Search Results

VITEK 2 Streptococcus Tigecycline is designed for antimicrobial susceptibility testing of Streptococcus species and is Intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Streptococcus Tigecycline is a qualitative test. Tigecycline has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.

Active in vitro and in clinical infections Streptococcus pneumoniae (penicillin-susceptible isolates) Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus) Streptococcus agalactiae Streptococcus pyogenes

The VITER 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.

The VITEK® 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology. The isolate to be tested is diluted to a standardized concentration in 0.45 - 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling and sealing operation. The VITEK® 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card.

The medical device, VITEK® 2 AST-ST Tigecycline, a fully automated short-term incubation cycle antimicrobial susceptibility system, was evaluated for its performance.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

The study encompassed fresh and stock clinical isolates, as well as a set of challenge strains. The specific sample size for fresh, stock, and challenge isolates is not explicitly detailed beyond "an external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains." The data provenance (country of origin) is not provided, and the study was retrospective as it compared the device performance to an established reference method.

3. Number and Qualifications of Experts:

This information is not provided in the document. The study evaluates the performance of an automated susceptibility testing system against a reference method, not against human expert interpretation requiring a ground truth established by experts.

4. Adjudication Method:

Adjudication methods like 2+1 or 3+1 are not applicable here. The study compares the results of the VITEK® 2 AST-ST Tigecycline directly with the CLSI broth microdilution reference method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A MRMC comparative effectiveness study was not conducted. This device is an automated system for antimicrobial susceptibility testing, not an imaging diagnostic tool that typically involves human readers.

6. Standalone Performance:

Yes, a standalone performance study was conducted. The VITEK® 2 AST-ST Tigecycline's performance was compared directly to the CLSI broth microdilution reference method without human-in-the-loop intervention.

7. Type of Ground Truth Used:

The ground truth was established using the CLSI broth microdilution reference method, which is a widely accepted laboratory standard for determining minimum inhibitory concentrations (MICs) of antimicrobials.

8. Sample Size for the Training Set:

The document does not explicitly state the sample size used for the training set. It mentions "an external evaluation was conducted," implying a test set, but no separation of a training set is detailed.

9. How the Ground Truth for the Training Set Was Established:

As the document does not explicitly detail a separate training set, the method for establishing ground truth for a training set is not provided. It is assumed that the development of the VITEK® 2 system itself would have involved extensive calibration and validation against reference methods during its initial design, but specifics for this particular submission are focused on the external evaluation/test set.

Ask a specific question about this device

In addition to the already cleared indications for use: For use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

Not Found

This 510(k) submission describes the Ceralas Diode Laser System and its substantial equivalence to a predicate device. It primarily focuses on regulatory approval rather than providing detailed clinical study results with acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided text.

The document states:

• "The minor technological differences between the new Ceralas D10-60 and the Diomed Laser raise no new questions of safety or effectiveness. Thus, the new Ceralas D10-60 is substantially equivalent." This indicates that the approval is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than new clinical trials with specified performance metrics and acceptance criteria.
• The FDA letter confirms the device is substantially equivalent "for the indications for use stated in the enclosure" to devices marketed prior to May 28, 1976. This is the basis for its approval, not a separate clinical performance study against pre-defined acceptance criteria for a new device.

Table of Acceptance Criteria and Reported Device Performance:

Not applicable, as no acceptance criteria or specific performance metrics from a study are provided in the document. The device's "performance" is implicitly deemed acceptable due to its substantial equivalence to the predicate device.

Other Requested Information:

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not provided.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
4. 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: Not applicable, as this is a laser device, not an AI diagnostic tool. No MRMC study was mentioned.
5. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable, as this is a laser device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided, as no specific performance study against a ground truth is detailed.
7. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device