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For in vitro diagnostic use:

Etest is a quantitative technique for the determination of antimicrobial susceptublity of both nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriansmassess, fastidious Grain negative and Chain posts ro associal, such as anaerones, Prammonons, Staphyloocws, Gonorous and Haemophius species. The system comprises a predefined and high in and the Streportus, Goldential and Plannylims openion inhibitory concentration (MIC) in ug/ml of gradent which is used to determine the minimals and media by overnight incubation. (Original FDA clearance for Etest - file K913459/A)

This Etest 510(k) submission is for an additional antibiotic i.c. Etest for MIC deemination of This Etest 310(K) Submission is 10.016 - 256 µg/ml with E. faecalis and E. Jaeium (vancomycin-Daptomyen in the MIC faires of over including methicillin resistant strains), coagulase negative Staphylococcus spp. and ß-haemolytic Streptococcus spp.

Etest is a quantitative technique for the determination of antimicrobial susceptublity of both nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriansmassess, fastidious Grain negative and Chain posts ro associal, such as anaerones, Prammonons, Staphyloocws, Gonorous and Haemophius species. The system comprises a predefined and high in and the Streportus, Goldential and Plannylims openion inhibitory concentration (MIC) in ug/ml of gradent which is used to determine the minimals and media by overnight incubation.

This document is a 510(k) clearance letter from the FDA for a new Etest® Daptomycin antimicrobial susceptibility test. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner you've requested for typical AI/diagnostic device applications.

The provided text is a regulatory clearance document, not a detailed study report. It indicates that the device has been found substantially equivalent to a legally marketed predicate device. The information you're asking for (e.g., sample sizes, expert qualifications, study methodologies, performance metrics like sensitivity/specificity) is usually found in a separate clinical study report, which is typically summarized in the 510(k) submission but not fully detailed in the clearance letter itself.

Therefore, I cannot populate the table or answer the specific questions based only on the text provided because it does not contain that level of detail.

However, I can tell you what is typically expected for such a device in terms of performance and how its substantial equivalence would have been established, based on the nature of antimicrobial susceptibility testing (AST) devices.

For AST devices like the Etest®, "acceptance criteria" usually refer to agreement rates with a reference method (e.g., broth microdilution or agar dilution). The "study" would be a clinical study comparing the Etest® results to these reference methods.

Here's how I would hypothetically complete your request for an AST device, based on common FDA requirements for such submissions, and indicate what is not present in the provided document:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

Device: Etest® Daptomycin 0.016-256 µg/mL

Intended Use: For in vitro diagnostic use to determine the minimum inhibitory concentration (MIC) of Daptomycin for specific bacterial species (E. faecalis, E. faecium, Staphylococcus spp., Streptococcus spp.).

This 510(k) clearance letter from the FDA indicates that the Etest® Daptomycin has been found substantially equivalent to a legally marketed predicate device. While the provided document does not contain the detailed study results or explicit acceptance criteria, for antimicrobial susceptibility testing (AST) devices, the performance is typically evaluated by comparing results to a recognized reference method.

Hypothetical Acceptance Criteria and Reported Device Performance (Based on typical AST device standards):

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