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The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable 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, Model P6900 (S1 endo) 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 S1 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. After LCS 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 S1 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 S1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.

The STERIS Corporation's SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, demonstrates substantial equivalence to its predicate device (K222615) based on non-clinical testing. The device is a liquid chemical sterilization system intended for processing immersible, reusable semi-critical medical devices and their accessories in healthcare facilities. The modifications being reviewed are limited to the use of alternative, drop-in replacement components for the control boards.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

The document mentions "non-clinical performance testing" and "the same methods used to verify the original design" but does not specify the exact sample size for the test set (e.g., number of sterilization cycles performed, number of control boards tested).

The data provenance is implicitly from STERIS Corporation's internal testing labs, as they designed and manufactured the device. The testing is retrospective in the sense that it's performed after the modifications were made to confirm functionality against established criteria. No external country of origin is mentioned for the testing data itself; it's generated by the manufacturer for regulatory submission in the U.S.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The testing appears to be objective, verifying technical specifications and operational parameters, rather than requiring expert interpretation for ground truth establishment in the traditional sense of medical image analysis or clinical diagnosis. The "ground truth" here is the expected functional performance of the device and its components.

4. Adjudication method for the test set:

This information is not provided as the nature of the testing (functional verification of control boards and software) would likely involve automated system checks and predefined pass/fail criteria rather than expert adjudication of subjective results.

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:

This is not applicable as the device is a liquid chemical sterilant processing system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

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

This is not applicable for the same reasons as #5. The device operates as an automated system; there isn't an "algorithm only" performance that would need to be separated from human interaction in the way an AI diagnostic tool might.

7. The type of ground truth used:

The ground truth used for these specific tests (related to new control boards and software) is functional criteria and predefined technical specifications. For example, a control board "fits" if it physically integrates correctly, "runs all cycles" if it successfully initiates and completes the sterilization sequence, and "runs without alarms" if no error states are triggered during operation. The software's "proper version" is a verifiable identifier, and its "proper operation of cycles and alarms" refers to its adherence to programmed logic and responses.

More broadly for the device as a sterilizer, the ultimate ground truth would be microbial efficacy (sterilization) and material compatibility, which are also stated to meet efficacy requirements based on in-vitro testing for its intended use (as described in Table 2).

8. The sample size for the training set:

This information is not applicable. The device is a physical sterilizer with a control system, not a machine learning or AI model that requires a training set. The "training" for such a system would be its design, engineering, and manufacturing processes, along with verification and validation testing.

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

This is not applicable as there is no "training set" in the context of an AI/ML model for this device. The ground truth for the device's overall function (sterilization efficacy) is established through standardized microbiological testing methods (e.g., AOAC Official Methods, simulated-use tests, clinical in-use tests as referenced in Table 2) against specific log reduction criteria for various microorganisms. For component performance (like the control boards), the ground truth is established by design specifications and functional requirements.

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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, Model P6900 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 current submission is provided to describe certain software modifications made after the clearance of K182827.

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. After LCS 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 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.

The provided text describes a 510(k) premarket notification for a medical device (SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900) which has undergone "certain software modifications made after the clearance of K182827" (its predicate device). The document primarily focuses on demonstrating substantial equivalence to the predicate, K182827.

The "study" referenced in the text pertains to the Software Validation of the modified device.

Here's the breakdown of the acceptance criteria and study as requested, based on the provided document:

Acceptance Criteria and Device Performance for Software Validation

Details of the Study (Software Validation)

1. Sample Size Used for the Test Set and Data Provenance:

   • The document states "New testing was performed to evaluate the modified device," specifically for "Software Validation," and indicates that the software was "validated."
   • However, no specific sample size (e.g., number of test cases, number of cycles) for this software validation test set is provided in the document.
   • Data Provenance: Not explicitly stated, but it would logically be controlled testing data from the manufacturer (STERIS Corporation) rather than patient or clinical data. Given the regulatory submission context, it would be considered prospective testing for the purpose of validating the software modifications. Country of origin for the data is not specified, but the submission is to the US FDA.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • This information is not provided in the document. Software validation typically involves testing against pre-defined requirements and expected outcomes, which are established by software engineers and subject matter experts (SMEs). The document does not specify the number or qualifications of these individuals involved in establishing the testing parameters or reviewing the results.

3. Adjudication Method for the Test Set:

   • The document states "The software that controls the system was validated and determined to operate effectively and as designed."
   • The adjudication method is implicitly direct verification against established functional and design specifications. There is no mention of a human consensus-based adjudication method (e.g., 2+1, 3+1) as commonly seen in medical image analysis.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

   • No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic aids or algorithms that directly impact human interpretation (e.g., radiologists reading images). This device is a sterilizing system with software controls, not a diagnostic tool requiring human reader performance evaluation.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

   • The software validation (implied as 'algorithm only' if considering the software as the 'algorithm') was indeed done. The device's operation is automated. The validation goal was to confirm the software performs as designed and controls the system effectively.

6. The Type of Ground Truth Used:

   • The ground truth for the software validation is implicit in the design specifications and functional requirements of the software. It's based on engineering specifications and expected system behavior rather than expert consensus, pathology, or outcomes data. The "acceptance criteria" listed essentially serve as the definition of "ground truth" for the software's performance.

7. The Sample Size for the Training Set:

   • This device is a hardware system with software controls, not an AI/ML algorithm that requires a "training set" in the conventional sense (e.g., for pattern recognition or predictive modeling). Therefore, the concept of a training set as used in machine learning is not applicable here, and no information about it is provided. The software was likely developed and then validated against its specifications.

8. How the Ground Truth for the Training Set Was Established:

   • As explained above, the concept of a training set is not applicable to this device's software validation as described.

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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 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, cleaned semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo LCS Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects.

This submission describes modifications to the processor's user interface and controller, to be introduced in Model P6900. The modifications will provide several user convenience features as compared to the originally cleared processor. Model P6800. The advantages for users include an intuitive touchscreen display, a barcode scanner, and the ability to electronically save and download cycle data for facility records. The P6900 model utilizes an updated electronic controller and suitable software, while providing cycles for liquid chemical sterilization (LCS) and system diagnostics identical to those of the original device. The modified SYSTEM 1 endo Processor, which is computer controlled and continually monitored, provides electronic documentation of each cycle. An external printer is available for printed records, if preferred.

The SYSTEM 1 endo Processor (whether Model P6800 or P6900) is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in six (6) minutes. After liquid chemical sterilant 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 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.

The STERIS SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical medical devices and their accessories in healthcare facilities. The device 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 P6900 model introduces modifications to the user interface and controller compared to its predicate device, Model P6800, including an intuitive touchscreen display, a barcode scanner, and the ability to electronically save and download cycle data for facility records, while maintaining identical processing parameters.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not specify a separate "test set" in the context of typical validation studies with human readers or clinical data. Instead, for Cycle Performance Qualification, the testing involved running three (3) Liquid Chemical Sterilization cycles and three (3) Diagnostic Cycles. The provenance of this data is not explicitly stated but is presumed to be from laboratory testing conducted by the manufacturer (STERIS Corporation). The data is retrospective in the sense that it's reported after the tests were conducted for regulatory submission. Its country of origin is not specified, but the manufacturer is based in Mentor, Ohio, USA.

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

This information is not applicable as the device is a chemical sterilant processing system, and its performance is evaluated against engineering and microbiological specifications, not based on expert interpretation of images or other subjective data. No human experts were explicitly mentioned for establishing ground truth related to the device's operational performance in the provided summary.

4. Adjudication Method for the Test Set:

Not applicable. The qualification tests rely on objective measurements and predefined pass/fail criteria for electrical safety, cycle parameters, and software functionality, not on human adjudication of subjective data.

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

Not applicable. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The STERIS SYSTEM 1 endo is a medical device sterilization system, and its effectiveness is determined by its ability to sterilize, not by human interpretation or diagnosis.

6. Standalone Performance Study:

Yes, a standalone performance study was done. The "Cycle Performance Qualification" and "Software Validation" tests, along with the Electrical Safety and EMC conformance, demonstrate the standalone performance of the algorithm (software) and the overall device. The device was tested to ensure it operates effectively and as designed (software validation) and that all cycle specifications (e.g., temperature, contact time, peracetic acid concentration) are met during the sterilization and diagnostic cycles.

7. Type of Ground Truth Used:

The ground truth used for the performance evaluation includes:

• Engineering and Safety Standards: For electrical safety and EMC (UL 61010-1, UL 61010-2-040, IEC 61326-1).
• Predefined Cycle Specifications: For cycle performance qualification (e.g., specific temperatures, contact times, chemical concentrations).
• Software Design Requirements: For software validation, ensuring the software operates as designed and effectively controls the system.
• Microbial Efficacy Data (from predicate device's S40 Sterilant Concentrate tables): Although not specifically re-tested for the P6900 device as the sterilant concentrate is unchanged, the efficacy of the sterilant (S40) itself is based on numerous in vitro and simulated use tests demonstrating sporocidal, fungicidal, bactericidal, and virucidal activity, as well as tuberculocidal activity (e.g., > 6 log10 reduction of Geobacillus stearothermophilus spores, absence of surviving microorganisms in clinical in-use tests).

8. Sample Size for the Training Set:

Training set information is not applicable to this device submission. This is a 510(k) submission for a physical medical device (sterilizer) with software modifications, not a machine learning or artificial intelligence-driven diagnostic tool that requires training data in the typical sense. The software validation ensures that the software correctly implements the predefined control logic and algorithms for the sterilization process, rather than "learning" from a training set.

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

Not applicable, as there is no training set in the context of machine learning for this device. The software functionality is based on deterministic control logic and pre-established sterilization parameters derived from extensive microbiological and engineering studies (as indicated by the numerous efficacy tests referenced in the S40 Sterilant Concentrate Comparison Table in the original submission for the predicate device, which are identical for this device).

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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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