(317 days)
The MicroScan Prompt® Inoculation System-D is used to standardize inocula for microdilution antimicrobial susceptibility tests.
The MicroScan Prompt Inoculation System-D is an accessory to the MicroScan Gram Negative and Gram Positive MIC/Combo Panels. Indications for use organisms are specific for each antimicrobial agent on the panel.
The MicroScan Prompt Inoculation System-D is a method for obtaining standardized bacterial inoculum while eliminating the need for incubation and turbidity adjustment with inocula prepared according to the CLSI procedure. It consists of an inoculation wand and a bottle of diluent. The wand is a polypropylene rod with a breakaway collar that serves as a wiping mechanism. The rod is attached to a stopper. At the tip of the wand is a groove designed to hold a specific amount of bacteria equivalent to a 0.5 McFarland standard. Thirty (30) ml of diluent (Pluronic is used as the surfactant) are provided in the plastic bottle. Each kit contains 60 plastic bottles, each containing 30 ml of stabilized aqueous Pluronic surfactants and 62 inoculation wands.
The provided text is a 510(k) Premarket Notification from the FDA for the Beckman Coulter MicroScan Prompt Inoculation System-D. While it discusses the device's intended use, description, and comparison to a predicate device, it does not contain the detailed study results, acceptance criteria, or specific performance metrics (like sensitivity, specificity, accuracy, or effect sizes) that would typically be found in a study report proving a device meets acceptance criteria.
The document states that "Clinical performance data obtained with the Prompt Inoculation System-D were evaluated in previously conducted studies described in recent 510(k) decision summaries for the MicroScan Dried Gram negative and Gram positive MIC/Combo panels for each antimicrobial agent." It further notes that "Performance of the MicroScan MIC/Combo panels were evaluated using the Prompt inoculation method and the turbidity method against the CLSI broth microdilution reference method and results were analyzed based on the recommended guidelines in the AST Class II Special Controls Guidance Document issued on August 28, 2009."
Therefore, I cannot extract the specific information requested in your prompt based on the provided text. The document refers to other 510(k) decision summaries and a guidance document for the actual performance data and acceptance criteria.
To answer your request thoroughly, I would need access to those referenced documents, specifically the "recent 510(k) decision summaries for the MicroScan Dried Gram negative and Gram positive MIC/Combo panels" and the "AST Class II Special Controls Guidance Document issued on August 28, 2009."
Without those, the most I can infer is that the acceptance criteria are based on the CLSI broth microdilution reference method, and the performance analysis follows the AST Class II Special Controls Guidance Document. The device's performance is likely evaluated in terms of its ability to standardize bacterial inocula for Antimicrobial Susceptibility Tests (AST) such that the AST results are consistent and accurate compared to the reference method.
Regarding your specific points, here's what the provided text does not contain:
- A table of acceptance criteria and the reported device performance: Not present.
- Sample sized used for the test set and the data provenance: Not present. It mentions "previously conducted studies" but no details on sample size or origin.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method: Not present.
- 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 an inoculation system, not an AI-assisted diagnostic device for human interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an inoculation system; its "performance" is in consistently producing a standardized inoculum, which then feeds into a downstream AST process (MicroScan MIC/Combo panels). The text mentions results were read both manually and with instruments, but doesn't detail a "standalone" algorithm performance study in the way it might for an AI diagnostic.
- The type of ground truth used: It references the "CLSI broth microdilution reference method" as the comparative standard, which serves as the ground truth for AST results.
- The sample size for the training set: Not applicable/not present. This is a physical device/reagent system, not a machine learning model that requires a training set.
- How the ground truth for the training set was established: Not applicable/not present.
In summary, the provided document describes the regulatory submission for an inoculation system, outlining its purpose and comparison to a predicate device. It specifically references other documents where the detailed performance data and acceptance criteria would be found, rather than including them directly.
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).