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The OSOM® Influenza A&B Test is an in vitro diagnostic immunochromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

The OSOM® Influenza A&B Test consists of a test stick that separately detects influenza A and B. The test procedure requires the solubilization of the nucleoproteins from a swab by mixing the swab in Extraction Buffer. The test stick is then placed in the sample mixture, which then migrates along the membrane surface. If influenza A and/or B viral antigens are present in the sample, it will form a complex with mouse monoclonal IgG antibodies to Influenza A and/or B nucleoproteins conjugated to colloidal gold. The complex will then be bound by another mouse anti-influenza A and/or B antibody coated on the nitrocellulose membrane. A pink to purple control line must appear in the control region of the stick for results to be valid. The appearance of a second and possibly a third light pink to purple line will appear in the test line region indicating an A, B or A and B positive result.

The provided text describes an update to the package insert of the OSOM® Influenza A&B Test (K092633) to include additional analytical reactivity information for specific H3N2v Influenza A strains. It is not an original submission for a new device, but rather a modification to an already cleared device. As such, the information typically found in an initial 510(k) for device performance and clinical studies demonstrating efficacy for establishing acceptance criteria and proving they are met is largely absent in this document.

However, based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here is the ability of the OSOM® Influenza A&B Test to react with and detect specific influenza A strains. The stated performance is that the device does react with these strains.

Note: The document specifies that "the performance characteristics of this device with clinical specimens that are positive for these 2009 H1N1 and H3N2v influenza viruses have not been established." This indicates these results are from analytical reactivity studies, not clinical performance studies.

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

The test set consisted of cultured strains of the H3N2v Influenza A virus. The specific sample size (i.e., number of replicates for each strain) is not provided.
The data provenance is from analytical testing (e.g., in vitro laboratory testing) of cultured strains of the H3N2v influenza A virus. The origin of the data is not explicitly stated as a country, but the strains themselves suggest a US origin (West Virginia, Pennsylvania, Minnesota, Kansas, Indiana). The study is retrospective in the sense that the strains were already cultured and tested.

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

This information is not applicable/provided in the document as the study described is an analytical reactivity study using cultured viral strains. The "ground truth" for the test set is the known presence and concentration of the specific influenza virus strains in the cultured samples.

4. Adjudication Method for the Test Set

This information is not applicable/provided as this was an analytical reactivity study, not a clinical study involving human interpretation of results requiring adjudication. The device's reaction (detectable or not) is a direct output.

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

No, an MRMC comparative effectiveness study was not done for this submission. The submission pertains to updating analytical reactivity information for an already cleared in vitro diagnostic device, not evaluating human reader performance.

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

Yes, a standalone performance evaluation was done. The OSOM® Influenza A&B Test is an immunochromatographic assay, which is a rapid diagnostic test that provides a visual result (appearance of a pink to purple line). Its performance in detecting the H3N2v strains was evaluated directly, without human interpretation in the loop beyond observing the presence or absence of the test line.

7. The Type of Ground Truth Used

The ground truth used was the known presence and estimated concentration (EID50/mL or TCID50/mL) of specific cultured influenza A viral strains, often provided by sources like the CDC. This is a form of analytical truth based on established viral culture and quantification methods.

8. The Sample Size for the Training Set

This information is not applicable/provided. The detailed analytical reactivity described is for the test set that demonstrates the device's updated capabilities. For an already cleared device, detailed training set information for its initial development and clearance (K092633) is not part of this specific submission to update labeling. The OSOM® Influenza A&B Test is a lateral flow immunoassay, not a machine learning algorithm, so the concept of a "training set" in the computational sense does not apply. If "training set" refers to samples used during the original development and optimization of the assay, that information is not present here.

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

This information is not applicable/provided for the reasons stated in point 8.

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The OSOM® Influenza A&B Test is an in vitro diagnostic immunochromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections.

This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

The OSOM Influenza A&B Test consists of a test stick that separately detects influenza A and B. The test procedure requires the solubilization of the nucleoproteins from a swab by mixing the swab in Extraction Buffer. The test stick is then placed in the sample mixture, which then migrates along the membrane surface. If influenza A and/or B viral antigens are present in the sample, it will form a complex with mouse monoclonal IgG antibodies to influenza A and/or B nucleoproteins conjugated to colloidal gold. The complex will then be bound by another mouse anti-influenza A and/or B antibody coated on the nitrocellulose membrane. A pink to purple control line must appear in the control region of the stick for results to be valid. The appearance of a second and possibly a third light pink to purple line will appear in the test line region indicating an A, B or A and B positive result.

The provided text describes a 510(k) summary for the OSOM® Influenza A&B Test, primarily focusing on updating the package insert with additional analytical reactivity information for the H1N1 Influenza A strain Mexico/4108/2009.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for clinical performance. Instead, it demonstrates the device's analytical reactivity with a specific strain of influenza. The acceptance is based on the device showing reactivity to the H1N1 strain.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: The document refers to testing with a "cultured strain" (A/Mexico/4108/2009) of the 2009 H1N1 Influenza A virus. It does not specify a "sample size" in terms of number of patient samples, but rather indicates a single viral strain was used for this analytical reactivity test.
• Data Provenance: The data is analytical reactivity information, presumably from a laboratory setting. Specific country of origin is not mentioned for this particular test, but the strain name "Mexico/4108/2009" indicates the origin of the virus strain. The study is a prospective analytical study, not a retrospective clinical study.

3. Number of Experts and Qualifications

Not applicable. This was an analytical reactivity study, not a study requiring expert interpretation of results. The determination of whether the test "reacts" is a direct laboratory observable.

4. Adjudication Method

Not applicable. There was no need for adjudication as this was an analytical reactivity study, not a clinical study involving multiple interpreters.

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

No. The document describes an analytical reactivity study, not a clinical effectiveness study. There is no mention of human readers or AI assistance.

6. Standalone Performance Study

Yes. The study described is a standalone analytical performance study, demonstrating the device's ability to detect the H1N1 strain in a cultured sample without human intervention in the result interpretation (beyond observing the test line).

7. Type of Ground Truth Used

The ground truth used was the cultured presence of the specific H1N1 Influenza A virus strain (A/Mexico/4108/2009). This is a laboratory-established ground truth.

8. Sample Size for the Training Set

Not applicable. This device is an immunochromatographic assay, not an AI/machine learning algorithm, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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The OSOM Influenza A&B Test is an in vitro diagnostic immunochromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

The OSOM Influenza A&B Test consists of a test stick that separately detects influenza A and B. The test procedure requires the solubilization of the nucleoproteins from a swab by mixing the swab in Extraction Buffer. The test stick is then placed in the sample mixture, which then migrates along the membrane surface. If influenza A and/or B viral antigens are present in the sample, it will form a complex with mouse monoclonal IgG antibodies to influenza A and/or B nucleoproteins conjugated to colloidal gold. The complex will then be bound by another mouse anti-influenza A and/or B antibody coated on the nitrocellulose membrane. A pink to purple control line must appear in the control region of the stick for results to be valid. The appearance of a second and possibly a third light pink to purple line will appear in the test line region indicating an A, B or A and B positive result.

This document is a 510(k) summary for the OSOM® Influenza A&B Test. It describes the device, its intended use, and compares it to a legally marketed predicate device (OSOM Influenza A&B Test K051244). The information provided focuses on the device's characteristics and its equivalence to the predicate, rather than a detailed study proving it meets specific acceptance criteria with performance metrics.

Therefore, much of the requested information regarding acceptance criteria, reported performance, and study details (sample sizes, ground truth establishment, expert involvement, MRMC studies) is not present in the provided text. The document is primarily a regulatory submission for substantial equivalence.

Here's an analysis of what can be extracted from the provided text based on your request:

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

The provided text does not include explicit acceptance criteria or detailed reported device performance (e.g., sensitivity, specificity, accuracy) from a clinical study. It focuses on comparing the new device's technological characteristics to a predicate device. The cross-reactivity data table shows potential interfering substances that were tested and found to have "no affect on the performance," but it doesn't quantify performance metrics.

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

This information is not provided in the document. The text describes the device and its intended use but does not detail any clinical study or the sample size used for a test set, nor the provenance of such data.

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. There is no mention of a test set, ground truth establishment, or experts involved in such a process.

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

This information is not provided in the document. There is no mention of a test set or any adjudication method.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. This device is an in vitro diagnostic immunochromatographic assay, not an AI-assisted diagnostic tool, so the concept of human readers improving with AI assistance is not applicable.

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

This device is a lateral flow immunoassay. Its performance is inherent to the chemical reaction and visual interpretation of the test stick, not an algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The test provides a direct result (pink to purple line) that is interpreted by the user.

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

The document states under "Intended Use": "A negative test is presumptive and it is recommended these results be confirmed by cell culture." This implies that cell culture is considered the gold standard or ground truth for confirming negative results of influenza infection. However, it does not explicitly state what was used as ground truth for any performance evaluation in this 510(k) submission.

8. The sample size for the training set

This information is not provided in the document. As a lateral flow immunoassay, there wouldn't typically be a "training set" in the machine learning sense. The device's formulation and antibodies are developed through a different process.

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

This information is not provided and is again not applicable in the context of this type of device.

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The OSOM Influenza A&B Test is an in vitro diagnostic immunochromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture.

Cross-reactivity with respiratory viruses other than influenza viruses has not been evaluated. The user is responsible for determining the cross-reactivity of other respiratory viruses with this test.

The OSOM Influenza A&B Test consists of a test stick that separately detects influenza A and B. The test procedure requires the solubilization of the nucleoproteins from a swab by mixing the swab in Extraction Buffer. The test stick is then placed in the sample mixture, which then migrates along the membrane surface. If influenza A and/or B viral antigens are present in the sample, it will form a complex with mouse monoclonal IgG antibodies to influenza A and/or B nucleoproteins conjugated to colloidal gold. The complex will then be bound by another mouse anti-influenza A and/or B antibody coated on the nitrocellulose membrane. A pink to purple control line must appear in the control region of the stick for results to be valid. The appearance of a second and possibly a third light pink to purple line will appear in the test line region indicating an A, B or A and B positive result.

Here's an analysis of the acceptance criteria and study that proves the OSOM Influenza A&B Test meets them, based on the provided text:

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

The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity, specificity, and agreement. However, the study results are presented as the device's performance. For the purpose of this response, I will interpret the reported performance values as implicitly meeting the unstated acceptance criteria for substantial equivalence to the predicate device.

Additional Performance Data:

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

• Sample Size for Clinical Performance (Test Set): 383 subjects.
  • 383 total samples for comparison to viral culture for both Influenza A and B.
  • Of these, 132 samples were from pediatric subjects (2-19 years) and 251 samples were from adults (> 20 years).
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. Given the context of a 510(k) submission to the FDA in the US, it is highly likely that the clinical study was conducted in the United States. The study involved enrollment of subjects, which suggests a prospective collection of samples for the clinical performance evaluation.

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)

• The ground truth for the clinical performance study (sensitivity, specificity, agreement) was established using viral cell culture as the reference method. This is a laboratory-based method, not dependent on human expert interpretation of the final result for the ground truth. Therefore, the concept of "number of experts" and their "qualifications" for establishing the ground truth does not directly apply here in the traditional sense of image or clinical interpretation.

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

• The document does not describe any human adjudication method for the ground truth (viral culture) or for the device's results. Viral culture results are objective laboratory findings. For the OSOM test results, it is a rapid diagnostic test with visually interpreted lines, implying a single interpretation per test, though reproducibility was assessed across different operators.
• Polymerase Chain Reaction (PCR) was performed on specimens that gave inconsistent results between the OSOM test and viral culture. This was done "for information only" and PCR was not FDA approved/cleared for this purpose at the time, meaning it was not used as a primary adjudication method for the final, reported clinical performance metrics directly, but rather for investigational purposes.

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, a MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic immunochromatographic assay (a rapid point-of-care test), not an AI-powered diagnostic imaging or interpretation system. It does not involve human readers interpreting complex images with or without AI assistance, so the concept of "effect size of how much human readers improve with AI" is not applicable.
• However, an Assay Reproducibility study was conducted to demonstrate that the test performs acceptably in the hands of various operators (nurses, nurse practitioners, physician's office personnel). This involved multiple operators interpreting coded and masked samples, which is a form of multi-reader evaluation for the device's interpretability. The overall accuracy was 97% for Flu A and 94% for Flu B in this reproducibility study.

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

• Yes, in essence, the primary clinical performance evaluation is a standalone study. The OSOM Influenza A&B Test is a lateral flow immunoassay that provides a visual reading (pink to purple lines). Although a human interprets these lines, the core "algorithm" (the immunochromatographic assay itself) operates independently. The sensitivity, specificity, and agreement reported in the "Agreement with Viral Culture" section represent the performance of the device on its own, with human interpretation assumed to be done according to instructions. The test is designed to be read directly by an operator, not to be an "AI algorithm" that outputs a result for a human to then validate or integrate into a diagnosis.

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

• The primary ground truth for the clinical performance (sensitivity, specificity) was viral cell culture. This is considered a gold standard for influenza virus detection.
• For the analytical specificity and cross-reactivity studies, the ground truth was the known identity of the bacterial isolates and influenza virus strains.

8. The sample size for the training set

• The document describes the clinical performance evaluation and various analytical studies. It does not describe a separate "training set" in the context of machine learning or AI models, as this is an immunoassay. The tests performed are validations of the developed assay, not training phases for an algorithm.

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

• As concluded in point 8, there isn't a "training set" for an AI model mentioned in the document. The development of an immunoassay like the OSOM test involves extensive laboratory work, including using known positive and negative samples, and samples spiked with varying concentrations of analytes, to optimize the assay's components and parameters (antibodies, reagents, flow characteristics, etc.). This iterative process would utilize known viral cultures and other characterized samples to ensure the assay functions as intended, but it's not typically referred to as a "training set" with ground truth in the same way as in AI/ML development.

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