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The Tetracore RedLine Anthrax Alert™ Test is intended for the rapid, in vitro qualitative detection of Bacillus anthracis from non-hemolytic colonies obtained from sheep blood agar plates. The test is intended for use in clinical, public health, and hospital laboratories in conjunction with other markers and testing for the identification of Bacillus anthracis.

The Tetracore RedLine Alert™Test is an immunochromatographic test intended for the rapid, in vitro qualitative presumptive identification of Bacillus anthracis from nonhemolytic Bacillus colonies cultured on sheep blood agar plates. The test is intended for use in clinical, public health, and hospital laboratories in conjunction with other markers and testing for the presumptive identification of Bacillus anthracis.

The RedLine Anthrax Alert™ Test Cassette includes a reagent strip consisting of a combination of monoclonal and polyclonal antibodies that selectively detect the presence of Bacillus anthracis in aqueous specimens. The RedLine Anthrax Alert™ Test is supplied with single use test cassettes, Colony Isolation Buffer, and Positive Control reagent.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines the acceptance criteria through the reported performance characteristics.

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

• Test set sample size:
  • Sensitivity: 145 isolates
  • Specificity: 59 isolates
• Data Provenance: Not explicitly stated. Given it's a 510(k) submission, the isolates would likely be from laboratory cultures and potentially clinical samples, but the geographic origin or whether they were retrospective/prospective is not mentioned.

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

• This information is not provided in the document. The document refers to "isolates" and their characteristics, implying that the ground truth for these isolates (i.e., whether they definitively were Bacillus anthracis or another species) was previously established, but the method and expertise involved are not detailed.

4. Adjudication Method for the Test Set:

• The document does not specify an adjudication method. The testing appears to have been directly against the established identification of the isolates.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No, an MRMC comparative effectiveness study was not done. This device is a diagnostic test (an immunochromatographic assay) designed for automated or semi-automated qualitative detection, not for human interpretation that would be improved by AI assistance.

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

• Yes, the performance characteristics reported (sensitivity and specificity) are for the standalone device (RedLine Anthrax Alert™ Test) without human interpretation affecting the result. The device itself produces the qualitative result.

7. The Type of Ground Truth Used:

• The ground truth used was based on the identity of the bacterial isolates from "non-hemolytic colonies obtained from sheep blood agar plates." This implies a microbiological gold standard, likely established through traditional microbiological identification methods (e.g., Gram staining, cultural characteristics, biochemical tests, molecular methods) which are considered definitive for bacterial species identification. The document does not explicitly state "pathology" or "outcomes data" but rather relies on confirmed bacterial identity.

8. The Sample Size for the Training Set:

• The document does not provide information regarding a separate training set size. The reported performance is based on the "testing of 145 isolates" and "59 isolates," which constitute the evaluation/test set. For a lateral flow immunochromatographic assay, the development and optimization (which could be considered a form of "training") might involve a different process than machine learning algorithms, often relying on reagent optimization and preliminary analytical studies.

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

• As a separate training set is not explicitly mentioned, the ground truth for any development or optimization phases would likely have been established using the same (or similar) microbiological gold standard as described for the test set (i.e., definitive identification of Bacillus anthracis and other relevant bacterial species).

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