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The System 83 Revolve® Endoscope Washer/Disinfector is designed for the high-level disinfection of one or two flexible submersible endoscopes that are used in the gastrointestinal and pulmonary tracts. Flexible endoscopes that undergo bedside cleaning, are manually cleaned, and then exposed to the wash/disinfect cycle of the System 83 Revolve® may be high-level disinfected when the validated disinfection cycle of the System 83 Revolve® corresponds with the labeled contact conditions of the high-level disinfectant.

The System 83 Revolve® Endoscope Washer/Disinfector is an automated, computer controlled, electro-mechanical system intended to wash and high-level disinfect one or two submersible flexible endoscopes utilizing a detergent and FDA cleared high-level disinfectant validated by Wassenburg Medical.

The System 83 Revolve® utilizes a processing chamber and the perform washing, disinfection, rinsing, and alcohol flush of an endoscope to render a high-level disinfected endoscope. The System 83 Revolve® is capable of automated detergent dispensing and transfer of disinfectant solution between the reservoir and processing chamber. Following disinfection, the endoscopes and channels are automatically rinsed with potable water that is filtered through a water filtration system that contains a 0.1 micron bacteria filter and the rhannels are then flushed with air. A semi-automated air/alcohol flush must be completed at the end of the cycle. At completion, the operator prints out the endoscope reprocessing information with a printer.

Built-in sensors detect fluid levels, fluid flow, and the operating states of the components within System 83 Revolve". The system contains a Touchscreen (Graphical User Interface), a Barcode Scanner, an LED Indicator Strip that displays the process status, and a reprocessing chamber lid operation that is hands free.

The provided text is a 510(k) summary for a medical device (System 83 Revolve® Endoscope Washer/Disinfector), which is a premarket notification for a Class II medical device. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than detailed performance study results of an AI algorithm or a standalone diagnostic device.

Therefore, the information typically requested for AI-driven diagnostic devices (such as a table of acceptance criteria vs. reported device performance for an AI, sample sizes for training/test sets for AI, expert qualifications, ground truth establishment methods for AI, or MRMC studies for AI assistance) is not present in this document. This document is about an endoscope washer/disinfector, an electromechanical system, not an AI or diagnostic imaging device.

Based on the provided document, here's what can be extracted regarding acceptance criteria and performance:

The document describes the acceptance criteria and performance for the endoscope washer/disinfector itself, ensuring it functions correctly and is safe, rather than evaluating an AI's diagnostic performance.

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

The document provides two tables:

• Table 2. New Testing: This table outlines testing performed for the subject device to ensure it meets safety and software standards. These are not performance metrics like sensitivity/specificity but rather compliance with engineering and software standards.
• Table 3. Testing performed for Predicate Device: This table lists performance testing conducted on the predicate device, which the subject device aims to be substantially equivalent to. The results from the predicate device's testing are used to support the subject device's equivalence.

Table 2. New Testing (for Subject Device: System 83 Revolve® Endoscope Washer/Disinfector)

Table 3. Testing performed for Predicate Device (Used to support SE of Subject Device)

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The enspire™ 3000 Series Cleaning and Liquid Chemical Sterilant Processing System is intended to effectively provide a pressure monitor, clean, provide liquid chemical sterilization, rinse, and air purge validated immersible, reusable, semi-critical, heat sensitive medical devices such as flexible endoscopes and their accessories.

The validated cleaning process replaces cleaning for endoscopes other than duodenoscopes. Manual cleaning of duodenoscopes according to the manufacturer's written instructions for use is required prior to placement in the enspire™ 3000 Series Processor.

The enspire™ 3000 Series Processor uses only Revital-Ox 2X Concentrate Enzymatic detergent to clean and S40 Sterilant Concentrate to liquid chemically sterilize medical devices. It 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 46.6 to 55°C and rinses the load with 0.2-micron filtered water.

The enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (CLCSPS) is a medical device processing system used for cleaning and liquid chemically sterilizing immersible, reusable, semi-critical, heat-sensitive devices such as flexible endoscopes and their accessories. The system consists of the enspire 3000 Processor, Revital-Ox 2X Concentrate Enzymatic Detergent, S40 Sterilant Concentrate and Max Flow Connectors.

The enspire 3000 Cleaning and LCSPS is an automated, self-contained device for the effective cleaning and liquid chemical sterilization of semi-critical medical devices and their accessories. The devices will not require manual cleaning prior to processing in the enspire 3000 Processor with the exception of duodenoscopes which must be manually cleaned per the manufacturer's instructions for use. In addition, prior to placement in the enspire 3000 processor, the device will undergo a manual leak test and the user will ensure the lumens are not blocked. If the device has internal channels or lumens, Max Flow Connectors are used to facilitate the delivery of detergent, sterilant use-solution and rinse water to internal channels.

Once the device is positioned in the enspire 3000 processor, the unit will create and maintain the conditions necessary for effective cleaning and liquid chemical sterilization of the load. At the beginning of the processing cycle, automated pressure monitoring is performed to confirm the integrity of the flexible endoscope throughout the process. The enspire 3000 processor maintains inflation of the processed device to prevent ingress of fluid during processing and the pressure monitoring is repeated at the end of the processing cycle to ensure that the device is leak tight after cleaning and liquid chemical sterilization. At the end of the processing cycle, the cleaned and liquid chemically sterilized devices are rinsed with 0.2 micron filtered potable water followed by a HEPA-filtered air purge to aid in drying the endoscope. The processor, which is computer controlled and continually monitored, provides documentation of each cycle.

The enspire 3000 processor utilizes Revital-Ox 2X Concentrate Enzymatic Detergent for cleaning and S40 Sterilant Concentrate for liquid chemical sterilization. S40 Sterilant Concentrate is a single use chemical sterilant concentrate; its active ingredient, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.

The provided text is an FDA 510(k) summary for a medical device called the "enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System." This document primarily focuses on demonstrating substantial equivalence to a predicate device, specifically for a modification to the existing device (changing materials in the Chemical Delivery System).

As such, the document does not describe a study involving human readers, AI assistance, ground truth labels from experts for diagnostic tasks, or a training set for an AI model. The "device" in question is not an AI/ML algorithm for image analysis or diagnosis. Instead, it's a machine for sterilizing endoscopes.

Therefore, many of the requested points, such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and AI model training details, are not applicable to this type of device and the information provided in the document.

However, I can extract the acceptance criteria and performance related to the modification of this physical device.

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

Acceptance Criteria and Device Performance for the Modified Enspire 3000 System

The study described is not for an AI/ML diagnostic device, but rather for a physical medical device (an endoscope reprocessor) that has undergone a material change in one of its components. The acceptance criteria and performance relate to the safety and efficacy of the modified reprocessing system.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other requested information, which is primarily relevant for AI/ML diagnostic devices, it is not found in this document because the device is not an AI/ML system.

Here's why each point is Not Applicable (N/A) in this context:

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

  • N/A: The "test set" here refers to physical tests conducted on the modified device and its components, not a dataset of medical images or patient data. The document mentions "multiple processing cycles" and "representative endoscope" but no specific numeric sample sizes for these qualitative/quantitative tests. Data provenance in terms of country of origin or retrospective/prospective is not relevant for this type of device testing.

• 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)

  • N/A: Ground truth for diagnostic AI models is established by human experts (e.g., radiologists). For this device, "ground truth" is based on established engineering and chemical standards (e.g., ISO standards, acceptable chemical residual levels, non-cytotoxicity). No human experts are described as "establishing ground truth" in the way they would for a diagnostic AI study.

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

  • N/A: Adjudication methods are used in AI studies where multiple human readers disagree on a diagnosis or annotation. This is a physical device subject to engineering and chemical validation tests.

• 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: An MRMC study is relevant for evaluating the impact of AI assistance on human diagnostic performance. This device is an endoscope reprocessor, having no direct interaction with human diagnostic reading.

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

  • N/A: "Standalone performance" refers to the accuracy of an AI algorithm in performing a diagnostic task without human intervention. This device performs a physical reprocessing function, not a diagnostic one.

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

  • N/A: As explained in point 3, the "ground truth" for this device's performance relies on engineering specifications, chemical analysis, and biocompatibility standards rather than medical diagnostic ground truth sources like pathology or patient outcomes.

• 8. The sample size for the training set

  • N/A: This device is a physical machine, not an AI/ML model that requires a "training set."

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

  • N/A: As this is not an AI/ML model, there is no training set or associated ground truth to establish in that context.

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The enspire™ 3000 Series Cleaning and Liquid Chemical Sterilant Processing System is intended to effectively provide a pressure monitor, clean, provide liquid chemical sterilization, rinse, and air purge validated immersible, semicritical, heat sensitive medical devices such as flexible endoscopes and their accessories.

The validated cleaning process replaces cleaning for endoscopes other than duodenoscopes. Manual cleaning of duodenoscopes according to the manufacturer's written instructions for use is required prior to placement in the enspire™ 3000 Series Processor.

The enspire™ 3000 Series Processor uses only Revital-Ox 2X Concentrate Enzymatic detergent to clean and S40 Sterilant Concentrate to liquid chemically sterilize medically 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 46.6 to 55°C and rinses the load with 0.2-micron filtered water.

The enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (CLCSPS) is a medical device processing system used for cleaning and liquid chemically sterilizing immersible, reusable, semi-critical, heat-sensitive devices such as flexible endoscopes and their accessories. The system consists of the enspire 3000 Processor, Revital-Ox 2X Concentrate Enzymatic Detergent, S40 Sterilant Concentrate and Max Flow Connectors.

The enspire 3000 Cleaning and LCSPS is an automated, self-contained device for the effective cleaning and liquid chemical sterilization of semi-critical medical devices and their accessories. The devices will not require manual cleaning prior to processing in the enspire 3000 Processor with the exception of duodenoscopes which must be manually cleaned per the manufacturer's instructions for use. In addition, prior to placement in the enspire 3000 processor, the device will undergo a manual leak test and the user will ensure the lumens are not blocked. If the device has internal channels or lumens, Max Flow Connectors are used to facilitate the delivery of detergent, sterilant use-solution and rinse water to internal channels. Once the device is positioned in the enspire 3000 processor, the unit will create and maintain the conditions necessary for effective cleaning and liquid chemical sterilization of the load. At the beginning of the processing cycle, automated pressure monitoring is performed to assess the integrity of the flexible endoscope throughout the process. The enspire 3000 processor maintains inflation of the processed device to reduce the risk of ingress of fluid during processing and the pressure monitoring is repeated at the end of the processing cycle. At the end of the processing cycle, the cleaned and liquid chemically sterilized devices are rinsed with 0.2 micron filtered potable water followed by a HEPA-filtered air purge to aid in drying the endoscope. The processor, which is computer controlled and continually monitored, provides documentation of each cycle.

The enspire 3000 processor utilizes Revital-Ox 2X Concentrate Enzymatic Detergent for cleaning and S40 Sterilant Concentrate for liquid chemical sterilization. S40 Sterilant Concentrate is a single use chemical sterilant concentrate; its active ingredient, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.

The document describes the enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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SCOPE BUDDY PLUS Endoscope Flushing Aid is an electro-mechanical device intended to pump fluids through the channels of flexible, immersible endoscopes during the manual cleaning process of endoscope reprocessing.

The subject device is intended to provide fluid delivery to endoscope channels in the same manner as a manual syringe would be used during the manual cleaning phase of endoscope reprocessing as defined by the endoscope manufacturer's instructions. The subject device utilizes an external peristaltic pump and 24-hour multi-use connection tubing (tubing used for 24 hours with multiple endoscopes and then discarded) to deliver specific volumes of detergent solution and rinse water to the endoscope channels during the manual cleaning phase. The minimum fluid volumes are defined by the endoscope manufacturer. SCOPE BUDDY PLUS Endoscope Flushing Aid is intended to be used only during the manual cleaning phase of endoscope reprocessing, in conjunction with the instructions and labeling provided by the endoscope manufacturer, to deliver a volume of fluid to the endoscope channels which exceeds the minimum fluid volumes specified by the endoscope manufacturer. The subject device is not an endoscope washer-disinfector and does not bear labeling claims for direct cleaning efficacy or high-level disinfection efficacy for endoscope reprocessing.

The provided text describes the acceptance criteria and a summary of performance data for the SCOPE BUDDY PLUS Endoscope Flushing Aid.

Here's an analysis of the requested information:

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 does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Performance testing to demonstrate substantial equivalence to the predicate has been completed."

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 tests described (Fluid Delivery Flow Rate, Tubing Durability, Software Verification) appear to be engineering/performance tests rather than tests requiring expert human interpretation or ground truth establishment based on clinical observations.

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

This information is not applicable/not provided as the tests described are technical performance verifications and do not involve human adjudication for ground truth.

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

An MRMC comparative effectiveness study was not done. The device is an electro-mechanical flushing aid for endoscopes, not an AI or diagnostic tool that assists human readers.

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

This concept is not applicable to this device. It is an electro-mechanical device with software control, not an algorithm performing a standalone diagnostic or interpretative function. The software verification confirms the software's functionality within the device.

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

The "ground truth" for the tests appears to be engineering specifications and defined performance metrics.

• For Fluid Delivery Flow Rate, the ground truth is the "manufacturers minimum requirements for individual channel flushing volumes."
• For Tubing Durability, the ground truth is the specified requirement to "withstand at least 40 full automatic cycles without leaking."
• For Software Verification, the ground truth is the "verification steps outlined in procedure."

These are objective, measurable criteria rather than clinical ground truth established by experts.

8. The sample size for the training set

The document does not mention a "training set" as this device is not a machine learning or AI model.

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

This question is not applicable as there is no mention of a training set.

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The OER-Elite is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Safe use requires detergent and an FDA-cleared high-level disinfectant/sterilant that Olympus has validated to be efficacious and compatible with the materials of the OER-Elite and Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Use of a detergent or high-level disinfectant/sterilant that has not been validated by Olympus may be ineffective and can damage the OER-Elite components and the endoscopes being reprocessed. Endoscopes must be cleaned by the user prior to reprocessing; however, use of the OER-Elite enables the user to perform modified manual cleaning of some endoscopes prior to automated cleaning and high-level disinfection in the OER-Elite.

The OER-Elite Endoscope Reprocessor is an automated endoscope reprocessor intended for high-level disinfection of Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories, utilizing both a detergent and FDA cleared high-level disinfectant validated by Olympus to be efficacious and compatible with the materials of the OER-Pro and Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories.

The OER-Elite originally featured an "extra disinfection process" which can provide an extra three-minute process for delivering fluid to both the forceps elevator area and elevator wire channel when reprocessing endoscopes with a forceps elevator.

The software of the OER-Elite was changed to apply the "extra disinfection process" to the ultrasound endoscope with balloon channel in addition to the endoscopes with a forceps elevator.

The proposed OER-Elite differs from the predicate OER-Elite in the following minor modifications:

Add "Extra disinfection process" to ultrasound endoscope with balloon channel.
Optimize the threshold values of existing error codes.
Replace the electronic cooling fan due to discontinuing of the product.
Change the material used for fluid pathways.

The OER-Elite is a one-basin automatic endoscope reprocessor that performs leak testing, cleaning, disinfection, rinsing, and an alcohol flush to render a high-level disinfected endoscope, their accessories, and endoscope reprocessor accessories.

The OER-Elite utilizes an immersion method for cleaning, disinfecting, and rinsing of endoscope and accessory external surfaces, and connectors for endoscope channel cleaning, disinfecting, and rinsing. Two endoscopes, with several exceptions, can be reprocessed simultaneously in the basin during one reprocessing cycle. The OER-Elite's cleaning cycle includes ultrasonic cleaning. which helps remove debris and dirt from endoscope surfaces.

The OER-Elite is capable of fully automated detergent/disinfectant solution dispensing and alcohol/air drying of endoscope channels. The 0.2-micron air/water filters are bacteria retentive and produce suitable rinse water and air for reprocessing. Built-in sensors detect fluid levels, fluid temperature, air/fluid pressure, fluid flow, and the operating states of the components within the OER-Elite.

The OER-Elite is also equipped with a RFID (Radio-Frequency Identification) function. With a built-in antenna, the OER-Elite is capable of reading user and scope ID data from the proprietary ID tag/chip. The scope/user ID information and each reprocessing result can be printed out with a built-in printer, displayed on a touch screen, or exported to a portable memory.

The OER-Elite is capable of using a concentrated disinfectant (e.g., Acecide-C) sealed in dedicated cassette bottles. The concentrated disinfectant is automatically diluted by filtered water until it reaches a specified quantity in the device.

The provided text describes the 510(k) premarket notification for the Olympus OER-Elite Endoscope Reprocessor. This document focuses on demonstrating substantial equivalence to a predicate device for a medical device (endoscope reprocessor), not an AI / Machine Learning (ML) enabled medical device. Therefore, the information requested in points 1-9 (acceptance criteria, sample sizes, expert ground truth, MRMC study, standalone performance, training set details) is not applicable to this document, as these are typically requirements for AI/ML device submissions, particularly for those involving image analysis or diagnostic support.

The OER-Elite is a physical device that cleans and disinfects endoscopes. The changes in this submission are minor modifications to its software (applying an "extra disinfection process" to an ultrasound endoscope with a balloon channel and optimizing error code thresholds), a hardware component change (cooling fan), and a material change for fluid pathways. The "performance testing" described is for the device's physical and operational parameters, not for an AI's analytical performance on data.

Therefore, since this document is not about an AI/ML device, I cannot extract the information requested in questions 1-9.

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System 83 Plus™ Washer/Disinfector is designed for the simultaneous high level disinfection of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts. Flexible endoscopes that are precleaned and manually cleaned, and then exposed to the washing /disinfection cycle of the System 83 Plu s™, may be high level disinfected when the disinfection cycle corresponds to the System 83 Plus™ validated contact conditions of the high level disinfectant.

Note: The System 83 Plus™ device includes two models.

· The System 83 Plus™ 2 has one processing chamber that can process 1 to 2 flexible endoscopes at a time .

· The System 83 Plus™ 9 has two processing chambers that can process 1 to 2 flexible endoscopes at a time in each independently operated processing chamber for a total of up to 4 endoscopes simultaneously.

The System 83 Plus™ is an automated, computer controlled, electro-mechanical system intended to wash and high-level disinfect one or two submersible flexible endoscopes (per bay) utilizing a detergent and FDA cleared high-level disinfectant validated by CUI. The System 83 Plus™ device family includes two models. The System 83 Plus™ 2; a model with one processing chamber, which can process one to two flexible endoscopes at a time. The System 83 Plus™ 9: a model with two processing chambers which can asynchronously reprocess up to 2 endoscopes per bay (total of up to 4 endoscopes).

The System 83 Plus™ utilizes a processing chamber and the immersion method to perform washing, disinfection, rinsing, and alcohol flush of an endoscope to render a high level disinfected endoscope. The System 83 Plus™ is capable of automated detergent dispensing and transfer of disinfectant solution between the reservoir and processing chamber. Following disinfection, the endoscopes and channels are automatically rinsed with potable water that is filtered through a water filtration system that contains a 0.1 micron bacteria filter and the channels are then flushed with air. A semi-automated air/alcohol flush must be completed at the end of the cycle. At completion, the operator prints out the endoscope reprocessing information with a printer.

Built-in sensors detect fluid levels, fluid temperature, fluid flow, and the operating states of the components within System 83 Plus™.

The provided text is a compilation of FDA documents related to the 510(k) premarket notification for the "System 83 Plus Washer/Disinfector." It describes the device, its intended use, comparison to a predicate device, and a summary of non-clinical testing performed to demonstrate its safety and effectiveness.

Here's an analysis 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

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The OER-Elite is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Safe use requires detergent and an FDA-cleared high-level disinfectant/sterilant that Olympus has validated to be efficacious and compatible with the materials of the OER-Elite and Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Use of a detergent or high-level disinfectant/sterilant that has not been validated by Olympus may be ineffective and can damage the OER-Elite components and the endoscopes being reprocessed. Endoscopes must be cleaned by the user prior to reprocessing; however, use of the OER-Elite enables the user to perform modified manual cleaning of some endoscopes prior to automated cleaning and high-level disinfection in the OER-Elite.

The OER-Elite Endoscope Reprocessor is an automated endoscope reprocessor intended for high-level disinfection of Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories, utilizing both a detergent and FDA cleared high-level disinfectant validated by Olympus to be efficacious and compatible with the materials of the OER-Pro and Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories.

The OER-Elite is a one-basin automatic endoscope reprocessor that performs leak test, cleaning, disinfection, rinse, and alcohol flush to render a high-level disinfected endoscope, their accessories, and endoscope reprocessor accessories. The OER-Elite utilizes an immersion method for cleaning, disinfecting, and rinsing of endoscope and accessory external surfaces, and connectors for endoscope channel cleaning, disinfecting, and rinsing. Two endoscopes, with several exceptions, can be reprocessed simultaneously in the basin during one reprocessing cycle. The OER-Elite's cleaning cycle includes ultrasonic cleaning, which helps remove debris and dirt from endoscope surfaces.

The OER-Elite is capable of fully automated detergent/disinfectant solution dispensing and alcohol/air drying of endoscope channels. The 0.2-micron air/water filters are bacteria retentive and produce suitable rinse water and air for reprocessing. Built-in sensors detect fluid levels, fluid temperature, air/fluid pressure, fluid flow, and the operating states of the components within the OER-Elite.

The OER-Elite is also equipped with a RFID (Radio-Frequency Identification) function. With a built-in antenna, the OER-Elite is capable of reading user and scope ID data from the proprietary ID tag/chip. The scope/user ID information and each reprocessing result can be printed out with a built-in printer, displayed on a touch screen, or exported to a portable memory.

The OER-Elite is capable of using a concentrated disinfectant (e.g., Acecide-C) sealed in dedicated cassette bottles. The concentrated disinfectant is automatically diluted by filtered water until it reaches a specified quantity in the device.

The provided text describes an Endoscope Reprocessor, not an AI/ML powered device. As such, it does not contain information related to AI/ML specific acceptance criteria or studies. The document describes the device's intended use, technical characteristics, and non-clinical testing performed to establish its safety and effectiveness for cleaning and high-level disinfection of endoscopes.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies that prove the device meets those criteria for an AI/ML powered device, as the provided content does not pertain to such a device.

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The ASP AEROFLEX™ Automatic Endoscope Reprocessor (AER) with AUTOSURE™ MRC Monitor is indicated for use with high-level disinfectant ASP AERO OPA™ ortho-Phthalaldehyde Solution to achieve high-level disinfection of flexible semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the AER.

The AEROFLEX Automatic Endoscope Reprocessor (AER) with AUTOSURE MRC Monitor is designed to provide high-level disinfection for flexible, submersible endoscopes that have been manually cleaned. The AEROFLEX system consists of the software-driven AER, the AUTOSURE MRC reagent, AERO-OPA™ disinfectant solution, and AEROZYME™ enzymatic detergent.

The AEROFLEX AER with AUTOSURE MRC Monitor is indicated for use with high-level disinfectant ASP AERO-OPA ortho-Phthalaldehyde Solution to achieve high-level disintection of semi-critical endoscopes; high-level disinfection requires that the AER be used with the AERO-OPA Solution per its Instructions for Use.

Manual cleaning of endoscopes is required prior to placement in the AEROFLEX AER. After an endoscope is manually cleaned according to its manufacturer's recommended procedures, it is loaded into the AER. After starting the reprocessing cycle, the AER displays its progress during the cycle and signals that the cycle is complete on the control panel and with an audible tone.

The minimum recommended concentration (MRC) of ASP AERO-OPA ortho-Phthalaldehyde Solution is automatically checked and verified by the AER for every cycle using an integrated MRC monitor and reagent. The MRC monitor- tests the OPA concentration in every high-level disinfection cycle without the use of test strips; if the OPA concentration is below the MRC the system cancels the cycle and notifies the user.

To reduce user error and facilitate assurance of disinfection efficacy, the AEROFLEX System uses Radio Frequency Identification (RFID) technology to identify the ASP-branded consumables that are used with the system. Additionally, to enable electronic record-keeping by hospitals, the AEROFLEX system can be configured by users to transmit cycle printout information and/or print cycle records from the facility's network; the AEROFLEX System will also be compatible with ASP ACCESS™ Technology to allow automated record keeping.

This document describes the premarket notification (510(k)) for the AEROFLEX™ Automatic Endoscope Reprocessor (AER) with AUTOSURE™ MRC Monitor. It focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance testing.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of acceptance criteria with corresponding performance metrics in the way one might expect for a diagnostic AI device. Instead, it describes various performance tests conducted and reports a "Pass" for each. The acceptance criteria are implicitly defined by the "Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities (August 1993)" and the relevant electrical safety and EMC standards.

Here's a summary of the performance testing and their reported results:

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

The document does not explicitly state specific sample sizes for most of the performance tests (e.g., number of cycles for simulated use, number of endoscopes for in-use testing). It refers to "worst-case conditions" and "various OPA solution and MRC reagent conditions," implying a robust testing methodology but lacking numerical specifics.

• Provenance: The data provenance is internal testing conducted by Advanced Sterilization Products (ASP). The geographic location of the testing facility is not explicitly stated, but the company address is Irvine, California, USA, implying the testing was likely conducted in the US.
• Retrospective or Prospective: The testing would be considered prospective as it involves controlled experiments and data collection designed specifically to evaluate the performance of the device prior to marketing.

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

This document describes a medical device (automatic endoscope reprocessor) rather than an AI/ML clinical diagnostic device. Therefore, the concept of "experts establishing ground truth for a test set" often seen in AI/ML performance studies is not directly applicable in the same way.

• Ground Truth Establishment: The "ground truth" for this device's performance is established by physical and chemical measurements (e.g., OPA concentration, temperature, flow rates, microbial reduction for disinfection efficacy) and engineering validation against predefined specifications and regulatory guidance documents.
• Experts: While not explicitly stated as "experts establishing ground truth," the development and testing would have involved qualified engineers, microbiologists, and other scientific personnel with expertise in sterilization, disinfection, and medical device design and validation. Summative Usability Testing involved "representative end-user technicians and nurses," who can be considered "experts" in the context of device usability in a clinical setting.

4. Adjudication Method for the Test Set

Again, given that this isn't an AI-powered diagnostic device, there's no "adjudication method" in the sense of reconciling disagreements between expert readers. Performance is determined by quantitative measurements and validation against predefined technical specifications and regulatory (FDA) guidance.

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

No. This is not an AI/ML diagnostic device that provides interpretations that human readers would then review. The device discussed is an Automatic Endoscope Reprocessor, focused on disinfection efficacy and automated processes. MRMC studies are not applicable here.

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

The "standalone" performance here refers to the device operating independently to perform its intended function. The various "Performance Testing" categories listed in the tables (Process Parameter Physical Testing, Simulated Use Testing, In-Use Testing, Self-Disinfection Efficacy, System Verification Testing, MRC Monitor Testing, etc.) represent the standalone performance of the AEROFLEX system in achieving its disinfection and monitoring goals without direct human intervention during the cycle. Human interaction occurs before loading and after completion, but the process itself is automated and tested as such.

7. The Type of Ground Truth Used

The ground truth used is primarily based on:

• Physical and Chemical Measurements: Direct measurements of parameters like OPA concentration, temperature, flow, volume, and contact time.
• Microbiological Efficacy: Likely involves challenging the system with known levels of microorganisms (bioburden) and demonstrating a specified log reduction (e.g., "greater than 6-log10 reduction" mentioned in Flow Characteristic Evaluation). This would involve laboratory-based testing using culturing methods to determine viable microbial counts before and after reprocessing.
• Engineering Specifications and Design Requirements: The device's performance is validated against its pre-established technical specifications and the requirements outlined in relevant FDA guidance documents and international standards (e.g., for electrical safety, EMC).
• Usability Feedback: For summative usability testing, the "ground truth" would be direct observations and feedback from the intended users regarding the device's ease of use and safety in a simulated environment.

8. The Sample Size for the Training Set

This product is an automatic endoscope reprocessor, not a machine learning model developed with training data. Therefore, the concept of a "training set" for an algorithm's development is not applicable. The device's internal algorithms and control systems are likely developed through traditional software engineering principles and validated through the extensive non-clinical testing described.

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

As explained above, there is no "training set" for an AI/ML algorithm in this context. The "ground truth" against which the device's performance is validated is established through established scientific methods, engineering principles, and adherence to regulatory standards for disinfection and medical device functionality.

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The Acu-sInQ Complete Endoscope Cleaning Aid System is intended to assist manual flexible endoscope cleaning according to the instructions provided by the endoscope manufacturer, by facilitating performance of a leak test, accurate detergent dosing with water temperature monitoring, channel flushing, rinsing, and process documentation.

The Acu-sInQ Complete Endoscope Cleaning Aid System is used in the reprocessing room of a hospital or endoscopy center, and aids technicians by providing a step-by-step cleaning sequence of flexible endoscopes for process management and reports. The Acu-sInQ Complete Endoscope Cleaning Aid System is a 4-in-1 system with automated scope inflation for performance of a leak test, precision chemical dosing, and automated channel flushing with pulsating fluid technology for main and auxiliary flush ports. The System also provides: Data management via printout with every cycle, USB drive and port output for capture and recording of process data and chemical usage, Software to enable transfer of data between system and Customer's PC, Barcode scanner to input endoscope serial number and technician ID which aids in documentation process, Pre-loading with Customer's endoscope inventory.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes used for each individual test. It mentions "non-clinical performance testing" was conducted. The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, but given it's a pre-market notification for a medical device, the testing would be prospective and conducted by the manufacturer, STERIS Corporation.

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 tests described are engineering and performance-based (e.g., fluid volume consistency, dosing accuracy, temperature accuracy, electrical safety, EMC) and do not typically involve human expert interpretation for ground truth.

4. Adjudication method for the test set:

Not applicable. The tests are objective and based on measurable engineering parameters, not subjective assessments requiring 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:

Not applicable. This device is an endoscope cleaning aid system, not an AI-powered diagnostic imaging tool that would involve human readers.

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

The device itself is a "Cleaning Aid System" that assists manual cleaning. The performance tests described (fluid flushing, dosing, temperature accuracy, electrical safety, EMC) are inherently standalone device performance evaluations without a human-in-the-loop component for the device's core functions being tested. While the device assists human operators, the tests performed assess the device's technical specifications.

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

The ground truth for the tests performed is based on established engineering and metrology standards. For example:

• Fluid Flushing/Dosing/Temperature Accuracy: Likely measured against calibrated instruments to verify accuracy against specified tolerances (e.g., ±5%).
• Electrical Safety/EMC: Compliance with international standards (IEC 61010-1, IEC 61326-1) which define specific test procedures and permissible limits.

8. The sample size for the training set:

Not applicable. This is a physical medical device, an endoscope cleaning aid, not an artificial intelligence algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

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