The Influenza A/B Typing Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an in vitro diagnostic real-time PCR instrument that has been FDA-cleared for use with this kit in conjunction with clinical and epidemiological information:

• For qualitative detection of influenza virus type A or B viral RNA in upper respiratory tract clinical specimens (including nasopharyngeal swabs [NPS], nasal swabs [NS], throat swabs [TS], nasal aspirates [NA], nasal washes [NW] and dual nasopharyngeal/throat swabs [NPS/TS]) and lower respiratory tract specimens (including bronchoalveolar lavage [BAL], bronchial wash [BW], tracheal aspirate [TA], sputum, and lung tissue) from human patients with signs and symptoms of respiratory infection and/or from viral culture.

• To provide epidemiological information for surveillance of circulating influenza viruses.

Performance characteristics for influenza were established during a season when seasonal influenza viruses A(H1N1) and A(H3N2) were the predominant influenza A viruses in circulation and during a season when the A(H1N1)pdm09 influenza virus was the predominant influenza A virus in circulation. Performance characteristics may vary with other emerging influenza A viruses.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted unless a BSL 3E facility is available to receive and culture specimens.

CDC Human Influenza Real-Time RT-PCR Diagnostic Panel: Influenza A Subtyping Kit (VER 4)

The Influenza A Subtyping Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an in vitro diagnostic real-time PCR instrument that has been FDA-cleared for use with this kit in conjunction with clinical and epidemiological information:

• For determination of the subtype of seasonal human influenza A viruses as seasonal A(H3) and/or A(H1)pdm09 from viral RNA in upper respiratory tract clinical specimens (including nasopharyngeal swabs [NPS], nasal swabs [NS], throat swabs [TS], nasal aspirates [NA], nasal washes [NW] and dual nasopharyngeal/throat swabs [NPS/TS]) and lower respiratory tract specimens (including bronchoalveolar lavage [BAL], bronchial wash [BW], tracheal aspirate [TA], sputum, and lung tissue) from human patients with signs and symptoms of respiratory infection and/or from viral culture;

• To provide epidemiological information for surveillance of circulating influenza viruses.

Performance characteristics for influenza were established during a season when seasonal influenza viruses A(H1N1) and A(H3N2) were the predominant influenza A viruses in circulation and during a season when the A(H1N1)pdm09 influenza virus was the predominant influenza A virus in circulation. Performance characteristics may vary with other emerging influenza A viruses.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted unless a BSL 3E facility is available to receive and culture specimens.

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit (VER 1.1 and 2)

The Influenza B Lineage Genotyping Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an in vitro diagnostic real-time PCR instrument that has been FDA-cleared for use with this kit in conjunction with clinical and epidemiological information:

• For the determination of the genetic lineage of human influenza B viruses as B/Victoria or B/Yamagata lineage from viral RNA in upper respiratory tract clinical specimens (including nasopharyngeal swabs [NPS], nasal swabs [NS], throat swabs [TS], nasal aspirates [NA], nasal washes [NW] and dual nasopharyngeal/throat swabs [NPS/TS]) from human patients with signs and symptoms of respiratory infection and/or from viral culture;

• To provide epidemiologic information for surveillance of circulating influenza viruses.

Performance characteristics for influenza B lineage genotyping were established during a season when influenza B/Victoria and B/Yamagata lineages were in circulation.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/H5 Subtyping Kit (VER 4)

The Influenza A/H5 Subtyping Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an in vitro diagnostic real-time PCR instrument that has been FDA-cleared for use with this kit in conjunction with clinical and epidemiological information:

• For the presumptive identification of virus in patients who may be infected with influenza A subtype A(H5) (Asian lineage) from viral RNA in human respiratory specimens, conjunctival swabs, and viral culture in conjunction with clinical and epidemiological risk factors;

• To provide epidemiologic information for surveillance of circulating influenza viruses.

Performance characteristics for influenza were established during a season when seasonal influenza viruses A(H1N1) and A(H3N2) were the predominant influenza A viruses in circulation and during a season when the A(H1N1)pdm09 influenza virus was the predominant influenza A virus in circulation. Performance characteristics may vary with other emerging influenza A viruses.

Testing with the influenza H5a and H5b primer and probe sets should not be performed unless the patient meets the most current U.S.Department of Health and Human Services (DHHS) clinical and epidemiologic criteria for testing suspect A(H5) specimens. The definitive identification of influenza A(H5) (Asian lineage) either directly from patient specimens or from virus cultures requires additional laboratory testing, along with clinical and epidemiological assessment in consultation with national influenza surveillance experts.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted unless a BSL 3E facility is available to receive and culture specimens.

The CDC Human Influenza Real-Time RT-PCR Diagnostic Panel is used in real-time RT-PCR (rRT-PCR) assays on an in vitro diagnostic real-time PCR instrument that has been FDA-cleared for use with the CDC device. The panel is configured in four separate kits. Each kit consists of oligonucleotide primers, fluorescently labeled hydrolysis probes, and controls which are used in rRT-PCR assays for the in vitro qualitative detection and characterization of influenza virus RNA in respiratory specimens from patients presenting with influenza-like illness (ILI) or from viral culture.

Oligonucleotide primers and probes for detection of influenza A, influenza B, and influenza A of swine origin were selected from highly conserved regions of the matrix (M), non-structural (NS), and nucleoprotein (NP) genes, respectively. Oligonucleotide primers and probes for characterization and differentiation of influenza A(H3) and A(H1)pdm09 viruses, avian influenza A(H5) viruses, and genetic lineages of influenza B were selected from highly conserved regions of their hemagglutinin (HA) genes. Oligonucleotide primers and probes to detect the human RNase P gene (RP) in control samples and clinical specimens is also included in the panel.

The provided document, K243274: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, is an FDA 510(k) clearance letter. This document primarily describes the device, its intended use, and confirms its substantial equivalence to a previously cleared predicate device (K243931). Critically, it states that no analytical or clinical testing was performed for this specific modification, as the submission was to add a Predetermined Change Control Plan (PCCP).

Therefore, the document does not contain the detailed study results, acceptance criteria, sample sizes, ground truth establishment, or expert involvement for the original validation of the device's performance. It explicitly states that "The performance characteristics of the CDC Flu rRT-PCR Dx Panel... were previously established and remain the same as the predicate device (K243931)."

As such, I cannot provide the specific information requested in the prompt based on the provided text alone. The prompt asks for details of "the device" meeting acceptance criteria, and this document pertains to a modification that did not involve re-evaluating performance.

However, I can interpret what would typically be sought for such an analysis in the context of an in vitro diagnostic (IVD) PCR panel like the one described. I will outline what the acceptance criteria and the study that proves the device meets them would likely entail for an IVD, but with the explicit understanding that the provided document does not contain these details.

Based on the provided document, the device's performance characteristics were "previously established" for the predicate device (K243931) and are simply carried over here as "remaining the same." The current submission (K243274) is for adding a Predetermined Change Control Plan (PCCP) and states that "No analytical testing was performed for this modification" and "No clinical testing was performed for this modification."

Therefore, the detailed information regarding acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth establishment for the original validation of this device is NOT present in the provided text. The tables and descriptions below represent what would typically be expected for an FDA cleared RT-PCR diagnostic panel, assuming the original studies were conducted to industry standards, but are not extracted directly from the given document.

Acceptance Criteria and Device Performance (Hypothetical for an RT-PCR IVD)

For a real-time RT-PCR diagnostic panel like the CDC Human Influenza Virus Panel, acceptance criteria and performance would typically focus on analytical sensitivity (Limit of Detection - LoD), analytical specificity (cross-reactivity, inclusivity), and clinical performance (sensitivity, specificity).

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical)

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CDC Human Influenza Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2)

The Influenza A/B Typing Kit contains reagents and controls of the CDC Human Influenza Virus RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an in vitro diagnostic real-time PCR instrument that has been FDA-cleared for use with this kit in conjunction with clinical and evidemiological information:

· For qualitative detection of influenza virus type A or B viral RNA in upper respiratory tract clinical specimens (including nasopharyngeal swabs [NPS], throat swabs [TS], nasal aspirates [NA], nasal washes [NW and dual nasopharyngeal/throat swabs [NPS/TS]) and lower respiratory tract specimens (including bronchoalveolar lavage [BAL], bronchial wash [BW], tracheal aspirate [TA], sputum, and lung tissue) from human patients with signs and symptoms of respiratory infection and/or from viral culture.

· To provide epidemiological information for surveillance of circulating influenza viruses.

CDC Human Influenza Real-Time RT-PCR Diagnostic Panel: Influenza A Subtyping Kit (VER 4)

The Influenza A Subtyping Kit contains reagents and controls of the CDC Human Influenza Virus RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an in vitro diagnostic real-time PCR instrument that has been FDA-cleared for use with this kit in conjunction with clinical and epidemiological information:

· For determination of the subtype of seasonal human influenza A viruses as seasonal A(H3) and/or A(H1)pdm09 from viral RNA in upper respiratory tract clinical specimens (including nasopharyngeal swabs [NS], throat swabs [TS], nasal aspirates [NA], nasal washes [NW] and dual nasopharyngeal/throat swabs [NPS/TS]) and lower respiratory tract specimens (including bronchoalveolar lavage [BAL], bronchial wash [BW], tracheal aspirate [TA], sputum, and lung tissue) from human patients with signs and symptoms of respiratory infection and/or from viral culture:

· To provide epidemiological information for surveillance of circulating influenza viruses.

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit (VER 1.1 and 2)

The Influenza B Lineage Genotyping Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an in vitro diagnostic realtime PCR instrument that has been FDA-cleared for use with this kit in conjunction with clinical and epidemiological information:

• For the determination of the genetic lineage of human influenza B viruses as B/Victoria or B/Yamagata lineage from viral RNA in upper respiratory tract clinical specimens (including nasopharyngeal swabs [NS], throat swabs [TS], nasal aspirates [NA], nasal washes [NW] and dual nasopharyngeal/throat swabs [NPS/TS]) from human patients with signs and symptoms of respiratory infection and/or from viral culture;

· To provide epidemiologic information for surveillance of circulating influenza viruses.

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/H5 Subtyping Kit (VER 4)

The Influenza A/H5 Subtyping Kit contains reagents and controls of the CDC Human Influenza Virus RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an in vitro diagnostic real-time PCR instrument that has been FDA-cleared for use with this kit in conjunction with clinical and epidemiological information:

· For the presumptive identification of virus in patients who may be infected with influenza A subtype A(H5) (Asian lineage) from viral RNA in human respiratory specimens, conjunctival swabs, and viral culture in conjunction with clinical and epidemiological risk factors;

· To provide epidemiologic information for surveillance of circulating influenza viruses.

The CDC Human Influenza Real-Time RT-PCR Diagnostic Panel consists of four real-time RT-PCR (rRT-PCR) assays used on IVD-labeled real-time PCR instruments that has been FDA-cleared for use with this device. The panel is configured in four separate kits: Influenza A/B Typing kit, Influenza A/H5 Subtyping kit, and Influenza B Genotyping kit. Each kit consists of oligonucleotide primers, fluorescently labeled hydrolysis probes, and controls which are used in rRT-PCR assays for the in vitro qualitative detection of influenza virus RNA in respiratory and conjunctival specimens from patients presenting with influenza-like illness (IL). Oligonucleotide primers and probes for detection of influenza A, influenza B, and 2009 influenza A (swine origin) were selected from highly conserved regions of the matrix (M), non-structural (NS), and nucleoprotein (NP) genes, respectively. Oligonucleotide primers and probes for characterization and differentiation of influenza A(H3) and A(H1)pdm09 viruses, genetic lineages of influenza A(H5) viruses were selected from highly conserved regions of their HA genes. Oligonucleotide primers and probes to detect the human RNase P gene (RP) in control samples and clinical specimens are also included in the panel.

The provided text describes the acceptance criteria and study proving the device meets those criteria for the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/H5 Subtyping Kit (VER 4), specifically concerning the addition of conjunctival swabs as a specimen type.

Here’s a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly present a table of acceptance criteria in terms of specific quantitative thresholds (e.g., minimum sensitivity/specificity percentages) for clinical performance. Instead, it describes an evaluation based on demonstrating successful detection capabilities and similarity to a predicate device. The performance is reported descriptively based on the clinical study results.

Reported Device Performance (for Influenza A/H5 Subtyping Kit (VER 4) on conjunctival swabs):

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

• Clinical Test Set Sample Size:
  • 46 total cases (44 confirmed, 2 probable) initially considered.
  • 35 confirmed cases were assessed for performance due to exclusion of 9 cases where not all necessary assay reagents were used.
  • 2 probable cases were assessed.
  • The document also specifies the number of clinical specimens available for testing: e.g., 32 confirmed cases had subject-matched paired URT and CS specimens, 3 confirmed cases had only CS specimens, 1 probable case had subject-matched paired URT and CS specimens, and 1 probable case had only a CS specimen.
• Data Provenance:
  • Country of Origin: US (from public health investigations in the US).
  • Retrospective or Prospective: The data was collected from specimens from March to November 2024 as part of public health investigations into outbreaks. This indicates a retrospective collection of existing specimens from human cases.

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

• The ground truth for confirmed/probable cases of A/H5N1 was established based on "the criteria described in the current Council of State and Territory Epidemiologists (CSTE) document 24-ID-09." The document does not specify the number of individual experts or their qualifications directly. This refers to established public health guidelines rather than individual expert consensus.

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

• The ground truth was established by adherence to existing CSTE criteria, not through a human reader adjudication process of the device's output. The device results were compared against these established "confirmed or probable case status."

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

• No, an MRMC comparative effectiveness study was not done. This document describes the validation of a laboratory diagnostic kit (RT-PCR) with specific specimen types and does not involve human readers interpreting images or AI assistance.

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

• Yes, this is effectively a standalone performance study. The device itself is an RT-PCR diagnostic panel. The "performance" described is that of the kit (reagents and controls run on a PCR instrument) in detecting viral RNA, without human interpretation of raw data beyond reading the instrument's output based on established cut-offs (e.g., Ct values). It's an "algorithm only" in the sense that the test results in a definitive positive, negative, or inconclusive outcome based on chemical reactions and signal detection.

7. The type of ground truth used:

• The ground truth for the clinical performance evaluation was based on "confirmed or probable case status for each case on the criteria described in the current Council of State and Territory Epidemiologists (CSTE) document 24-ID-09." This can be categorized as outcomes data/epidemiological criteria as determined by public health authorities.

8. The sample size for the training set:

• The document describes the validation of a diagnostic panel (PCR-based), not an AI algorithm. Therefore, there is no specific "training set" in the machine learning sense. The device's components (primers, probes) and their performance characteristics are established through analytical studies (e.g., LoD, interfering substances) and clinical validation with patient samples. The development of such a kit is based on extensive prior knowledge of influenza virus genetics and PCR technology, but not a "training set" in the context of supervised learning for AI.

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

• As there is no "training set" in the AI sense, this question is not applicable to the device described. The "ground truth" for the analytical development of the RT-PCR panel would be based on well-characterized viral samples (e.g., BPL inactivated virus with known concentrations) and established laboratory techniques for nucleic acid detection.

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NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® Instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection. The organism types and subtypes detected by the test are Influenza A H1, Influenza A H3, Influenza B, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Coronavirus OC43, Coronavirus NL63, Coronavirus HKU1, Human Metapneumovirus, Rhinovirus, Adenovirus, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae.

The test is indicated as an aid in the detection of viral and bacterial agents causing respiratory tract infections in symptomatic adult and pediatic patients, who are either hospitalized, admitted to emergency departments or who are outpatients with suspected respiratory tract infection.

The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens not detected by this test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other pathogens. The agent detected may not be the cause of disease. The use of additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory tract infection.

Performance characteristics for influenza A were established using specimens obtained during the 2013/2014 and 2014/2015 influenza seasons when influenza A/H3 and A/H1 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorties, specimens should be collected with appropriate infections for novel virulent Influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® Instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection. The organism types and subtypes detected by the test are Influenza A H1, Influenza A H3, Influenza B, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Coronavirus OC43, Coronavirus NL63, Coronavirus HKU1, Human Metapneumovirus, Rhinovirus, Adenovirus, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae.

The information provided does not contain details about specific acceptance criteria or a study proving the device meets those criteria. The document is an FDA clearance letter for the NxTAG Respiratory Pathogen Panel, indicating that the device has been substantially equivalenced to a predicate device for its stated indications for use.

While the "Indications for Use" section (Page 3) describes the intended use of the device and some general performance characteristics for influenza A, it does not present a table of acceptance criteria or detailed study results. It mentions that performance characteristics for influenza A were established using specimens from specific influenza seasons, but it doesn't quantify those characteristics or define specific thresholds for acceptance.

Therefore, I cannot fulfill your request for the detailed table, sample sizes, expert information, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information based on the provided text. This document is a regulatory clearance, not a performance study report.

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The BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini is a multiplexed polymerase chain reaction (PCR) test intended for use with the BIOFIRE® System for the simultaneous, qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swab (NPS) specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19; (Respiratory menu) or in throat swab (TS) specimens from individuals with signs and symptoms of pharyngitis (Sore Throat menu).

The following analytes are identified and differentiated using the SPOTFIRE R/ST Panel Mini:

Respiratory Menu:
Viruses
Coronavirus SARS-CoV-2
Human rhinovirus
Influenza A virus
Influenza B virus
Respiratory syncytial virus

Sore Throat Menu:
Viruses
Human rhinovirus
Influenza A virus
Influenza B virus
Respiratory syncytial virus
Bacteria
Streptococcus pyogenes (group A Strep)

Nucleic acids from the viral and bacterial organisms identified by this test are generally detectable in NPS/TS specimens during the acute phase of infection. The detection and identification of specific viral and bacterial nucleic acids from individuals exhibiting signs and symptoms of respiratory infection and/or pharyngitis is indicative of the presence of the identified microorganism and aids in diagnosis if used in conjunction with other clinical and epidemiological information, and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Negative results in the setting of a respiratory illness and/or pharyngitis may be due to infection with pathogens that are not detected by this test, or a respiratory tract infection that may not be detected by an NPS or TS specimen. Positive results do not rule out co-infection with other organisms. The agent(s) detected by the SPOTFIRE R/ST Panel Mini may not be the definite cause of disease.

Additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection and/or pharyngitis.

The SPOTFIRE R/ST Panel Mini simultaneously identifies 5 different respiratory viral pathogens in nasopharyngeal swabs (NPS) or 5 different viral and bacterial pharyngitis pathogens in throat swabs (TS) from individuals with signs and symptoms of respiratory tract infections or pharyngitis, respectively, (see Table 1) The SPOTFIRE R/ST Panel Mini is compatible with the BIOFIRE® System, a polymerase chain reaction (PCR)-based in vitro diagnostic system for infectious disease testing. The BIOFIRE System Sottware executes the SPOTFIRE R/ST Panel Mini test and interprets and reports the test results. The SPOTFIRE R/ST Panel Mini was designed to be used in CLIA-waived environments.

A test is initiated by loading Hydration Solution injection solution injection port of the SPOTFIRE R/ST Panel Mini pouch and NPS or TS specimen, mixed with the provided Sample injection port of the SPOTFIRE R/ST Panel Mini pouch and placing it in the SPOTFIRE System. The reagents required for specimen testing and analysis in a freeze-dried format; the addition of Hydration and Sample/Buffer Mix rehydrates the reagents. After the pouch is prepared, the SPOTFIRE System Software guides the user through the steps of placing the pouch into the instrument, scanning the sample identification, and initiating the run.

The SPOTFIRE System contains coordinated systems 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. 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 SPOTFIRE R/ST Panel Mini pouch using mechanical Ivsis followed by purfication using standard magnetic bead technology. After extracting and purifying nucleic acids from the unprocessed sample, the SPOTFIRE System performs a nested multiplex PCR that is executed in two stage. During the first stage, the SPOTFIRE System performs a single, large volume, highly multiplexed reverse transcription PCR (rt-PCR) reaction. The products from first stage PCR are then diluted and combined with a fresh, primer-free master mix and a fluorescent doublestranded DNA binding dye (LC Green® Plus, BioFire Diagnostics). 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 singleplex fashion 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 2nd stage PCR captures fluorescent images of the PCR reactions and software interprets the data.

The SPOTFIRE System 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 SPOTFIRE R/ST Panel Mini.

This document describes the BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini, a multiplex PCR test.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides extensive analytical performance data rather than a direct comparison of acceptance criteria to reported clinical performance metrics (like PPA and NPA). However, the "Summary of Performance Data" for clinical studies does present sensitivity/PPA and specificity/NPA, which can be interpreted as the reported device performance against implied clinical acceptance criteria.

Clinical Performance Summary (NPS Specimens - Respiratory Menu)

Clinical Performance Summary (TS Specimens - Sore Throat Menu)

Analytical Acceptance Criteria and Results for key studies:

2. Sample Sizes and Data Provenance

• Clinical Performance (Test Set):
  • NPS Specimens (Respiratory Menu - Prospective): Total of 1115 specimens. The document doesn't explicitly state the country of origin but implies clinical sites (e.g., "as tested by intended users"). This is prospective data.
  • NPS Specimens (Respiratory Menu - Archived): Used for some analytes, e.g., Human Rhinovirus (30 positive, 454 negative), Influenza A (59 positive, 423 negative), Influenza B (30 positive, 28 negative), RSV (37 positive, 447 negative). This is retrospective data.
  • TS Specimens (Sore Throat Menu - Prospective): Total of 876 specimens for most viral targets. Streptococcus pyogenes had 217 positive (PCR) / 177 positive (Culture) and 660 negative (PCR) / 692 negative (Culture). This is prospective data.
  • TS Specimens (Sore Throat Menu - Archived): Used for some analytes, e.g., Human Rhinovirus (2 positive, 57 negative), Influenza A (11 positive, 44 negative), Influenza B (20 positive, 0 negative), RSV (2 positive, 57 negative), Streptococcus pyogenes (39 positive, 10 negative). This is retrospective data.
  • TS Specimens (Sore Throat Menu - Contrived): Used for some analytes, e.g., Influenza A (93 positive, 332 negative), Influenza B (49 positive, 333 negative), RSV (50 positive, 381 negative). This would be laboratory-generated data.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number or qualifications of experts used to establish the ground truth for the clinical test set. It mentions using "molecular assays or known specimen composition" as comparator methods for most analytes, and "culture" as the reference method for Streptococcus pyogenes.

4. Adjudication Method

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing the ground truth or resolving discrepancies in the clinical test set.

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

No MRMC comparative effectiveness study is mentioned or implied, as this device is an in vitro diagnostic (IVD) PCR test for direct pathogen detection, not an AI-assisted diagnostic imaging or interpretation tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

6. Standalone Performance

Yes, the studies described are for standalone performance. The BIOFIRE® SPOTFIRE® R/ST Panel Mini provides automated interpretation and reporting of test results based on the PCR assay. It is designed to be used independently to generate a qualitative detection and identification of microbial nucleic acids.

7. Type of Ground Truth Used

• Clinical Performance (Prospective/Archived): The ground truth for most analytes was established using molecular assays or, in some cases, known specimen composition. For Streptococcus pyogenes, culture was also used as a reference method for some comparisons.
• Analytical Performance (LoD, Inclusivity, Exclusivity, Interference, Reproducibility, Matrix Validation, Transport Media Validation, Carry Over): The ground truth was established through known specimen composition (e.g., contrived samples with known concentrations of organisms, presence of interfering substances, specific transport media).

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI algorithm development. This device is a PCR-based test, and its performance is validated through analytical and clinical studies, not typically through a machine learning training phase with a distinct dataset. The "training" in this context refers to the development and optimization of the PCR primers, probes, and reaction conditions.

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

Given that this is a PCR diagnostic device, not an AI algorithm in the typical sense of needing a "training set" for model learning, this question isn't directly applicable. The "ground truth" for developing and optimizing the PCR assays themselves would have been established through:

• Careful selection and validation of synthetic nucleic acid targets.
• Testing with characterized microbial isolates and clinical samples whose status was confirmed by established reference methods (e.g., sequencing, culture, validated molecular tests).
• In silico analysis of genetic sequences to design primers and probes with high specificity and inclusivity.

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The Influenza A Subtyping Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an in vitro diagnostic real-time PCR instrument that has been FDA-cleared for use with this kit in conjunction with clinical and epidemiological information:

· For determination of the subtype of seasonal human influenza A viruses as seasonal A(H3) and/or A(H1)pdm09 from viral RNA in upper respiratory tract clinical specimens (including nasopharyngeal swabs [NS], throat swabs [TS], nasal aspirates [NA], nasal washes [NW] and dual nasopharyngeal/throat swabs [NPS/TS]) and lower respiratory tract specimens (including bronchoalveolar lavage [BAL], bronchial wash [BW], tracheal aspirate [TA], sputum, and lung tissue) from human patients with signs and symptoms of respiratory infection and/or from viral culture;

· To provide epidemiologic information for surveillance of circulating influenza viruses.

The Influenza A Subtyping Kit contains components of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel that is used in rRT-PCR assays on an FDA-cleared in vitro diagnostic real-time PCR instrument. The primer and probe sets contained in the Influenza A Subtyping Kit are designed for the detection and characterization of influenza type A viruses that infect humans.

The Influenza A Subtyping Kit consists of oligonucleotide primers and dual-labeled hydrolysis (TagMan®) probes and controls. which may be used in rRT-PCR assays for the in vitro qualitative detection and characterization of the human influenza virus RNA in respiratory specimens from patients presenting with influenza-like illness (IL). The oligonucleotide primers and probes for detection of Influenza A and 2009 Influenza A (swine origin) were selected from highly conserved regions of the matrix (M), and the nucleoprotein (NP), respectively. Oligonucleotide primers and probes for characterization and differentiation of seasonal influenza A(H3) and A(H1)pdm09 viruses were selected from highly conserved regions of their respective HA genes. Detection of viral RNA not only aids in the diagnosis of illness caused by seasonal. newly emerging, and novel influenza viruses in patients with ILI, but also provides epidemiological and surveillance information on influenza and aids in the presumptive laboratory identification of specific novel influenza A viruses.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied through the performance metrics evaluated and compared to the predicate device and NGS as a gold standard. The core idea is that the modified assay should perform equivalently or better than the previous version, especially for strains with the 3' mutation.

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

• Sample Size (Clinical Evaluation):
  • Positive Specimen Panel: 60 influenza A(H3) specimens (30 with 3' mutation, 30 without 3' mutation).
  • Negative Specimen Panel: 60 negative specimens (from symptomatic patients known to be positive for influenza H1N1).
  • Total Clinical Test Set: 120 specimens (60 positive, 60 negative).
• Data Provenance: Retrospective study. Clinical specimens were collected from patients during previous influenza seasons in the United States.

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

Not applicable. The ground truth for the clinical test set was established using Next Generation Sequencing (NGS) and direct clinical specimen classification, not through expert consensus of visual or diagnostic interpretation.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for the clinical test set was established via Next Generation Sequencing (NGS), which directly determines the genetic identity of the virus, rather than a consensus among human reviewers.

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 an in vitro diagnostic real-time RT-PCR diagnostic panel, not an AI-assisted diagnostic tool that would involve human readers interpreting AI output.

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

Yes, the performance evaluation in this submission is of the standalone device (algorithm only). The RT-PCR assay itself provides the result, without human interpretation of the assay's primary output (e.g., a visual scan of a reaction). The results are considered definitive from the machine output.

7. The Type of Ground Truth Used

• Analytical Performance: The ground truth for analytical sensitivity (LoD) and inclusivity studies was based on known, quantified viral stocks (EID50/mL or ID50/mL) of specific influenza strains.
• Clinical Performance: The ground truth for positive and negative clinical specimens was established using Next Generation Sequencing (NGS) as the comparator assay. This method directly confirms the identity and specific genetic characteristics (e.g., presence of 3' mutation) of the influenza virus in the samples.

8. The Sample Size for the Training Set

The document does not explicitly state a "training set" in the context of device development. This is a modification to an existing RT-PCR assay, and the "development" or "training" of such a device primarily involves bioinformatic analysis, primer/probe design adjustments, and analytical testing with known isolates. The "in-silico analysis" described (Process 1: assessment of primers against global H3N2 sequence information from GISAID EpiFlu database; Process 2: BLAST against NCBI nr/nt database) serves a similar function to a training set for algorithm-based devices by informing the optimal primer and probe sequences. No numerical sample size is provided for these bioinformatic databases.

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

As noted above, for an RT-PCR assay, the "training set" concept is different from an AI/ML context. The ground truth for informing the primer/probe design (which is effectively the "training" data for the assay's specificity and sensitivity for detecting target sequences) was established through:

• GISAID EpiFlu database: This database contains comprehensive, publicly shared influenza sequence information, used to assess potential primer and probe sets against known H3N2 sequences and calculate nucleotide mismatches. The sequences in this database are derived from laboratories globally undergoing influenza surveillance.
• NCBI BLAST+ against the nr/nt database: This is a vast database of non-redundant nucleotide sequences, against which primer sequences were compared to confirm inclusivity for H3 Influenza virus HA segments and exclusivity against non-target sequences.

This information is based on established genetic sequences, which serve as the fundamental "ground truth" for designing molecular diagnostic assays.

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The BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel is a multiplexed polymerase chain reaction (PCR) test intended for use with the BIOFIRE® System for the simultaneous, qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swab (NPS) specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19; (Respiratory menu) or in throat swab (TS) specimens from individuals with signs and symptoms of pharyngitis (Sore Throat menu).

The following organism types and subtypes are identified and differentiated using the SPOTFIRE R/ST Panel:

Respiratory Menu Viruses Adenovirus Coronavirus SARS-CoV-2 Coronavirus (seasonal) Human metapneumovirus Human rhinovirus/enterovirus Influenza A virus Influenza A virus/H1-2009 Influenza A virus/ H3 Influenza B virus Parainfluenza virus Respiratory syncytial virus

• Bacteria Bordetella parapertussis Bordetella pertussis Chlamydia pneumoniae Mycoplasma pneumoniae
  Sore Throat Menu Viruses Adenovirus Coronavirus (seasonal) Human metapneumovirus Human rhinovirus/enterovirus Influenza A virus Influenza A virus/H1-2009 Influenza A virus/H3 Influenza B virus Parainfluenza virus Respiratory syncytial virus

Bacteria Chlamydia pneumoniae Mycoplasma pneumoniae Streptococcus dysgalactiae (Group C/G Strep) Streptococcus pyogenes (Group A Strep)

Nucleic acids from the viral and bacterial organisms identified by this test are generally detectable in NPS/TS specimens during the acute phase of infection and identification of specific viral and bacterial nucleic acids from individuals exhibiting signs and symptoms of respiratory infection and/or pharyngtis are indicative of the identified microorganism and aids in diagnosis if used in conjunction with other clinical and epidemiological information, and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Negative results in the setting of a respiratory illness and/or pharyngitis may be due to infection with pathogens that are not detected by this test, or a respiratory tract infection that may not be detected by an NPS or TS specimen. Positive results do not rule out coinfection with other organisms. The agent(s) detected by the SPOTFIRE R/ST Panel may not be the definite cause of disease.

Additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection and/or pharyngitis.

The SPOTFIRE R/ST Panel simultaneously identifies 15 different respiratory viral and bacterial pathogens in nasopharyngeal swabs (NPS) or 14 viral and bacterial pharyngitis pathogens in throat swabs (TS) from individuals with signs and symptoms of respiratory tract infections or pharyngitis, respectively, (see Intended Use:). The SPOTFIRE R/ST Panel is compatible with the SPOTFIRE System, a polymerase chain reaction (PCR)-based in vitro diagnostic system for infectious disease testing. The SPOTFIRE System Software executes the SPOTFIRE R/ST Panel test and interprets and reports the test results. The SPOTFIRE RIST Panel was designed to be used in CLIA-waived environments. A test is initiated by loading Hydration Solution into one port of the SPOTFIRE R/ST Panel pouch and NPS or TS specimen, mixed with the provided Sample Buffer, into the port of the SPOTFIRE R/ST Panel pouch and placing it in the SPOTFIRE System. 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 SPOTFIRE System Software guides the user through the steps of placing the instrument, scanning the pouch barcode, entering the sample identification, and initiating the run.

The SPOTFIRE System contains coordinated systems of inflatable bladders and seal points, which act on the pouch to control the movement of liguid between the pouch blisters. When a bladder is inflated over a reagent blister, it forces liguid 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. 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 and cooling of the pouch to drive the PCR reactions and the melt curve analysis.

Nucleic acid extraction occurs within the SPOTFIRE R/ST Panel pouch using mechanical and chemical lysis followed by purification using standard magnetic bead technology. After extracting and purifying nucleic acids from the unprocessed sample, the SPOTFIRE System performs a nested multiplex PCR that is executed in two stage, the SPOTFIRE System performs a single, large volume, highly multiplexed reverse transcription PCR (rt-PCR) reaction. The products from first stage PCR are then diluted and combined with a fresh, primer-free master mix and a fluorescent doublestranded DNA binding dye (LC Green® Plus, BioFire Diagnostics). 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, is performed in singleplex fashion 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 2nd stage PCR captures fluorescent images of the PCR reactions and software interprets the data.

The SPOTFIRE System Software automatically interprets the results of each DNA met curve analysis and combines the data with the results of the internal pouch controls to provide a test result for each organism on the SPOTFIRE R/ST Panel.

Here's a breakdown of the acceptance criteria and study proving the device meets those criteria, based on the provided FDA 510(k) summary for the BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel:

The document describes the BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel, a multiplexed PCR test for simultaneous, qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids. The data presented primarily focuses on analytical performance and clinical performance to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the performance metrics reported, specifically the Positive Percent Agreement (PPA) / Sensitivity and Negative Percent Agreement (NPA) / Specificity. For analytical studies, acceptance criteria related to percentages of positive results and agreement levels are explicitly stated.

Clinical Performance Acceptance Criteria (Implied by Data Reported):
For each analyte, the acceptance criteria are generally to achieve high PPA and NPA. While specific numerical thresholds for PPA/NPA are not explicitly listed as "acceptance criteria" in the clinical tables themselves, the FDA's clearance implies that the presented performance met their internal requirements for substantial equivalence. For diagnostic tests, generally, PPA and NPA values in the high 90s are expected.

Analytical Performance Acceptance Criteria and Reported Performance:

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

The sample sizes vary by analyte and study type (prospective, archived, contrived).

• Clinical Performance (Test Set):

  • NPS Specimens (Respiratory Menu):
    • Prospective Data: The total number of NPS specimens tested across all viruses and bacteria is not explicitly stated as a single number but can be aggregated from the "Positive" and "Negative" counts for each analyte. For example, for Adenovirus, there were 33 positives and 1082 negatives, totaling 1115 prospective NPS specimens where Adenovirus was assessed. This appears to be the total number of clinical samples evaluated in the prospective study.
    • Archived Data: Similarly, for Adenovirus, there were 31 positives and 439 negatives, totaling 470 archived NPS specimens.
    • Contrived Data: Indicated as 0/0 for all NPS analytes, suggesting contrived samples were not used for clinical performance evaluation of NPS specimens.
  • TS Specimens (Sore Throat Menu):
    • Prospective Data: For Adenovirus, 65 positives and 810 negatives (total 875). This seems to be the total number of clinical throat swab specimens assessed.
    • Archived Data: For Adenovirus, 11 positives and 48 negatives (total 59).
    • Contrived Data: For Adenovirus, 50 positives and 381 negatives (total 431). Contrived samples were used for TS clinical performance studies.
  • Data Provenance: The document states "as tested by intended users," implying clinical sites. No specific country of origin is mentioned, but typically, these studies for FDA clearance involve sites within the US. The "Prospective" studies indicate prospective collection, while "Archived" refers to retrospective samples. "Contrived" samples are laboratory-prepared.

• Analytical Performance (Test Set):

  • Limit of Detection (LoD): At least 20 replicates (e.g., 19/20) tested at LoD and 10-fold below LoD for each analyte.
  • Analytical Reactivity (Inclusivity): 3/3 or 4/5 replicates tested within 10x LoD for each isolate.
  • Near-LoD/Reproducibility: Not explicitly stated but mentions "multiple days," "multiple operators," "three unique SPOTFIRE Systems," "three distinct clinical sites holding a CLIA waiver." The reported positive and negative agreement totals are 2070 (BioFire) and 1380 (clinical sites) tests.

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

The document does not specify the number of experts or their qualifications (e.g., radiologist with 10 years of experience) used to establish the ground truth. This is a common characteristic of in vitro diagnostic (IVD) submissions focusing on molecular diagnostic tests.

• For molecular tests, the "ground truth" is typically established by comparator methods, often laboratory-developed tests (LDTs) or other cleared/validated molecular diagnostic assays (e.g., PCR followed by sequencing, or highly sensitive and specific reference PCR methods).
• For bacterial culture (used for Streptococcus dysgalactiae and Streptococcus pyogenes), the ground truth is established by standard microbiological culture and identification techniques, performed by trained laboratory personnel.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for the clinical test sets. This is expected given that the ground truth is established by laboratory reference methods (molecular or culture), which typically do not involve human reader adjudication in the same way imaging studies might. Any discrepancies between the investigational device and the reference method would be investigated by the manufacturer, rather than through an expert consensus adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for imaging-based AI devices where human readers interpret medical images, and the AI assists or augments their performance. The BIOFIRE SPOTFIRE R/ST Panel is a molecular diagnostic test where the output is an automated detection of nucleic acids, not an interpretation by a human reader that could be augmented by AI.

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

Yes, the performance data presented (Tables 2 and 3 for Clinical Performance, and Table 4 for Analytical Performance) represents the standalone performance of the BIOFIRE SPOTFIRE R/ST Panel, which includes the instrument and its automated software interpretation. The device itself is designed to provide automated results without human interpretive input for the detection of targets. The "as tested by intended users" for clinical performance indicates that the device was used in a realistic setting, but the performance metrics reflect the direct output of the system.

7. The Type of Ground Truth Used

The ground truth for the clinical performance evaluation was established using:

• Comparator molecular assays or known specimen composition for most analytes (referred to as "molecular assays or known specimen composition were used as comparator methods" for PPA/NPA). This suggests a combination of validated PCR assays, and potentially sequencing for confirmation.
• Culture for Streptococcus dysgalactiae (Group C/G Strep) and Streptococcus pyogenes (Group A Strep). This is explicitly stated: "Performance measures of sensitivity and specificity refer to the prospective and archived Streptococcus and archived Streptococcus analytes for which culture was used as the reference method."

For analytical studies, the ground truth was established by:

• Known concentrations of organisms (e.g., viable or infectious units, nucleic acid copies/mL) for LoD and Inclusivity studies.
• Defined panels of organisms or substances for Exclusivity and Interference studies.

8. The Sample Size for the Training Set

This document does not provide information on the training set size directly. The presented studies are for validation/testing of the device's performance. For molecular diagnostic assays like this, the 'training' of the algorithms (e.g., primer design, melt curve analysis interpretation) typically happens during the assay development phase, often using synthetic targets, cultured organisms, and preliminary clinical samples. However, this is not detailed in a 510(k) summary, which focuses on validation data against a defined product. The "software was verified and validated" statement implies that developmental data was used, but details on sample size for that specific phase are not provided in this regulatory summary.

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

Since the training set details are not provided, the method for establishing its ground truth is also not explicitly stated in this document. However, based on typical IVD development practices:

• Ground truth for assay development (which informs the 'training' of a molecular diagnostic system) would involve well-characterized positive and negative controls, reference strains, and potentially sequenced clinical isolates.
• Molecular target sequences (in silico analysis)
• Analytical dilution series where the exact concentration of the pathogen is known.
• Samples confirmed by multiple, orthogonal laboratory methods.

The rigorous analytical and clinical studies described in the results section serve as the validation of the final trained/developed system.

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The ID NOW™ Influenza A & B 2 assay performed on the ID NOW™ Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in direct nasal or nasopharyngeal swabs and nasal or nasopharyngeal swabs eluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.

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

Performance characteristics for influenza A were established during the 2016-2017 influenza season when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

ID NOW Influenza A & B 2 is a rapid, instrument-based isothermal test for the qualitative detection and differentiation of influenza A and influenza B from nasal swab or nasopharyngeal swabs tested directly or after elution in viral transport media collected from patients presenting with signs and symptoms of respiratory infection.

All ID NOW™ assays utilize isothermal nucleic acid amplification technology and are comprised of:

• Sample Receiver single use, disposable containing the elution buffer .
• Test Base single use, disposable comprising two sealed reaction tubes, each . containing a lyophilized pellet
• Transfer Cartridge single use, disposable for transfer of the eluted sample to the Test . Base, and
• ID NOW™ Instrument repeat use reader .

The reaction tubes in the ID NOW Influenza A & B 2 Test Base contain the reagents required for amplification of the target nucleic acid and an internal control. ID NOW Influenza A & B 2 utilizes a pair of templates (similar to primers) for the specific amplification of RNA from influenza A and B and a fluorescently labeled molecular beacon designed to specifically identify the amplified RNA targets.

ID NOW Influenza A & B 2 is performed within the confinement of the Test Base, and no other part of the ID NOW Instrument has contact with the sample during the amplification process. This reduces the risk of instrument contamination and sample carry-over between measurements.

To perform the assay, the Sample Receiver and Test Base are inserted into the ID NOW™ Instrument and the elution buffer is automatically heated by the instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, resuspending the lyophilized pellets contained within the Test Base and target amplification. Heating, mixing and detection by fluorescence is provided by the instrument. with results automatically reported.

Results are displayed by the ID NOW Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the ID NOW Instrument by the operator. and the date/time the test was performed. Data can be retrieved and downloaded by the operator at any time after testing. An external Universal Printer can be attached via USB to the ID NOW Instrument to print test results.

The provided text describes a 510(k) submission for the ID NOW™ Influenza A & B 2 assay, specifically focusing on a software modification to mitigate potential false positive Influenza B test results during sequential workflow testing. The submission is a "Special 510(k)," indicating that the changes are minor and do not significantly alter the device's fundamental technology or safety/effectiveness.

The document emphasizes the equivalence to a legally marketed predicate device (ID NOW Influenza A & B 2, K220801). Therefore, the study presented here is primarily a comparative study to demonstrate that the modified device performs equivalently to the predicate, rather than establishing de novo performance characteristics against a clinical ground truth for a novel device.

Here's an analysis of the provided information, framed by your request for acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this Special 510(k) are implicitly tied to demonstrating non-inferiority or equivalence of the modified device's performance to the predicate device, particularly concerning the reduction of false positives for Influenza B. The document states:

• "A modification of the ID NOW Influenza A & B 2 algorithm was made, as a preventive measure, to mitigate the potential occurrence of false positive Influenza B test results during sequential workflow testing."
• "ID NOW Influenza A & B 2 incorporating the software modification was compared to the legally marketed predicate device, the 510(k) cleared ID NOW Influenza A & B 2."

While the document states the purpose and the comparison, it does not explicitly list quantitative acceptance criteria (e.g., a specific percentage reduction in false positives, or a non-inferiority margin for sensitivity/specificity) or the reported device performance in a table format as you requested. The provided text is a summary letter and general description, not a detailed study report. For a device like this, the performance data (sensitivity, specificity, positive predictive value, negative predictive value) for both the modified and predicate devices would typically be presented in the detailed 510(k) submission, but this information is not included in the provided excerpt.

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

The provided text does not explicitly state the sample size used for the test set. It mentions the study compares the modified device to the predicate, implying a test set was used for this comparison.

Regarding data provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. These details would be crucial for a full understanding of the study's design.

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

For a molecular diagnostic test like ID NOW Influenza A & B 2, the "ground truth" is typically established by a highly sensitive and specific reference method, such as RT-PCR (Reverse Transcription Polymerase Chain Reaction), which is considered the gold standard for viral detection. The document does not mention the use of human experts (e.g., radiologists) to establish ground truth because this is a laboratory diagnostic assay, not an imaging device. Therefore, no information is provided on expert qualifications or the number of experts.

4. Adjudication Method for the Test Set

Since the ground truth for molecular diagnostics is typically established by a reference laboratory method (e.g., RT-PCR), an "adjudication method" involving human readers (like 2+1 or 3+1 for imaging studies) is not applicable in this context and is therefore not mentioned.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not applicable and therefore not done. MRMC studies are typically used for evaluating diagnostic imaging systems where human interpretation plays a critical role, and the impact of AI assistance on human reader performance is being assessed. The ID NOW Influenza A & B 2 is an automated molecular diagnostic test; human "readers" do not interpret results in the same way as in imaging.

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

Yes, the very nature of this device (an automated molecular diagnostic test) means that the performance is standalone (algorithm only without human-in-the-loop performance). The ID NOW Instrument performs the test, processes the sample, and reports results automatically. The software modification described directly impacts this automated process. The comparison to the predicate device would inherently evaluate the standalone performance of the modified algorithm against the predicate algorithm.

7. The Type of Ground Truth Used

As mentioned in point 3, the ground truth for molecular diagnostic tests like this is almost universally established by a highly sensitive and specific reference laboratory method, typically RT-PCR. While the document does not explicitly state "RT-PCR was used as ground truth," this is the industry standard for validating such devices. "Expert consensus," "pathology," or "outcomes data" are generally not the primary ground truth methods for direct viral detection assays.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This is a software modification to an existing, cleared device, implying the original device would have undergone substantial training and validation. For a Special 510(k) focusing on a specific bug fix (false positives in sequential workflow), the emphasis is on a targeted verification and validation of the change, rather than retraining a comprehensive model. If a machine learning model were involved, reporting training set size would be crucial, but the description here suggests a more rule-based or algorithmic adjustment.

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

Since no information on a specific "training set" for the software modification is provided, there is also no information on how the ground truth for such a training set (if it existed) was established.

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The Panther Fusion® AdV/hMPV/RV assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of Adenovirus (AdV), human Metapneumovirus (hMPV), and Rhinovirus (RV). Nucleic acids are isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection.

This assay is intended to aid in the differential diagnosis of Adenovirus, human Metapneumovirus, and Rhinovirus infections in humans. Negative results do not preclude Adenovirus, human Metapneumovirus, and Rhinovirus infections and should not be used as the sole basis for treatment or other management decisions. This assay is designed for use on the Panther Fusion system.

The Panther Fusion AdV/hMPV/RV assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of Adenovirus (AdV) human Metapneumovirus (RV). Nucleic acids are isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection.

Prior to processing and testing on the Panther Fusion system, specimen Lysis Tube containing specimen transport media (STM) that lyses the cells, releases target nucleic acid and protects them from degradation during storage. The Internal Control-S (IC-S) is added to each test specimen and controls via the working Panther Fusion Capture Reagent-S (wFCR-S). The lC-S in the reagent monitors specimen processing, and detection. Capture oligonucleotides hybridize to nucleic acid in the test specimen. Hybridized nucleic acid is then specimen in a magnetic field. Wash steps remove extraneous components from the reaction tube. The elution step elutes acid. During the nucleic acid capture and elution step, total nucleic acid is isolated from specimens.

During the elution transfer step, eluted nucleic acid is transferred to a Panther Fusion tube already containing oil and reconstituted masternix. For RV, hMPV, and internal control targets, amplification occurs via RT-PCR. A reverse transcriptase step qenerates DNA copies of the target sequence. For AdV, target amplification occurs via PCR. For all targets, specific forward and reverse primers and probes amplify targets while simultaneously detecting and discriminating multiplex PCR. The Panther Fusion system compares the fluorescence signal to a predece a qualitative result for the presence or absence of the analyte. The assay analytes (Adenovirus, human Metapheumovirus, and Internal Control) through specific gene targets (Hexon, Nucleocapsid, 5' UTR, and n/a, respectively) are detected in different channels of the Panther Fusion system (HEX, ROX, FAM, and RED677, respectively).

The provided text describes a 510(k) premarket notification for the "Panther Fusion AdV/hMPV/RV Assay," an in vitro diagnostic test. The notification details the device, its intended use, and a comparison to a predicate device. Crucially, it highlights that the subject device incorporates "software algorithm changes" to improve hMPV specificity, specifically to decrease false positives, without significantly altering clinical results or assay claims.

However, the document states: "All analytical and clinical data used to support the predicate device intended use and performance was re-analyzed with the updated software. All pre-determined acceptance criteria from the original protocols were met." It does not provide the specific acceptance criteria or the detailed results of this re-analysis, nor does it describe a new study conducted to prove the device meets acceptance criteria. It only affirms that the previous data, when re-analyzed with the new software, continued to meet the original acceptance criteria.

Because the document only states that original acceptance criteria were met by re-analysis of existing data, and does not outline specific acceptance criteria or an independently designed study for the new software, I can only infer information from what is provided.

Here's an attempt to answer your questions based on the limited information that can be extracted or reasonably inferred from the provided text:

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

The document does not provide a specific table of acceptance criteria or reported device performance for the new software. It only states: "All pre-determined acceptance criteria from the original protocols were met." Without the original protocols, the exact acceptance criteria and the specific performance metrics (e.g., sensitivity, specificity, accuracy) are not available in this document. The focus of the changes is on improving hMPV specificity, implying that this was a key performance area.

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

The document states: "All analytical and clinical data used to support the predicate device intended use and performance was re-analyzed with the updated software." This indicates that the same test set (both analytical and clinical data) used for the predicate device was re-used for the updated software. The sample size and data provenance are therefore not detailed in this document, as it refers to pre-existing data. It doesn't specify if the original data was retrospective or prospective, nor its country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The study described is a re-analysis of previously established analytical and clinical data for an in-vitro diagnostic test. Establishing "ground truth" for clinical samples in an IVD context typically involves clinical diagnosis or other validated laboratory methods, rather than expert radiology reads as might be the case for imaging AI.

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

This information is not provided in the document. As an IVD device, the "adjudication method" in the context of clinical studies for diagnostic accuracy would typically refer to how the true status of a specimen (positive/negative for a pathogen) was determined.

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

No, an MRMC comparative effectiveness study was not done or described. This device is an in-vitro diagnostic test (a laboratory assay), not an AI imaging analysis tool that assists human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

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

The device is an in-vitro diagnostic test that operates on a "Panther Fusion system." The "software algorithm changes" affect how the assay results are processed and interpreted by the system itself. This is essentially a "standalone" or "algorithm only" performance, as the algorithm's output directly determines the qualitative detection and differentiation of the viruses. Human intervention likely involves sample preparation and loading, and subsequent interpretation of the system's output. The re-analysis was of the system's performance with the new software.

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

The document relates to an In Vitro Diagnostic (IVD) test for nucleic acid detection. For such assays, "ground truth" for the test set would typically be established by:

• Reference laboratory methods: Such as highly sensitive and specific PCR methods, sequencing, or culture that are considered gold standard.
• Clinical diagnosis: Based on a physician's assessment, symptoms, and other diagnostic tests.
• Composite reference standard: A combination of clinical and laboratory findings.

The exact type of ground truth used for the original predicate device data (which was re-analyzed) is not specified in this document.

8. The sample size for the training set

The document states that "All analytical and clinical data used to support the predicate device intended use and performance was re-analyzed with the updated software." This implies that the software updates likely occurred after the initial assay development. It's not explicitly stated that a new training set was used for the "software algorithm changes." The changes are presumably based on internal development and validation, potentially informed by performance issues (like the hMPV false positives). Details about any specific training set for the software algorithm are not provided.

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

As there is no specific mention of a separate training set for the new algorithm within this document, the method for establishing its ground truth is also not provided. If the algorithm was developed iteratively based on observed performance issues (e.g., false positives), the "ground truth" for its development would be based on the established true status of the samples that generated those observed issues, similar to how the ground truth is established for the test set (reference methods or clinical diagnosis).

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The Lyra RSV + hMPV Assay is a multiplex Real-Time PCR (RT-PCR) assay for the qualitative detection and identification of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) ribonucleic acid (RNA) extracted from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of RSV and hMPV infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV.

Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.

Conversely, positive results do not rule-out bacterial infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection.

The Lyra RSV + hMPV Assay can be performed using ether the Life Technologies QuantStudio Dx RT-PCR Instrument, the Applied Biosystems 7500 Fast Dx RT-PCR Instrument, or the Cepheid SmartCycler II System.

The Lyra RSV + hMPV Assay detects viral nucleic acids that have been extracted from a patient sample using the NucliSENS® easyMAG® or NucliSENS® EMAG® automated extraction platform. A multiplex RT-PCR reaction is then performed in a single tube generating amplicons for each of the target viruses present in the sample. This reaction is performed utilizing either the Cepheid SmartCycler® II, the Applied Biosystems 7500 Fast DX, or the Life Technologies QuantStudio" Dx. Identification of RSV and hMPV and the PRC occurs by the use of target-specific primers and fluorescent-labeled probes that hybridize to conserved regions in the genomes of RSV and hMPV and the PRC.

The acceptance criteria and the study proving the device meets these criteria for the Lyra RSV + hMPV Assay are detailed below. It's important to note that the provided documents primarily describe a change to an existing device (the addition of a new extraction platform, BioMerieux NucliSENS EMAG) and compare its performance to the previously cleared predicate device. Therefore, the "acceptance criteria" and "reported device performance" are framed around this equivalency.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the information provided, the overall acceptance criterion is equivalent performance of the modified Lyra RSV + hMPV Assay (with the new extraction platform) to the predicate device (Quidel RSV+hMPV Assay using the original extraction platform). The performance is assessed through "non-clinical and clinical verification and validation activities."

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

The exact sample sizes for the "Limit of Detection Equivalency Study" and "Clinical Equivalence Study" are not explicitly stated in the provided 510(k) summary.

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The nature of "clinical equivalence study" typically implies prospective or retrospectively collected clinical samples, but details are lacking.

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

This information is not provided in the given text. For a PCR-based assay like this, ground truth is typically established using a highly sensitive and specific reference method (e.g., another validated PCR assay or sequencing), rather than expert clinical consensus in the traditional sense of image interpretation.

4. Adjudication Method for the Test Set

This information is not provided in the given text. Given that this is a molecular diagnostic assay, adjudication methods like N+1 for expert review (common in imaging studies) are generally not applicable. Instead, the "ground truth" would be determined by the reference method itself.

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

No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for medical imaging interpretation where different human readers interpret cases, often with and without AI assistance. This device is a molecular diagnostic assay (RT-PCR) and does not involve human interpretation of complex images in the same way.

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

Yes, implicitly. The device itself is an in vitro diagnostic test, specifically a Real-Time PCR assay. Its performance (qualitative detection of RNA) is inherently "standalone" as it produces a result without direct human interpretive input during the assay itself. The studies ("Limit of Detection Equivalency Study" and "Clinical Equivalence Study") would evaluate the accuracy of the assay's output against a reference method, which is a standalone performance assessment.

7. The Type of Ground Truth Used

The type of ground truth used is not explicitly stated but can be inferred to be a highly reliable reference method, likely another validated molecular diagnostic test (e.g., gold standard PCR assay or culture/sequencing) for detecting RSV and hMPV. For Limit of Detection studies, ground truth would be established by precisely quantifying viral RNA in samples.

8. The Sample Size for the Training Set

This information is not applicable in the context of this device. The Lyra RSV + hMPV Assay is a Real-Time PCR assay, which is a biochemical reaction-based test, not an AI/Machine Learning algorithm that requires a "training set" in the traditional sense. The "training" for such an assay involves optimization of reagents, primers, probes, and reaction conditions.

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

This information is not applicable as there is no "training set" in the context of an AI/ML algorithm for this device. The development of the assay involves establishing analytical ground truth through various laboratory experiments to ensure the primers and probes are specific and sensitive to the target viruses, and that the internal control functions correctly.

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The Lyra Influenza A+B Assay is a multiplex Real Time RT-PCR assay for the in vitro qualitative detection and differentiation of influenza A and influenza B viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of influenza A and influenza B viral infections in humans in conjunction with clinical and endemiological risk factors. The assay does not detect the presence of influenza C virus.

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

Performance characteristics for influenza A were established during the 2013 influenza seasons when influenza A/H3 and 2009 H1N1 influenza were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The assay can be performed using either the Life Technologies QuantStudio Dx, the Applied Biosystems 7500 Fast Dx or the Cepheid SmartCycler II.

The Lyra Influenza A+B Assay detects viral RNA that have been extracted from a patient sample using the NucliSENS easyMAG or EMAG automated extraction platform. A multiplex RT-PCR is carried out under optimized conditions in a single tube generating amplicons for each of the target viruses present in the sample. This reaction is performed utilizing either the Life Technologies QuantStudio™ Dx, the Applied Biosystems® 7500 Fast Dx, or the Cepheid® SmartCycler® II. Identification of influenza A occurs by the use of target specific primers and a fluorescent-labeled probe that hybridizes to a conserved influenza A sequence within the matrix protein gene. Identification of influenza B occurs by the use of target specific primers and fluorescent-labeled probes that will hybridize to a conserved influenza B sequence within the neuraminidase gene.

The provided text describes a 510(k) premarket notification for the Lyra Influenza A+B Assay. The notification primarily focuses on a modification to the device, specifically the inclusion of a new nucleic acid extraction platform (BioMerieux NucliSENS EMAG) while maintaining the original intended use and other core functionalities.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that "All verification and validation activities were performed in accordance with relevant standards, established plans, protocols, and Design Control procedures. Testing verified all acceptance criteria were met." However, the specific quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) are not detailed in the provided text. Similarly, the specific quantitative reported device performance metrics (e.g., exact sensitivity and specificity values) from the studies are not presented in the provided summary.

The summary only states: "Non-clinical and clinical verification activities conducted with the Lyra Influenza A+B Assay demonstrate that the modified device met predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device."

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

The text mentions a "Clinical Equivalency Study" but does not provide details on the sample size used for its test set or the data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of Experts and Qualifications for Ground Truth

The document does not provide information on the number of experts used to establish ground truth for the test set or their qualifications.

4. Adjudication Method for the Test Set

The document does not provide information on the adjudication method used for the test set.

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

The text does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The focus is on the performance of the assay itself, not human reader improvement with/without AI assistance.

6. Standalone Performance Study

The studies mentioned ("Limit of Detection Equivalency Study" and "Clinical Equivalency Study") describe the performance of the device (algorithm/assay only), implying a standalone performance evaluation. However, the text does not explicitly use the term "standalone" or specify that it was "algorithm only without human-in-the-loop performance." Given that it's an RT-PCR assay, its performance by definition is standalone.

7. Type of Ground Truth Used

The text does not explicitly state the type of ground truth used for the clinical equivalency study. For diagnostic assays like this, ground truth is typically established through a combination of:

• Confirmatory laboratory methods (e.g., viral culture, another highly sensitive and specific PCR method, or sequencing as a gold standard).
• Clinical diagnosis by a physician.

However, this information is not provided.

8. Sample Size for the Training Set

The text does not provide information on a training set sample size. This is a modification to an existing assay, and the studies mentioned are verification/validation studies for the modification, not development studies for a new algorithm that would typically involve a separate training set.

9. How Ground Truth for the Training Set was Established

Since no training set information is provided, there is no information on how its ground truth was established.

Summary of Missing Information:

A significant amount of detail regarding the studies, particularly the quantitative acceptance criteria, reported performance, sample sizes, and ground truth methodologies, is not present in the provided FDA 510(k) summary letter. The letter serves as an approval notification and summary of the device's substantial equivalence, focusing on the change (new extraction platform) rather than a comprehensive, detailed clinical study report.

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