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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):

Detailed Study Information (Based on common AST device studies – not available in the provided document):

1. Sample size used for the test set and the data provenance:

   • Sample Size: This information is not present in the document. Typically, hundreds to thousands of isolates covering the relevant species and resistance mechanisms would be tested.
   • Data Provenance: This information is not present in the document. Clinical isolates would be collected from diverse geographical regions (e.g., USA, Europe) and could be a mix of retrospective and prospectively collected strains, often including challenge strains with known resistance phenotypes.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts/Ground Truth Method: This information is not present in the document. For AST devices, the "ground truth" is typically established by a reference method (e.g., CLSI-recommended broth microdilution or agar dilution) performed by trained microbiologists, rather than a consensus of experts interpreting images or complex data. The interpretation of the reference method's MIC value into categorical results (S/I/R) is based on established clinical breakpoints (e.g., CLSI guidelines).

3. Adjudication method for the test set:

   • Adjudication Method: This information is not present in the document. Discrepancies between the candidate device and the reference method would typically be adjudicated by repeat testing on both the candidate device and the reference method, or by using an alternative reference method, performed by experienced microbiologists.

4. 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:

   • MRMC Study: No. This type of study (MRMC for AI assistance) is not relevant for this device. Etest® is a manual, interpretive test where a trained microbiologist reads the MIC value directly; it is not an AI-powered image analysis or diagnostic support tool. The comparison is between the device's output and a reference method's output, not human performance with/without AI.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Standalone Performance: Not applicable in the context of AI. Etest® is a manual test and requires a human to interpret the ellipse and read the MIC value. Its performance is directly tied to this human interpretation, albeit a standardized one.

6. The type of ground truth used:

   • Ground Truth Type: This information is not explicitly stated but for AST devices, the ground truth is established by a reference method, such as broth microdilution or agar dilution, performed according to recognized standards (e.g., CLSI M07 guidelines).

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable. Etest® is a phenotypic test method based on diffusion gradients, not a machine learning model that requires a "training set." The methodology is predetermined.

8. How the ground truth for the training set was established:

   • Training Set Ground Truth: Not applicable (as above).

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