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The STERIS Resert XL Test Strip is a high level disinfectant concentration monitor dedicated for use with Resert® XL HLD High-Level Disinfectant. The purpose of the STERIS Resert XL Test Strip is to determine whether the concentration of a Resert XL HLD High-Level Disinfectant solution is above the minimum recommended concentration (MRC) of 1.5%.

The STERIS Resert XL Test Strip only indicates hydrogen peroxide concentration and does not confirm disinfection.

The STERIS Resert XL Test Strip is a chemical indicator strip consisting of an absorbent paper pad impregnated with the reactive chemicals, which is adhesively bonded to one end of a polymer film. The STERIS Resert XL Test Strip has been developed to monitor the Resert® XL HLD High-Level Disinfectant (K080420) that has an MRC of 1.5%.

The provided text describes the STERIS Resert XL Test Strip, its intended use, and its substantial equivalence to predicate devices, but does not contain a detailed study report with specific acceptance criteria or performance metrics in the format requested.

Therefore, I cannot populate the table or answer most of the questions directly from the provided text. The document is a 510(k) summary and FDA clearance letter, which focuses on regulatory approval based on "substantial equivalence" rather than a comprehensive efficacy study report with detailed performance data against pre-defined acceptance criteria.

However, I can extract what is implicitly present or inferable:

Implicit Acceptance Criteria (Inferred from Intended Use):

• Accuracy: The test strip must reliably determine if the Resert® XL HLD High-Level Disinfectant solution is above or below the Minimum Recommended Concentration (MRC) of 1.5% hydrogen peroxide.
• Specificity: The test strip only indicates hydrogen peroxide concentration and does not confirm disinfection (as stated in the "Indications for Use").

Information Available from the Text:

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

   • Acceptance Criteria (Inferred): Accurate detection of whether Resert® XL HLD is above or below 1.5% MRC.
   • Reported Device Performance: The document states the device is "substantially equivalent" to predicate devices, implying its performance meets regulatory standards for its intended use. However, no specific performance metrics (e.g., sensitivity, specificity, accuracy percentages) are provided in this document.

   Acceptance Criteria	Reported Device Performance (as stated or inferred)
   Reliably determines if Resert® XL HLD concentration is > 1.5% MRC. (Inferred)	The device is deemed "substantially equivalent" to legally marketed predicate devices, meaning its performance for determining concentration > 1.5% MRC is considered acceptable for its intended use, without raising new issues of safety or efficacy. Specific quantitative performance data (e.g., sensitivity, specificity) is not provided in this 510(k) summary.
   Reliably determines if Resert® XL HLD concentration is < 1.5% MRC. (Inferred)	As above.
   Only indicates hydrogen peroxide concentration and does not confirm disinfection. (Explicit in Indications for Use)	This is explicitly stated as an intended performance characteristic.

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

   • Not provided. This document does not detail specific study methodologies or sample sizes for performance testing.

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

   • Not provided. This information would typically be in a detailed study report, not a 510(k) summary.

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

   • Not provided.

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 device is a chemical indicator test strip, not an AI-assisted diagnostic tool for human readers.

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

   • Not applicable. This is a chemical indicator, not an algorithm. Its "standalone" performance is its direct chemical reaction providing the visual result.

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

   • Inferred: For a chemical indicator, the ground truth would typically be established by analytical chemistry methods (e.g., titration, spectrophotometry) to accurately determine the actual hydrogen peroxide concentration in a solution.

8. The sample size for the training set:

   • Not provided. This information would be specific to the development and validation of the chemical formulation and strip design.

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

   • Inferred: Likely established through laboratory analytical methods for precise measurement of hydrogen peroxide concentrations in various solutions.

In summary, the provided text is a regulatory submission focused on demonstrating "substantial equivalence" rather than a detailed scientific study report. It does not contain the granular data on acceptance criteria, test methodology, sample sizes, or ground truth establishment that would typically be found in a comprehensive performance study.

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