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The Reliance PI Process Indicator is a single use chemical indicator designed to change from the "START" dark pink color to the "ENDPOINT" orange color or lighter upon exposure to an effective dose of peracetic acid generated from Reliance™ DG Dry Germicide during the Reliance Endoscope Processing Cycle.

The Reliance PI Process Indicator is intended to be used exclusively for the independent monitoring of the Reliance Endoscope Processing Cycle. The Reliance PI Process Indicator is not an indicator of load disinfection or cleaning efficacy.

The Reliance PI Process Indicator is a single use chemical indicator strip that is designed to confirm an effective dose of peracetic acid (PAA), the active ingredient generated from Reliance DG Dry Germicide in the Reliance Endoscope Processor's HLD cycle.

This test strip consists of a 0.2-square inch reagent-containing indicator pad attached to one end of a 0.2 x 3.25-inch polystyrene handle. The indicator pad contains an indicator dye with a background dye that together form a dark pink color.

Upon exposure to the effective dose of PAA generated during the Reliance Endoscope Processing Cycle, the indicator dye only is oxidized by the Reliance DG Dry Germicide use dilution during the Reliance Endoscope Processing Cycle. During the processing cycle, the indicator pad color transitions through a lighter pink color until an orange coloration, based on the background dye, is visible.

The Reliance™ PI Process Indicator is a chemical indicator designed to confirm an effective dose of peracetic acid (PAA) in the Reliance Endoscope Processor's High-Level Disinfection (HLD) cycle.

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sensitivity Studies: The exact sample size for the "Sensitivity Studies" is not explicitly stated as a number of strips but implies multiple tests to determine the PAA dose thresholds for pass/fail.
• Simulated-Use Studies:
  • One study involved 27 cycles using eight flexible endoscopes to detect intended PAA levels.
  • Another study involved 9 cycles using three worst-case flexible endoscopes to test the minimum recommended PAA dose (9000 mg/L PAA min).
• Data Provenance: Not explicitly stated, but the submission is from STERIS Corporation in Mentor, Ohio, USA, suggesting the studies were conducted within the US or under their oversight. The studies appear to be prospective as they were specifically designed and executed for device validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not explicitly state the number of experts or their qualifications used to establish the ground truth for interpreting the process indicator's color change or the PAA concentration measurements. However, it does mention "correctly interpreted by the clinical users" in an in-use study, implying clinical personnel were involved in observing the indicator results in a real-world setting, but their expert role in establishing the ground truth for validation is unclear.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method (e.g., 2+1, 3+1, none) for the test set. The evaluation of the indicator's color change (pass/fail) seems to be based on predefined objective criteria related to specific PAA concentrations, rather than subjective expert consensus requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in the context of comparing human readers' performance with and without AI assistance, as this device (a chemical indicator) does not involve AI or human interpretation in the same way an imaging diagnostic device would. It's a binary "pass/fail" chemical reaction.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the device is a physical chemical indicator, not an algorithm. Its performance is inherent to its chemical reaction to PAA, and while human observation is required to read the indicator, the "performance" described refers to the indicator's objective chemical response.

7. Type of Ground Truth Used

The ground truth used for the device's performance relies on objective chemical measurements of peracetic acid (PAA) concentrations.

• "Kinetic Studies validated the Reliance Endoscope Processor's delivery of peracetic acid in concentrations appropriate for PI performance testing."
• "The complete ENDPOINT color (pass) when the dose of PAA is >= 11,500 mg/L PAA min."
• "Fails to reach that color (incomplete endpoint reading, not acceptable) when the PAA dose is < 9000 mg/L PAA min."
  This indicates that the ground truth for "effective dose" and "minimum recommended dose" was established by precise measurements of PAA concentration (mg/L PAA min).

8. Sample Size for the Training Set

The document does not specify a separate "training set" as this is a chemical indicator, not a machine learning model. The validation tests described serve to establish its performance characteristics against defined chemical criteria.

9. How the Ground Truth for the Training Set Was Established

As there's no "training set" in the machine learning sense, this question is not applicable. The underlying "ground truth" for the device's function (i.e., known PAA concentrations and their effect on the indicator) would have been established through controlled laboratory experiments and chemical analysis during the development and kinetic studies of the indicator itself.

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