(260 days)
Reasonable assurance that this device is safe and effective was determined through the use of valid scientific nonclinical investigations including in vitro studies. The results of these studies are summarized in the attached Technical Insert. This device is effective when tested under the conditions for its Each test kit contains a technical insert which intended use.
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Acceptance Criteria and Device Performance for RPR Liquid Controls
This submission pertains to the RPR Liquid Controls device for which "reasonable assurance that this device is safe and effective was determined through the use of valid scientific nonclinical investigations including in vitro studies." The submission indicates that "relative sensitivity and specificity data" are provided within the accompanying technical insert, but the specific acceptance criteria and detailed performance metrics are not explicitly stated in the provided text.
Based on the provided data tables, the study appears to be a comparative study of the REMEL RPR CARD TEST CONTROLS against Reference Positive and Negative Controls. The performance is assessed by comparing the qualitative results (Reactive-R/moderately Reactive-Rmod/Non-Reactive-N or NR) of the REMEL controls against the established Reference controls.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The acceptance criteria are inferred from the study design where the REMEL controls are expected to match the Reference controls. The provided data demonstrates this matching.
| Acceptance Criterion (Inferred) | Reported Device Performance (Summary from data tables) |
|---|---|
| Positive Control Performance: REMEL Positive Control (RPR CARD TEST CONTROLS) should consistently show a "Reactive" (R) or "Moderately Reactive" (Rmod/mR/me) result. | At both testing sites (Michigan Department of Public Health and UTex), the REMEL Positive Control consistently showed a "Reactive" (R) or "Moderately Reactive" (Rmod, mR, me, R4+) result, matching the Reference Positive Control. |
| Negative Control Performance: REMEL Negative Control (RPR CARD TEST CONTROLS) should consistently show a "Non-Reactive" (N or NR) result. | At both testing sites, the REMEL Negative Control consistently showed a "Non-Reactive" (N or NR) result, matching the Reference Negative Control. |
| Agreement with Reference Controls: REMEL Positive and Negative Controls should consistently provide results that match the corresponding Reference Positive and Negative Controls. | 100% agreement between the REMEL RPR CARD TEST CONTROLS and the Reference Controls for both positive and negative controls across all recorded dates and testing sites. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Michigan Dept. of Public Health Site: The data table shows recorded results for 23 distinct dates for both positive and negative controls. Each date represents a test run.
- UTex Site: The data table shows recorded results for 15 distinct dates for both positive and negative controls. Each date represents a test run.
- Total Test Observations: 38 test observations (dates) across two sites for both positive and negative controls.
- Data Provenance: The data comes from two distinct sites:
- Michigan Dept. of Public Health, with H. Stiefel as the Principal Investigator (PI).
- UTex, with Hartwell as the Principal Investigator (PI).
The data appears to be prospective, as it's dated chronologically from July/August 1995 to October 1995, indicating ongoing testing of the controls.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The provided document does not mention the use of experts or their qualifications for establishing ground truth for this particular study. This study is for RPR Liquid Controls, which are themselves reference materials used to validate the performance of an RPR CARD TEST. The "Reference Pos Crtl" and "Reference Neg Crtl" serve as the ground truth in this context, representing established standards for positive and negative reactivity.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). Since the comparison is between a test control and a reference control, the result is likely a direct match/non-match rather than requiring expert consensus for interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This study evaluates the performance of laboratory controls, not the interpretation by human readers, and therefore, the concept of "human readers improving with AI vs. without AI assistance" is not applicable here.
6. Standalone Performance (Algorithm Only)
This device (RPR Liquid Controls) is a laboratory control material, not an algorithm or an AI-powered device. Therefore, a standalone (algorithm only) performance assessment, as typically understood for AI, is not applicable. The data presented shows the performance of the liquid controls themselves when used in a standard RPR card test.
7. Type of Ground Truth Used
The ground truth used in this study is based on established "Reference Positive Controls" and "Reference Negative Controls." These are presumably well-characterized and validated materials that are known to elicit a specific (positive or negative) reaction in the RPR test. This is a form of reference standard (or gold standard) truth based on known characteristics of the samples.
8. Sample Size for the Training Set
The document does not mention any training set. This is expected as the RPR Liquid Controls are a reagent/control product, not a machine learning model that requires training. The data presented is for validation/verification of the control's performance.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this product, this question is not applicable.
§ 866.3820
Treponema pallidum nontreponemal test reagents.(a)
Identification. Treponema pallidum nontreponemal test reagents are devices that consist of antigens derived from nontreponemal sources (sources not directly associated with treponemal organisms) and control sera (standardized sera with which test results are compared) used in serological tests to identify reagin, an antibody-like agent, which is produced from the reaction of treponema microorganisms with body tissues. The identification aids in the diagnosis of syphilis caused by microorganisms belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).