(16 days)
SASTM StrepAlert is a rapid visual test for the presumptive, qualitative detection of group A streptococcal antigen from throat swab specimens. The test is for professional use.
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This document is a 510(k) clearance letter from the FDA for the SAS™ StrepAlert device, which is a rapid visual test for the presumptive, qualitative detection of group A streptococcal antigen from throat swab specimens.
Generally, 510(k) clearances establish substantial equivalence to a predicate device rather than showing proof of meeting specific acceptance criteria through a detailed study. Such studies are typically part of a PMA (Premarket Approval) application for higher-risk devices.
Based on the provided document, the following information can be extracted regarding the "study" referenced implicitly by the 510(k) clearance, which would be a comparison to a predicate device:
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A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or provide a table of performance data. For a 510(k), the "acceptance criteria" are generally demonstrating substantial equivalence to a legally marketed predicate device. This usually involves showing comparable performance (e.g., sensitivity, specificity) but detailed numerical criteria and results are not present in this summary letter. -
Sample size used for the test set and the data provenance
This information is not provided in the FDA clearance letter. Such details would typically be found in the 510(k) submission itself, not in the summary letter. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the FDA clearance letter. For a test detecting a biological antigen, the "ground truth" would likely be established through bacterial culture. -
Adjudication method for the test set
This information is not provided in the FDA clearance letter. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done
This is highly unlikely for a rapid in vitro diagnostic test like StrepAlert. MRMC studies are typically for imaging devices where human readers interpret results "with and without AI assistance." The SAS™ StrepAlert is a "rapid visual test" for antigen detection, not an image interpretation system. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is described as a "rapid visual test," implying human interpretation of results (e.g., color change on a test strip). Therefore, a "standalone algorithm only" performance would not be applicable in the sense of a machine learning algorithm. Its performance is inherent to the chemical reactions and visual indicators. -
The type of ground truth used
While not explicitly stated in this document, for in vitro diagnostic tests for bacterial antigens, the gold standard "ground truth" is almost universally bacterial culture. That is, a throat swab would be cultured to definitively identify the presence or absence of Group A Streptococcus, and this result would be compared to the rapid test result. -
The sample size for the training set
This information is not provided. For this type of rapid diagnostic test, there isn't a "training set" in the machine learning sense. The device's performance is based on its chemical and biological design, which is validated through clinical studies rather than by training a model on data. -
How the ground truth for the training set was established
As there is no "training set" in the context of a machine learning algorithm, this question is not applicable. The device's performance characteristics are inherent to its design and validated against a biological gold standard (likely culture) in clinical trials.
§ 866.3740
Streptococcus spp. serological reagents.(a)
Identification. Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identifyStreptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusStreptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.