Search Results

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.

Not Found

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:

1. 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.

2. 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.

3. 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.

4. Adjudication method for the test set
   This information is not provided in the FDA clearance letter.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

Ask a specific question about this device

SASTM StrepAlert is a visual test for the qualitative detection of Group A Streptococcus antigen in throat swab specimens. The test is for professional use.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the SAS™ StrepAlert device. This document confirms the device's substantial equivalence to a legally marketed predicate device but does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in a study report or a more extensive submission document.

Therefore, I cannot provide the requested table of acceptance criteria and device performance, or details about the study design, sample sizes, ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided FDA clearance letter.

The letter primarily focuses on:

• Device Name: SAS™ StrepAlert
• Regulation Number: 21 CFR 866.3740 (Streptococcus spp. Serological reagents)
• Regulatory Class: Class I
• Product Code: GTY
• Indications for Use: "SASTM StrepAlert is a visual test for the qualitative detection of Group A Streptococcus antigen directly from throat swab specimens. The test is for professional use."
• 510(k) Number: K013379

To obtain the detailed information regarding acceptance criteria and study results, one would typically need to refer to the original 510(k) submission document or a summary thereof, which often includes a "Summary of Safety and Effectiveness Data" that details the studies performed to demonstrate substantial equivalence. This information is not found within the provided FDA clearance letter.

Ask a specific question about this device