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The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heat-sensitive medical devices and their accessories in healthcare facilities.

The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects.

The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle. The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - peracetic acid - is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.

The interchangeable processing trays/containers are made to accommodate a variety of semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Points not explicitly addressed in the provided text:

The provided text (a 510(k) Summary for a medical device) focuses on demonstrating substantial equivalence to a predicate device, rather than a typical clinical study report for AI/machine learning devices. Therefore, several points in your requested information are not applicable or explicitly mentioned in this type of document.

Here's how the remaining points relate to the provided text:

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

• Test Set Sample Size: Not explicitly stated for each test. For "In-Use Testing," it mentions "Clinically used, cleaned semi-critical heat-sensitive medical devices," implying a sample was used but the size isn't quantified. For Water Filter Performance, refers to "numerous Liquid Chemical Sterilization Cycles and Diagnostic Cycles." For Cycle Qualification, it states "three (3) cycles each, Liquid Chemical Sterilization and Diagnostic."
• Data Provenance: Not explicitly stated. The document is submitted to the FDA in the USA, suggesting the testing was likely conducted in accordance with US regulatory standards, but the physical location or origin of the samples/data is not mentioned.
• Retrospective or Prospective: Not explicitly stated, though "In-Use Testing" implies real-world usage, which could be prospective if the testing was specifically set up for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable for this type of device. The device is a liquid chemical sterilant processing system. Ground truth is established through microbiological testing (e.g., absence of viable microorganisms) and engineering verification, not human expert interpretation of images or other subjective data. No experts (like radiologists) are involved in establishing ground truth for this device's performance.

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

• Not applicable for this type of device. Adjudication methods are typically used in studies where human interpretation or classification is compared, often with disagreements needing resolution. For a sterilization system, the performance is measured objectively against predefined microbial reduction targets or engineering specifications.

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 not an AI-assisted diagnostic tool that involves human readers.

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

• Partially applicable, but not in the AI sense. The "device performance" in this context (sterilization efficacy, electrical safety, filter performance, software operation) is inherently "standalone" in that it's the system itself performing its intended function. There isn't an "algorithm-only" performance study distinct from the device's operational performance, as the device is the sterilizing algorithm/process. The tests described (e.g., In-Use Testing, Water Filter Performance) evaluate the device's standalone capability.

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

• Microbiological Negativity / Sterility: For the "In-Use Testing," the ground truth of "effectively liquid chemically sterilized" implies the absence of viable microorganisms (i.e., sterility) after processing. This would typically be verified through standard microbiological culture methods.
• Engineering Specifications: For Electrical Safety, Water Filter Performance, Water Filter Integrity Test, Cycle Qualification, and Software Validation, the ground truth is adherence to predefined engineering specifications, industry standards (e.g., UL standards), or functional requirements.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set. The device operates based on fixed chemical and physical parameters, not learned data.

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

• Not applicable. No training set is used for this device.

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The SYSTEM IE Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned. immersible, and reusable critical and semi-critical heatsensitive medical devices in healthcare facilities.

The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 46 to 55°C, and rinses the load with extensively treated* potable water. The processed load should be used immediately.

The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

• The extensive treatment of EPA potable water consists of:
  • 1. Pre-filtration through two pre-filters:
    • · Pre-filter 1 is a gross depth filter that removes approximately 5 micron or larger particles/contaminants.
    • Pre-filter 2 is a surface filter that removes particles/contaminants > 0.1 micron.
  • 2. UV Irradiation:
    • · During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
  • 3. 0.1 micron filtration:
    • · The water prepared by pre-filtration and UV irradiation is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.

The SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, heat sensitive, flexible and rigid endoscopes and their accessories, and microsurgical instruments. The system consists of the SYSTEM IE Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects.

The device was originally cleared under K090036. Following the initial clearance the FDA was notified of a second qualified supplier of an ultraviolet light water treatment subsystem providing equivalent water treatment performance, safety, and effectiveness to that described within K090036. This modification was subsequently cleared under K101409. Minor revisions to software that did not alter cycle parameters were cleared under K102462 and K113520.

The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light treatment subsystem, and then through two 0.1 micron filter membranes. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.

S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed exclusively for use in the SYSTEM 1E Processor. The active ingredient in S40, peracetic acid, is combined with inert ingredients to form a use dilution which inhibits corrosion of metals, polymers and other materials.

The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific SYSTEM IE Quick Connects, if required, facilitate delivery of the liquid chemical sterilant use-solution and rinse water to internal channels.

The provided document describes a 510(k) premarket notification for a modification to the STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. This document focuses on demonstrating that the modifications to the device do not affect its safety or effectiveness, rather than a de novo study of the entire device's performance against clinical endpoints. Therefore, many of the requested fields regarding extensive studies are not applicable or cannot be extracted from this specific 510(k) summary.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes verification activities related to specific hardware and software modifications. It does not mention a "test set" in the context of clinical or large-scale performance evaluation using data. The tests focus on confirming that the modifications themselves do not negatively impact the device.

• Sample Size: Not applicable in the context of a "test set" for performance evaluation against ground truth. The "sample" would be the modified components or software itself undergoing specific engineering verification.
• Data Provenance: Not applicable. The "data" comes from internal engineering and quality testing of the modified device components and software.

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

Not applicable. The "ground truth" here is the established safety and effectiveness of the original SYSTEM 1E, and the tests aim to ensure the modifications do not deviate from that. This is not a study requiring expert clinical adjudication.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert opinions.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. This document does not describe an MRMC comparative effectiveness study. It's a 510(k) clearance for device modifications, focusing on maintaining substantial equivalence to a predicate device, not on improving human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a way. The tests reported (Biocompatibility, Processor Performance, Software Verification, Software Validation, Machine Validation) are essentially standalone in that they assess the device's technical specifications and function without direct human interaction or interpretation in a clinical diagnostic setting. The device (STERIS SYSTEM 1E) is an automated liquid chemical sterilant processing system.

7. The Type of Ground Truth Used

The "ground truth" for the acceptance criteria is based on the established performance and safety specifications of the predicate SYSTEM 1E Liquid Chemical Sterilant Processing System (K090036 and subsequent modifications under K101409, K102462, K113520). The studies described here verify that the implemented modifications do not alter this existing profile.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device requiring a training set. It's a physical medical device.

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

Not applicable. This is not a machine learning or AI-driven device requiring a training set.

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