(145 days)
RHMK II is intended for use in the isolation and identification of virus from clinical specimens from patients having a viral infection.
RhMK II, (Expanded Primary Rhesus Monkey Kidney Cell Culture)
The provided text describes the acceptance criteria and a study for the BioWhittaker RhMK II cell culture device.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Similar sensitivity to inoculated viruses | Similar sensitivity to inoculated viruses (polio 1, coxsackie B1, influenza A, parainfluenza 2, measles and mumps) |
| Performance as well as currently available Primary Rhesus Monkey Kidney Cell Culture for viral isolation in clinical specimens | Performs as well as the currently available Primary Rhesus Monkey Kidney Cell Culture for viral isolation in clinical specimens |
Note: The document implies the acceptance criteria through the conclusion of substantial equivalence. The specific quantitative acceptance thresholds are not explicitly stated, but the qualitative assessment of "similar sensitivity" and "performing as well as" serves as the criteria met by the device.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in terms of number of samples or cases. It only mentions "infectivity comparison testing" for "inoculated viruses."
Data Provenance: The document does not specify the country of origin of the data. The study appears to be a prospective comparison given it involves "infectivity comparison testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study involves comparing the performance of two cell cultures in detecting viruses, which typically relies on laboratory observation of cytopathic effects (CPE), hemadsorption, or fluorescent antibody staining. While experts in virology would interpret these results, the number and qualifications are not detailed.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method.
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 done. This study focuses on the performance of a biological cell culture in isolating viruses, not on human interpretation of clinical data, with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The concept of "standalone" performance (algorithm only) is not applicable here as the device is a cell culture, not an algorithm or AI system. The evaluation is of the biological performance of the cell culture itself.
7. The Type of Ground Truth Used
The ground truth used is based on the presence or absence of viral replication as evidenced by:
- Characteristic cytopathic effect (CPE)
- Hemadsorption
- Staining with specific virus fluorescent antibody markers
This is effectively a laboratory-established "ground truth" based on observable biological phenomena.
8. The Sample Size for the Training Set
The document does not specify a training set size. The study describes "infectivity comparison testing" rather than a machine learning model that would require a distinct training set.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of an algorithm, the method for establishing ground truth for a training set is not applicable or described. The study is a direct comparison of the two cell culture types.
§ 864.2280 Cultured animal and human cells.
(a)
Identification. Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.(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 § 864.9.