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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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