(313 days)
is intended for use in conjunction with the Vitek® System for the automated identification of clinically significant streptococci, staphylococci, and a selected group of Gram positive bacilli.
The VITEK® Gram Positive Identification Card containing new claims for the identification of Enterococcus casseliflavus Enterococcus gallinarum Enterococcus hirae
Here's the analysis of the provided text regarding the acceptance criteria and study for the Vitek® GPI Card:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correct genus call percentage (after repeat and supplemental testing for enterococcal isolates) | 96.7% |
| Correct species call percentage (for correctly identified genus) | 91.1% |
| Mis-identification rate for enterococcal isolates | 3.3% |
| Equivalency of identification between new and current software (overall agreement) | 99.8% |
| Reproducibility of identification | The new software reproducibly identifies specified gram-positive organisms. |
| No adverse effect on performance of GPI Card for non-enterococcal isolates | Performance remains the same as current software. |
| No adverse effect on performance of GPI Card for existing species with new software | Performance remains the same as current software. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the total sample size used for the test set of enterococcal isolates. It mentions "clinical testing was performed" and "Correlation Studies on enterococcal isolates."
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be retrospective as they involve analyzing existing clinical isolates or comparing current software with new software.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not mentioned in the provided text.
4. Adjudication Method for the Test Set
Not mentioned in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The study described focuses on the performance of the automated Vitek® system and its software, not on human readers' performance with or without AI assistance.
6. Standalone Performance Study (Algorithm Only)
Yes, a standalone study was performed. The entire context describes the performance of the Vitek® GPI Card and its software in identifying bacteria, which is an automated algorithm-only performance. The "Correlation Studies on enterococcal isolates" and "Equivalency Study" directly describe the algorithm's performance.
7. Type of Ground Truth Used
The type of ground truth is not explicitly specified as "pathology" or "outcomes data." However, based on the context of bacterial identification in a clinical laboratory setting, the ground truth would likely be established through:
- Reference laboratory methods: Often involving biochemical tests, molecular methods (e.g., PCR, sequencing), or advanced phenotypic characterization, considered the gold standard for bacterial identification.
- Expert consensus: Among microbiologists using a combination of methods.
8. Sample Size for the Training Set
Not mentioned in the provided text. The document describes validating the addition of new claims to existing software, implying the core identification algorithms were already established and likely trained on a separate dataset.
9. How the Ground Truth for the Training Set Was Established
Not mentioned in the provided text.
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Summary of Safety and Effectiveness Information for the Enterococcus spp. claims added to the Vitek® GPI Card
The VITEK® Gram Positive Identification Card containing new claims for the identification of Enterococcus casseliflavus Enterococcus gallinarum Enterococcus hirae
is intended for use in conjunction with the Vitek® System for the automated identification of clinically significant streptococci, staphylococci, and a selected group of Gram positive bacilli.
Safety and effectiveness issues for the new software which contains the three additional species claims for Enterococcus for the bioMérieux Vitek GPI include the following considerations:
- . The study was designed to validate the addition of six new species of enterococcus to the bioMérieux Vitek, Inc. GPI software. After clinical testing was performed it was determined that the addition of Enterococcus malodoratus. Enterococcus raffinosus and Enterococcus mundtii did not improve the software. Not only was the testing on these organisms irreproducible, the react file lines affected the accuracy of the Enterococcus faecium call. Enterococcus malodoratus is not a clinical isolate and the other two species have little clinical utility, therefore it was determined to limit the FDA submission data to Enterococcus casseliflavis, Enterococcus gallinarum and Enterococcus hirae.
- Performance characteristics: Performance of the GPI Card remains the same utilizing the . new software compared to the current software as documented by clinical testing. The addition of three new enterococcal species does not affect the performance of the GPI card.
- . Reproducibility: The new software reproducibly identifies specified gram-positive organisms.
- The Correlation Studies on enterococcal isolates gave a correct genus call 96.7% of the . time after repeat and supplemental testing. Of these, 91.1% also correctly identified to the species level. Mis-identifications occurred at 3.3%.
- . Performance of the GPI Card for non-enterococcal isolates remains the same utilizing the new software compared to the current software. The addition of three new enterococcal species does not affect the performance of the GPI Card as documented by clinical testing. In the Equivalency Study, the overall agreement of identification between the new software and the current software occurred at 99.8%.
bioMérieux Vitek, Inc.
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Summary of Safety and Effectiveness Information for the Enterococcus spp. claims added to the Vitek® GPI Card
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- Validation of software design: The software Certification Statement attests to our . adherence to design, validation and testing procedures, and that release of this software takes place only when these written criteria are met.
When used within the context of the package insert, the new software containing the new Enterococcus species will perform as claimed. Additional information may be found in the package insert and technical bulletin.
§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of 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.