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solid phase migratory chromatography immunoassay in vitro diagnostic test kit
Here's an analysis of the provided text regarding the Excel OneStep Group A Strep Antigen Module Test, structured according to your requested information.
The provided text describes a Summary of Safety and Effectiveness for the Excel OneStep Group A Strep Antigen Module Test, a device used for the qualitative detection of Group A Strep antigen from throat swabs.
Acceptance Criteria and Device Performance
The document does not explicitly state pre-defined "acceptance criteria" in terms of specific performance thresholds that the device had to meet. Instead, it describes a correlation study where the device's performance was compared against a recognized gold standard (culture). The reported performance metrics from this correlation study serve as the factual performance of the device.
Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (from correlation study) |
|---|---|---|
| Sensitivity | Not explicitly stated (implied: high agreement with culture) | Not explicitly stated in the provided text |
| Specificity | Not explicitly stated (implied: high agreement with culture) | Not explicitly stated in the provided text |
| Accuracy | Not explicitly stated (implied: high agreement with culture) | Not explicitly stated in the provided text |
Note: The provided text describes the study design and the methodologies but does not report the numerical results (sensitivity, specificity, accuracy, etc.) of the correlation study. Therefore, the "Reported Device Performance" column cannot be filled with quantitative values from this document. It only states that the study was conducted.
2. Sample Size and Data Provenance
- Sample Size (Test Set): Not explicitly stated in the provided text. The document refers to "each throat swab" suggesting a collection of samples, but no total number is given.
- Data Provenance: Not explicitly stated. The document refers to "throat swabs" without specifying the country of origin or whether the data was retrospective or prospective. Given the nature of a medical device submission, it is highly likely to be prospective data collected for the purpose of the study.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable in the traditional sense of human readers interpreting images. The ground truth for the test set was established through laboratory procedures (culture and latex agglutination), not by human expert interpretation of the test device itself.
- Qualifications of Experts: The ground truth involved standard microbiological laboratory techniques. While personnel performing these tests would be qualified laboratory technicians/microbiologists, the document does not elaborate on their specific qualifications.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The ground truth for each throat swab was established by a definitive laboratory method (culture followed by latex agglutination for confirmation). This is an objective, multi-step process for determining the presence of Group A Strep, not an interpretative task requiring human adjudication for discrepancies. The "gold standard" here is a sequential laboratory process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in the provided text. This study is a standalone performance assessment of the device against a laboratory gold standard, not a comparison of human reader performance with and without AI assistance.
6. Standalone Performance Study
- Standalone Performance Study: Yes, a standalone performance study was conducted. The entire description in the provided text focuses on the device's ability to detect Group A Strep antigen by itself, independent of human interpretation or assistance beyond performing the test procedure correctly. The device's results were directly compared to the culture-based ground truth.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth used was established through a two-step laboratory process:
- Culture: Throat swabs were used to inoculate sheep blood (trypticase) soy agar plates for the cultivation and isolation of microorganisms.
- Confirmation: Group A Streptococci isolated from the cultures were then confirmed by a latex agglutination assay (using a commercially available strep grouping kit from Diagnostic Product Corporation).
This combination provides a highly accepted and reliable laboratory-based ground truth for the presence of Group A Strep.
8. Sample Size for the Training Set
- Sample Size (Training Set): Not applicable. The Excel OneStep Group A Strep Antigen Module Test is a rule-based immunoassay, not an artificial intelligence (AI) or machine learning algorithm. Therefore, it does not have a "training set" in the computational sense. The device's mechanism is based on specific chemical reactions and antibody-antigen binding, which are inherently designed and manufactured, not "trained" on data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as this is not an AI/ML device that requires a training set. The "ground truth" related to its development would involve validation of the chemical and biological components during its manufacturing and quality control, ensuring the antibodies and reagents perform as intended.
§ 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.