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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 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.

Each Cycle can sterilize non-luments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.

The V-PRO s2 Sterilizer Non Lumen Cycle can sterilize: † Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.

The V-PRO s2 Sterilizer Fast Cycle can sterilize: * Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:

• Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm (~1/32”) internal diameter (ID) and ≤ 410 mm (~16-9/64”) in length
• Triple channeled devices with stainless steel lumens that are either: ≥ 1.2 mm (~3/64”) ID and ≤ 275 mm (~10-53/64”) in length ≥ 1.8 mm (~5/64”) ID and ≤ 310 mm (~12-13/64”) in length or ≥ 2.8 mm (~7/64”) ID and ≤ 317 mm (12-31/64”) in length
  Non-lumened instruments including non-lumened general medical instruments. non-lumened rigid, semi-rigid and flexible endoscopes.

The V-PRO s2 Sterilizer Flexible Cycle can sterilize: @ One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.

• The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm (~3/64”) ID and ≤ 990 mm (38-63/64”) in length.
• Additional load, up to 11 lb (5 kg) can include stainless steel lumens with the following dimensions ≥ 2 mm (~5/64”) ID and ≤ 400 mm (~15 3/4”) in length ≥ 0.76 mm (~1/32”) ID and ≤ 233 mm (~9 11/64”) in length ≥ 1.0 mm (~3/64”) ID and ≤ 254 mm (~10”) in length

The V-PRO s2 Sterilizer Lumen Cycle can sterilize: ^ Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:

• Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm (~1/32”) internal diameter (ID) and ≤ 410 mm (16-9/64”) in length
• Triple channeled devices with stainless steel lumens that are either: ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-53/64") in length ≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length or ≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length

The V-PRO® s 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.

Each Cycle can sterilize non-luments and instruments with diffusionrestricted spaces such as the hinged portion of forceps and scissors.

The V-PRO 60 Sterilizer Non Lumen Cycle can sterilize: t Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.

The V-PRO 60 Sterilizer Flexible Cycle can sterilize: @ One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.

• The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm (~3/64”) ID and ≤ 990 mm (38-63/64”) in length.
• Additional load, up to 11 lb (5 kg) can include stainless steel lumens with the following dimensions ≥ 2 mm (~5/64”) ID and ≤ 400 mm (~15 3/4”) in length ≥ 0.76 mm (~1/32”) ID and ≤ 233 mm (~9 11/64”) in length ≥ 1.0 mm (~3/64”) ID and ≤ 254 mm (~10”) in length

The V-PRO 60 Sterilizer Lumen Cycle can sterilize: ^ Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:

• Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm (~1/32”) internal diameter (ID) and ≤ 410 mm (16-9/64”) in length
• Triple channeled devices with stainless steel lumens that are either: ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-53/64") in length ≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length or ≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length

The V-PRO s2 Low Temperature Sterilization System is a new vaporized hydrogen peroxide sterilizer model to be added to the STERIS V-PRO family of sterilizers. The V-PRO product line currently consists of the V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO maX 2 and V-PRO 60 Sterilizers.

The V-PRO s2 Sterilizer contains the same three sterilization cycles as the predicate device (K172319), the Lumen, Non Lumen and Flexible Cycles, with a new cycle, the Fast Cycle. In addition, compared to the claimed predicate device, the proposed device contains a cabinetry modification, adds additional claims for devices that may be processed in the Flexible Cycle, and increases the maximum claimed load weight for the Non Lumen Cycle.

The V-PRO 60 Low Temperature Sterilization System is a vaporized hydrogen peroxide sterilizer model that currently exists in the STERIS V-PRO family of sterilizers. The current proposed device claims are intended to modify the indications for use statement.

As with the predicate device (K172319), the V-PRO 60 Sterilizer has three preprogrammed cycles: the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycle, none of which are being altered. The V-PRO 60 Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged surgical instruments used in healthcare facilities.

The V-PRO s2 and V-PRO 60 Low Temperature Sterilization Systems are intended for terminal sterilization of cleaned, rinsed, dried and packaged surgical instruments used in healthcare facilities and utilizes VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The pre-programmed cycles all utilize a conditioning phase, a sterilize phase and an aeration phase. The packaged sterilized devices are ready for use at the completion of the cycle, no cool down or aeration period is required following completion of the cycle.

The provided text is a 510(k) Premarket Notification from the FDA, detailing the substantial equivalence of the STERIS V-PRO s2 Low Temperature Sterilization System and modifications to the V-PRO 60 Low Temperature Sterilization System to a legally marketed predicate device. This document describes the acceptance criteria and the study that proves a medical device (sterilizer) meets these criteria, rather than an AI/ML powered device.

Therefore, the requested information points related to AI/ML device studies (sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, etc.) do not apply to this document as it pertains to a physical sterilization device and not a diagnostic AI/ML system.

However, I can extract the acceptance criteria for the sterilization device and the reported performance based on the provided text.

Acceptance Criteria and Reported Device Performance (for a Sterilization Device)

The "acceptance criteria" for a sterilizer device are typically demonstrated through various validation studies to ensure the device effectively sterilizes medical instruments. The "reported device performance" is the conclusion that these studies meet the established criteria.

Here's a table based on the "Summary of Nonclinical Tests" section (Page 17-18) which outlines the tests conducted (functioning as acceptance criteria) and their successful results (reported performance):

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI/ML-specific questions, as stated previously, this document does not contain information on an AI/ML powered device. Therefore, the following points are not applicable:

2. Sample size used for the test set and the data provenance: Not applicable. The document discusses "validation studies" and "validation loads" for a sterilizer, which are physical materials and instruments, not data samples for an AI test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a sterilizer is established through scientific validation (e.g., microbial kill, chemical indicators), not human expert review.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For a sterilizer, the ground truth is the demonstrable absence of viable microorganisms ("sterility") and material compatibility, established through laboratory methods (e.g., biological indicators, chemical indicators, and material analysis) under worst-case conditions, as opposed to expert consensus, pathology, or outcomes data in the context of diagnostic AI.
8. The sample size for the training set: Not applicable. This refers to a physical device, not an AI model.
9. How the ground truth for the training set was established: Not applicable.

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