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Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. Used in a diagnostic workflow to and clinicians in determining potential treatment options for patients suspected of having a microbial infection, these discs are intended to determine susceptibility against microorganisms for which specific drugs have been shown to be active both clinically and in vitro.

The Thermo Scientific Oxoid Sulbactam Disc (10/10 ug) SUD20 can be used to determine susceptibility to Sulbactam/Durlobactam against the following bacteria for which Sulbactam has been shown to be active both clinically and in vitro:

Acinetobacter-baumannii calcoaceticus complex

Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 ug) SUD20

The provided FDA letter and "Indications for Use" document do not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving the device meets them. This type of information is typically found in the 510(k) summary or the full 510(k) submission, neither of which is present in the provided text.

However, I can extract what is available and indicate where information is missing.

Here's a breakdown of the information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The provided document does not contain specific acceptance criteria or reported device performance metrics such as sensitivity, specificity, accuracy, or zone diameter interpretive criteria. It only describes the intended use of the device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not present in the provided text. The device is an antimicrobial susceptibility test disc, so the ground truth would likely refer to established microbiological methods, not expert human interpretation in the way, for example, a radiology AI device would use.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not present in the provided text.

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

The device is an antimicrobial susceptibility test disc, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device.

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

The device itself is a physical disc used in a laboratory procedure. It is not an algorithm. The "performance" refers to the accuracy of the disc's susceptibility determination against established reference methods. While it operates "standalone" in the sense that its results are read directly, it's not an algorithm in the typical AI sense. The study would test the disc's performance in determining susceptibility against reference methods.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For antimicrobial susceptibility testing, the ground truth is typically established by reference methods such as broth microdilution (BMD) or agar dilution, performed according to recognized standards (e.g., Clinical and Laboratory Standards Institute (CLSI) guidelines). The provided document does not explicitly state the ground truth method, but this is the standard for such devices.

8. The sample size for the training set

The concept of a "training set" is usually associated with machine learning or AI models. This device is a physical antimicrobial susceptibility test disc. Therefore, there isn't a "training set" in the conventional AI sense. The development of such discs involves extensive laboratory testing and formulation, but not a dataset to train an algorithm.

9. How the ground truth for the training set was established

As explained above, the concept of a "training set" and associated ground truth establishment for a training set is not applicable to this type of device.

Summary of Device and Indication from the Text:

• Device Name: Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 ug) SUD20
• Regulation Number: 21 CFR 866.1620
• Regulation Name: Antimicrobial susceptibility test disc
• Intended Use: To determine susceptibility to Sulbactam/Durlobactam against Acinetobacter baumannii-calcoaceticus complex using the semi-quantitative agar diffusion test method for in vitro susceptibility testing. This assists clinicians in determining potential treatment options for patients with microbial infections.
• Type of Use: Prescription Use.

To get the detailed information you are seeking, you would typically need to review the full 510(k) summary (K232276) available on the FDA's website, which often includes details about the analytical studies performed to demonstrate substantial equivalence.

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