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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 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):

| Cycles | Sterilize
Temperature | Sterilize
Time | Dry Time | Maximum Recommended Load |
|-------------|--------------------------|-------------------|------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 20 minutes | Fabric Packs. Refer to Table 2 for
recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays,
maximum weight 25 lbs (11.3 kg)
each and Fabric Packs. Refer to Table
2 for recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays,
maximum weight 25 lbs (11.3 kg)
each. Refer to Table 2 for
recommended quantities. |
| Prevac-IUSS | 270°F (132°C) | 4 minutes | 1 minute | Immediate use – single unwrapped
tray |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument trays,
maximum weight 25 lbs (11.3 kg)
each. Refer to Table 2 for
recommended quantities. |
| Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3.5 minutes | 1 minute | Bowie-Dick Test Pack, DART Test
Pack |
| Leak Test | N/A | N/A | N/A | N/A |

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 sterilizer accomplishes this by removing the air in the chamber, exposing the load to saturated steam for a defined combination of time and temperature, and drying the load. Removal of air from the chamber occurs using either of two methods, gravity displacement or mechanical vacuum. Once the air removal phase is completed, the sterilizer progresses to the steam exposure phase. During the steam exposure phase, every surface of the load is exposed to saturated steam for a defined combination of time and temperature. Once the steam exposure phase is completed, steam is removed from the chamber and the load is dried using the latent heat in the load and the vacuum pump.

The provided FDA 510(k) summary describes the AMSCO 600 Steam Sterilizer and its nonclinical testing. This document is a premarket notification for a medical device and thus the "acceptance criteria" here refers to the performance standards and regulatory requirements the device must meet to be deemed substantially equivalent to a predicate device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes nonclinical testing and references compliance with standards like ANSI/AAMI ST8, IEC 61010-1, IEC 61010-2-40, FCC 47 CFR Part 15 - Subpart B, and ASME Boiler Pressure Vessel Code, Section VIII (Division 1).

• Sample Size: The document does not specify the sample size for these nonclinical tests in terms of specific units tested (e.g., number of sterilizers, number of loads processed). It states that "The testing demonstrated that subject device met the acceptance criteria described in these standards."
• Data Provenance: The document does not provide details on the country of origin of the data or whether the studies were retrospective or prospective. Nonclinical testing typically involves laboratory or in-house validation rather than patient data.

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

This information is not provided in the document. For nonclinical tests of a steam sterilizer, "ground truth" would typically be established by established engineering standards and methodologies, rather than expert human consensus on clinical images or outcomes.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable to nonclinical engineering and performance testing of a steam sterilizer. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of results (e.g., by multiple radiologists).

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. This type of study is relevant for AI-powered diagnostic or assistive devices where human interpretation is involved. The AMSCO 600 Steam Sterilizer is an automated sterilization device and does not involve human readers for interpretation in the context of its primary function.

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

This concept is not applicable to the AMSCO 600 Steam Sterilizer. It is a physical device that performs a function (sterilization) based on programmed cycles, not an algorithm that interprets data. Its performance is inherent in its operation and validated against physical and microbiological standards.

7. The Type of Ground Truth Used

The ground truth used for proving the device meets the acceptance criteria is based on:

• Engineering and Performance Standards: Compliance with recognized international and national standards (ANSI/AAMI ST8, IEC 61010-1, IEC 61010-2-40, FCC 47 CFR Part 15 - Subpart B, ASME Boiler Pressure Vessel Code, Section VIII (Division 1)). These standards define acceptable performance metrics for sterilization, electrical safety, EMC, and pressure vessel integrity.
• Microbiological Sterility Assurance: The specification of a Sterility Assurance Level (SAL) of 10^-6 implies that the ground truth for sterilization efficacy is the reduction of microbial population to a probability of 1 in a million, which is typically demonstrated through biological indicator challenges and physical parameter monitoring.

8. The Sample Size for the Training Set

This information is not applicable as the AMSCO 600 Steam Sterilizer is not an AI/ML device that requires a training set.

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

This information is not applicable as the AMSCO 600 Steam Sterilizer is not an AI/ML device that requires a training set and associated ground truth.

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