Human herpesvirus 6 Human parechovirus Varicella zoster virus
Yeast:

Cryptococcus neoformans/gattii

The FilmArray ME Panel is indicated as an aid in the diagnosis of specific agents of meningitis and/or encephalitis and results are meant to be used in conjunction with other clinical, epidemiological, and laboratory data.

Results from the FilmArray ME Panel are not intended to be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with organisms not included in the FilmArray ME Panel. The agent detected may not be the definite cause of the disease. Negative results do not preclude central nervous system (CNS) infection. Not all agents of CNS infection are detected by this test and sensitivity in clinical use may differ from that described in the package insert.

The FilmArray ME Panel is not intended for testing of specimens collected from indwelling CNS medical devices.

The FilmArray ME Panel is intended to be used in conjunction with standard of care culture for organism recovery, serotyping, and antimicrobial susceptibility testing.

The FilmArray ME Panel is a multiplex nucleic acid-based test designed to be used with FilmArray or FilmArray 2.0 system ("FilmArray systems" or "FilmArray instruments"). The FilmArray ME panel includes a FilmArray ME Panel pouch which contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex polymerase chain reaction (PCR) with DNA melt analysis. The FilmArray ME Panel simultaneously conducts 14 tests for the identification of potential CNS pathogens from CSF specimens obtained via lumbar puncture. Results from the FilmArray ME Panel are available within about one hour.

A test is initiated by loading Hydration Solution into one port of the pouch and a CSF sample mixed with the provided Sample Buffer ampoules into the other port of the pouch and placing it in the FilmArray Instrument. The pouch contains all of the reagents required for specimen testing and analysis in a freeze-dried format; the addition of Hydration Solution and the Sample Buffer rehydrates the reagents. After the pouch is prepared, the FilmArray Software on the FilmArray systems guides the user though the steps of placing the instrument, scanning the pouch barcode, entering the sample identification, and initiating the run on the FilmArray systems.

The FilmArray instruments contain a coordinated system of inflatable bladders and seal points, which act on the pouch to control the movement of liquid between the pouch blisters. When a bladder is inflated over a reagent blister, it forces liquid from the blister into connecting channels. Alternatively, when a seal is placed over a connecting channel it acts as a valve to open or close a channel.

Nucleic acid extraction occurs within the pouch using mechanical and chemical lysis followed by purification using standard magnetic bead technology. After extracting and purifying nucleic acids from the unprocessed sample, a nested multiplex PCR is executed in two stages. The solution is then distributed to each well of the array. Array wells contain sets of primers designed specifically to amplify sequences internal to the PCR products generated during the first stage PCR reaction. The 2nd stage PCR, or nested PCR, is performed in each well of the array. At the conclusion of the 2nd stage PCR, the array is interrogated by melt curve analysis for the detection of signature amplicons denoting the presence of specific targets. A digital camera placed in front of the array captures fluorescent images of the PCR2 reactions and software interprets the data.

The FilmArray software automatically interprets the results of each DNA melt curve analysis and combines the data with the results of the internal pouch controls to provide a test result for each organism on the panel.

This document describes the evaluation of the FilmArray Meningitis/Encephalitis (ME) Panel for a De Novo classification. It includes information on analytical and clinical studies to demonstrate the device's performance.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as strict numerical thresholds in the provided text for all performance metrics. However, they are implied through the detailed reporting of study results and statements like "The overall success rate for initial specimen tests in the prospective study was 98.9%" or "Overall PPA for clinical and contrived specimens combined was 97.5% with the lower bound of the two-sided 95% confidence interval (95% CI) at 92.9%, and overall NPA was 99.7% with the lower bound of the two-sided 95% CI at 99.3%." For analytical studies, acceptance criteria like "a minimum of 9/10 replicates detected" for specimen stability or "Delta Tm values between the two systems were less than or equal to 0.4℃... passed the study acceptance criteria of less than 0.5℃" are explicitly mentioned.

For the purpose of this table, I will use the clinical performance reported as the "device performance" and extract the implied acceptance criteria where possible.

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