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Micro-X Potency Test Strips are intended for use as a semi-quantitative test of the presence of peracetic acid in dialyzers after reprocessing. This device may be used with all peroxyacetic/peracetic acid germicides used in the reprocessing of dialyzers as part of an established quality assurance program.

Micro X Potency Test Strips are approximately 0.25" x 2.0" packaged 100strips /container. The strips are labeled for use in Reprocessing Hemodialyzers. Micro Xen Potency Test Strips are impregnated with an indicator solution which is activated by the presence of peracetic acid. The reaction results in a color change of the indicator which provides visual confirmation of the presence of peracetic acid.

The provided text describes a medical device called "Micro X Potency Test Strips" and its 510(k) submission. However, the document does not contain explicit "acceptance criteria" in a tabulated format or a detailed description of a "study that proves the device meets the acceptance criteria" in the way one would expect for a quantitative performance study involving AI or complex diagnostics.

The core of the submission is a demonstration of substantial equivalence to a predicate device, not necessarily a demonstration of meeting predefined numerical performance targets in a standalone study.

Here's an attempt to extract and infer the requested information based on the provided text, while acknowledging the limitations of what's available:

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

Based on the document, the primary "acceptance criterion" is the demonstration of "identical performance" to the predicate device. The device's fundamental characteristic is a binary output (YES/NO) for the presence of peracetic acid above a minimum level.

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

The document states: "Comparative testing between Micro X Potency Strips, Renalin Indicator Test Strips indicate identical performance among the test strips."

• Sample Size for Test Set: Not specified. The phrase "among the test strips" suggests multiple strips were tested, but no specific number is provided.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It appears to be a laboratory comparison performed by the manufacturer.

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

This information is not provided. The "ground truth" for this type of chemical indicator would typically be established by known concentrations of peracetic acid solutions, rather than expert interpretation of a complex image or signal.

4. Adjudication method for the test set

Not applicable/Not specified. Given the nature of a chemical indicator changing color, visual observation is the method. There's no indication of multiple readers adjudicating results or complex decision-making.

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

• MRMC Study: No.
• Effect Size: Not applicable. This device is a simple chemical indicator, not an AI-powered diagnostic tool.

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

No. This is a manual chemical indicator, requiring human visual interpretation of a color change. It is not an algorithm or an AI device.

7. The type of ground truth used

The implicit ground truth is the known presence/absence and concentration of peracetic acid solutions. The device is activated by the presence of a minimum level of peracetic acid.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set."

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

Not applicable. There is no training set for this device.

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