(34 days)
biorapid Mononucleosis is a one-step immunoassay for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum, and plasma samples. The test aids in the diagnosis of infectious mononucleosis.
biorapid Mononucleosis is a one-step immunoassay for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum, and plasma samples. The test aids in the diagnosis of infectious mononucleosis. biorapid Mononucleosis uses the same methodology (immunochromatography test) as the predicate OSOM Mono Test.
The provided text describes the performance of the biorapid Mononucleosis device. There are no explicit "acceptance criteria" presented as specific numerical thresholds that the device must meet in relation to a given ground truth. Instead, the study compares the device's performance against a legally marketed predicate device (OSOM Mono Test) to demonstrate substantial equivalence.
Here's an breakdown based on the provided information, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, explicit "acceptance criteria" (e.g., "The device must achieve >95% sensitivity") are not stated. The performance is reported relative to the predicate device.
| Metric | Acceptance Criteria (Not explicitly stated, but implied by "substantially equivalent" to predicate) | Reported Device Performance (biorapid Mononucleosis vs. OSOM Mono Test) |
|---|---|---|
| Positive Agreement (between biorapid and predicate) | Implied to be high, demonstrating similar ability to detect positive cases. | 100% |
| Negative Agreement (between biorapid and predicate) | Implied to be high, demonstrating similar ability to detect negative cases. | 99.6% (478/480) |
| Overall Agreement (between biorapid and predicate) | Implied to be high, demonstrating overall similar performance. | 99.7% |
| Reproducibility | 100% agreement with expected results in reproducibility study. | 100% agreement with expected results |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A total of 622 specimens.
- 296 serum samples
- 261 plasma samples
- 65 whole blood samples
- Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It only mentions that the specimens "were evaluated internally and in an external study."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. The study uses the OSOM Mono Test (predicate device) as the comparator, implying that the "ground truth" for the performance comparison is the result obtained by the predicate device, not an independent expert consensus or clinical outcome.
4. Adjudication Method for the Test Set
This information is not provided. Given that the comparison is device-to-device rather than device-to-expert ground truth, a formal adjudication method as typically used with human readers is not applicable in the context described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described in the provided text in the context of human readers improving with or without AI assistance. The study focuses on comparing the new device's performance to a predicate device, not on human reader performance.
6. If a Standalone Study Was Done (Algorithm only without human-in-the-loop performance)
Yes, the performance reported is a standalone evaluation of the biorapid Mononucleosis device compared to the predicate device. The results (positive agreement, negative agreement, overall agreement) reflect the device's intrinsic performance. The reproducibility study also evaluates the device's standalone performance under different user conditions.
7. The Type of Ground Truth Used
The "ground truth" for the primary performance evaluation (agreement study) was the results obtained from the predicate device (OSOM Mono Test). This is a common approach in 510(k) submissions for in vitro diagnostics where substantial equivalence is demonstrated by comparing performance to a legally marketed device.
For the reproducibility study, the "expected results" were used as the ground truth for the three positive and three negative samples. This implies that these samples had a predetermined positive or negative status.
8. The Sample Size for the Training Set
This information is not provided. The document focuses on the performance evaluation of the final device and does not detail any development or training phases. For an immunoassay, the concept of a "training set" in the context of machine learning (AI) is not typically applicable in the same way.
9. How the Ground Truth for the Training Set Was Established
This information is not provided, as details about a training set or its ground truth establishment are not mentioned in the context of this immunoassay.
§ 866.5640 Infectious mononucleosis immunological test system.
(a)
Identification. An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.(b)
Classification. Class II (performance standards).