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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 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 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™ Strep A 2 is a rapid, instrument-based, molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus pyogenes, Group A Streptococcus bacterial nucleic acid in throat swab specimens obtained from patients with signs and symptoms of pharyngitis. It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections.

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.

ID NOW™ Strep A 2 is a rapid, instrument-based isothermal test for the qualitative detection of Group A Strep from throat swab specimens.

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.

The reaction tubes in the ID NOW™ Strep A 2 Test Base contain the reagents required for Group A Strep bacterial lysis and the subsequent amplification of the target nucleic acid and an internal control. ID NOW™ Strep A 2 utilizes a pair of templates (similar to primers) for the specific amplification of DNA from Group A Strep and a fluorescently labeled molecular beacon designed to specifically identify the amplified nucleic acid target.

All ID NOW™ assays are 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 initiating bacterial lysis (for ID NOW™ Strep A 2) 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 document describes the modified software for the ID Now Instrument, encompassing ID NOW Influenza A & B 2 and ID NOW Strep A 2 assays. The modification specifically addresses false invalid results caused by baseline values being lower than allowed by the original algorithm, leading to incorrect identification as "Empty Tube Values." This is an algorithm update only, with no changes made to the chemistry of the assays.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the modified software address the reduction of false invalid results. The document implies that the "performance" here relates to the analytical performance characteristics of the assays (e.g., sensitivity, specificity) remaining equivalent to the predicate devices despite the software change. While explicit numerical acceptance criteria for reduction in false invalid rate are not provided in this excerpt, the study aims to demonstrate that the new algorithm resolves the "false invalid" issue without compromising the core analytical performance.

For ID NOW™ Influenza A & B 2 (with software modification):

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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.

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.

The ID NOW Influenza & B 2 system utilizes isothermal nucleic acid amplification technology and is 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 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 Receiver and transferred via the Transfer Cartridge to the Test Base, resuspending the lyophilized pellets contained within the Test Base and initiating 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 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 Alere™ 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 a software modification to the ID NOW Influenza A & B 2 device. The software modification aims to optimize the recognition of partial/non-dispense of samples and prevent false invalids due to system noise. This submission is a "Special 510(k)" because it's an algorithm update only, with no changes to the assay chemistry. Therefore, the study focuses on demonstrating that the modified device performs equivalently to the predicate device (the previously cleared ID NOW Influenza A & B 2, K190204).

Given the nature of a Special 510(k) for a software update to an existing in vitro diagnostic device, the acceptance criteria and study design will be focused on non-inferiority or equivalence to the predicate device, particularly concerning the impact of the software change on invalid rates and overall performance.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria:

The document does not explicitly state numerical acceptance criteria in the typical format of sensitivity, specificity, and confidence intervals for a new device's de novo clearance. Instead, the acceptance criteria are implicitly defined by demonstrating that the modified device's performance does not degrade compared to the predicate device for relevant metrics impacted by the software change (false invalids, sensitivity, specificity).

The study described is an equivalence study comparing the performance of the ID NOW Influenza A & B 2 (with the new software) against the predicate ID NOW Influenza A & B 2 (K190204).

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a software modification to optimize existing functionality (reducing false invalids and improving baseline recognition), the acceptance criteria would primarily revolve around demonstrating non-inferiority in terms of invalid rates and clinical performance (sensitivity and specificity) when compared to the predicate device. The document does not provide a table with explicit numerical acceptance criteria and reported device performance of the software modified device compared to the predicate in a clinical study. Instead, it emphasizes that the "modified ID NOW Influenza A & B 2 demonstrated performance that was substantially equivalent to the predicate device."

However, we can infer the intent of the acceptance criteria based on the purpose of the software update:

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

The document mentions that "ID NOW Influenza A & B 2 incorporating the software modification was compared to the legally marketed predicate device." However, it does not specify the sample size used for this comparison or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). For a software update to an existing device, a validation might involve re-testing archived samples or conducting a limited prospective study.

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

For an in vitro diagnostic (IVD) device like this, the "ground truth" for influenza detection is typically established by a reference method, not by human expert interpretation of images or clinical findings in the same way as an imaging AI device. The reference method for influenza detection would commonly be RT-PCR (Reverse Transcription Polymerase Chain Reaction), which is a highly sensitive and specific molecular test. Therefore, the concept of "number of experts" for establishing ground truth isn't applicable in this context.

4. Adjudication Method for the Test Set:

Not applicable in the human expert sense for an IVD device. The ground truth is established by a reference laboratory method (e.g., RT-PCR), and the device's results are compared directly to this objective reference.

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

No, an MRMC study was not done. MRMC studies are typically performed for AI-powered diagnostic imaging devices where human readers interpret medical images. This device is an in vitro diagnostic (IVD) test that automates the detection of viral RNA, and its output is a qualitative result (Influenza A positive/negative, Influenza B positive/negative). There are no "human readers" interpreting the device's output in a way that would require an MRMC study.

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

Yes, a standalone study was done. The ID NOW Influenza A & B 2, both the predicate and the modified version, operates as a standalone diagnostic device. It processes the sample, runs the assay, and automatically reports the result ("Automated" Interpretation, "Qualitative" Assay Result, "13 minutes or less" Time to Result). The software modification itself is an algorithm-only change that affects the internal processing of the instrument without requiring human intervention in the result interpretation beyond reading the displayed result. The comparison to the predicate device evaluates this standalone performance.

7. Type of Ground Truth Used:

The ground truth for an influenza diagnostic test is typically established using a highly sensitive and specific molecular reference method, such as Reverse Transcription Polymerase Chain Reaction (RT-PCR). The text states the device is for "qualitative detection and discrimination of influenza A and B viral RNA," implying the ground truth would be based on the presence or absence of this RNA as determined by a gold-standard molecular test.

8. Sample Size for the Training Set:

The document does not specify the sample size used for the training set. Since this is a software update for an existing algorithm focused on optimizing signal processing and invalid interpretation, the "training" might involve internal testing with various scenarios (e.g., partial dispense, low signal) rather than a large, clinical training set as seen in de novo AI model development. If external data was used for refining the algorithm, its size is not mentioned here.

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

The document does not specify how the ground truth for the training set was established. Analogous to the test set, if a training set were used for algorithm refinement (e.g., to teach the algorithm to detect partial dispenses or filter system noise), the ground truth for those scenarios would likely be established through controlled experiments or by expert review of raw signal data, potentially using a reference method (e.g., RT-PCR) to confirm true positive/negative status in various challenging sample conditions.

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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 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.

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 or nasopharyngeal swabs tested directly or after elution in viral transport media collected from patients presenting with signs and symptoms of respiratory infection.

The ID NOW Influenza A & B 2 system utilizes isothermal nucleic acid amplification technology and is 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 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 initiating 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 Alere™ Universal Printer can be attached via USB to the ID NOW Instrument to print test results.

The provided FDA 510(k) clearance letter and summary for the "ID NOW Influenza A & B 2" device (K190204) primarily focus on a labeling modification to expand specimen transport and storage instructions. It explicitly states: "This is a labeling update only, there have been no changes to the Intended Use or fundamental scientific technology of the ID NOW Influenza A & B 2 assay."

Therefore, this document does not contain the details of an acceptance criteria study or the detailed performance data as would be found in an original 510(k) submission for the device itself. Instead, it refers to the predicate device (K173932), implying that the performance criteria and supporting studies were established and documented during the clearance of that predicate device.

Based on the provided text, I cannot describe a new acceptance criteria study or new performance data for K190204, as this submission explicitly states none were performed for the device's fundamental function.

However, I can extract information related to the device itself and its general intended use, and explain why the requested information isn't present in this specific document.

Analysis of Provided Document's Relevance to Acceptance Criteria and Study Details:

The current document (K190204) is a "Special 510(k)" submission for a modification to an already cleared device. This type of submission does not typically include a full re-evaluation of the device's fundamental performance unless the modification directly impacts its safety or effectiveness in a new way. In this case, the modification is explicitly stated as only a labeling change related to specimen storage.

Therefore, the document does not provide the following information directly:

• A table of acceptance criteria and reported device performance for K190204 itself, because no new performance study was conducted for this specific submission. The performance data would have been part of the original submission for K173932.
• Sample sizes used for a test set for this submission.
• Protocols for establishing ground truth (experts, adjudication, etc.) for a substantial performance study.
• Details of MRMC studies or effect sizes.
• Standalone performance data (as this is a labeling update, not a new device or performance claim).
• Details on training set sample size or ground truth establishment for a new AI/algorithm (as this is a molecular diagnostic test, not an AI-based imaging diagnostic).

Information that can be inferred or directly stated from the document:

• Device Type: Rapid molecular in vitro diagnostic test. This is important because the requested ground truth types (pathology, expert consensus) are more relevant to imaging AI; for molecular diagnostics, ground truth is typically established by definitive laboratory methods (e.g., PCR reference methods, viral culture).
• Technology: Isothermal nucleic acid amplification technology.
• Targets: Influenza A and B viral RNA.
• Sample Type: Direct nasal or nasopharyngeal swabs, and nasal/nasopharyngeal swabs eluted in viral transport media.
• Result Type: Qualitative (detection/discrimination).
• Internal Control: Yes.
• Result Interpretation: Automated.
• Predicate Device: K173932 (ID NOW Influenza A & B 2). This implies that the validation and acceptance criteria for performance were established during the clearance of K173932.

Hypothetical Example of how the requested information would be presented for a diagnostic device, if this document were an original submission with performance data:

If this were an original 510(k) submission for a new diagnostic device requiring clinical validation, the document would typically include sections detailing:

1. Acceptance Criteria and Performance:

   Performance Metric	Acceptance Criteria (e.g., % Concordance)	Reported Performance (e.g., % Concordance, Sensitivity, Specificity)
   Overall Agreement	≥ 95%	97.2%
   Positive Agreement (PPA) for Flu A	≥ 90% (vs. Comparator X)	93.5% (vs. RT-qPCR)
   Negative Agreement (NPA) for Flu A	≥ 95% (vs. Comparator X)	98.1% (vs. RT-qPCR)
   Positive Agreement (PPA) for Flu B	≥ 90% (vs. Comparator X)	92.8% (vs. RT-qPCR)
   Negative Agreement (NPA) for Flu B	≥ 95% (vs. Comparator X)	97.5% (vs. RT-qPCR)
   Limit of Detection	Defined concentration (e.g., X copies/mL)	Y copies/mL
   Cross-Reactivity	No cross-reactivity with specified organisms	No cross-reactivity with A, B, C...
   Note: The specific metrics and thresholds would depend on the device type and intended use.

2. Sample Sizes and Data Provenance (for test set, if applicable to a clinical study):

   • Sample Size: e.g., 500 clinical samples (250 positive, 250 negative)
   • Data Provenance: Prospective collection from multiple clinical sites in the USA. Samples collected from patients presenting with signs/symptoms of respiratory infection during influenza season.

3. Ground Truth Establishment (for test set, if applicable):

   • Number of Experts/Reference Methods: Ground truth established by a highly sensitive and specific reference method, such as real-time Reverse Transcription Polymerase Chain Reaction (RT-qPCR) with validated primers and probes, performed by a CLIA-certified laboratory.
   • Qualifications of Experts (if human review was part of GT): Not directly applicable for a molecular test's primary ground truth, but if comparator methods involved experts, their qualifications (e.g., board-certified clinical microbiologists) would be relevant.

4. Adjudication Method:

   • Not applicable as primary ground truth is objective molecular test; if discordant results between the device and the reference method were analyzed, they might be adjudicated by re-testing or sequencing.

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

   • Not applicable for a molecular diagnostic device of this type, as it does not involve human readers interpreting images or data for diagnosis. This type of study is common for AI-powered imaging devices.

6. Standalone Performance:

   • The "reported performance" table above is the standalone performance for a fully automated molecular diagnostic device like this. There is no "human-in-the-loop" for result interpretation.

7. Type of Ground Truth Used:

   • Reference molecular testing: Typically RT-qPCR or similar highly sensitive and specific molecular assays, often using independent, validated methods. In some cases, viral culture could also be used as a reference. Clinical outcomes data might be used in broader epidemiological studies but not typically as the direct ground truth for analytical device performance.

8. Training Set Sample Size:

   • For a molecular diagnostic test, "training set" doesn't apply in the same way as for AI. Instead, there would be extensive analytical validation data (e.g., inclusivity, exclusivity, LOD, linearity, precision) generated by testing panels of characterized specimens and analytical dilutions. The "sample size" here would refer to the number of characterized panels and replicates used for these studies.

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

   • Again, for a molecular diagnostic, this refers to how the analytical samples were characterized. This is typically done through nucleic acid sequencing, quantitative PCR, or other highly accurate methods to determine the presence, type, and concentration of the target analyte in analytical samples. Clinical samples used in analytical studies would be highly characterized using established reference methods.

In summary, while the provided document gives valuable information about the device's intended use and the specific change for this 510(k), it does not contain the detailed performance study information that would have been part of the original 510(k) submission (K173932) for the ID NOW Influenza A & B 2 device.

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