(28 days)
Use of HardyDisk™ Telavancin 30 µg 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 Telavancin 30 ug has been shown to be active against most isolates of the following microorganisms both in vitro and in clinical infections:
Methicillin-resistant staphylococci, streptococci, and vancomycinsusceptible enterococci.
Not Found
The document is a 510(k) premarket notification letter from the FDA regarding the Hardy Disk μg Telavancin, 30μg. It primarily focuses on the regulatory approval and indications for use, and does not contain the detailed study information needed to fully answer your request regarding acceptance criteria and performance studies.
However, based on the provided text, I can infer some information relevant to your request, specifically about the Indications for Use, which often form the basis for performance criteria in such devices.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
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Acceptance Criteria (Inferred from Indications for Use):
- The device should accurately determine the susceptibility of bacteria to telavancin.
- The concentration of Telavancin 30 ug should be "active against most isolates of the following microorganisms both in vitro and in clinical infections: Methicillin-resistant staphylococci, streptococci, and vancomycin-susceptible enterococci."
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Reported Device Performance:
- The document states that the device has been determined to be "substantially equivalent" to legally marketed predicate devices. This is the primary "performance" reported from a regulatory standpoint in this letter.
- More specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, agreement rates with a reference method) are not provided in this document. Such data would typically be found in the more detailed 510(k) submission itself, not in the approval letter.
2. Sample sized used for the test set and the data provenance
- Not provided in this document. This information would be part of the technical data submitted to the FDA, not typically included in the approval letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not provided in this document. This information is relevant for studies involving human interpretation (e.g., imaging devices), but for an antimicrobial susceptibility test disc, the "ground truth" is typically established via a reference method (e.g., broth microdilution) rather than expert consensus in the same way.
4. Adjudication method
- Not applicable/Not provided in this document. For an AST disc, the determination of susceptibility or resistance is based on measuring zone sizes and comparing them to established breakpoints, rather than subjective expert adjudication.
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. This device is an antimicrobial susceptibility test disc, not an AI-powered diagnostic imaging or interpretation tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical test disc, not an algorithm. The "performance" is its intrinsic ability to produce a measurable zone of inhibition when incubated with bacteria. Human interpretation (reading the zone size) is inherent to its use.
7. The type of ground truth used
- Inferred: For antimicrobial susceptibility testing, the typical "gold standard" or ground truth is a reference antimicrobial susceptibility testing method, such as broth microdilution or agar dilution, performed according to CLSI (Clinical and Laboratory Standards Institute) guidelines. The document itself does not explicitly state the type of ground truth, but this is the standard for such devices.
8. The sample size for the training set
- Not applicable/Not provided in this document. For a conventional AST disc, there isn't a "training set" in the machine learning sense. The disc's performance is based on its chemical composition and the drug concentration, which determine its interaction with bacteria. Calibration and validation are done against reference methods on a set of isolates, but it's not a "training set" for an algorithm.
9. How the ground truth for the training set was established
- Not applicable/Not provided in this document. (See point 8).
Summary of what is present in the document:
- Device Name: Hardy Disk μg Telavancin, 30μg
- Intended Use/Indications for Use: In vitro agar diffusion susceptibility testing to determine susceptibility of bacteria to telavancin. Specifically, it has been shown to be active against most isolates of Methicillin-resistant staphylococci, streptococci, and vancomycin-susceptible enterococci.
- Regulatory Status: Substantially equivalent to a legally marketed predicate device.
To get the comprehensive information you requested (sample sizes, specific performance metrics, detailed study design), you would need to access the full 510(k) submission for K093807, which is a much more extensive technical dossier than the FDA approval letter provided.
§ 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).