(14 days)
Use of Telavancin 30µg BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Telavancin. The concentration of 30ug 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.
Active In Vitro and in Clinical Infections Against:
Facultative Gram-positive Microorganisms Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus pvogenes Enterococcus faecalis (vancomycin-susceptible isolates only) Streptococcus agalactiae Streptococcus anginosus group (includes S. anginosus, S. intermedius and S. constellatus)
Active In Vitro Against:
Facultative Gram-positive Microorganisms
Enterococcus faecium (vancomycin-susceptible isolates only) Staphylococcus haemolyticus Streptococcus dysgalactaie subsp. equisimilis Staphylococcus epidermidis
Telavancin30µg BBL" Sensi-Disc" is prepared by impregnating high quality paper with accurately determined amounts of Telavancin supplied by the drug manufacturer. Each Telavancin disk is clearly marked on both sides with the agent and drug content. Telavancin cartridges each contain 50 impregnated disks that are packed as either a single cartridge in a single box, or in a package containing ten cartridges. Telavancin disks are used for semi-quantitative in vitro susceptibility evaluations by the agar diffusion test method.
Agar diffusion susceptibility methods employing dried filter paper disks impregnated with specific concentrations of antimicrobial agents were developed in the 1940s. In order to eliminate or minimize variability in the testing. Bauer et al. developed a standardized procedure in which Mueller Hinton Agar was selected as the test medium.
Various regulatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized procedures were those published by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the Clinical and Laboratory Standards Institute (CLSI) [Formerly National Committee for Clinical Laboratory Standards (NCCLS)] and is periodically updated.
Here's an analysis of the provided text, outlining the acceptance criteria and the study details based on the information given.
It's important to note that the provided text is a 510(k) summary, which often refers to predicate devices and previously established methods rather than detailing a new, comprehensive study within the document itself. The information about the study proving the device meets acceptance criteria is largely indirect or refers to external documents.
Acceptance Criteria and Device Performance for Telavancin 30µg BBL™ Sensi-Disc™
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Telavancin 30µg BBL™ Sensi-Disc™ are not explicitly stated as numerical targets within this document. Instead, the criteria are implied by adherence to established clinical and laboratory standards for antimicrobial susceptibility testing, specifically those published by the Clinical and Laboratory Standards Institute (CLSI) (formerly NCCLS). The performance is linked to the correlation of zone diameters with minimum inhibitory concentrations (MICs) and agreement with categorical interpretations (Susceptible [S], Intermediate [I], Resistant [R]).
| Acceptance Criteria (Implied) | Reported Device Performance (Summary from Text) |
|---|---|
| Correlation with MIC values: Implied by comparison of zone diameters to established ranges in CLSI/NCCLS documents M2 and M100 to determine categorical interpretations (S/I/R). This ensures the disk test accurately reflects the organism's susceptibility. | The device provides "antimicrobic minimum inhibitory concentration (MIC) results based on measurements of zone diameters." The user determines categorical interpretations by comparing zone diameters to CLSI/NCCLS Approved Standards M2 and M100. |
| Reproducibility and Reliability: The method aims to eliminate or minimize variability in testing, as per the Bauer-Kirby method and subsequent standardized procedures. | The disk is prepared by "impregnating high quality paper with accurately determined amounts of Telavancin." The method follows "standardized reference procedures based on the Bauer-Kirby method," adopted by CLSI and "periodically updated." |
| Clinical Relevance/Antimicrobial Activity: To correctly identify organisms susceptible to Telavancin. | "The concentration of 30µg has been shown to be active in vitro against most strains of microorganisms listed," as described in the FDA approved drug insert for Telavancin. Specific microorganisms are listed as "Active In Vitro and in Clinical Infections Against" and "Active In Vitro Against." |
| Substantial Equivalence: The device should be similar enough to a predicate device in intended use, technology, and performance to ensure safety and effectiveness. | The device is deemed "substantially equivalent" to the BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 µg in its method for susceptibility testing, intended use, providing MIC results based on zone diameters, requiring CLSI/NCCLS standards for interpretation, and using pure bacterial cultures. |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to the Telavancin drug package insert, "Microbiology" for "SUBSTANTIAL EQUIVALENCE TESTING DATA." This indicates that the primary data supporting the device's performance, including any test set sample sizes, would be found in that external document. The 510(k) summary itself does not provide these details.
Therefore, the specific sample size, country of origin of the data, and whether it was retrospective or prospective cannot be determined from the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the 510(k) summary. Given that the testing refers to CLSI/NCCLS standards and the drug package insert, it's highly likely that ground truth would be established through reference methods overseen by qualified microbiologists or clinical laboratory professionals, but the specifics are not detailed here.
4. Adjudication Method for the Test Set
The document does not specify an explicit adjudication method (e.g., 2+1, 3+1). The "ground truth" is implicitly established by comparing the zone diameters to the "established zone size ranges for individual antimicrobial agents" found in CLSI/NCCLS documents M2 and M100. This is a direct comparison against a standard, rather than a consensus among multiple human reviewers for each case.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study, as typically understood for AI-assisted diagnostics comparing human performance with and without AI, was not done or reported in this document. This device is a measurement tool (an antimicrobial susceptibility disk) and not an AI algorithm designed to assist human readers in interpretation. Its performance is validated against established microbiological methods and standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable in the context of this device. The Telavancin 30µg BBL™ Sensi-Disc™ is a physical diagnostic tool for in vitro antimicrobial susceptibility testing, not an algorithm. Its "standalone" performance is measured by its ability to produce accurate zone diameters that correlate with MICs and subsequently lead to correct categorical interpretations when compared against established standards (CLSI/NCCLS). The output (zone diameter measurement and subsequent interpretation) requires human involvement to measure the zone and compare it to the CLSI tables, but the device itself is not an "algorithm" as typically defined in AI contexts.
7. The Type of Ground Truth Used
The ground truth used is primarily based on expert consensus embodied in standardized reference procedures and documents. Specifically:
- CLSI/NCCLS Documents M2 and M100: These documents provide the "established zone size ranges" and corresponding "categorical interpretation [S], intermediate (I), or resistant (R)" for various antimicrobial agents and organisms. This represents a consensus of expert microbiologists and clinicians.
- FDA Approved Drug Insert for Telavancin: This document describes in vitro activity and clinical efficacy against specific microorganisms, contributing to the overall understanding of Telavancin's effectiveness and thus informing the expected susceptibility patterns.
8. The Sample Size for the Training Set
The document does not provide details about a "training set" in the context of machine learning. For traditional in vitro diagnostic devices like this, development and validation involve testing against a diverse set of clinically relevant bacterial isolates to establish expected zone diameter ranges and correlations with MICs. The sample sizes for this development work would be extensive but are not specified here. The "SUBSTANTIAL EQUIVALENCE TESTING DATA" references the Telavancin drug package insert, which would contain relevant studies used to establish its microbiological activity.
9. How the Ground Truth for the Training Set Was Established
Similar to point 8, the concept of a "training set" and its ground truth establishment, as typically understood in AI, is not directly applicable to this device. For traditional antimicrobial susceptibility test development, the "ground truth" (e.g., MIC values obtained via broth microdilution or agar dilution) would be established using reference methods (e.g., broth microdilution susceptibility testing) as defined by regulatory bodies and standards organizations like CLSI. These reference methods are considered the gold standard for determining the true susceptibility phenotype of an organism. The disk diffusion method is then correlated with these reference methods to establish interpretive criteria (zone diameter breakpoints).
§ 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).