(40 days)
Use of BD BBL™ Sensi-Disc™ Ceftazidime avibactam (30/20µg) for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Ceftazidime avibactam. The concentration of 30/20µg has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA approved drug insert for this antimicrobic.
BD BBL™ Sensi-Disc™ Ceftazidime avibactam (30/20ug), Antimicrobial Susceptibility Test Discs are prepared by impregnating high quality paper with accurately determined amounts of Ceftazidime avibactam (30/20uq) supplied by the drug manufacturer. Each Ceftazidime avibactam (30/20ug) disc is clearly marked on both sides with the agent and drug content. Ceftazidime avibactam (30/20ug) cartridges each contain 50 impregnated discs that are packed as a single cartridge in a single box. Ceftazidime avibactam (30/20μq) discs are used for semi-quantitative in vitro susceptibility evaluations by the agar diffusion test method.
The provided text describes the BD BBL™ Sensi-Disc™ Ceftazidime avibactam (30/20ug), Antimicrobial Susceptibility Test Discs. However, it does not contain specific acceptance criteria, detailed study results, or information regarding the sample size for testing, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established for the training set.
The document primarily focuses on the device's intended use, its comparison to a predicate device, and the general principle of antimicrobial susceptibility testing using agar diffusion. It explicitly states: "See the Ceftazidime avibactam drug package insert, 'Microbiology'. Shelf life (stability data) for the drug is being collected and will be maintained on file at BD as indicated in the guidance document." This indicates that the detailed performance data, including acceptance criteria and study results, would be found in the drug package insert, which is not provided in the given text.
Therefore, I cannot provide a complete answer with all the requested information based solely on the provided text. I can only extract what is present.
Information Extracted from the Provided Text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in the provided text. The document refers to "established zone size ranges for individual antimicrobial agents" and "respective organism tables of the FDA drug insert and/or CLSI/NCCLS Document M2 ('Performance Standards for Antimicrobial Disk Susceptibility Tests') and of CLSI/NCCLS Document M100 ('Performance Standards for Antimicrobial Susceptibility Testing')." These external documents would contain the specific acceptance criteria (zone diameter ranges for Susceptible, Intermediate, Resistant categories).
- Reported Device Performance: Not explicitly stated in the provided text. The document mentions "Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer and received FDA approval under NDA Number 206494." The actual performance data (e.g., categorical agreement, essential agreement, or specific zone diameter values for tested strains) is not included here.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the provided text.
4. Adjudication method for the test set:
- Not specified in the provided text.
5. 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/Not mentioned. This device is an antimicrobial susceptibility test disk, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not mentioned. This device is a manual disc diffusion test that requires human interpretation of zone diameters.
7. The type of ground truth used:
- The document implies that the ground truth for establishing zone interpretations would be derived from the "FDA approved drug insert for this antimicrobic" and "CLSI/NCCLS Document M2" and "CLSI/NCCLS Document M100," which set the clinical breakpoints or interpretative categories (Susceptible, Intermediate, Resistant). These are typically established based on extensive microbiological data, pharmacokinetic/pharmacodynamic studies, and clinical outcomes data related to the antimicrobial agent.
8. The sample size for the training set:
- Not applicable/Not mentioned. This is not a machine learning or AI device that typically uses a training set in that context.
9. How the ground truth for the training set was established:
- Not applicable/Not mentioned for the same reason as above.
§ 866.1620 Antimicrobial susceptibility test disc.
(a)
Identification. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).