(187 days)
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STREPTOLEX-STAT™ is substantially equivalent to several commercially available products utilizing similar methodology for the identification of streptococcal groups A, B, C, F and G.
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Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state pre-defined acceptance criteria (e.g., "must achieve X% sensitivity"). However, it presents the reported performance of the STREPTOLEX-STAT™ device, implying that these results are considered acceptable for demonstrating safety, efficacy, and substantial equivalence.
| Strep Group/No. Tested | Reported Device Performance (Sensitivity) | Implied Acceptance Range (from "overall agreement of 97%") |
|---|---|---|
| Group A | 111/111 (100%) | >= 97% |
| Group B | 117/120 (98%) | >= 97% |
| Group C | 80/83 (96%) | >= 97% (Note: This is slightly below the overall, but individual results are presented) |
| Group F | 59/66 (89%) | >= 97% (Note: This is considerably below the overall, but individual results are presented) |
| Group G | 90/90 (100%) | >= 97% |
| Total | 457/470 (97%) | >= 97% |
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set:
- Group A: 111
- Group B: 120
- Group C: 83
- Group F: 66
- Group G: 90
- Total: 470 isolates
- Data Provenance: The study was conducted at "three test sites": one clinical laboratory in the US, one in Canada, and one in the UK. This indicates a multi-site, international study. The data appears to be prospective, generated specifically for this comparison.
- Sample Size for Test Set:
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not specify the number of experts used or their qualifications for establishing the ground truth. The ground truth appears to be based on the results from "commercially available, substantially equivalent grouping kits," implying these kits served as a reference standard.
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Adjudication Method for the Test Set:
For discrepancies (e.g., initial negative reactions for Groups B, C, and F), the document states: "Discrepancies were related to insufficient number of colonies used. Discrepancies were resolved upon retest." This suggests a re-testing and re-evaluation approach for identified discrepancies, rather than a formal expert adjudication panel.
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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:
This is not applicable. The device is a diagnostic kit (latex agglutination test for streptococcal grouping), not an AI-powered system that assists human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the performance data presented is for the STREPTOLEX-STAT™ device itself, functioning as a standalone diagnostic test. Human interpretation is involved in reading the latex agglutination, but the performance metrics are for the device's ability to correctly identify the streptococcal groups.
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The type of ground truth used:
The ground truth was established by comparison to the results obtained from "three commercially available, substantially equivalent grouping kits" (Streptex and Streptex - Acid Extraction Kit by Murex Diagnostics, PathoDx® Strep Grouping by Diagnostic Products Corporation, and Streptococcal Grouping Kit by Unipath Limited, Oxoid). This represents a comparator device reference standard. The document specifies that the STREPTOLEX-STAT™ performance was specifically compared to the Unipath (Oxoid) Streptococcal Grouping Kit for the reported data table.
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The sample size for the training set:
The document does not mention a separate training set. The study describes a performance comparison against existing similar products, implying the presented data is from a validation or test set.
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How the ground truth for the training set was established:
Not applicable, as a separate training set is not described or implied in the provided text.
§ 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.