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The enspire™ 300 Series Automated Endoscope Reprocessor System is intended to effectively provide a pressure and channel monitor, clean, high-level disinfect, rinse and air purge validated immersible, reusable, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled naso-endoscopes. The validated cleaning process replaces manual cleaning for endoscopes other than duodenoscopes. Manual Cleaning of endoscopes is required prior to placement in high level disinfection only cycle.

The enspire 300 Series Automated Endoscope Reprocessor System uses Revital-Ox PAA High Level Disinfectant to provide high level disinfection of validated immersible, reusable, semi-critical, heat sensitive medical devices. It automatically mixes the Part B solutions, high level disinfects the load during a controlled cycle and rinses the load. The wash phase of the enspire 300 Series Automated Endoscope Reprocessor System cycle uses only Revital-Ox 2X Concentrate Enzymatic Detergent to perform cleaning.

The Revital-Ox PA High Level Disinfectant (HLD) is a two-part solution, which when mixed, is intended to provide high level disinfection of validated immersible, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled nasoendoscopes, when used in the enspire 300 AER.

The enspire 300™ Series Automated Endoscope Reprocessor (AER) is a medical device processing system used for cleaning and high level disinfection of immersible, reusable, semi-critical, heat-sensitive devices such as flexible endoscopes and their accessories. The system consists of the enspire 300 AER. Revital-Ox 2X Concentrate Enzymatic Detergent (R2X), and Revital-Ox Peracetic Acid High Level Disinfectant.

The enspire 300 series AER is an automated, self-contained device for the effective cleaning and high level disinfection of semi-critical medical devices and their accessories. Prior to placement in the processor, users will be instructed to perform bedside (point of use) cleaning and manual leak testing. The devices will not require manual pre-cleaning prior to processing, with the exception of duodenoscopes which will still require manual cleaning per the manufacturer's written instructions. Channel Connectors, as identified in STERIS labeling, are used to facilitate the delivery of the R2X detergent, HLD solution and rinse water to internal channels of devices that have them.

On the first process of an endoscope, the user must create a scope profile for the endoscope in the AER. The creation of the scope profile saves key endoscope attributes to the AER which are used to monitor the cycle during processing of the device. Once the device is positioned in the enspire 300 AER and optional operator ID, case ID, procedure ID and physician information is inputted, the operator initiates the processing cycle during which the Processor will create and maintain the conditions necessary for effective cleaning and high level disinfection. At the beginning of the processing cycle, an automated pressure monitor is performed to confirm the integrity of the flexible endoscope. In parallel with the pressure monitor and prior to initiation of the cleaning phase, the processing system will evaluate the flow coefficient of each individual channel and compare to their respective reference value stored in the device profile created prior to first processing. The enspire 300 AER maintains inflation of the processed device throughout the process to prevent ingress of fluid in the event of any loss of integrity. At the end of the processing cycle, the cleaned and high level disinfected devices are rinsed with 0.2 micron filtered potable water followed by a dried, oil free, filtered compressed air purge to evacuate rinse water from the endoscope channels. The AER, which is micro-processor controlled and continually monitored, provides documentation of each cycle.

The enspire 300 AER utilizes Revital-Ox 2X Concentrate Enzymatic Detergent for cleaning and Revital-Ox Peracetic Acid High Level Disinfectant for high level disinfection. Revital-Ox PAA HLD is a two part solution consisting of Part A, 15% PAA, and Part B, conditioner.

The document discusses an Automated Endoscope Reprocessor (AER) and its comparison to a predicate device, focusing on non-clinical testing. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: This table is directly extracted from the provided text. The "modified device" refers to the enspire 300 Series AER with new support material for its pre-filters.

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

The document does not explicitly state the sample size used for the performance testing with replacement pre-filters. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature). The testing is described as "new testing" performed to evaluate the modified device.

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 described is performance testing of a medical device, which typically involves engineering and microbiology evaluations, not expert review for ground truth in the way it might be for an AI model interpreting medical images.

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

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiologists interpreting images) to establish a consensus ground truth. This document describes performance testing of an automated reprocessing device, which doesn't involve such human interpretive adjudication.

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 an Automated Endoscope Reprocessor, not an AI-assisted diagnostic or interpretive system. Therefore, no MRMC study or effect size related to human readers improving with AI assistance would have been conducted or reported here.

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

The device itself is a "standalone" automated system for reprocessing endoscopes. The described "Performance testing with replacement pre-filters" evaluates the device's functional performance in this automated capacity. There isn't an "algorithm only" aspect in the sense of a software-based diagnostic tool, but rather the overall automated operation of the mechanical and chemical processes.

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

For the "Performance testing with replacement pre-filters," the ground truth implicitly refers to the established performance requirements for an Automated Endoscope Reprocessor (e.g., effective cleaning and high-level disinfection, proper fluid delivery, temperature control, etc., as detailed in the "Description of Device" and "Process Monitors" sections). The acceptance criterion "The modification does not affect the performance of the device" implies that the device's ability to meet these established functional and safety parameters, which would be verified through specific engineering and potentially microbiological tests, serves as the ground truth. It's not a ground truth derived from expert consensus on interpretations or patient outcomes data directly from this specific test.

8. The sample size for the training set:

This information is not applicable. The device is a physical medical device (Automated Endoscope Reprocessor), not a machine learning or AI model that requires a training set.

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

This information is not applicable since there is no training set for this type of device.

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The enspire™ 300 Series Automated Endoscope Reprocessor System is intended to effectively provide a pressure and channel monitor, clean, high-level disinfect, rinse and air purge validated immersible, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled naso-endoscopes. The validated cleaning process replaces manual cleaning for endoscopes other than duodenoscopes. Manual Cleaning of endoscopes is required prior to placement in high level disinfection only cycle.

The enspire 300 Series Automated Endoscope Reprocessor System uses Revital-Ox PAA High Level Disinfectant to provide high level disinfection of validated immersible, reusable, semi-critical, heat sensitive medical devices. It automatically mixes the Part A and Part B solutions, high level disinfects the load during a controlled cycle and rinses the load. The wash phase of the enspire 300 Series Automated Endoscope Reprocessor System cycle uses only Revital-Ox 2X Concentrate Enzymatic Detergent to perform cleaning.

The Revital-Ox PA High Level Disinfectant (HLD) is a two-part solution, which when mixed, is intended to provide high level disinfection of validated immersible, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled naso-endoscopes, when used in the enspire 300 AER.

The enspire 300™ Series Automated Endoscope Reprocessor System (AER) is a medical device processing system used for cleaning and high level disinfection of immersible, reusable, semi-critical, heat-sensitive devices such as flexible endoscopes and their accessories. The system consists of the enspire 300 AER, Revital-Ox 2X Concentrate Enzymatic Detergent (R2X), and Revital-Ox Peracetic Acid High Level Disinfectant (HLD).

The enspire 300 series AER is an automated, self-contained device for the effective cleaning and high level disinfection of semi-critical medical devices and their accessories. Prior to placement in the processor, users will be instructed to perform bedside (point of use) cleaning and manual leak testing. The devices will not require manual cleaning prior to processing, with the exception of duodenoscopes which will still require manual cleaning per the manufacturer's written instructions. Channel Connectors, as identified in STERIS labeling, are used to facilitate the delivery of the R2X detergent, HLD solution and rinse water to internal channels of devices that have them.

On the first process of an endoscope, the user must create a scope profile for the endoscope in the AER. The creation of the scope profile saves key endoscope attributes to the AER which are used to monitor the cycle during processing of the device. Once the device is positioned in the enspire 300 AER and optional operator ID, case ID, procedure ID and physician information is inputted, the operator initiates the processing cycle during which the Processor will create and maintain the conditions necessary for effective cleaning and high level disinfection. At the beginning of the processing cycle, an automated pressure monitor is performed to assess the integrity of the flexible endoscope. In parallel with the pressure monitor and prior to initiation of the cleaning phase, the processing system will evaluate the flow coefficient of each individual channel and compare to their respective reference value stored in the device profile created prior to first processing. The enspire 300 AER maintains inflation of the processed device throughout the process to reduce the risk of ingress of fluid in the event of any loss of integrity. At the end of the processing cycle, the cleaned and high level disinfected devices are rinsed with 0.2 micron filtered potable water followed by a dried, oil free, filtered compressed air purge to evacuate rinse water from the endoscope channels. The AER, which is micro-processor controlled and continually monitored, provides documentation of each cycle.

The enspire 300 AER utilizes Revital-Ox 2X Concentrate Enzymatic Detergent for cleaning and Revital-Ox Peracetic Acid High Level Disinfectant for high level disinfection. Revital-Ox PAA HLD is a two part solution consisting of Part A, 15% PAA, and Part B. conditioner.

The STERIS enspire 300 Series Automated Endoscope Reprocessor System underwent several non-clinical studies to demonstrate its safety and effectiveness.

Here is a summary of the acceptance criteria and reported device performance for these studies, along with other requested information where available from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as bronchoscopes, GI flexible endoscopes including duodenoscopes, and their accessories. High level disinfection is achieved within the 50-57°C HLD phase of the endoscope processing cycle (4-minute generation sequence followed by a 6-minute exposure sequence).

The Reliance Endoscope Processing System is a high level disinfection system that can wash and high level disinfects up to two manually precleaned, immersible, reusable, heatsensitive, semi-critical devices such as GI flexible endoscopes and related accessories. The system utilizes Reliance™ DG Dry Germicide, a proprietary, safe, and dry peracetic acid generating oxidative chemistry. The Reliance Endoscope Processing System was designed to be versatile in meeting the growing demands of the modern flexible endoscope processing department, while offering patient and staff safety. The Reliance Endoscope Processing System is a combination of products that are used to wash and high level disinfect flexible endoscopes and their accessories.

• The Reliance Endoscope Processor is an electromechanical washer/high level disinfector with a microprocessor-based controller that provides for automated endoscope processing cycles and processor self-decontamination cycles.
• 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.
• Optional washing is provided through the automated delivery of Klenzyme Enzymatic Presoak and Cleaner during the wash phase of the cycle.
• 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.
• Various accessories are available to accommodate the processing needs of specific endoscopes and endoscopic accessories.
• VERIFY Reliance CI Process Indicator is available to monitor for the presence of the Reliance DG active ingredient, peracetic acid.

The provided document is a 510(k) summary for the STERIS Reliance Endoscope Processing System. It outlines the device's indications for use, technological characteristics, and a summary of non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Key takeaway for your request: This document primarily focuses on showing the equivalence of a slightly modified device (due to a raw material change) to an already cleared predicate device. It is not a study demonstrating the initial performance acceptance criteria for the original device for the purpose of a device efficacy study in terms of AI performance. The device in question is an endoscope reprocessing system, not an AI-powered diagnostic device. Therefore, a significant portion of your requested information, particularly relating to AI performance, ground truth, expert readers, and MRMC studies, is not applicable to this document.

However, I can extract the acceptance criteria and performance results directly from the provided Table 3, which summarizes the new testing performed for this 510(k) submission (related to a raw material change).

Here's the relevant information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify quantitative sample sizes for the "Fit test," "Technical specifications," or "Biocompatibility and Chemical Compatibility" evaluations. These typically involve material evaluations, bench testing, and potentially a limited number of device assemblies rather than large-scale patient-based test sets as would be seen for an AI diagnostic.
• Data Provenance: The document does not explicitly state the country of origin for this specific testing data beyond it being a submission to the U.S. FDA by a company based in Mentor, Ohio, USA. The testing would have been conducted by or for STERIS Corporation. The nature of these tests (material properties, component fit, chemical compatibility) suggests laboratory or manufacturing facility-based evaluations, not clinical data. The document indicates this was non-clinical testing (Page 12, Section 6).

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

• Not Applicable. This document pertains to the mechanical, chemical, and material compatibility performance of an endoscope processing system, not an AI diagnostic device that requires expert-established ground truth from images or other medical data.

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

• Not Applicable. As above, this type of adjudication is relevant for human interpretation of medical data (e.g., radiology reads), not for the engineering and material performance tests described.

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 an automated endoscope reprocessing system, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant for this type of device.

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

• Not Applicable. This device does not involve an AI algorithm; it is a physical system for high-level disinfection of endoscopes.

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

• For the tests conducted (Fit test, Technical specifications, Biocompatibility/Chemical Compatibility), the acceptance criteria inherently define the "truth." For example, for "Fit test," the ground truth is simply whether the components physically fit and function as intended without interference, consistent with the original design. For "Technical specifications," it's comparison to established material specifications. For "Biocompatibility/Chemical Compatibility," it's compliance with ISO standard requirements for non-cytotoxicity and resistance to the processing chemicals. These are not clinical "ground truths" in the diagnostic sense.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device; therefore, there is no training set.

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

• Not Applicable. As there is no training set for an AI model, this question is not relevant.

In summary, the provided document is a regulatory submission for an endoscope reprocessing system, focusing on demonstrating substantial equivalence after a minor material change. It does not involve AI or diagnostic imaging, and therefore, most of the requested information regarding AI performance testing (MRMC, standalone performance, expert ground truth) is outside the scope of this document.

Ask a specific question about this device

The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as bronchoscopes including duodenoscopes, and their accessories. High level disinfection is achieved within the 50 - 57°C HLD Phase of the endoscope processing cycle (4 minute generation sequence followed by a 6-minute exposure sequence).

The Reliance Endoscope Processing System is a high level disinfection system that can wash and high level disinfect up to two manually precleaned, immersible, reusable, heatsensitive, semi-critical devices such as GI flexible endoscopes and related accessories. The system utilizes Reliance™ DG Dry Germicide, a proprietary, safe, and dry peracetic acid generating oxidative chemistry. The Reliance 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 Endoscope Processing System is a combination of products that are used to wash and high level disinfect flexible endoscopes and their accessories.

The provided text is a 510(k) Summary for the STERIS Reliance Endoscope Processing System. This document details the device, its intended use, and a comparison to a predicate device, along with a summary of non-clinical testing performed to demonstrate substantial equivalence.

Based on the provided information, I will answer the questions regarding acceptance criteria and the study that proves the device meets them.

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

2. Sample sized used for the test set and the data provenance

The document does not specify the exact sample sizes for the "selected worst-case duodenoscope models" or the number of medical devices used in biocompatibility testing. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. However, based on the context of a 510(k) submission for a medical device and the type of tests performed (e.g., efficacy, biocompatibility, stability), these would typically be controlled laboratory studies conducted prospectively.

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

The document does not provide information on the number of experts or their qualifications for establishing ground truth in these non-clinical tests. These types of tests (disinfection efficacy, biocompatibility, stability) are generally conducted by laboratory technicians and scientists following established protocols (e.g., ISO standards, AOAC methods) and do not typically involve human expert consensus for "ground truth" in the way a diagnostic AI system would. The "ground truth" for these tests is based on the measurable outcomes of the chemical and biological assays.

4. Adjudication method for the test set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation by multiple human readers. For the non-clinical laboratory tests described here (efficacy, biocompatibility, stability), an adjudication method is not applicable as the results are quantitative and based on predefined measurement thresholds.

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

No, an MRMC comparative effectiveness study was not done. The device in question is an automated endoscope processing system, which performs automated cleaning and high-level disinfection. It is not an AI-assisted diagnostic tool that aids human readers. Therefore, the concept of human readers improving with or without AI assistance does not apply here.

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

The primary tests reported are for the performance of the automated system itself (efficacy of disinfection, biocompatibility of the germicide, stability of the germicide). In this context, the "standalone" performance is precisely what was evaluated. The device functions automatically without a human actively making decisions based on its output during the disinfection process.

7. The type of ground truth used

For the efficacy test, the ground truth is the microbiological log reduction of Mycobacterium terrae following the disinfection process. For biocompatibility, the ground truth is cellular response (e.g., non-cytotoxicity) based on ISO 10993-5 standards. For stability, the ground truth is the chemical and functional properties of the germicide maintaining within acceptance criteria over time. These are all objective, measurable laboratory outcomes.

8. The sample size for the training set

The document describes non-clinical performance testing for a physical device (an automated endoscope reprocessor and its germicide). It does not involve machine learning or AI models with "training sets." Therefore, the concept of a training set size is not applicable.

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

As there is no training set involved for this type of device, this question is not applicable.

Ask a specific question about this device

The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes and their accessories. High level disinfection is achieved within the 50 - 57°C HLD Phase of the endoscope processing cycle (4 minute generation sequence followed by a 6-minute exposure sequence).

The Reliance Endoscope Processing System is a high level disinfection system that can wash and high level disinfect up to two manually precleaned, immersible, reusable, heatsensitive, semi-critical devices such as GI flexible endoscopes and related accessories. The system utilizes Reliance™ DG Dry Germicide, a proprietary, safe, and dry peracetic acid generating oxidative chemistry. The Reliance 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 Endoscope Processing System is a combination of products that are used to wash and high level disinfect flexible endoscopes and their accessories.

The provided text describes a 510(k) premarket notification for a medical device called the "Reliance Endoscope Processing System." The submission is to demonstrate substantial equivalence to a legally marketed predicate device (K102244) and specifically addresses a change to the ink used on the label of the Reliance DG Dry Germicide.

Therefore, the study described is not for the primary performance of an AI/ML medical device, but rather a biocompatibility study related to a minor modification in a non-AI medical device's labeling. As such, many of the requested elements for an AI/ML device (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment) are not applicable (N/A) to this specific submission.

However, I can extract the relevant information regarding the acceptance criteria and the biocompatibility study performed.

Acceptance Criteria and Device Performance (Biocompatibility Study)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated in terms of number of samples, but refers to "Extracts from devices processed in the Reliance EPS with Reliance DG with the alternate ink on the label." This is a laboratory-based biomechanical/biocompatibility test, not a clinical study with patients.
• Data Provenance: The study is a non-clinical, laboratory test (biocompatibility). Country of origin is not specified, but it's a verification activity performed by the manufacturer, STERIS Corporation. It is prospective testing for this specific change.

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

• N/A. This is a non-clinical biocompatibility test with a defined chemical/biological assay (ISO 10993-5:2009, Annex A Neutral Red Assay). The "ground truth" is measured objectively by the assay, not by expert consensus.

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

• N/A. Not applicable for a laboratory biocompatibility test. The result is a direct measurement against a predefined standard.

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:

• N/A. This is not an AI/ML device.

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

• N/A. This is not an AI/ML device.

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

• For this biocompatibility study: The "ground truth" is the objective measurement of cytotoxicity as defined by the ISO 10993-5:2009, Annex A Neutral Red Assay.

8. The sample size for the training set:

• N/A. This is not an AI/ML device, and no training set is described or relevant for this type of non-clinical testing.

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

• N/A. As no training set is relevant, this question is not applicable.

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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.

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.

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.

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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The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories. High level disinfection is achieved within the 50 - 57℃ HLD Phase of the Endoscope Processing Cycle (4 minute generation sequence followed by a 6-minute exposure sequence).

The Reliance Endoscope Processing System is an economical, easy-to-use high level disinfection system intended to wash and high level disinfect up to two manually cleaned, 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, and dry peracetic acid generating oxidative chemistry. The Reliance 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 Endoscope Processing System is a combination of products that are used to wash and high level disinfect flexible endoscopes and their accessories.

• The Reliance Endoscope Processor is an electromechanical washer/high level disinfector with a microprocessor-based controller that provides for automated endoscope processing cycles and processor self-decontamination cycles.
• 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.
• Optional washing is provided through the automated delivery of Klenzyme Enzymatic Presoak and Cleaner during the wash phase of the cycle.
• 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.
• Various accessories are available to accommodate the processing needs of specific endoscopes and endoscopic accessories.
• Verify Reliance CI Process Indicator is available to monitor for the presence of the Reliance DG active ingredient, peracetic acid.

The provided text describes the STERIS® Reliance® Endoscope Processing System, an automated endoscope reprocessor. The document is a 510(k) summary submitted to the FDA, demonstrating substantial equivalence to a predicate device and providing performance data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the success of the tests conducted according to FDA guidance documents for germicidal efficacy, simulated-use, and in-use studies. The reported device performance indicates that these criteria were met.

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The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories. High level disinfection is achieved within the 50 - 57°C HLD Phase of the Endoscope Processing Cycle (4 minute generation sequence followed by a 6-minute exposure sequence).

The Reliance Endoscope Processing System is an economical, easy-to-use high level disinfection system intended to wash and high level disinfect up to two manually cleaned, 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, and dry peracetic acid generating oxidative chemistry. The Reliance 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 Endoscope Processing System is a combination of products that are used to wash and high level disinfect flexible endoscopes and their accessories.

Here's a breakdown of the acceptance criteria and study information for the Reliance® Endoscope Processing System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a formal table of "acceptance criteria," but rather describes various performance validations and their successful outcomes. I've synthesized this information into a table format based on the description of safety and substantial equivalence testing.

2. Sample Sizes and Data Provenance

• Test Set (Simulated-Use): Triplicate trials for the Mycobacterium terrae reduction study, using "selected clinically relevant flexible endoscopes and their accessories." The document states these "represented the range of most challenging devices, accessories, and processing situations." No specific number of endoscopes or accessories is provided beyond "selected."
• Test Set (In-Use): Three flexible endoscopes were used, representing the range of types indicated in the product labeling. Triplicate evaluations were performed for each endoscope.
• Test Set (Material Compatibility): "300 processing cycles" were performed on medical devices, including flexible endoscopes and/or common materials of device construction.
• Data Provenance:
  • The "In-Use" study was conducted in a "US hospital."
  • Other studies (Sporicidal, Tuberculocidal, Virucidal, Bactericidal, Fungicidal, Simulated-Use, Biocompatibility, Material Compatibility, Stability) appear to be laboratory-based studies.
  • All data are prospective as they are part of a premarket notification for a new device.

3. Number of Experts and Qualifications

The document does not specify the number or qualifications of experts used to establish ground truth for any of the described tests. The studies rely on established microbiological test methods (e.g., AOAC) and standard laboratory and in-use protocols rather than expert consensus on diagnostic imaging or similar subjective assessments.

4. Adjudication Method

Adjudication methods (like 2+1 or 3+1 for resolving discrepancies) are typically used in studies involving human interpretation or subjective assessment where a "ground truth" needs to be established from multiple readers. This document describes performance testing of a physical device and chemical efficacy, which relies on objective measurements (e.g., bacterial reduction, presence of residues, visual cleanliness, functional integrity) rather than subjective human interpretation. Therefore, no adjudication method as typically described in imaging studies was used or mentioned.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document is for an automated endoscope processing system, which does not involve human readers interpreting cases or images.

6. Standalone (Algorithm Only) Performance Study

The entire document describes the standalone performance of the "Reliance Endoscope Processing System," which is an automated device performing the washing and high-level disinfection process. All the performance figures reported (microbiological efficacy, cleaning efficacy, cycle performance, material compatibility) characterize the device's inherent capabilities without human intervention during the defined processing cycle (though human manual pre-cleaning and loading/unloading are explicit parts of the overall process).

7. Type of Ground Truth Used

The ground truth for the various tests was established using:

• Microbiological assays: For sporicidal, tuberculocidal, virucidal, bactericidal, fungicidal, and Mycobacterium terrae reduction (quantitative measures of organism reduction/kill).
• Visual inspection and quantitative protein assays: For cleaning efficacy (visual cleanliness and µg/cm² protein).
• Chemical analysis and cytotoxicity testing: For residue levels and biocompatibility.
• Functional and visual inspection after repeated cycles: For material compatibility.
• Analytical measurements: For critical process parameters (temperature, volume, pressure, etc.) and germicide stability.
• Clinical observation/microbiological cultures: For the in-use study (recovery of organisms).
• Standardized electrical tests: For electrical standards compliance.

8. Sample Size for the Training Set

The document focuses on validation studies, not on the development of a machine learning algorithm that would require a distinct "training set." Therefore, no training set sample size is applicable or mentioned. The device's operational parameters and design would have been developed iteratively, but not through a formal "training set" in the context of AI/ML.

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

As there is no training set for an AI/ML algorithm involved, the question of how its ground truth was established is not applicable.

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The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories. High level disinfection is achieved within the 50 -57°C HLD Phase of the Endoscope Processing Cycle (4 minute generation sequence followed by a 6 minute exposure sequence).

The Reliance Endoscope Processing System includes the Reliance Endoscope Processor, Reliance DG Dry Germicide, Klenzyme Enzymatic Presoak and Cleaner, and CIP 200 Acid-Based Process and Research Cleaner. The Reliance Endoscope Processor is an electromechanical washer/high level disinfector with a microprocessor-based controller that provides for automated endoscope processing cycles and processor self-decontamination cycles. The processor utilizes a proprietary, single use, dry, germicide package (Reliance DG Dry Germicide) that generates the active ingredient, peracetic acid, upon automatic dilution in water by the processor. In the optional washing phase, washing is provided through the automated delivery of Klenzyme Enzymatic Presoak and Cleaner. CIP 200 Acid-Based Process and Research Cleaner is used in one of the two self-decontamination cycles. The system provides endoscope processing cycles with optional programmable washing phases and a non-optional high level disinfection phase, followed by a rinse phase and an air purge phase. The processor prints a detailed cycle summary. The processor also features two decontamination cycles, D-SHORT and D-LONG, to be used without endoscopes in the processor.

Acceptance Criteria and Device Performance for Reliance® Endoscope Processing System

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the Reliance® Endoscope Processing System, which is designed for washing and high-level disinfection of semi-critical medical devices. The acceptance criteria and device performance are primarily focused on germicidal efficacy, biocompatibility, material compatibility, and processor performance, adhering to FDA guidance documents.

Here's a summary:

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

• Clinical In-Use Study: Three flexible endoscopes representing the range of types indicated in the product labeling were used in clinical procedures. Data provenance is a US hospital (retrospective or prospective is not explicitly stated, but "in-use study" strongly implies prospective).
• Simulated-Use Test: Performed in "triplicate trials" on "selected clinically relevant flexible endoscopes and their accessories." The exact number of endoscopes or accessories is not specified beyond "selected," but implies at least the number required for triplicate testing.

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the test sets. The studies referenced are based on recognized microbiological and toxicology standards (AOAC, EPA) and FDA guidance documents.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method. For the in-use studies and simulated-use studies, the reported results are quantitative microbial reductions or absence of organisms. For material compatibility, it refers to "no deleterious effects" and "minor cosmetic changes."

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses on the device's ability to disinfect rather than human interpretation aided by AI.

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

Yes, the studies are standalone performance evaluations of the automated reprocessing system (processor and germicide) without direct human intervention impacting the disinfection efficacy once the cycle is initiated. Human actions primarily involve manual pre-cleaning and loading the device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used is primarily microbiological viability (log reduction of specific microorganisms, absence of microorganisms) and chemical/physical property measurements (protein levels, toxicity, material changes, electrical standards conformity).

8. The Sample Size for the Training Set

The document does not refer to a training set in the context of an AI/ML algorithm. This is a medical device (endoscope reprocessing system), not an AI/ML product. Therefore, the concept of a training set as typically understood for machine learning is not applicable here. The development and validation of the system involved extensive laboratory testing (e.g., germicidal efficacy, material compatibility, functional performance) and a clinical in-use study.

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

As stated above, the concept of a training set for an AI/ML algorithm is not applicable to this device. The "ground truth" for the device's performance was established through standardized testing methodologies (e.g., AOAC, EPA methods) and adherence to FDA guidance, which define the expected outcomes for high-level disinfection and safety. For instance, sporicidal activity is proven by demonstrating a reduction in specified spores to required levels, and biocompatibility by demonstrating toxicity profiles below established thresholds.

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