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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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The Steris Verify Spore Test Strip for S40 is intended to provide users with a means to assess spore kill by the S40 sterilant at its use dilution in the System 1E Liquid Chemical Sterilant Processing System. A "no growth" result from the Steris Verify Spore Test Strip for S40 after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 10 viable spores (5 logs) on the test strip. The Steris Verify Spore Test Strip for S40 does not confirm the expected full performance of the SYSTEM 1E Liquid Chemical Sterilization Cycle.

The Steris Verify Spore Test Strip for S40 consists of a 1 3/8 in x ¼ in filter paper-based strip inoculated with Geobacillus stearothermophilus spores and is enclosed in a glassine envelope. The Spore Test Strips are provided with media vials containing a modified tryptic soy broth with phenol red pH indicator, and a transfer clip. The transfer clip holds the Spore Test Strip in a single location during a processing cycle in the System 1E Liquid Chemical Sterilant Processing System (System 1E processor; cleared under K090036) and enables aseptic transfer of the Strip from the processor into the growth media vial. Using the clip, the Spore Test Strip is secured on the available post located in the tray of the System 1E processor.

Here's an analysis of the acceptance criteria and study details for the Steris Verify Spore Test Strip for S40, based on the provided text:

Evaluation of Automatic Class III Designation (De Novo) for the STERIS VERIFY SPORE TEST STRIP FOR S40

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set (Reduced Incubation Time - RIT):

  • Use Dilution Vessel (0 and 3 month time points): 100 Spore Test Strips per lot per time point (3 lots = 600 strips).
  • System 1E processor (6, 9, and 12 month time points): 100 Spore Test Strips from each of 3 lots (300 strips per time point, total 900 strips).
  • Provenance: Retrospective, derived from laboratory testing conducted by STERIS Corporation (implied by manufacturer's submission). Country of origin is not specified but is a US-based company.

• Test Set (Viable Spore Population - Builders Only):

  • Initial Characterization: 10 Spore Test Strips/Lot (for maceration), 3 Spore Test Strips/Lot (for growth media) - total 39 strips (13 per lot).
  • Shelf-Life: 10 Spore Test Strips per lot per time point (3 lots * 5 time points = 150 strips).
  • Provenance: Retrospective, laboratory testing.

• Test Set (D-value characterization):

  • 100 Spore Test Strips evaluated per lot (for 3 lots = 300 strips).
  • Shelf-Life: Not explicitly stated but "10 Spore Test Strips per lot per 5 exposure times" for D-value study in shelf-life section implies significant numbers.
  • Provenance: Retrospective, laboratory testing.

• Test Set (Survival/Kill Window):

  • 100 Spore Test Strips evaluated per lot (for 3 lots = 300 strips).
  • Shelf-Life: "50 Spore Test Strips per lot per survival time or kill time" implies 300 strips total.
  • Provenance: Retrospective, laboratory testing.

• Test Set (Simulated Use Testing in System 1E - Pass/Fail):

  • 80 Spore Test Strips per lot (for 3 lots = 240 strips).
  • Provenance: Retrospective, laboratory testing.

• Other tests (Growth Inhibition, Media Validation, Neutralization, Color Stability): Sample sizes varied, typically small numbers of strips or media vials (e.g., 6 strips for growth inhibition, 10 vials for color stability).

3. Number of Experts and Qualifications for Ground Truth

• The ground truth in this submission is not established by human experts in the medical field (like radiologists). Instead, it is based on objective biological and chemical measurements and observations using established laboratory protocols.
• The "experts" are the laboratory personnel who conducted these tests, but their specific qualifications are not detailed beyond being able to perform the described scientific studies (e.g., microbiology techniques, chemical analysis).

4. Adjudication Method for the Test Set

• There appears to be no adjudication method in the traditional sense of multiple human readers independently assessing results.
• The ground truth is determined by direct scientific measurement and observation of biological phenomena (spore growth/kill, color change, spore count) and chemical properties (PAA concentration, pH). Results are quantitative or clearly qualitative (growth/no growth) and are not subject to expert interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This device is a biological indicator (spore test strip) for a sterilization process, not an imaging or diagnostic device that involves human interpretation of complex data. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here. The device itself provides a direct biological outcome.

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

• Yes, the studies are essentially standalone performance evaluations of the device itself. The device provides a direct, objective result (growth or no growth, spore count, D-value) that is then interpreted according to established acceptance criteria. There isn't an "algorithm" in the sense of artificial intelligence, but rather a set of physical and biological processes designed to yield a clear outcome. Human involvement is primarily in executing the protocol and observing/recording the predetermined biological response (e.g., color change indicating growth).

7. The Type of Ground Truth Used

The ground truth used is primarily based on:

• Biological Activity and Quantitative Microbiology: Direct measurement of viable spore populations (colony forming units, cfu), observation of bacterial growth (colony formation, turbidity, color change), and calculation of resistance parameters like D-value and survival/kill times.
• Chemical Analysis: Measurement of peracetic acid (PAA) concentration and pH to define test conditions.
• Physical Observation: Assessment of strip material integrity.
• Reference Standards: Comparison against manufacturer's stated population and pre-defined acceptable ranges for specifications.

8. The Sample Size for the Training Set

• This submission describes a de novo classification for a medical device (spore test strip), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The studies described are validation and performance testing of the physical and biological properties of the device.

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

• As there is no "training set" for an AI/ML algorithm, this question is not applicable. The device's performance is intrinsically linked to the physical and biological characteristics of the Geobacillus stearothermophilus spores, the filter paper strip, and the chemical sterilant system, all validated through direct laboratory experimentation.

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The SYSTEM 1E 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 1E Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects. The device was originally cleared under K090036. Following this 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 K 101409.

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 the 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 IE 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 Quick Connects ensure thorough circulation of the sterilant solution and rinses.

This document describes a Special 510(k) Premarket Notification for modifications to the STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. The modifications primarily concern device software.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

   Test	Acceptance Criteria	Reported Performance
   Software Verification / Code Walk-Through	Only targeted modifications were implemented to the device software	Pass
   Software Validation	Only targeted modifications were implemented to the device software	Pass
   Machine Validation	Targeted modifications do not affect the performance of the device	Pass

2. Sample size used for the test set and the data provenance:
   The document does not specify a separate "test set" in the traditional sense for evaluating an AI model. This submission is for modifications to a physical sterilization system's software, not an AI/ML device. The "tests" mentioned are verification and validation activities for software and machine performance. The data provenance is not applicable as this is a device modification, not a study involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. Ground truth, in the context of expert consensus, pathology, or outcomes data, is typically for diagnostic or prognostic AI models. This submission is about a sterilizer's software update. The "ground truth" for the acceptance criteria is implicitly defined by the system's intended function and pre-established engineering specifications.

4. Adjudication method for the test set:
   Not applicable. There's no mention of a human adjudication process for resolving disagreements in "ground truth" for a test set, as this is a software/machine validation.

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 is not a comparative effectiveness study involving human readers or AI assistance. It's a regulatory submission for a modification to a sterilizer.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable in the context of AI algorithms. The "software" in question runs within the SYSTEM 1E Processor, an automated, self-contained device. The software's performance is standalone in the sense that it controls the machine, but it's not a standalone diagnostic or predictive algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The "ground truth" for these tests relates to engineering requirements and the system's operational specifications. For example, for "Software Verification," the ground truth is whether "only targeted modifications were implemented." For "Machine Validation," the ground truth is whether "targeted modifications do not affect the performance of the device" according to its established sterilization and functional parameters. This would be based on design specifications, functional requirements, and performance data from the machine itself.

8. The sample size for the training set:
   Not applicable. This is not an AI/ML device where a "training set" of data is used to develop an algorithm.

9. How the ground truth for the training set was established:
   Not applicable, as there is no training set for an AI/ML algorithm.

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