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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

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