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The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram negative organisms. This 510(k) is for the removal of limitation number 22 in the Sensititre technical insert. The limitation to be removed is: "The ability of the Sensititre system to detect resistance to vancomycin for Staphylococcus aureus is unknown because there are not an adequate number of strains available for testing. An alternate procedure such as broth microdilution or agar dilution with a full 24 hour incubation should be used to confirm results. CDC has reported (26) that BHI agar supplemented with 6ug/mL vancomycin is useful in detecting staphylococci with reduced susceptibilities to vancomycin and that this method is also reliable with the first three recognized VRSA isolated reported to CDC." Then the following statement would be added to the technical insert: Sensititre 18-24 hour MIC susceptibility plates is capable of detecting vancomycin resistance in the VRSA S. aureus strains available at the time of comparative testing. The ability of the Sensititre 18-24 hour MIC susceptibility plates to detect vancomycin resistance in other S. aureus strains is unknown due to the limited number of resistant strains available for comparative testing.

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This document is a 510(k) premarket notification for a medical device called "Susceptibility Test Panel for Vancomycin VRSA 1-128µg/ml." It's an in vitro diagnostic product used for clinical susceptibility testing of gram-positive and gram-negative organisms. The 510(k) specifically aims to remove a previous limitation regarding the device's ability to detect vancomycin resistance in Staphylococcus aureus (VRSA) and add a new statement about its capability.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Study Information:

The document is a regulatory approval letter and an "Indications for Use" statement, not a detailed study report. Therefore, it does not contain specific acceptance criteria values or detailed study results. It mentions that the device "is capable of detecting vancomycin resistance in the VRSA S. aureus strains available at the time of comparative testing" but does not quantify this capability with metrics like sensitivity, specificity, or agreement rates. It also explicitly states that the ability to detect resistance in other S. aureus strains is unknown due to the limited number of available resistant strains.

However, based on the context of removing a limitation and adding a positive statement, we can infer the intent of the acceptance criteria was to demonstrate the device's capability to detect vancomycin resistance in the available VRSA strains, likely against a reference method (broth microdilution or agar dilution).

Information that CANNOT be extracted from the provided text:

• A table of acceptance criteria and reported device performance (specific values are missing).
• Sample sizes for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
• Effect size of human reader improvement.
• Information about a standalone (algorithm only) performance study (as this is a test panel, not an AI algorithm in the contemporary sense).
• Sample size for the training set.
• How ground truth for the training set was established.

Information that CAN be inferred or directly stated from the provided text:

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

2. Sample sized used for the test set and the data provenance

• Sample Size: Not specified in the provided text. It mentions "VRSA S. aureus strains available at the time of comparative testing" but does not give a number. The text also notes "the limited number of resistant strains available for comparative testing," indicating a small, possibly very small, number.
• Data Provenance: Not specified.

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

• Not specified. This type of device relies on microbiological culture and reference methods rather than human expert interpretation of images or complex data.

4. Adjudication method

• Not applicable/specified. For a microbiological susceptibility test, ground truth is typically established by agreed-upon reference methods and not by expert adjudication in the way it's done for image analysis.

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 is not an AI-assisted diagnostic device, nor is it an imaging device that would involve human readers in that sense.

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

• The device itself is a standalone test panel. Its performance is evaluated directly against reference methods, so in a sense, it's "algorithm-only" if you consider the panel's reaction as the algorithm. It does not involve human interpretation in the loop in the same way an AI image analysis tool would.

7. The type of ground truth used

• Reference Microbiological Methods: The previous limitation explicitly mentioned "broth microdilution or agar dilution with a full 24 hour incubation" as an alternate procedure for confirmation. It also referenced "BHI agar supplemented with 6ug/mL vancomycin." Therefore, the ground truth for evaluating the Sensititre panel's performance would have been established by these recognized reference microbiological methods for determining vancomycin susceptibility.

8. The sample size for the training set

• Not applicable/specified. This type of device does not typically involve a "training set" in the machine learning sense. Its design and performance are based on biochemical reactions and known antimicrobial susceptibility patterns.

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

• Not applicable.

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