(182 days)
OSOM™ Strep A Test is an immunochromatographic assay for the qualitative detection of Group A Streptococcal antigen from throat swabs or confirmation of presumptive Group A Streptococcal colonies from culture.
OSOM Strep A Test uses color immunochromatographic dip stick technology with antibodies coated on the membrane. If group A Streptococcus is present in the swab sample, a blue test line will appear to indicate a positive result.
Here's an analysis of the provided text regarding the OSOM™ Strep A Test, focusing on the requested information about acceptance criteria and the study:
The provided document does not contain detailed information about specific acceptance criteria (e.g., sensitivity, specificity thresholds) or a formal clinical study with a specified test set sample size, ground truth establishment, or expert adjudication as typically found in comprehensive medical device submissions.
Instead, it focuses on demonstrating substantial equivalence to an existing method (isolation of Group A Streptococcus colonies on sheep blood agar medium followed by serological grouping). The "performance" described is in the context of this substantial equivalence claim.
However, based only on the provided text, here's what can be extracted and inferred against your questions:
1. Table of Acceptance Criteria and Reported Device Performance
As specific numerical acceptance criteria (e.g., "Sensitivity must be >90%") are not explicitly stated in the provided text, I will delineate the basis of acceptance implied by the substantial equivalence claim and the performance characteristics mentioned.
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance |
|---|---|
| Detection of Group A Streptococcus: Intended for use in qualitatively detecting Group A Streptococcus. | Qualitative Detection: Performed through an immunochromatographic assay. A blue test line indicates a positive result. |
| In vitro Test: The device is an in vitro diagnostic tool. | In vitro Test: Confirmed. |
| Equivalence to Existing Method: Results should be substantially equivalent to those obtained by isolation of Group A Streptococcus colonies on sheep blood agar medium followed by serological grouping. | Substantial Equivalence Claim: Stated directly through a comparison of intended use and in vitro nature, while acknowledging differences in speed and detection of non-viable organisms. |
| Speed/Timeliness: (Implicit advantage over standard culture) | Rapid Results: Results can be obtained in minutes, compared to 18-24 hours or longer for culture methods. |
| Detection of Organism Viability: (Implicit advantage over standard culture) | Detects non-viable as well as viable organisms. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified. The document does not indicate the country of origin of any data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document mentions "serological grouping" but does not detail who performs this or their qualifications.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, not indicated. The document describes a comparison for substantial equivalence, but not a MRMC comparative effectiveness study involving human readers.
- Effect Size of Human Readers with vs. without AI Assistance: Not applicable as no MRMC study or AI assistance is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Performance: Yes, implicitly. The OSOM™ Strep A Test is described as an "immunochromatographic assay" that produces a result (blue test line) without human interpretation of complex images or data beyond reading the presence/absence of the line. This is a standalone diagnostic test where the device itself provides the qualitative result. The "performance" being compared to existing methods would be its standalone diagnostic capability.
7. The Type of Ground Truth Used
- Ground Truth Type: Established by comparative method. The "ground truth" against which the OSOM Strep A Test is being "substantially equivalent" to is "results obtained through isolation of Group A Streptococcus colonies on sheep blood agar medium followed by a serological grouping of presumptive Group A Streptococcus." Serotyping is used to confirm identity. This is a laboratory-based, culture-confirmed method.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not specified. The document does not mention a "training set" in the context of machine learning or algorithm development. The device is an immunoassay, not an AI/ML-based system.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment for Training Set: Not applicable. As there is no mention of a training set or an AI/ML algorithm requiring one, this point is not relevant based on the provided text.
Summary of Limitations Based on Provided Text:
The provided 510(k) Summary focuses heavily on the "Substantial Equivalence" claim, explicitly comparing the OSOM Strep A Test to established laboratory methods. It highlights differences in speed and detection of non-viable organisms as advantages of the new device. However, it lacks the detailed quantitative performance data (e.g., sensitivity, specificity, PPV, NPV with confidence intervals) and the specifics of a rigorous clinical study that would answer many of your detailed questions about sample sizes, expert involvement, and adjudication methods. This kind of detail is typically found in the full submission, not necessarily in the brief 510(k) Summary.
§ 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.