(421 days)
The BioStar® STREP A OIA® MAX assay is for the qualitative detection of Group A Streptococcal antigen directly from throat swabs. This test is intended for in vitro diagnostic use to rapidly identify Group A Streptococci in throat swab specimens from patients with suspected Group A streptococci-associated pharyngitis as an aid in the diagnosis of streptococcal infection.
Not Found
The provided document is a 510(k) clearance letter for the BioStar STREP A OIA® MAX assay, not a study report. As such, it does not contain the detailed information necessary to answer all the questions about acceptance criteria and a study proving the device meets them.
However, based on the context of a 510(k) clearance, we can infer some general aspects and extract limited information.
Here's what can be answered and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be fully answered from this document. This document is a clearance letter, not a clinical study report. It does not provide specific acceptance criteria values (e.g., minimum sensitivity, specificity) or the reported device performance against those criteria. Such details would typically be found in the 510(k) submission summary or a separate clinical study report.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be answered from this document. The document does not specify the sample size of any test set or the provenance of the data used for validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Cannot be answered from this document. For an in vitro diagnostic device like this, the "ground truth" would typically be established by a reference method (e.g., bacterial culture) rather than expert consensus on images. The document does not provide details on how ground truth was established, nor does it refer to "experts" in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Cannot be answered from this document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of medical images or other subjective data. For an in vitro diagnostic assay, the "ground truth" is usually determined by objective laboratory methods, not by human adjudication of independent expert interpretations.
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
- No. This is not applicable to an in vitro diagnostic device. MRMC studies are relevant for AI-powered image analysis devices where human readers interpret medical images. The BioStar STREP A OIA® MAX is a rapid in vitro diagnostic assay for antigen detection, not an AI-based imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The device itself is a standalone in vitro diagnostic assay. Its performance is evaluated on its own ability to detect the Group A Streptococcal antigen. There isn't a "human-in-the-loop" aspect to its fundamental operation or interpretation. Its performance would be assessed as a standalone diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Inferred: For a diagnostic assay like Strep A OIA, the ground truth would almost certainly be established by a bacterial culture of the throat swab specimen. Culture is the gold standard for detecting the presence of Group A Streptococcus.
8. The sample size for the training set
- Not applicable/Cannot be answered from this document. This is an antigen detection assay, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its development would involve optimization and validation, but not typically a labeled training data set for an algorithm.
9. How the ground truth for the training set was established
- Not applicable. As mentioned above, there isn't a "training set" in the AI/ML context for this type of device.
Summary based on available information:
The provided document is limited to a 510(k) clearance letter for the BioStar® STREP A OIA® MAX assay. It indicates the device is for the qualitative detection of Group A Streptococcal antigen directly from throat swabs as an aid in diagnosing streptococcal pharyngitis.
While the letter confirms the device was found substantially equivalent to a predicate device, it does not contain the detailed performance data or study methodology typically found in a clinical study report or the 510(k) summary (which is a separate document). Therefore, most of the specific questions regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment cannot be definitively answered from this document alone. We can infer that its performance as a standalone in-vitro diagnostic was evaluated, with bacterial culture likely serving as the ground truth.
§ 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.