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The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Influenza A & B Detection Kit is intended for use on the JBAIDS instruments, for the in vitro qualitative detection of influenza A and influenza B viral nucleic acids isolated and purified nasopharygeal swab (NPS) and nasopharygeal wash (NPW) specimens from human patients with signs and symptoms of respiratory infection.

The JBAIDS Influenza A & B Detection Kit contains reverse transcriptase real-time polymerase chain reaction (rRT-PCR) assays that target the Matrix protein gene of influenza A viruses, and the Non-structural protein gene of influenza B viruses. This kit is not intended to detect influenza C viruses.

Test results are to be used in conjunction with other clinical and epidemiological information. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.

Performance characteristics for detection of influenza A were established when 2009 H1N1 Influenza, Influenza A H1N1, and Influenza A H3N2 were the predominant influenza A viruses in circulation. Due to low seasonal prevalence, performance characteristics for detection of seasonal Influenza A/H1 were established primarily with retrospective and surrogate clinical specimens. When other influenza A viruses are present, performance characteristics may vary.

All users, analysts, and any person reporting diagnostic results from use of this device should be trained to perform and interpret the results from this procedure by JBAIDS instructors or designees prior to use. Use of this device is limited to designated Department of Defense (DoD) laboratories equipped with the JBAIDS instruments.

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 departments for testing. Viral culture should not be attempted in these cases unless a biosafety (BSL) 3+ facility is available to receive and culture specimens.

The JBAIDS Influenza A & B Detection Kit is a rRT-PCR test kit, which, when used with the JBAIDS instrument and software, allows the qualitative in vitro detection of influenza A and B viral RNA. These two assays have been optimized as freeze-dried assays with primer and fluorescent-probe sets for the detection of influenza A and B viral RNA. In particular, the influenza A assay targets a region of the matrix gene specific to the influenza A virus genera, and the influenza B assay targets a region of the nonstructural gene specific to the influenza B virus genera. The tests are performed using the previously FDA-cleared JBAIDS instrument and software. A human gene target assay (RNAse P target) will be used as an inhibition and extraction control.

The provided text describes the JBAIDS Influenza A & B Detection Kit, a real-time PCR assay for the qualitative in vitro detection of influenza A and B viral nucleic acids. The information primarily focuses on the technical aspects of the device and its substantial equivalence to a previously cleared predicate device, especially regarding the detection of specific influenza strains.

However, the document does not contain the kind of information typically found in a study proving a new device meets acceptance criteria, specifically not for an AI/ML-based diagnostic or imaging device. The document is a 510(k) summary for a premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study against acceptance criteria in the way one would for a novel device, especially one involving AI.

Therefore, many of the requested items (e.g., sample size for training set, number of experts for ground truth, MRMC study, effect size of AI assistance) are not applicable or cannot be extracted from this document, as it describes a PCR-based diagnostic kit, not an AI/ML device.

Given the constraints of the provided document, I will extract the available relevant information and note where information is not present or non-applicable given the nature of the device described.

Acceptance Criteria and Device Performance (Limited to Analytical Sensitivity/LoD)

The document describes selected analytical studies to determine the Limit of Detection (LoD) for certain influenza A strains, specifically H3N2 and H7N9, which were additions to the device's labeling. This can be interpreted as demonstrating the device's performance against an implicit analytical sensitivity acceptance criterion.

Table 1: Acceptance Criteria (Implied Analytical Sensitivity) and Reported Device Performance

• Estimated LoD: 4 x 10^4^ EID50/mL (confirmed)
• 3/3 replicates positive at 4 x 10^4^ EID50/mL
• 2/3 replicates positive at 8.0 x 10^3^ EID50/mL
  Influenza A H3N2 (seasonal):
• A/Victoria/361/2011: LoD = 63.0 TCID50/mL
• A/Perth/16/2009: LoD = 6.3 TCID50/mL
  Influenza A swine variant H3N2v:
• A/West/Virginia/06/2011: LoD = 31.6 TCID50/mL
• A/Minnesota/11/2010: LoD = 2.0 TCID50/mL |

Note: The document explicitly states: "Serial dilutions were run in triplicate, with all three replicates required to read positive in order for that dilution to be called positive." This stringent requirement for calling a dilution positive influences the reported LoD values.

Study Details:

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

   • Test set sample size: Not specified as a distinct "test set" in the context of clinical validation data for a new device. The data presented is for analytical sensitivity (LoD) testing.
     • For LoD, serial dilutions of viral strains were tested. The number of replicates per dilution is specified: "Serial dilutions were run in triplicate." It is implied that multiple concentrations were tested for each strain.
   • Data provenance: Not explicitly stated for all strains, but the H3N2v and H7N9 strains suggest a focus on variant strains that would have emerged more recently (e.g., A/Anhui/1/2013 for H7N9). The samples were "simulated nasopharyngeal swab samples" meaning they were laboratory-prepared samples rather than clinical patient specimens. The study is described as "Selected Analytical Studies", indicating a laboratory-based evaluation of the assay itself. This falls under retrospective data generated in a controlled lab setting, not real-world clinical samples. No country of origin for test data is specified beyond the DoD context.

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

   • Not applicable. For an analytical sensitivity study of a PCR-based diagnostic kit, the "ground truth" is typically defined by the known concentration of the purified viral standard used to prepare the simulated samples. This does not involve human expert interpretation of results, as the device provides a qualitative "positive, negative, or uncertain" result based on fluorescence thresholds.

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

   • Not applicable. As the "ground truth" is based on known viral concentrations in simulated samples and the device provides an automated qualitative result, there is no human adjudication process involved in interpreting the device's output or establishing the true state of the samples. The requirement for positivity was "all three replicates required to read positive".

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

   • Not applicable. This device is a molecular diagnostic (PCR-based) kit, not an AI-assisted imaging device or a diagnostic requiring human reader interpretation in the context of an MRMC study design. It delivers an objective "positive/negative" result based on molecular detection.

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

   • Yes, this is a standalone device. The JBAIDS kit itself, when used with the JBAIDS instrument and software, performs the detection and provides a result (positive, negative, or uncertain) without requiring human diagnostic interpretation of complex outputs like images. The document states: "JBAIDS Software analyzes the fluorescence amplification curves and reports results as positive, negative, or uncertain."

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

   • For the analytical studies described, the ground truth was based on known concentrations of purified viral strains (e.g., EID50/mL or TCID50/mL) in simulated samples. This is a highly controlled laboratory ground truth, not clinical ground truth from patients (like pathology or outcomes data).

7. The sample size for the training set:

   • Not applicable/Not specified. This document describes a traditional real-time PCR diagnostic kit, not an AI/ML device that requires a training set in the machine learning sense. The "training" of such a device involves optimizing primer/probe sets and reaction conditions during its development, not training on a large dataset like an AI model.

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

   • Not applicable. (See point 7). The "ground truth" during the development of such a PCR kit would involve characterizing the specificity and sensitivity of the molecular components against known viral targets and non-targets, rather than establishing ground truth for a training set in an AI/ML context.

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The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Influenza A Subtyping Kit is intended for the in vitro qualitative detection and differentiation of seasonal Influenza A/H1, seasonal Influenza A/H3, and 2009 H1N1Influenza viral nucleic acids isolated and purified from nasopharyngeal swab (NPS) and nasopharyngeal wash (NPW) specimens from human patients with signs and symptoms of respiratory infection, in conjunction with clinical and epidemiological risk factors. The JBAIDS Influenza A Subtyping Kit contains reverse transcriptase real-time polymerase chain reaction (rRT-PCR) assays for use on the JBAIDS instruments. The Flu A H1. Flu A H3. and Flu A H1 2009 assays of the JBAIDS Influenza A Subtyping Kit target a region of the hemagglutinin (HA) gene of the respective Influenza A virus. The Flu A Sw assay of the JBAIDS Influenza A Subtyping Kit targets a region of the nucleocapsid protein (NP) gene of the 2009 H1N1 Influenza virus, as well as some other Influenza A viruses of swine lineage. This kit is not intended to detect Influenza B or Influenza C viruses.

A negative result for all assays in the JBAIDS Influenza A Subtyping Kit is a presumptive negative result for Influenza A. These results should be confirmed using the JBAIDS Influenza A & B Detection Kit.

Test results are to be used in conjunction with other clinical and epidemiological information. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.

Due to low seasonal prevalence, performance characteristics for detection of seasonal Influenza A/H1 were established primarily with retrospective and contrived clinical specimens.

All users, analysts, and any person reporting diagnostic results from use of this device should be trained to perform and interpret the results from this procedure by JBAIDS instructors or designees prior to use. Use of this device is limited to designated Department of Defense (DoD) laboratories equipped with the JBAIDS instruments.

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 departments for testing. Viral culture should not be attempted in these cases unless a biosafety laboratory (BSL) 3+ facility is available to receive and culture specimens.

The JBAIDS Influenza A Subtyping Kit is a real time RT-PCR test kit, which, when used with the JBAIDS instrument and software, allows the qualitative in vitro detection and identification of influenza A subtypes H1, H3, and H1 2009 (swine lineage) viral RNA. The assays have been optimized as freeze-dried assays with primer and fluorescent-probe sets for the detection of influenza A/H1, A/H3, and A/2009 H1 viral RNA. In particular, the Flu A H1, Flu A H3, and Flu A H1 2009 assays target distinct regions of the hemagglutinin gene specific to those subtypes, and the Flu A Sw assay targets a region of the nucleocapsid protein gene as a secondary target for the influenza A/2009 H1(swine lineage) virus. The tests are performed using the JBAIDS instrument and software.

Here's an analysis of the acceptance criteria and study details for the JBAIDS Influenza A Subtyping Kit based on the provided text:

Preamble Regarding Acceptance Criteria:
The document provided, a 510(k) Summary, details performance data but does not explicitly state pre-defined "acceptance criteria" in the format of pass/fail thresholds for the clinical study. Instead, it presents the achieved performance metrics (PPA and NPA with 95% Confidence Intervals) from the clinical and analytical studies, implicitly demonstrating that these achieved results were deemed sufficient for substantial equivalence. For the purpose of this response, I will present the reported performance as the "acceptance criteria met," recognizing that the specific numerical targets for acceptance are not explicitly listed in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

As described above, explicit acceptance criteria (i.e., specific numerical targets prior to testing) were not provided in the 510(k) summary. However, the reported performance from the clinical studies served as the basis for the device's clearance. The table below summarizes the reported clinical performance.

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

• Clinical Performance (Prospective Study):

  • Sample Size: 795 valid specimens (312 NPS, 483 NPW) were analyzed. 6% (44/795) required retesting due to invalid/inconclusive/unsubtypeable initial results.
  • Data Provenance: Prospective, collected from 5 geographically separated military clinical sites in the U.S. during the 2010-2011 influenza season (December 2010 to April 2011).

• Testing of Preselected Archived Samples (for Seasonal Influenza A/H1):

  • Sample Size: 51 NPS specimens (30 known positive seasonal Influenza A/H1, 21 influenza-negative).
  • Data Provenance: Retrospective, pre-selected archived clinical NPS specimens obtained and confirmed at two different clinical study sites in the U.S.

• Testing of Surrogate Clinical Specimens (for Seasonal Influenza A/H1):

  • Sample Size: 136 individual influenza-negative clinical specimens (68 NPS, 68 NPW) were spiked with known concentrations of seasonal Influenza A/H1 virus. Valid results obtained for 128 (62 NPW, 66 NPS).
  • Data Provenance: Contrived clinical samples generated from residual influenza-negative NPS and NPW samples. Sent to two different clinical trial sites in the U.S.

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

The document does not explicitly state the number or qualifications of individual experts who established the ground truth. However, the ground truth for the clinical and archived samples was established using a reference method:

• "The reference method was the CDC rRT-PCT Flu Panel influenza A and influenza B assays, followed by subtype-specific PCR and bi-directional sequencing of amplicons."
• "the presence of Influenza A/H1 viral RNA was confirmed using 'validation' PCR assays. The validation PCR assays were identical to the comparator assays that were used for the prospective clinical evaluation study."

This implies that the "experts" were the personnel performing and interpreting the CDC assays and sequencing results, which would typically be highly trained laboratory professionals and molecular biologists proficient in these techniques, likely adhering to CDC protocols. No specific number of such experts is given.

4. Adjudication Method for the Test Set

The document states: "JBAIDS Software analyzes the fluorescence amplification curves and reports results as positive, negative, or uncertain. A failure of the Positive or Negative Control will result in the entire run being called invalid. Retesting is required to resolve uncertain or invalid results."

For the clinical study, 6% of specimens (44/795) required retesting. Specifically, "Invalid" (32/44), "Inconclusive" (1/44), and "Unsubtypeable" (1/44). "Forty (40) out of 44 samples resolved upon a 1st retest and the remaining 4 samples required a re-extraction and retest and resolved." This indicates a retesting and re-extraction protocol for initial indeterminate or invalid results rather than a multi-expert adjudication panel for interpretive discrepancies. The ground truth itself (CDC rRT-PCR + sequencing) would have its own internal validation/adjudication processes, but this is not detailed for external review.

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

No multi-reader, multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was performed. This device is a diagnostic kit (real-time RT-PCR assay) that provides automated qualitative results, not an imaging AI diagnostic aid for human interpretation. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not directly apply to this type of device.

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

Yes, the studies described (clinical performance, archived samples, surrogate samples) represent standalone performance of the algorithm/device. The "JBAIDS Software analyzes the fluorescence amplification curves and reports results as positive, negative, or uncertain." While human operators perform the physical tests, the interpretation of the raw PCR data into a final qualitative result (positive/negative/uncertain) is automated by the device's software (algorithm). The clinical performance data presented (PPA and NPA) are a direct measure of this standalone performance against a defined ground truth.

7. Type of Ground Truth Used

The ground truth used was:

• Expert Consensus/Reference Method: For prospective clinical specimens and archived samples, the reference method was the CDC rRT-PCR Flu Panel influenza A and influenza B assays, followed by subtype-specific PCR and bi-directional sequencing of amplicons. This is a highly robust and accepted laboratory method for viral identification and subtyping.
• Known Spiked Concentration: For surrogate clinical specimens, the ground truth for positive samples was established by spiking influenza-negative clinical samples with known concentrations of seasonal Influenza A/H1 virus. Un-spiked negative samples also served as ground truth negatives.

8. Sample Size for the Training Set

The document does not provide details on a specific "training set" sample size or data for the development of the device's algorithm, as would typically be described for machine learning or AI models. This device is a PCR-based assay, where the "algorithm" is primarily the pre-defined thresholds and analysis logic within the JBAIDS software to interpret PCR amplification curves. Performance characteristics are primarily established through analytical validation (LoD, inclusivity, exclusivity) and clinical validation with independent test sets, rather than an explicit training-validation split in the context of an adaptive or learning algorithm. The design of the primers and probes, and the associated software interpretation, would have been iteratively developed and optimized, but a formal "training set" as understood in AI/ML is not mentioned.

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

As noted above, a formal "training set" for an AI/ML algorithm is not described for this diagnostic kit. The underlying principles of the PCR assay (primer/probe design, reaction conditions) are established through extensive analytical studies to ensure specificity and sensitivity. The "ground truth" for developing the analytical performance characteristics (like LoD, exclusivity, inclusivity) would involve testing well-characterized viral strains and non-target organisms with known concentrations, typically obtained from reference collections. This process establishes the analytical sensitivity and specificity that the device is designed to achieve when interpreting a sample.

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The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Influenza A & B Detection Kit is intended for use on the JBAIDS instruments, for the in vitro qualitative detection of Influenza A and Influenza B viral nucleic acids isolated and purified from nasopharyngeal swab (NPS) and nasopharyngeal wash (NPW) specimens from human patients with signs and symptoms of respiratory infection. The JBAIDS Influenza A & B Detection Kit contains reverse transcriptase real-time polymerase chain reaction (rRT-PCR) assays that target the Matrix protein gene of Influenza A viruses, and the Non-structural protein gene of Influenza B viruses. This kit is not intended to detect Influenza C viruses.

Test results are to be used in conjunction with other clinical and epidemiological information. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.

Performance characteristics for detection of influenza A were established when 2009 H1N1 Influenza, Influenza A H1N1, and Influenza A H3N2 were the predominant influenza A viruses in circulation. Due to low seasonal prevalence, performance characteristics for detection of seasonal Influenza A/H1 were established primarily with retrospective and surrogate clinical specimens. When other influenza A viruses are present, performance characteristics may vary.

All users, analysts, and any person reporting diagnostic results from use of this device should be trained to perform and interpret the results from this procedure by JBAIDS instructors or designees prior to use. Use of this device is limited to designated Department of Defense (DoD) laboratories equipped with the JBAIDS instruments.

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 departments for testing. Viral culture should not be attempted in these cases unless a biosafety laboratory (BSL) 3+ facility is available to receive and culture specimens.

The JBAIDS Influenza A & B Detection Kit is a rRT-PCR test kit, which, when used with the JBAIDS instrument and software, allows the qualitative in vitro detection of influenza A and B viral RNA. These two assays have been optimized as freeze-dried assays with primer and fluorescent-probe sets for the detection of influenza A and B viral RNA. In particular, the influenza A assay targets a region of the matrix gene specific to the influenza A virus genera, and the influenza B assay targets a region of the non-structural gene specific to the influenza B virus genera. The tests are performed using the previously FDA-cleared JBAIDS instrument and software. A human gene target assay (RNAseP target) will be used as an inhibition and extraction control.

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

For the JBAIDS Influenza A & B Detection Kit, the primary performance metrics are Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to a reference method. The document does not explicitly state pre-defined acceptance criteria (e.g., "PPA must be >90%"). However, the reported performance is presented to demonstrate substantial equivalence, implying that these agreement percentages were considered acceptable for clearance.

2. Sample Sizes and Data Provenance

• Clinical Performance (Prospective Study):
  • Test Set Sample Size: 804 valid specimens (314 NPS, 490 NPW).
  • Data Provenance: Prospective study conducted at 5 geographically separated military clinical sites in the U.S. during the 2010-2011 influenza season (December 2010 to April 2011).
• Testing of Preselected Archived Specimens:
  • Test Set Sample Size: 51 NPS specimens (30 known positive seasonal Influenza A/H1, 21 influenza-negative).
  • Data Provenance: Retrospective, pre-selected archived clinical NPS specimens. Country of origin not explicitly stated but implied to be US-based given the context of US military sites.
• Testing of Surrogate Clinical Specimens:
  • Test Set Sample Size: 136 individual influenza-negative clinical specimens (68 NPS, 68 NPW) that were spiked. 128 produced valid test results for analysis.
  • Data Provenance: Contrived clinical samples created by spiking residual influenza-negative NPS and NPW samples. Origin of the original negative specimens is clinical, likely from the US military sites or similar sources.
• Analytic Studies (LoD, Inclusivity, Exclusivity, Reproducibility):
  • These studies used distinct sample sizes, generally involving multiple replicates (e.g., 20 replicates for LoD, 30-90 results per spike level for reproducibility). The samples were either live, quantified virus strains or simulated NPS/NPW matrices spiked with specific organisms.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of human experts to establish ground truth for the test sets in the clinical performance study.

• Clinical Performance (Prospective, Archived, and Surrogate Studies): The ground truth was established by a comparator method, the CDC rRT-PCR Flu Panel influenza A and influenza B assays. This is a laboratory-based reference standard, not a human expert consensus.
• Analytic Studies: The ground truth for these (e.g., LoD, inclusivity, exclusivity) was based on the known presence and concentration of specific viruses or bacteria in the spiked samples.

4. Adjudication Method

There is no mention of an adjudication method in the studies described, as the comparator method (CDC rRT-PCR Flu Panel) served as the direct reference standard. The results of the JBAIDS kit were compared to this objective method.

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

No MRMC comparative effectiveness study was performed or described. This device is an in-vitro diagnostic (IVD) assay designed for laboratory use, not for direct interpretation by human readers in the same way an image-based diagnostic AI might be. Therefore, the concept of human readers improving with AI assistance is not applicable in this context. The device's results are intended to be interpreted by trained laboratory personnel.

6. Standalone Performance

Yes, a standalone performance study was done. The entire set of clinical and analytical performance evaluations (PPA, NPA, LoD, inclusivity, exclusivity, reproducibility) directly measures the performance of the JBAIDS Influenza A & B Detection Kit algorithm and associated testing procedure in isolation (without human-in-the-loop performance influencing the assay's output). The device's software automatically analyzes fluorescence amplification curves and reports results (positive, negative, or uncertain).

7. Type of Ground Truth Used

• Clinical Performance (Prospective, Archived, Surrogate): The ground truth was based on the results from a legally marketed comparator device: the CDC rRT-PCR Flu Panel influenza A and influenza B assays. This is a highly sensitive and specific laboratory-based molecular diagnostic method, often considered a "gold standard" for viral nucleic acid detection.
• Analytical Studies (LoD, Inclusivity, Exclusivity, Reproducibility): The ground truth was based on known concentrations of specific viral or bacterial strains in the spiked samples.

8. Sample Size for the Training Set

The document does not specify a separate training set for the JBAIDS Influenza A & B Detection Kit. As an IVD based on rRT-PCR, the "training" analogous to machine learning models is typically inherent in the assay design and optimization process (e.g., primer and probe design, reaction condition optimization), rather than a distinct data-driven training phase on labeled samples as seen in AI/ML products. The mentioned studies focus on the validation of the optimized kit.

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

As no explicit training set is described in the context of an AI/ML model, this question is not directly applicable. If one considers the development and optimization of the rRT-PCR assays as an analogous process, the "ground truth" during this phase would involve using well-characterized viral isolates and clinical samples with confirmed presence/absence of influenza to optimize the assay's sensitivity and specificity parameters.

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The JBAIDS Influenza A/H5 (Asian lineage) Detection Kit is intended for use in real-time reverse-transcriptase polymerase chain reaction (rRT-PCR) assays on the Joint Biological Agent Identification and Diagnostic System (JBAIDS) instruments for the in vitro qualitative detection of Influenza A/H5 (Asian lineage) viral RNA in patient nasopharyngeal swab (NPS) or throat swab (TS) specimens for the presumptive laboratory identification of Influenza A/H5 (Asian lineage) virus.

Testing with the JBAIDS Influenza A/H5 (Asian lineage) Detection Kit should be in conjunction with other laboratory testing and clinical observations for the following indications:

1. Providing epidemiological information for the surveillance of human infection with Influenza A/H5 (Asian lineage) virus.
2. Identifying patients who may be infected with Influenza A/H5 (Asian lineage) virus based on clinical and epidemiological risk factors.

Testing with the JBAIDS Influenza A/H5 (Asian lineage) Detection Kit 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 suspected 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.

Use is limited to laboratories with appropriate biosafety equipment and containment procedures. It is intended for use by experienced laboratory personnel who have training in standardized molecular testing procedures and expertise in viral diagnosis, and have received training on the JBAIDS Instrument.

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 departments for testing. Viral culture should not be attempted in these cases unless a biosafety laboratory (BSL) 3+ facility is available to receive and culture specimens.

The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Influenza A/H5 (Asian lineage) Detection Kit is a real-time reverse transcriptase polymerase chain reaction (rRT-PCR) test kit, which, when used with the JBAIDS instrument and software, allows the qualitative in vitro detection of Influenza A/H5 (Asian lineage) viral RNA. The kit contains two freeze-dried assays with primer and fluorescent-probe sets for the detection of Influenza A/H5 (Asian lineage) viral RNA. In particular, the two assays specifically target distinct regions of the influenza A hemagglutinin gene of the highly pathogenic H5N1 viruses from the Asian lineage, without detection of other influenza A virus subtypes, including the North American lineage influenza A/H5 viruses. The tests are performed using the previously FDA-cleared JBAIDS instrument and software. A human gene target assay will be used as an inhibition and extraction control.

Here's an analysis of the acceptance criteria and study details for the JBAIDS Influenza A/H5 (Asian lineage) Detection Kit, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Analytical Sensitivity (LoD): 20 individual specimens (from independent donors) per specimen type (NPS, TS) per purification kit (VIBE, Platinum Path) for confirmation (total 80 confirmed LoD tests). The provenance is not explicitly stated as country of origin, but it implies laboratory-prepared specimens. This was a prospective study design for LoD determination.
• Analytical Specificity (Inclusivity & Reactivity): 8 Influenza A/H5 (Asian lineage) strains, each spiked into TS specimens at multiple concentrations. The exact number of replicates per concentration is not detailed, but it was "multiple concentrations."
• Analytical Specificity (Exclusivity): 45 non-target organisms, each spiked into TS specimens at high concentrations. The exact number of replicates is not detailed.
• Clinical Performance (Surrogate Clinical Sensitivity):
  • Influenza A/H5 Strains: 8 strains, each at 4 concentrations (LoD, 5x LoD, 10x LoD, 100x LoD).
  • Seasonal Influenza Strains: 6 strains, each at 2 concentrations (LoD, 100x LoD).
  • Unspiked samples: 6 specimens.
  • All panels were spiked into TS or NPS specimens. Each specimen was purified with two different kits (IT 1-2-3 M VIBE and IT 1-2-3 ™ Platinum Path).
  • This results in a total of:
    • 8 (H5 strains) * 4 (concentrations) * 2 (specimen types) * 2 (purification kits) = 128 H5-containing samples.
    • 6 (seasonal strains) * 2 (concentrations) * 2 (specimen types) * 2 (purification kits) = 48 seasonal influenza samples.
    • 6 (unspiked) * 2 (specimen types) * 2 (purification kits) = 24 unspiked samples.
  • Total test set for surrogate clinical sensitivity: 128 + 48 + 24 = 200 specimens. These were laboratory-prepared "surrogate" clinical samples. This indicates a prospective design for testing these surrogate samples.
• Clinical Specificity:
  • NPS specimens: 314 (VIBE purified) + 299 (Platinum Path purified) = 613 specimens.
  • TS specimens: 298 (VIBE purified) + 283 (Platinum Path purified) = 581 specimens.
  • The total number of unique specimens used for clinical specificity is not explicitly stated (some could be both NPS and TS from the same patient, but the numbers suggest separate sample pools).
  • Total specimens tested for clinical specificity = 613 + 581 = 1194.
  • Data Provenance: Frozen, banked NPS and TS specimens previously tested for respiratory pathogens. They were obtained and tested at 3 different test sites. No specific country of origin is mentioned, but "US Department of Health and Human Services" context suggests US-based data. This is a retrospective study design using banked specimens.

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

The document does not explicitly mention the number or qualifications of experts used to establish ground truth for the test set.

• For Analytical Performance (LoD, Inclusivity, Exclusivity) and Surrogate Clinical Sensitivity, the "ground truth" was established by the precise spiking of known quantities of viral strains into samples by the study designers. This is a laboratory-controlled ground truth, not based on expert interpretation.
• For Clinical Specificity, the ground truth was based on the results of a "CDC rRT Flu Panel" (the predicate device) which had previously tested the banked clinical specimens. The document states "Specimens were removed from the study if they did not have a valid result for the CDC comparator assay," implying the CDC panel's results served as the reference. The expertise involved in the original testing of these banked samples by the CDC panel is not detailed here.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set.

• For analytical studies and surrogate clinical sensitivity, the ground truth was defined by the experimental setup (spiking concentrations, known positive/negative samples).
• For clinical specificity, the predicate device's results served as the comparison, implying a direct comparison rather than an adjudication process of ambiguous results. The JBAIDS software provides automated analysis (positive, negative, uncertain), and invalid/uncertain results required retesting, but this is a retest protocol, not an adjudication process involving experts to resolve discrepancies.

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 done.

This device is a molecular diagnostic assay (rRT-PCR kit) that provides automated results (positive, negative, uncertain). The output is interpreted by the JBAIDS software, not by multiple human readers. Therefore, there is no "human-in-the-loop" performance that would be assessed in an MRMC study or an effect size demonstrating human reader improvement with AI assistance.

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

Yes, the studies presented are effectively standalone performance studies of the algorithm/device. The device and its accompanying software provide automated interpretation (positive, negative, uncertain) of the rRT-PCR results. The performance characteristics described (LoD, inclusivity, exclusivity, clinical specificity, surrogate clinical sensitivity) represent the device's ability to achieve these results directly from the sample, without human interpretative input into the primary result. Human intervention is limited to operating the instrument, preparing samples, and initiating retesting for uncertain/invalid results, not interpreting the raw amplification curves as "positive" or "negative."

7. The Type of Ground Truth Used

• Analytical Studies (LoD, Inclusivity, Exclusivity): Laboratory-controlled ground truth (known viral strains spiked at specific concentrations).
• Surrogate Clinical Sensitivity: Laboratory-controlled ground truth (known viral strains spiked into clinical matrices at specific concentrations).
• Clinical Specificity: Comparator Assay ground truth. The "CDC rRT Flu Panel" was used as the reference standard for the banked clinical specimens.

8. The Sample Size for the Training Set

The document does not provide information about a separate "training set" or its sample size. This is common for molecular diagnostic kits like this. The device is likely developed and validated using a structured process that involves internal data for assay optimization and parameter setting (which could broadly be considered "training" in a development sense), but there isn't a formally defined "training set" in the context of machine learning model development as typically described in AI/ML device studies. The performance characteristics are derived from the test sets described above.

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

Since no specific "training set" is identified in the document, there's no information on how its ground truth would have been established. Any internal development and optimization would likely have relied on laboratory-controlled samples with known viral presence/absence and concentration.

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