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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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The SAS™ Legionella Test is a visually read, in vitro immunochromatographic rapid assay for the presumptive qualitative detection of Legionella pneumophila serogroup 1 antigens in human urine. This test is intended to aid in the presumptive diagnosis of Legionnaires' disease in conjunction with culture and other methods for patients with signs and symptoms of pneumonia. This test is for prescription use only.

The SAS™ Legionella test utilizes a combination of polyclonal antibodies against the antigens of Legionella pneumophila. The SAS™ Legionella test begins with the addition of urine to the test device. The specimen is absorbed by the sample pad and then moves through the conjugate pad which contains dried gold conjugated antibodies which are specific for Legionella pneumophila antigens; if the Legionella antigens are present in the urine sample, a "half-sandwich" immunocomplex is formed. This immuno-complex then migrates via capillary action along a nitrocellulose membrane containing immobilized antibodies to Legionella pneumophila antigens. The immobilized antibodies bind the "half-sandwich" immuno-complex to form a "whole sandwich" immuno-complex. Thus, when the "whole sandwich" is formed, a visible, pink colored line develops in the specimen zone on the test device. In the absence of a Legionella 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 Legionella antigen. The test is available in cassette format.

{
  "1_table_of_acceptance_criteria_and_reported_device_performance": {
    "Acceptance Criteria (Implicit)": "To demonstrate substantial equivalence to the predicate device (Binax™ Now® Legionella Urinary Antigen Test) and to culture methods for the detection of Legionella pneumophila serogroup 1 antigens in human urine.",
    "Reported Device Performance": "The SAS™ Legionella Test performed substantially equivalent to the predicate device, Binax™ Now® Legionella Urinary Antigen Test and to culture. Cross reactivity and interference studies showed no interference or cross-reaction with common viral and bacterial strains found in human urine."
  },
  "2_sample_size_used_for_the_test_set_and_data_provenance": {
    "Sample Size (Test Set)": "Not explicitly stated. The document mentions \"frozen and fresh urine specimens\" were used for comparison but does not provide a specific number.",
    "Data Provenance": "Not explicitly stated (e.g., country of origin). The data is retrospective based on the use of \"frozen and fresh urine specimens\" for comparison."
  },
  "3_number_of_experts_used_to_establish_the_ground_truth_for_the_test_set_and_qualifications": "Not applicable. The ground truth was established by comparison to a predicate device (Binax™ Now® Legionella Urinary Antigen Test) and culture methods, not by expert interpretation of the device results.",
  "4_adjudication_method_for_the_test_set": "Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus on image interpretation, which is not relevant for this immunochromatographic rapid assay.",
  "5_if_a_multi_reader_multi_case_mrmc_comparative_effectiveness_study_was_done": "No. This is an immunochromatographic rapid assay, not an imaging device requiring human reader interpretation in a MRMC study.",
  "6_if_a_standalone_performance_study_was_done": "Yes. The performance of the SAS™ Legionella Test (algorithm only, as it's a diagnostic kit) was directly compared against established methods (predicate device and culture) for diagnostic accuracy.",
  "7_the_type_of_ground_truth_used": "Comparison to a legally marketed predicate device (Binax™ Now® Legionella Urinary Antigen Test) and culture methods. Culture is generally considered a gold standard for bacterial identification.",
  "8_the_sample_size_for_the_training_set": "Not applicable. As a diagnostic test kit, there isn't a 'training set' in the machine learning sense. The device is developed through biochemical assays and optimizations, not by training an algorithm on a 'training set' of data.",
  "9_how_the_ground_truth_for_the_training_set_was_established": "Not applicable. See #8. The development of such a test relies on established scientific principles of immunology and antigen-antibody reactions, and validation against known Legionella-positive and -negative samples, rather than a 'ground truth' established for a training set in machine learning."
}

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