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SASTM Influenza A Test is a visual and rapid assay for the presumptive in-vitro qualitative detection of influenza A viral nucleoprotein antigens from nasal washes and nasal aspirates of symptomatic patients. The test is not intended for the detection of Influenza Type B viral antigen or Influenza Type C viral antigen. This test is for professional use only.

Negative results do not preclude infection with influenza A and should not be used as the sole basis for treatment or other patient management decisions. It is recommended that negative results be confirmed by cell culture.

SASTM FluAlert A & B Test is a visual and rapid assay for the presumptive in-vitro qualitative detection of Influenza A and Influenza B viral nucleoprotein antigens from nasal washes and nasal aspirates of symptomatic patients. The test is not intended for the detection of Influenza Type C viral antigen. This test is for professional use only.

Negative results do not preclude infection with influenza A and/or influenza B and should not be used as the sole basis for treatment or other patient management decisions. It is recommended that negative results be confirmed by cell culture.

The SASTM Influenza A Test utilizes antibodies against influenza type A viral nucleoproteins. The SASTM Influenza A test begins with an extraction of Type A nucleoproteins. After the extraction has been completed, the sample is placed into the sample well of the test. The specimen is absorbed and migrates via capillary action through membranes that contain dried gold conjugated antibody, which is specific for influenza A viral nucleoproteins. If these nucleoproteins are present, a "half-sandwich" immunocomplex is formed. The membrane contains immobilized antibody to influenza A nucleoproteins, which binds the "half sandwich" complex. Thus, in the presence of influenza A nucleoproteins, a "whole sandwich" immunocomplex is formed and a visible, pink-colored line develops in the specimen zone of the test device. In the absence of an influenza A antigen, a "sandwich" immunocomplex is not formed and a negative result is indicated. To serve as a procedural control, a pink-colored control line will always appear in the control zone of each strip regardless of the presence or absence of influenza A nucleoproteins.

The SASTM FluAlert A & B Test utilizes antibodies against influenza type A and influenza type B viral nucleoproteins. After the extraction has been completed, the sample is placed into two separate sample wells. The specimen is absorbed and migrates via capillary action through membranes that contain dried gold conjugated antibody, which is specific for either influenza A or influenza B viral nucleoproteins. If these nucleoproteins are present, a "half-sandwich" immunocomplex is formed. The membrane contains immobilized antibody to influenza A or influenza B nucleoproteins, respectively, which bind the "half sandwich" complex. Thus, in the presence of influenza nucleoproteins, a "whole sandwich" immunocomplex is formed and a visible, pink-colored line develops in the specimen zone of the test device. In the absence of an influenza antigen, a "sandwich" immunocomplex is not formed and a negative result is indicated. To serve as a procedural control, a pink-colored control line will always appear in the control zone of each strip regardless of the presence or absence of influenza A or influenza B nucleoproteins.

The provided text describes two influenza detection tests: the SASTM Influenza A Test (K041441) and the SASTM FluAlert A & B Test (K080380). The current submission (K132352) is primarily focused on updating the predicate devices for these tests to include sensitivity data for the H7N9 strain, rather than presenting a new clinical study with acceptance criteria for device performance. Therefore, a table of acceptance criteria and device performance as typically understood for a novel device's clinical study is not explicitly provided in this document.

The document primarily focuses on analytical sensitivity (Limit of Detection) and cross-reactivity for the H7N9 strain, rather than clinical performance metrics like sensitivity and specificity in patient cohorts.

Here's a breakdown of the information that can be extracted, addressing your points where possible:

Acceptance Criteria and Study Details for SASTM Influenza A Test and SASTM FluAlert A & B Test

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit acceptance criteria for clinical performance (e.g., sensitivity, specificity thresholds) are not provided in this document. The studies described are analytical studies for the H7N9 strain.

Analytical Performance for both devices (SASTM Influenza A Test and SASTM FluAlert A & B Test) for H7N9:

Note on Clinical Performance: The document explicitly states: "Performance characteristics for detecting the 2013 H7N9 influenza virus from human specimens have not been established." and "Although this test has been shown to detect the 2013 H7N9 from a cultured isolate, the performance characteristics of this test with clinical specimens that are positive for the 2013 H7N9 influenza virus have not been established." This indicates that the presented data is entirely analytical, not clinical.

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

• Sample Size: The test sets for the analytical sensitivity studies consisted of serial dilutions of cultured viral strains. The exact number of replicates for each dilution is not specified, but the results for the Limit of Detection are provided. For the cross-reactivity study, various cultured viral strains were tested at specific concentrations. The exact number of specimens (or "samples") is not individually quantified beyond the listed strains and their concentrations.
• Data Provenance: The viral strains used (e.g., A/Anhui/1/2013 H7N9, various H1N1, H3N2, Influenza B strains) were obtained from ATCC and the CDC. The data is prospective in the sense that the experiments were conducted for this submission (analytical studies), but they used cultured isolates, not retrospective or prospective human clinical samples. The country of origin for the data is implied to be the United States (where SA Scientific is based and the CDC/ATCC are located).

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

• This information is not applicable as the studies are analytical (laboratory-based detection of cultured viruses), not clinical studies requiring expert ground truth interpretation of patient data. The "ground truth" here is the known presence and concentration of the virus in the cultured samples. The CDC provided the H7N9 strain with a known titer, though SA Scientific did not independently verify this titer.

4. Adjudication Method for the Test Set

• This information is not applicable as the studies are analytical and do not involve human interpretation or adjudication of clinical outcomes. The results are based on the visual detection of a pink line on the rapid immunoassay.

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

• This is not applicable. The device is an immunoassay (a rapid test strip), not an AI-powered diagnostic imaging or interpretive device. There is no AI component or human-reader performance improvement study described.

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

• This is not applicable. The device is a rapid immunoassay, which is a standalone test in itself (it provides a visible result without external computational algorithms). There is no "algorithm" in the context of AI being tested. The human "in-the-loop" is simply reading the visual result.

7. The Type of Ground Truth Used

• The ground truth used was the known presence and concentration of specific cultured viral strains. For example, for the H7N9 strain, it was A/Anhui/1/2013, with a known titer provided by the CDC. This is a form of analytical ground truth derived from laboratory-established viral cultures.

8. The Sample Size for the Training Set

• This is not applicable. As a rapid immunoassay (not an AI model), there is no "training set" in the context of machine learning. The device's design and antibodies are developed through traditional biological and chemical means, not by training on a dataset.

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

• This is not applicable for the reasons stated above (not an AI model).

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SAS™ FluAlert A Test is a visual and rapid assay for the presumptive in-vitro qualitative detection of Influenza A viral nucleoprotein antigens from nasal washes and nasal aspirates of symptomatic patients. The test is not intended for the detection of Influenza Type B viral antigen or Influenza Type C viral antigen. This test is for professional use only.

Negative results do not preclude infection with influenza A and should not be used as the sole basis for treatment or other patient management decisions. It is recommended that negative results be confirmed by cell culture.

The SASTM FluAlert A Test utilizes antibodies against influenza type A viral nucleoproteins. The SASTM FluAlert A Test begins with an extraction of Type A nucleoproteins. After the extraction has been completed, the sample is placed into the sample well of the test. The specimen is absorbed and migrates via capillary action through membranes that contain dried gold conjugated antibody, which is specific for influenza A viral nucleoproteins. If these nucleoproteins are present, a "half-sandwich" immunocomplex is formed. The membrane contains immobilized antibody to influenza A nucleoproteins, which binds the "half sandwich" complex. Thus, in the presence of influenza A nucleoproteins, a "whole sandwich" immunocomplex is formed and a visible, pink-colored line develops in the specimen zone of the test device. In the absence of an influenza A antigen, a "sandwich" immunocomplex is not formed and a negative result is indicated. To serve as a procedural control, a pink-colored control line will always appear in the control zone of each strip regardless of the presence or absence of influenza A nucleoproteins.

The provided text describes the SASTM FluAlert A Test, a rapid immunoassay for the presumptive in-vitro qualitative detection of Influenza A viral nucleoprotein antigens. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SASTM FluAlert A Test are based on its analytical sensitivity (Limit of Detection - LoD) for various influenza A viral strains. The reported performance demonstrates the concentration at which the device can detect these strains.

Note: The document implies that the device is intended to "detect" these strains, thus the acceptance criteria are that the device demonstrates a measurable Limit of Detection for each. The specific numerical thresholds for acceptance were not explicitly defined as pass/fail criteria in the provided text, but the reported LoD values demonstrate the device's capability.

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

The provided text describes an analytical sensitivity study (Limit of Detection) rather than a clinical test set with human samples.

• Sample Size for the test set: For each influenza viral strain tested, the study involved serial dilutions to determine the Limit of Detection (LoD). The exact number of replicates or individual test instances at each dilution is not specified, but the methodology implies multiple tests per dilution series to establish the LoD.
• Data Provenance: The strains tested were obtained from ATCC (American Type Culture Collection), a global non-profit biological resource center. These are cultured viral strains, not directly human clinical samples. The document states "a positive human specimen" was used to culture the FluA/California/04/2009 (H1N1) virus, but the LoD study itself used the cultured strain rather than direct clinical specimens for this particular virus. The study is therefore retrospective in the sense that it uses established and archived viral strains. The country of origin of the ATCC strains is not specified in this document.

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

There were no human experts used to establish ground truth for this particular analytical sensitivity study. The ground truth was established by the known titers of the viral strains obtained from ATCC. The document states: "This viral strain used in this study was obtained from ATCC with a known titer. SA Scientific, Ltd did not verify this titer."

4. Adjudication Method for the Test Set

Not applicable. This was an analytical study determining the Limit of Detection using cultured viral strains with known titers, not a study involving human adjudication of results.

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. The study described is an analytical sensitivity study of the device's ability to detect specific viral strains, not a study comparing human reader performance with or without AI assistance.

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

Yes, this was a standalone performance study from the perspective of the device. The study evaluated the SASTM FluAlert A Test's ability to detect influenza A viral nucleoprotein antigens without human interpretation being part of the primary measurement for the LoD. The "visual" aspect of the assay implies a human performs the reading, but the study focuses on the lowest concentration the device can detect, independent of variations in human interpretation during clinical use.

7. The Type of Ground Truth Used

The type of ground truth used was known viral titers provided by ATCC for the various influenza A strains. This is a form of analytical ground truth, based on established biological standards.

8. The Sample Size for the Training Set

No information is provided about a "training set" in the context of machine learning or algorithm development. The SASTM FluAlert A Test is described as an "immunoassay utilizing immunochromatographic technology," which typically means it relies on biochemical reactions (antibody-antigen binding) rather than an AI algorithm that requires a training set.

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

Not applicable, as no training set for an AI algorithm appears to have been used in the development or evaluation of this immunoassay device.

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SAS™ Influenza A Test is a visual and rapid assay for the presumptive qualitative detection of Influenza Type A antigens from nasal washes and aspirates. Negative results should be confirmed via culture. This test is not intended for the detection of Influenza Type B or C viral antigen. The test is for professional use.

The SASTM Influenza A test utilizes a set monoclonal antibodies against Influenza Type A viral nucleoproteins. The SASTM Influenza test begins with an extraction of Type A nucleoproteins. After the extraction has been completed, the sample is placed into the test and observed for the formation of colored lines. The specimen is absorbed and migrates via capillary action through a membrane that contains dried gold conjugated antibody, which is specific for Influenza Type A nucleoproteins. If Type A nucleoproteins are present, a "half-sandwich" immuno-complex is formed. The membrane contains immobilized antibody to Influenza Type A nucleoproteins, which binds the "half sandwich" complex. Thus, in the presence of Influenza nucleoproteins, a "whole sandwich" immuno-complex is formed and a visible, pink colored line develops in the specimen zone of the test device. In the absence of an Influenza antigen, a "sandwich" immuno-complex is not formed and a negative result is indicated. To serve as a procedural control, a pink colored control line will always appear in the control zone regardless of the presence or absence of Influenza nucleoproteins.

Here's an analysis of the provided text regarding the SAS™ Influenza A Test, focusing on the acceptance criteria and the supporting study:

The provided document describes a 510(k) submission for the SAS™ Influenza A Test. It claims substantial equivalence to a predicate device, the Binax™ NOW® Flu A Test, based on performance with freshly collected nasal wash specimens.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device. The performance of the SAS™ Influenza A Test is reported in comparison to the predicate.

Note: The document focuses on showing substantial equivalence and mentions "Performance Summary: The SAS™ Influenza A test performed substantially equivalent to the predicate device, Binax™ NOW® Flu A test. This was verified by comparison to freshly collected nasal wash specimens." Specific metrics like sensitivity, specificity, or agreement rates are not explicitly provided within this summary, but are inferred to be comparable to the predicate for substantial equivalence.

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

• Test Set Sample Size: The document does not explicitly state the numerical sample size used for the comparison study. It only mentions "freshly collected nasal wash specimens."
• Data Provenance: The document does not explicitly state the country of origin. It can be inferred that the study was conducted to support a US FDA 510(k) submission, suggesting it was likely conducted in the US or under US regulatory standards. The study design is prospective, as it used "freshly collected nasal wash specimens."

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

• Number of Experts: Not specified.
• Qualifications of Experts: The ground truth for positive influenza A cases was "confirmed via culture." The document does not specify who performed or interpreted these cultures, or their qualifications.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for reconciling discordant results between the SAS™ Influenza A Test, the predicate device, and the culture confirmation.

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

This question is not applicable to this device. The SAS™ Influenza A Test is an in vitro diagnostic immunoassay that provides a visual result (colored lines) and does not involve human readers interpreting complex images or AI assistance.

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

This question is not applicable to this device. It is a rapid immunoassay, a "standalone" device in the sense that it produces a result directly without requiring an additional algorithm or human interpretation beyond observing the presence or absence of colored lines.

7. The Type of Ground Truth Used

The ground truth used for positive cases was culture confirmation. Specifically, "Negative results should be confirmed via culture." and "confirmed via culture." for positive cases.

8. The Sample Size for the Training Set

This question is not applicable to this device. The SAS™ Influenza A Test is a rapid immunoassay that utilizes monoclonal antibodies and immunochromatographic technology. It is not an algorithm or AI-based device that requires a "training set."

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

This question is not applicable for the same reasons as point 8. No training set was used.

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