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The Reliance™ Advance Endoscope Processing System is intended for cleaning and high level disinfection of up to two immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories.

During the system's standardized Endoscope Processing Cycle, cleaning is achieved within the Cleaning phase, and high level disinfection is achieved within the 50 - 57°C HLD phase (4 minute generation sequence followed by a 6-minute exposure sequence).

Manual cleaning is not required prior to processing in Reliance Advance Endoscope Processing System.

Device Description

The Reliance Advance Endoscope Processing System is an economical, easy-to-use cleaning and high level disinfection system that can clean and high level disinfect up to two immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes and related accessories.

The system utilizes Reliance™ DG Dry Germicide, a proprietary, safe, dry peracetic acid generating oxidative chemistry. The Reliance Advance Endoscope Processing System was designed to be versatile in meeting the growing demands of the modern flexible endoscope processing department, while offering the highest level of patient and staff safety. The Reliance Advance Endoscope Processing System is a combination of products that are used to clean and high level disinfect flexible endoscopes and their accessories.

The Reliance Advance Endoscope Processor is an electromechanical . washer/high level disinfector with a microprocessor-based controller that provides for automated endoscope processing cycles and processor selfdecontamination cycles.
. The proprietary enzymatic detergent is dispensed automatically during the Cleaning phase of the cycle to effectively clean endoscope(s) and accessories.
. Reliance DG Dry Germicide is a proprietary, two-part, dry, single-use oxidative chemistry, designed to generate the high level disinfection solution upon automatic dilution in water within the Reliance Endoscope Processor.
. Various accessories are available to accommodate the processing needs of specific endoscopes and endoscopic accessories.
VERIFY Process Indicator for Reliance EPS is available to monitor for the . effective dose of the Reliance DG active ingredient, peracetic acid.
CIP 200 Acid-Based Process and Research Cleaner, a general cleaning agent, is . used in one of the two self-decontamination cycles provided by the processor.

AI/ML Overview

The STERIS Reliance™ Advance Endoscope Processing System is intended for cleaning and high-level disinfection of immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes, and their accessories. Manual cleaning is not required prior to processing.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides performance testing summaries across several categories, with implicit acceptance criteria that the device achieved the stated outcomes.

Acceptance Criteria Category	Specific Acceptance Criteria (Implicit)	Reported Device Performance
Cleaning Phase Efficacy	Simulated Use: All test articles visually clean; all recovered samples from soiled areas meet established "clean" acceptance levels for protein, carbohydrates, and total organic carbon.	Simulated Use Studies: * Fifteen (15) heat-sensitive flexible endoscopes, dilators, and accessories, soiled with select test soils, were processed. * Performance: "1) all test articles were visually clean, and 2) all samples recovered from previously soiled areas for all test articles met the established acceptance levels defined as 'clean' for protein, carbohydrates, and total organic carbon in validated assays for those components."
	Clinical In-Use: All tested clinically soiled endoscopes visually clean; all meet soil pre-determined "clean" acceptance levels for protein, carbohydrates, and total organic carbon.	Clinical In-Use Studies: * Four types of flexible endoscopes (bronchoscopes, gastroscopes, colonoscopies, duodenoscopes) and their accessories, after clinical use and bedside pre-cleaning, were processed only through the cleaning phase. * Performance: "In triplicate evaluations, each of the tested clinically soiled endoscopes 1) was visually clean, and 2) met the soil pre-determined 'clean' acceptance levels for protein, carbohydrates, and total organic carbon in validated assays."
Enzymatic Detergent Stability	Stable in Bag-in-Box packaging for 12 months under representative storage conditions.	"The proprietary enzymatic detergent has been shown to be stable in its Bag-in-Box packaging through 12 months under representative storage conditions." (Note: ongoing testing for shelf-life extension)
Software Validation	Meet FDA requirements for a Major Level of Concern determination based on FDA Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities dated August 1993.	"All acceptance criteria were met."
Material Compatibility	No deleterious effects (other than minor cosmetic changes) on common materials of endoscope and accessory construction after 300 processing cycles; no functional changes.	Enzymatic Detergent: "After 300 processing cycles, no deleterious effects were observed other than minor cosmetic changes. No functional changes in flexible endoscopes were observed." Reliance DG: "After 300 processing cycles, no deleterious effects were observed other than minor cosmetic changes. No functional changes in flexible endoscopes were observed."
Processor Performance	Critical process parameters (water temperature/volume, DG container detection, boot pressure, water filter integrity, cleaning/HLD solution delivery) within required specifications under worst-case conditions. Each phase effective under worst-case conditions. Self-decontamination cycles effective.	"The critical process parameters for the processor (...) have each been evaluated in replicate under worst case conditions, and found to be within required specifications." "Each processor phase or cycle has been separately evaluated and shown to be effective under worst case conditions." Self-decontamination: D-LONG can disinfect after high-level challenge with Pseudomonas aeruginosa. D-SHORT can kill bacteria that have potential to form biofilm.
Reliance DG Microbial Efficacy	Sporicidal, Tuberculocidal, Virucidal, Bactericidal, Fungicidal: Meet defined AOAC or other criteria within 6 minutes exposure time. Minimum 6 log10 reduction of Mycobacterium terrae in simulated use. No organisms recovered in clinical in-use.	Potency: * Sporicidal: Proven sporicidal (AOAC Sporicidal Activity Test, 6 min exposure), confirmed in processor and in vitro with aged DG. * Tuberculocidal: Proven tuberculocidal (AOAC Tuberculocidal Activity Test, 6 min exposure), confirmed with aged DG. * Virucidal: Poliovirus Type 1, adenovirus Type 5, herpes simplex virus Type 1 reduced by > 4 log10. * Bactericidal: Proven bactericidal (AOAC Bactericidal Activity Test, 6 min exposure) in situ or in vitro. * Fungicidal: Proven fungicidal (AOAC Tuberculocidal Activity Test, 6 min exposure) in situ or in vitro. Simulated-Use: "reproducibly achieved greater than a 6 log10 reduction of Mycobacterium terrae in triplicate trials within the Reliance Endoscope Processor for each selected clinically relevant flexible endoscope and its accessory." In-Use: "In triplicate evaluations of each endoscope, no organisms were recovered after processing." (Bioburden before HLD up to 10^5 CFU/device).
Reliance DG Stability	Stable for 18 months in unopened packaging. Opened containers used within 2 weeks or by expiration.	"Reliance DG has been shown to be stable for 18 months in the unopened moisture-resistant package at the stated conditions for storage. Once opened, the five Reliance DG containers within each package are to be used within two (2) weeks, or by the expiration date on the container, whichever comes first."
Biocompatibility	Chemical formulations and residuals safe for handling and use, below established residue limits, and non-cytotoxic.	"The Reliance chemical formulations, as supplied in packaging as well as in use dilutions, can be safely handled and used by customers. Residues that may remain on medical endoscopes and accessories are below established residue limits and do not pose a risk to patients." Testing: In vitro cytotoxicity, chemical residual analysis, literature reviews of toxicity data for enzymatic detergent components. For Reliance DG: acute oral/ocular toxicity, dermal irritation, in vitro bacterial mutation genotoxicity, sensitization, in vitro cytotoxicity, literature reviews. Performance: "Use dilution reaches non-cytotoxic levels with minimal dilution." "Biocompatibility testing of extracts from processed medical devices demonstrated that no toxic residuals remain on devices under worst case circumstances."
VERIFY Process Indicator	"Change to colorless (complete change)" at or above minimum effective PAA dose of 9000 mg/L PAA; failure to change (incomplete change) below.	Acceptance criteria stated as: "NOT colorless (incomplete change) at end of Reliance Advance Endoscope Processing Cycle using the minimum effective PAA dose of 9000 mg/L PAA min, or in a processing cycle without PAA." This implies the indicator should change color to indicate sufficient PAA, and not change if insufficient. The actual performance against this acceptance criterion is not explicitly stated as "met" or "passed" in the provided text.

2. Sample Sizes and Data Provenance

Cleaning Phase Efficacy (Simulated Use):
- Test Set Sample Size: 15 heat-sensitive flexible endoscopes, dilators, and their accessories.
- Data Provenance: Not explicitly stated, but "simulated use studies" typically imply laboratory-controlled settings, likely in the US (where STERIS Corporation is based). Retrospective (if using existing designs) or prospective (for new device evaluation).
Cleaning Phase Efficacy (Clinical In-Use):
- Test Set Sample Size: Four types of flexible endoscopes (bronchoscopes, gastroscopes, colonoscopies, and duodenoscopes) and their accessories. "In triplicate evaluations" implies 3 runs for each endoscope type.
- Data Provenance: "US hospital." Prospective (actual clinical use).
Reliance DG Microbial Efficacy (Simulated-Use):
- Test Set Sample Size: "each selected clinically relevant flexible endoscope and its accessory," with "triplicate trials." Specific number of endoscopes not detailed beyond "each selected."
- Data Provenance: Not explicitly stated, likely laboratory-based, possibly in the US. Retrospective or prospective.
Reliance DG Microbial Efficacy (In-Use):
- Test Set Sample Size: "Three flexible endoscopes representing the range of types indicated in the product labeling." "In triplicate evaluations of each endoscope."
- Data Provenance: Not explicitly stated, but "clinical procedures" suggests data from a healthcare setting, likely in the US. Prospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts or their qualifications for establishing ground truth for cleaning or disinfection efficacy. The "clean" acceptance levels for protein, carbohydrates, and total organic carbon are described as "established" and "pre-determined," implying standards or expert consensus, but details are not provided. Microbial studies refer to AOAC tests, which are standardized protocols rather than expert consensus on individual cases.

4. Adjudication Method for Test Set

Not applicable. The studies described are performance tests against established criteria (e.g., visual cleanliness, chemical residue levels, microbial reduction logs, standardized test protocols like AOAC), not image-based diagnostic studies requiring reader adjudication.

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

No. This type of study (MRMC for comparing human reader performance with/without AI) is not relevant to the described device, which is an automated endoscope reprocessor, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance

Yes, in essence. The described performance studies (cleaning efficacy, microbial efficacy, processor performance) represent the standalone performance of the device (the Reliance Advance Endoscope Processing System) without human intervention in the core processing steps, beyond loading and initiating the cycle. Manual cleaning is explicitly not required prior to processing, emphasizing its standalone cleaning capability. The human role is minimal during the automated cycle.

7. Type of Ground Truth Used

Cleaning Efficacy:
- Simulated Use: A combination of established acceptance levels for protein, carbohydrates, and total organic carbon (measured by validated assays) and visual cleanliness.
- Clinical In-Use: Similar to simulated use, relying on pre-determined "clean" acceptance levels for chemical residues and visual cleanliness.
Microbial Efficacy:
- Potency (Sporicidal, Tuberculocidal, Virucidal, Bactericidal, Fungicidal): Based on standardized microbiological test protocols (e.g., AOAC tests) which define specific reduction requirements against target microorganisms.
- Simulated-Use & In-Use: Measured microbial reduction logs (e.g., > 6 log10 reduction) and absence of recovered organisms after processing, determined by laboratory culturing methods.
Other tests (Material Compatibility, Stability, Processor Performance): Based on objective measurements, observations, and adherence to predefined engineering or chemical specifications.

8. Sample Size for the Training Set

The document does not describe the development of an AI algorithm or a "training set" in the context of machine learning. The device is an electromechanical system with a microprocessor-based controller and proprietary chemistry, the development of which would involve engineering, chemistry, and microbiology rather than machine learning training data.

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

Not applicable, as there is no mention of a training set for an AI algorithm. The "ground truth" for the device's design and engineering would be based on scientific principles, regulatory standards, and performance testing results.

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