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SAS™ 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. Negative results should be confirmed via culture. This 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 or 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 SAS™ 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.

Here's a breakdown of the acceptance criteria and study details for the SAS™ FluAlert A & B Test, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document. Instead, the study aims to demonstrate "substantial equivalence" to predicate devices (SAS™ Influenza A Test and SAS™ Influenza B Test). The performance benchmarks are effectively the agreement rates with these predicate devices for positive and negative influenza cases.

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

• Prospective Clinical Study:
  • Sample Size: 461 nasal clinical specimens (nasal washes and nasal aspirates combined).
  • Data Provenance: Prospectively collected from four clinical trial sites in Texas and South Dakota, USA. An approximately equal mix of adult (>21 years) and pediatric patients (0-21 years) for nasal washes, and predominantly pediatric patients for nasal aspirates.
• Retrospective Study:
  • Sample Size: 191 frozen, archived nasal wash samples.
  • Data Provenance: Retrospective, from a children's hospital in Texas, USA.

In the prospective study, 13 samples yielded invalid results and were excluded from the totals.

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

The document does not specify the number of experts or their qualifications for establishing the ground truth for the clinical specimens. The comparison is made against the predicate devices (SAS™ Influenza A Test and SAS™ Influenza B Test) and also mentions "cell culture or DFA" for those predicate devices in the "Results Summary" chart reference, but not explicitly for the new device's test set.

4. Adjudication Method for the Test Set

The document states that the clinical specimens were tested "blindly and prospectively comparing the SAS™ Influenza A Test and The SAS™ FluAlert A&B (combined) Test performance" and similarly for Influenza B. This implies that the results of the new device were compared against the established results of the predicate devices. There is no explicit mention of an adjudication method like 2+1 or 3+1 by human readers; the comparison is device-to-device.

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 compares the new device's performance directly to the predicate devices, not human readers with and without AI assistance. The "reproducibility" section involved "non-professional users," but this was to assess consistent device results, not to evaluate human reader improvement with AI.

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

Yes, this is essentially a standalone performance study. The SAS™ FluAlert A & B Test is a rapid immunoassay (visual and rapid assay) that produces a visible, pink-colored line. Its performance is evaluated directly against predicate devices based on its ability to detect influenza viral nucleoprotein antigens. There is no "human-in-the-loop" component mentioned for interpreting the device's fundamental output beyond simply reading the presence or absence of a line.

7. The Type of Ground Truth Used

The primary ground truth for evaluating the SAS™ FluAlert A & B Test's performance in the clinical studies is the results from the substantially equivalent predicate devices (SAS™ Influenza A Test and SAS™ Influenza B Test). For these predicate devices, the document refers to a comparison to "cell culture or DFA" in an older summary, implying that those methods serve as a "gold standard" for the predicate devices, and by extension, for this new device's evaluation against the predicates.

8. The Sample Size for the Training Set

The document describes performance studies for a diagnostic device, not a machine learning algorithm that typically requires a separate training set. Therefore, there is no explicit training set or sample size for training mentioned as it's not applicable in the context of this type of diagnostic device submission.

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

As there is no explicit training set for a machine learning algorithm, there is no description of how ground truth for a training set was established. The studies conducted are for performance evaluation against established methods and devices.

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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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