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The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisture- stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles.
The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues.
The V-PRO s2 Low Temperature Sterilization System using VAPROX® HC Sterilant are intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and low temperature, suitable for processing medical devices without leaving toxic residues.
The RAS Racks are used in the RAS Cycle of the AMSCO 7052HP Single-Chamber Washer/Disinfector and the AMSCO 7053HP Single-Chamber Washer/Disinfector for the effective cleaning, rinsing, intermediate level disinfection and drying of reusable da Vinci® X/Xi and S/Si EndoWrist® instruments.
The V-PRO® 60 Low Temperature Sterilization System using VAPROX® HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and low temperature, suitable for processing medical devices without leaving toxic residues.

The AMSCO 600 Steam Sterilizer uses saturated steam, generated from a house steam utility (e.g. boiler system) or from a steam generator, to sterilize heat-stable health care products.
The V-PRO Low Temperature Sterilization System is a vaporized hydrogen peroxide sterilizer. It has the following pre-programmed cycles (the Lumen Cycle, the Non Lumen Cycle, the Flexible Cycle and the Fast Non Lumen Cycle). The V-PRO Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities.
The V-PRO s2 Sterilizer executes four sterilization cycles (the Lumen, Non Lumen, Flexible Cycles and Fast Cycle). The V-PRO s2 Sterilizer contains a cabinetry modification and is free-standing.
The RAS Racks are designed to enable the mechanical cleaning, rinsing, and disinfection of up to twelve (12) robotic-assisted surgery instruments in a compatible washer-disinfector.
The V-PRO s2 Sterilizer executes four sterilization cycles (the Lumen, Non Lumen, Flexible Cycles and Fast Cycle). The V-PRO s2 Sterilizer contains a cabinetry modification and is free-standing.

The provided FDA 510(k) summary describes several sterilization and washer-disinfector systems. The acceptance criteria and testing detailed are for modifications related to component obsolescence (oscillator replacement, coin cell battery to super capacitor, flash memory component alternates and associated software updates). The document does not describe a study related to AI or human-in-the-loop performance. Therefore, questions related to expert consensus, MRMC studies, effect size, and standalone algorithm performance are not applicable.

Here's an analysis of the acceptance criteria and supporting studies for the component modifications across the various devices:

1. Table of Acceptance Criteria and Reported Device Performance

Across all devices (AMSCO 600 Steam Sterilizer, V-PRO maX 2, V-PRO s2, V-PRO 60 Low Temperature Sterilization Systems, and RAS Racks/Cycle), the acceptance criteria and performance for the specific modifications are consistent:

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

The document does not explicitly state the specific sample sizes (e.g., number of cycles, number of biological indicators) used for these non-clinical performance tests. It refers to "worst-case load" for the sterility assurance tests.

The provenance of the data is non-clinical performance testing conducted by the manufacturer, STERIS Corporation. The country of origin is implicitly the United States, given STERIS's address in Mentor, Ohio, and the FDA submission. The studies are retrospective in the sense that they are proving the modified device performs equivalently to the original validated design.

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

This question is not applicable as the studies described are non-clinical performance tests verifying device functionality and sterility/cleaning efficacy, not diagnostic or interpretive tasks requiring human expert ground truth. The "ground truth" for these tests is defined by established sterilization and cleaning standards (e.g., "no growth" for biological indicators, confirmed cleaning efficiency).

4. Adjudication Method for the Test Set

This question is not applicable for non-clinical performance tests. The results (e.g., growth/no growth, successful software operation) are typically objective and determined by laboratory analysis or automated system checks.

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 document explicitly states that the modifications "has no impact on the device performance" compared to the predicate device because the changes are related to component obsolescence, not a change in the fundamental operating principle or intended use that would require a comparison of human reader effectiveness.

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

This question is not applicable. The devices are sterilization and cleaning equipment, not algorithms that perform diagnostic or interpretive functions. The software tests performed are focused on verifying the proper functioning of the embedded system software controlling the sterilizers/washer-disinfectors, not standalone interpretive performance.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests is based on:

• Biological indicator results: "No growth" post-sterilization, indicating successful killing of microorganisms. This is a direct measure of sterility.
• Physical and chemical parameters verification: Ensuring cycle data (time, temperature, pressure, sterilant injection weight) for sterilizers and cleaning/thermal disinfection parameters for the washer-disinfector (temperature, time, chemical dosing, pump pressure) meet pre-defined specifications.
• Software functionality: Verification that the embedded software correctly sets and reads Real-Time Clock (RTC), loads and runs applications, and ensures proper operation using serial flash memory.
• Cleaning efficiency: For the RAS Racks/Cycle, comparison of cycle data between modified and original controllers to confirm equivalent cleaning efficiency.

These "ground truths" are derived from validated operational parameters and expected biological/physical outcomes inherent to sterilization and cleaning processes, as per industry standards and internal validation protocols.

8. The Sample Size for the Training Set

This question is not applicable. These are hardware/software modifications to existing medical devices, not AI/ML algorithms that require a separate training set. The "associated software updates" are to accommodate new hardware components (flash memory, super capacitor) and ensure the existing validated sterilization/cleaning cycles continue to operate as intended.

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

This question is not applicable, as there is no "training set" in the context of these device modifications.

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The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles (Table 1):
The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues.
The V-PRO s2 Low Temperature Sterilization System using VAPROX® HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and low temperature, suitable for processing medical devices without leaving toxic residues.
The RAS Racks are used in the RAS Cycle of the AMSCO 7052HP Single-Chamber Washer/Disinfector and the AMSCO 7053HP Single-Chamber Washer/Disinfector for the effective cleaning, intermediate level disinfection and drying of reusable da Vinci® X/Xi and S/Si EndoWrist® instruments.

The AMSCO 600 Steam Sterilizer uses saturated steam, generated from a house steam utility (e.g. boiler system) or from a steam generator, to sterilize heat-stable health care products.
The V-PRO Low Temperature Sterilization System is a vaporized hydrogen peroxide sterilizer. It has the following pre-programmed cycles (the Lumen Cycle, the Non Lumen Cycle, the Flexible Cycle and the Fast Non Lumen Cycle). The V-PRO Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities.
The V-PRO s2 Sterilizer executes four sterilization cycles (the Lumen, Non Lumen, Flexible Cycles and Fast Cycle). The V-PRO s2 Sterilizer contains a cabinetry modification and is free-standing.
The RAS Racks are designed to enable the mechanical cleaning, rinsing, and disinfection of up to twelve (12) robotic-assisted surgery instruments in a compatible washer-disinfector.

The provided text describes premarket notifications (510(k) summaries) for several sterilization and washer-disinfector systems, focusing on modifications to the control boards (using refurbished or slightly modified boards). It does not describe an AI/ML-based medical device. Therefore, the information required to answer the prompt regarding acceptance criteria and study proving device meets criteria (which typically applies to AI/ML device performance, ground truth establishment, expert review, MRMC studies, etc.) is largely not present in the provided document.

The document discusses acceptance criteria and study conclusions in the context of validating sterilization efficacy and proper operation of mechanical systems, not AI performance.

Therefore, for aspects related to AI/ML device performance (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, etc.), the answer will be "N/A" (Not Applicable) or "Not relevant" because the document does not pertain to such a device.

Here's an attempt to extract relevant information wherever possible, and indicate N/A where the information is not provided or not relevant to the type of device described:

Device Category: Sterilization and Washer-Disinfector Systems (Mechanical/Chemical Medical Devices)

1. Table of acceptance criteria and the reported device performance:

Since this document describes multiple devices, I'll consolidate the general nature of the tests and criteria. The performance is consistently reported as "Pass" for all listed tests, indicating they met the defined acceptance criteria.

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

• Sample Size for Test Set: Specific numerical sample sizes for the "tests" listed (e.g., how many 1/2 cycle sterility tests were performed, on how many units, or specific amounts of biological indicators) are not detailed in this summary. The validation studies mentioned for different load configurations (e.g., "two instrument trays", "one pouched instrument tray", "two flexible endoscopes") relate to the type of load tested for sterilization efficacy, not the statistical sample size of individual tests.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. These are typically controlled laboratory validation studies rather than clinical data collection.

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

• Not relevant. The "ground truth" for these devices, which are sterilizers/disinfectors, is typically established through microbiology (proving sterility/disinfection) and engineering evaluations (confirming operational parameters and software functionality), not through human expert interpretation of images or other data for diagnostic purposes. The "ground truth" is typically defined by the absence of microbial growth on biological indicators or the achievement of specified physical parameters (time, temperature, pressure).

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

• Not relevant. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human experts are making subjective assessments that need to be reconciled (e.g., image interpretation). This document describes validation of mechanical systems and biological efficacy.

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, not done. MRMC studies are specific to evaluating the clinical impact of AI models on human reader performance, typically in diagnostic imaging. This document is about sterilizers and washer-disinfectors, which are not AI-assisted diagnostic tools.

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

• Not relevant. This question is formulated for an AI/ML algorithm. The "performance" of these devices is their ability to independently execute sterilization/disinfection cycles according to defined parameters and standards. The "software confirmation test" listed in the table is the closest equivalent, verifying the algorithm's (software's) proper operation.

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

• Biological/Physical Performance Ground Truth: For the sterility assurance tests, the ground truth is established by microbiological culture results (absence of growth on biological indicators) coupled with physical parameter monitoring (time, temperature, pressure). For the cleaning efficiency tests, the ground truth would similarly be based on pre-defined levels of contamination removal as verified by analytical methods, and the adherence to critical cycle parameters. This is not derived from expert consensus, pathology, or outcomes data in the way an AI diagnostic device would be.

8. The sample size for the training set:

• Not applicable. These devices are not AI/ML systems that undergo a "training" phase with a dataset in the conventional sense. The "training" for these systems would be the engineering design, development, and iterative testing/refinement of the hardware and embedded software.

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

• Not applicable. As above, there is no "training set" in the context of an AI/ML model for these devices. The "ground truth" for the development of these systems would be the established scientific principles of sterilization/disinfection and adherence to relevant industry standards (e.g., ANSI/AAMI ST79 for steam sterilization, or specific standards for low-temperature sterilization and washer-disinfectors).

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The RAS Racks are used in the RAS Cycle of the AMSCO 7052HP Single-Chamber Washer/Disinfector and the AMSCO 7053HP Single-Chamber Washer/Disinfector for the effective cleaning, rinsing, intermediate level disinfection and drying of reusable da Vinci® X/Xi and S/Si EndoWrist® instruments.

The RAS Racks are designed to enable the mechanical cleaning, rinsing, and disinfection of up to twelve (12) robotic-assisted surgery instruments in a compatible washer-disinfector. Twelve soiled da Vinci X/Xi and S/Si Endowrist® instruments, with limited prior manual pre-cleaning, are loaded into the appropriate RAS Rack according to the provided instructions for use. The rack is placed in the AMSCO 7052HP or 7053HP Single-Chamber Washer/Disinfector, and the RAS Cycle is selected.

The RAS Cycle performs automated cleaning through a validated series of spraywashing, lumen flushing steps that use Prolystica Ultra Concentrate HP Enzymatic Cleaner alternately with Prolystica Ultra Concentrate HP Neutral Detergent in temperature-controlled solutions. When the series of automated prewash and washing stages are complete, a one-minute rinse occurs. Next the RAS Cycle completes a thermal rinse to achieve intermediate level disinfection of the load before drying it. Upon RAS Cycle completion, the devices are ready to be prepared and packed for steam sterilization.

The provided text is related to a 510(k) premarket notification for STERIS RAS 12 Rack / RAS 12 Long Rack, used in a washer-disinfector for surgical instruments. This is a medical device, specifically an accessory for automated cleaning and disinfection.

The request asks for details about "acceptance criteria and the study that proves the device meets the acceptance criteria," with a focus on an AI/Machine Learning context. However, the provided document does not describe an AI/Machine Learning device or any study involving AI performance.

Instead, it details the substantial equivalence of a physical medical device (racks for a washer-disinfector) to a legally marketed predicate device. The "performance testing" mentioned is non-clinical and relates to the cleaning and disinfection efficacy of the washer-disinfector system for surgical instruments, not an AI model's diagnostic accuracy or similar metrics.

Therefore, most of the requested information, which is specific to AI/ML device studies (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and effect size for human reader improvement with AI), is not present in this document.

The document states:

• "The purpose of this Special 510(k) is to update labeling consistent with a labeling revision being enacted by Intuitive Surgical to allow for automated cleaning and intermediate level disinfection of reusable da Vinci X/Xi and S/Si EndoWrist® instruments in the RAS Racks and RAS Cycles of the AMSCO 7052HP and 7053HP Single-Chamber Washer/Disinfectors. The RAS Racks and associated RAS Cycles were not altered in anyway."
• "Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well or better than the legally marketed predicate device (K200577), Class II (21 CFR 876.1500), product code NVE."

This indicates that the "study" is a non-clinical performance test to establish cleaning and disinfection efficacy, likely involving standards for residual protein, blood, or other contaminants, rather than diagnostic accuracy.

Given the provided text, I cannot answer the questions specific to AI/ML performance studies because the document does not pertain to an AI/ML device.

I can, however, extract information about the device characteristics and the basis for its clearance as presented in the document, which primarily relies on substantial equivalence to a predicate device and non-clinical performance data for cleaning/disinfection.

What I can infer from the document regarding the device and its assessment:

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

• The document doesn't present "acceptance criteria" in a typical table format with quantitative performance metrics for a diagnostic device. Instead, it relies on demonstrating that the proposed device has "identical" or "similar" technological characteristics and performs "as well or better" than its predicate device through non-clinical performance testing related to cleaning, rinsing, disinfection, and drying efficacy.
• The "performance" referred to is the successful demonstration of effective cleaning and intermediate level disinfection of specific surgical instruments (da Vinci® X/Xi and S/Si EndoWrist® instruments) when processed in the RAS Racks within the specified washer-disinfector cycles. This would involve meeting established benchmarks for sterility or cleanliness, though the specific criteria (e.g., maximum allowable protein residue) are not detailed in this summary. The table provided is a "Technological Characteristics Comparison Table" comparing the proposed device to the predicate, not a performance table against specific acceptance criteria.

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

• Not applicable/mentioned for an AI/ML context. Likely involves a set number of contaminated instruments to be processed and tested, but specific "sample sizes" (e.g., number of instruments, number of cycles) are not detailed in this summary.
• Data provenance (country of origin, retrospective/prospective) is not relevant to this type of device assessment and is not mentioned.

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

• Not applicable. "Ground truth" in this context would be laboratory testing results for cleanliness/disinfection, not expert clinical interpretation.

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

• Not applicable. This is for AI/ML diagnostic studies.

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 document does not describe an AI-assisted diagnostic device.

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

• Not applicable. This is a physical device used for cleaning/disinfection.

7. The type of ground truth used:

• For the non-clinical performance testing referenced, the "ground truth" would be established via laboratory assays measuring the reduction of biological contaminants (e.g., protein, hemoglobin) or microbial load on the instruments after processing. This is a direct measurement of the device's efficacy in cleaning and disinfection, not an expert consensus or outcomes data in the clinical sense.

8. The sample size for the training set:

• Not applicable. This is for AI/ML devices.

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

• Not applicable. This is for AI/ML devices.

In summary, the provided document does not contain information relevant to an AI/ML device study or its performance criteria. It describes a 510(k) clearance for a non-AI medical device based on substantial equivalence and non-clinical performance testing for cleaning and disinfection efficacy.

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The RAS Racks are used in the RAS Cycles of AMSCO 7052HP and 7053HP Single-Chamber Washer/Disinfectors for the effective cleaning, rinsing, drying and intermediate level disinfection of reusable da Vinci EndoWrist® X/Xi, S/Si, and Single-Site instruments and staplers.

The RAS Racks are designed to enable the mechanical cleaning, rinsing, and disinfection of up to twelve (12) robotic-assisted surgery instruments in a compatible washer-disinfector. Twelve soiled da Vinci Endowrist® X/Xi, S/Si, or Single-Site instruments and staplers, without prior manual cleaning, are loaded into the appropriate RAS Rack according to the provided instructions for use. The rack is placed in the AMSCO 7052HP or 7053HP Single-Chamber Washer/Disinfector, and the RAS Cycle is selected.

The RAS Cycle performs automated cleaning through a validated series of spraywashing, lumen flushing steps that use Prolystica Ultra Concentrate HP Enzymatic Cleaner alternately with Prolystica Ultra Concentrate HP Neutral Detergent in temperature-controlled solutions. When the series of automated prewash and washing stages are complete, a one-minute rinse occurs. Next the RAS Cycle completes a thermal rinse to achieve intermediate level disinfection of the load before drying it. Upon RAS Cycle completion, the devices are ready to be prepared and packed for steam sterilization.

I am sorry, but the provided text does not contain the acceptance criteria or a study proving that the device meets acceptance criteria. The document is an FDA 510(k) premarket notification for a medical device (STERIS RAS 12 Rack and RAS Cycle), which states that the proposed device is substantially equivalent to a legally marketed predicate device (K190081).

The document details the device's intended use, technological characteristics, and compares it to the predicate device. However, it explicitly states in "Summary of Non-Clinical Performance Testing" that "The purpose of this Special 510(k) is to update labeling based on a labeling revision being enacted by Intuitive Surgical to allow for automated cleaning and intermediate level disinfection... The RAS Racks and associated RAS Cycles were not altered in anyway." This implies that the performance testing was likely conducted for the predicate device (K190081) and is referenced, but the details of such a study are not present in this document.

Therefore, I cannot extract the requested information such as a table of acceptance criteria and reported performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, type of ground truth, or training set details.

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The RAS Racks are used in the RAS Cycles of AMSCO 7052HP and 7053HP Single-Chamber Washer/Disinfectors for the effective cleaning, rinsing, drying and intermediate level disinfection of reusable da Vinci EndoWrist® X/Xi, S/Si, and Single-Site instruments and staplers.

The RAS Racks are designed to enable the mechanical cleaning, rinsing, and disinfection of up to twelve (12) robotic-assisted surgery instruments in a compatible washer-disinfector. Twelve soiled da Vinci Endowrist X/Xi, S/Si, or Single-Site instruments and staplers, without prior manual cleaning, are loaded into the appropriate RAS Rack according to the provided instructions for use. The rack is placed in the AMSCO 7052HP or 7053L Single-Chamber Washer/Disinfector, and the RAS Cycle is selected.

The RAS Cycle performs automated cleaning through a validated series of spraywashing, lumen flushing steps that use Prolystica Ultra Concentrate HP Enzymatic Cleaner alternately with Prolystica Ultra Concentrate HP Neutral Detergent in temperature-controlled solutions. When the series of automated prewash and washing stages are complete, a one-minute rinse occurs. Next the RAS Cycle completes a thermal rinse to achieve intermediate level disinfection of the load before drying it. Upon RAS Cycle completion, the devices are ready to be prepared and packed for steam sterilization.

The provided text describes a 510(k) premarket notification for a medical device (RAS-12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO® 7052HP/7053HP Single Chamber Washer/Disinfector) and its performance testing. However, the information is primarily focused on the cleaning, rinsing, drying, and intermediate level disinfection capabilities of the device for reusable surgical instruments, rather than an AI/ML powered medical device.

Therefore, many of the typical acceptance criteria and study components related to AI/ML device performance (such as sample size for test/training sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable or not provided in this document.

The document discusses performance criteria for the washer-disinfector and its accessories, which are mechanical and chemical efficacy tests.

Here's an attempt to extract the relevant information based on the provided text, and point out where information typically associated with AI/ML device studies is absent:

Device Studied: RAS-12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO® 7052HP/7053HP Single Chamber Washer/Disinfector

Purpose of the Study: To demonstrate the substantial equivalence of the subject device to a legally marketed predicate device (da Vinci SonicPro Cleaning System: K073112) for the cleaning, rinsing, drying, and intermediate level disinfection of reusable da Vinci EndoWrist® X/Xi, S/Si, and Single-Site instruments and staplers.

1. Table of Acceptance Criteria and Reported Device Performance

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