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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.

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

The Non Lumen Cycle can sterilize: †

Non-lumened instruments including non-luments, non-luments, non-lumened rigid, sem-rigid and flexible endoscopes.

t The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).

The Fast Non Lumen Cycle can sterilize: *

Non-lumened instruments including non-luments. non-luments. non-lumened rigid, semi-rigid and flexible endoscopes.

• The validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg).

The Flexible Cycle can sterilize:

Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two load configurations:

1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain single or dual channel lumens that are > 1 mm internal diameter (ID) and ≤ 1050 mm in length. * The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).

2. One flexible endoscope with a light cord (if not integral to endoscope accessories, mat, and additional instruments. ** The flexible endoscope may contain single or dual channel lumens that are > 1 mm ID and ≤ 1050 mm in length

• Additional instruments may include non-lumened or lumened medical devices with the following configurations:

o Single, dual or triple channel stainless steel lumen that is

· ≥ 0.48 mm ID and ≤ 100 mm in length

** The validation studies were conducted with a flexible endoscope accessories, silicone mat, light cord (if not integral to endoscope) and 5 stainless steel lumens. Also included in the load was a tray with additional instruments, and silicone mat for a total weight of 24 lbs (11 kg).

The Lumen Cycle can sterilize: †

Medical devices with the following configurations:

· Single, dual or triple channeled stainless steel lumen that are:

• ≥ 0.77 mm ID and ≤ 527 mm in length

• ≥ 0.8 mm ID and ≤ 542 mm in length

• ≥ 0.48 mm ID and ≤ 100 mm in length
• · Dead end lumen that is ≥ 1.3 mm ID and ≤ 73 mm in length
• Rigid non-metallic lumen (such as those used in endoscope sheaths, take-apart forceps and trocars) that are:
• ≥ 3 mm ID and ≤ 298 mm in length
• ≥ 4 mm ID and

The V-PRO Low Temperature Sterilization Systems are vaporized hydrogen peroxide sterilizers.

The V-PRO maX 2 sterilizer has the following pre-programmed cycles: the Lumen Cycle, the Non Lumen Cycle, the Flexible Cycle, the Fast Non Lumen Cycle, and the Specialty Cycle. The V-PRO Low Temperature Sterilization Systems are intended for terminal sterilization of cleaned, rinsed, dried, and packaged surgical instruments used in healthcare facilities.

The five pre-programmed cycles all use 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.

VAPROX HC Sterilant is a 59% hydrogen peroxide sterilant used only the V-PRO Low Temperature Sterilization Systems (V-PRO). It was originally cleared for use in K062297 and the cup was modified in K112813. It has also been cleared as part of the various V-PRO Sterilizer models. The most recent Premarket Notifications for each model are identified in Table 1. This Premarket Notification is only for a proposed modification to VAPROX HC; there are no modifications to any of the V-PRO Low Temperature Sterilization Systems listed below:

• V-PRO 1
• V-PRO 1 Plus ●
• V-PRO maX ●
• V-PRO maX 2 ●
• V-PRO 60
• V-PRO s2 ●

The provided text does not describe a study involving an AI/ML device for medical image analysis. Instead, it describes a 510(k) premarket notification for a V-PRO maX 2 Low Temperature Sterilization System, a device used for sterilizing medical instruments. The "acceptance criteria" and "study" described in the document relate to the performance of this sterilization system and its associated sterilant, not to an AI system.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study for an AI/ML medical device based on the provided text. The document is about a sterilization system, not an AI product.

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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.

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

The Non Lumen Cycle can sterilize: †

Non-lumened instruments including non-luments, non-luments, non-lumened rigid, sem-rigid and flexible endoscopes.

• The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).

The Fast Non Lumen Cycle can sterilize: *

Non-lumened instruments including non-luments. non-luments. non-lumened rigid, semi-rigid and flexible endoscopes.

• The validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg).

The Flexible Cycle can sterilize:

Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations:

1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain single or dual channel lumens that are ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length. * The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).

2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments. ** The flexible endoscope may contain single or dual channel lumens that are > 1 mm ID and ≤ 1050 mm in length

Additional instruments may include non-lumened or lumened medical devices with the following configurations: Single, dual or triple channel stainless steel lumen that is ≥ 0.48 mm ID and ≤ 100 mm in length

++ The validation studies were conducted with a flexible endoscope in a tray with endoscope accessories, silicone mat, light cord (if not integral to endoscope) and 5 stainless steel lumens. Also included in the load was a tray with additional instruments, and silicone mat for a total weight of 24 lbs (11 kg).

The Lumen Cycle can sterilize: †

Medical devices with the following configurations:

· Single, dual or triple channeled stainless steel lumen that are:

• 0.77 mm ID and

The V-PRO Low Temperature Sterilization Systems are vaporized hydrogen peroxide sterilizers.

The V-PRO maX 2 sterilizer has the following pre-programmed cycles: the Lumen Cycle, the Non Lumen Cycle, the Flexible Cycle, the Fast Non Lumen Cycle, and the Specialty Cycle. The V-PRO Low Temperature Sterilization Systems are intended for terminal sterilization of cleaned, rinsed, dried, and packaged surgical instruments used in healthcare facilities.

The V-PRO Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The five preprogrammed cycles all use 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 describes a 510(k) premarket notification for the STERIS V-PRO maX 2 Low Temperature Sterilization System. It focuses on the substantial equivalence of the proposed device to a predicate device, specifically regarding the addition of a "Specialty Cycle."

Based on the provided information, the device is a sterilizer, and the "acceptance criteria" and "study proving the device meets the acceptance criteria" refer to the sterilization efficacy and the validation studies conducted to demonstrate that the new Specialty Cycle effectively sterilizes the specified materials/devices.

Here's the breakdown of the information requested, based on the provided document:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for a sterilizer is to demonstrate the elimination of viable microorganisms. This is typically shown through achieving sterility with a certain Sterility Assurance Level (SAL), often by processing inoculated Biological Indicators (BIs). The effectiveness is demonstrated through "½ Cycle (Sterilization) Efficacy" and "Final Process Qualification."

Table of Acceptance Criteria and Reported Device Performance (Inferred from the document's validation summary):

Additional Requested Information:

1. Sample sizes used for the test set and the data provenance:

• Test Set Sample Sizes:
  • Non Lumen Cycle: Validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).
  • Fast Non Lumen Cycle: Validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg).
  • Flexible Cycle (Config 1): Two flexible endoscopes with a light cord and mat (no additional load).
  • Flexible Cycle (Config 2): One flexible endoscope with a light cord and mat, plus a tray with additional instruments and silicone mat for a total weight of 24 lbs (11 kg). This configuration also included 5 stainless steel lumens.
  • Lumen Cycle: Validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg), with a maximum of 20 lumens per load.
  • Specialty Cycle (Non-lumened instruments): Validation load consisting of one pouched instrument tray or one pouch with guide(s)/model(s) (with or without tray) for a total weight of 11 lbs (5 kg).
  • Specialty Cycle (3D Printed Materials): Validation load consisting of pouched guide(s)/model(s) (with or without tray) for a total weight of 5 lbs (2.3 kg) 3D printed material.
• Data Provenance: The document implies these are prospective validation studies conducted by STERIS Corporation for regulatory submission. The country of origin is not explicitly stated but can be inferred as the United States given the FDA submission.

2. 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):

• This is a sterilization device, not an AI diagnostic tool. Ground truth for sterilizers is established through microbiological assays (e.g., biological indicators) and physical/chemical measurements (temperature, pressure, time, hydrogen peroxide concentration, etc.), not expert reader consensus like in imaging. Therefore, the concept of "experts establishing ground truth for the test set" in the context of human readers does not apply here. The expertise lies in microbiology, engineering, and quality assurance to design and execute the validation studies.

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

• Not applicable for a sterilization device validation study. Sterility is typically determined by the absence of growth in biological indicators, which is an objective measurement rather than a subjective human interpretation requiring adjudication.

4. 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 a sterilizer, not an AI or diagnostic imaging system. There are no "human readers" involved in performing or interpreting the sterilization process in a way that would warrant an MRMC study.

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

• Not applicable. This is a physical device, a sterilizer, not an algorithm. The "performance" is the physical process of sterilization.

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

• The ground truth for sterilization efficacy is established through microbiological assays, specifically the 6-log reduction or complete kill of highly resistant bacterial spores (Geobacillus stearothermophilus) contained within biological indicators (BIs). This is an objective, quantitative measure of sterilization. Additional ground truth includes adherence to engineering specifications for process parameters and chemical validation.

7. The sample size for the training set:

• Not applicable. This is a medical device (sterilizer) and its validation, not an AI/machine learning model that requires a "training set." The performance data comes from experimental validations and engineering studies.

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

• Not applicable, as there is no "training set" in the context of an AI model. The validation studies demonstrate the device's capability to sterilize.

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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 maX 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.

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

The V-PRO maX Sterilizers' Non Lumen Cycle can sterilize: t

Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid, semi-rigid and flexible endoscopes.

t The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).

The V-PRO maX Sterilizer's Flexible Cycle can sterilize:

Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations:

1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain single or dual channel lumens that are ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length. * The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).

2. One flexible endoscope with a light cord (if not integral to endoscope accessories and mat, and additional instruments. ** The flexible endoscope may contain single or dual channel lumens that are ≥ 1 mm ID and ≤ 1050 mm in length

Additional instruments may include non-lumened or lumened medical devices with the following configurations:

Single, dual or triple channel stainless steel lumen that is ≥ 0.48 mm ID and ≤ 100 mm in length

** The validation studies were conducted with a flexible endoscope accessories, silicone mat, light cord (if not integral to endoscope) and 5 stainless steel lumens. Also included in the load was a tray with additional instruments and silicone mat for a total weight of 24 lbs (11 kg).

The V-PRO maX Sterilizers' Lumen Cycle can sterilize: * Medical devices with the following configurations:

· Single, dual or triple channeled stainless steel lumen that are:

• ≥ 0.77 mm ID and ≤ 527 mm in length
• ≥ 0.8 mm ID and ≤ 542 mm in length
• ≥ 0.48 mm ID and ≤ 100 mm in length
• · Dead end lumen that is ≥ 1.3 mm ID and ≤ 73 mm in length
• · Rigid non-metallic lumen (such as those used in endoscope sheaths, take-apart forceps and trocars) that are:
• ≥ 3 mm ID and ≤ 298 mm in length
• · ≥ 4 mm ID and

The V-PRO Low Temperature Sterilization Systems are vaporized hydrogen peroxide sterilizers.

The sterilizers have three or more of 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 Systems are intended for terminal sterilization of cleaned, rinsed, dried, and packaged reusable surgical instruments used in healthcare facilities.

The V-PRO Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The four preprogrammed cycles all use 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 manufacturer is seeking 510(k) clearance for modifications to the V-PRO maX and V-PRO maX 2 Low Temperature Sterilization Systems. These modifications involve changes to the indications for use, specifically by simplifying claims descriptions for Flexible and Lumen Cycles, adding stainless steel lumen claims to the Flexible Cycle, adding non-metallic and stainless steel lumen claims to the Lumen Cycle, and adding diffusion-restricted materials for Non Lumen and Fast Non Lumen Cycles. No physical changes were made to the devices, only changes to the labeling (operator manual).

Here's an analysis of the acceptance criteria and the study presented:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a dedicated table for each performance outcome. Instead, it reports "PASS" for all tests, indicating that the device met the internal established criteria for each study. The underlying acceptance for sterilization efficacy is typically a complete kill of biological indicators, resulting in sterility.

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

• 1/2 Cycle Verification of Mated Surfaces: The document does not explicitly state the sample size for this test. It refers to "mated surfaces" and "worst-case conditions."
• 1/2 Cycle Efficacy: The document does not explicitly state the sample size. It refers to "the validation load used to qualify each sterilizer cycle."
• Simulated Use Test: The document does not explicitly state the sample size. It refers to "medical devices" and "worst-case processing conditions."
• In Use Test: The document does not explicitly state the sample size. It refers to "patient-soiled, clinically-cleaned, medical instruments."

For all tests, the provenance of the data (country of origin, retrospective or prospective) is not explicitly stated. However, given the context of a 510(k) submission to the U.S. FDA, it is highly probable that the studies were conducted in accordance with recognized standards, likely within the U.S. or using internationally recognized protocols acceptable to the FDA. The nature of these sterilization validation studies often involves prospective testing.

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

This type of information is not applicable to this submission. The "device" in question is a sterilization system, not a diagnostic or AI-driven decision support system that requires expert interpretation to establish ground truth (e.g., presence/absence of disease in an image). The "ground truth" in sterilization validation is binary: either sterility is achieved (e.g., biological indicator shows no growth) or it is not. This is typically determined by laboratory analysis of biological indicators, not expert consensus.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons mentioned above. Adjudication methods like 2+1 or 3+1 are used when there's subjective interpretation involved, such as in image analysis by multiple readers. Sterilization efficacy is an objective outcome measured by biological indicators.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is a sterilization system, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is a physical sterilization system, not an algorithm.

7. The type of ground truth used:

The ground truth used for these sterilization studies is based on biological indicator (BI) kill and potentially chemical indicator (CI) response, which are direct measures of sterilization efficacy. In sterilization validation, biological indicators containing a known resistant microorganism (e.g., Geobacillus stearothermophilus) are exposed to the sterilization process. The "ground truth" that sterility has been achieved is established when these biological indicators show no growth after incubation, indicating that the microorganisms have been inactivated. This is an objective, laboratory-derived ground truth.

8. The Sample Size for the Training Set:

This is not applicable. The device is a physical sterilization system. There is no "training set" in the context of machine learning. The "training" and "validation" in this field refer to the rigorous process of developing and confirming the sterilization cycle parameters to reliably achieve sterility across a defined range of medical devices and load configurations.

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

This is not applicable for the reasons stated above. There is no machine learning training set. The "ground truth" for establishing sterilization parameters is derived from extensive scientific and engineering studies testing the lethality of the sterilant under various conditions, typically using biological indicators and physical parameter monitoring. This involves determining the "D-value" (decimal reduction time) of the biological indicator organism and then designing a cycle that provides a sufficient "sterility assurance level" (SAL), often 10^-6, meaning a one-in-a-million chance of a non-sterile item.

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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 V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems 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 temperature, suitable for processing medical devices without leaving toxic residues. Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle.

The V-PRO 1 Plus and V-PRO maX Sterilizers' Non Lumen Cycle can sterilize:
Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid and flexible endoscopes.

The V-PRO maX Sterilizer's Flexible Cycle can sterilize:
Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations:

1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. The flexible endoscopes may contain either:
   A single lumen that is ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length
   Or two lumens with:
   One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
   And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length
2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments. The flexible endoscope may contain either:
   A single lumen that is > 1 mm ID and ≤ 1050 mm in length
   Or two lumens with:
   One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
   And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length.

The V-PRO 1, V-PRO 1 Plus and V-PRO maX Sterilizers' Lumen Cycle can sterilize:
Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:
Single channeled devices with a stainless lumen that is ≥ 0.77 mm ID and ≤ 500 mm in length
Single channeled devices with a stainless lumen that is ≥ 1.8 mm ID and ≤ 542 mm in length
Dual channeled devices with stainless lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length
Triple channeled devices with stainless lumens that are either
≥ 1.2 mm ID and ≤ 275 mm in length
≥ 1.8 mm ID and ≤ 310 mm in length or
≥ 2.8 mm ID and ≤ 317 mm in length

The V-PRO maX 2 Low Temperature Sterilization Systems 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 temperature, suitable for processing medical devices without leaving toxic residues.
Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle and Fast Non Lumen Cycle.

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

The Fast Non Lumen Cycle can sterilize:
Non-lumened instruments including non- lumened general medical instruments, non- lumened rigid, semi-rigid and flexible endoscopes.

The Flexible Cycle can sterilize:
Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations:

1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. The flexible endoscopes may contain either:
   A single lumen that is ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length
   Or two lumens with:
   One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
   And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length
2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments. The flexible endoscope may contain either:
   A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length
   Or two lumens with:
   One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
   And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length.

The Lumen Cycle can sterilize:
Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:
Single channeled devices with a stainless lumen that is ≥ 0.77 mm ID and ≤ 500 mm in length
Single channeled devices with a stainless lumen that is ≥ 1.8 mm ID and ≤ 542 mm in length
Dual channeled devices with stainless lumens that are > 0.77 mm ID and

The V-PRO Low Temperature Sterilization Systems are vaporized hydrogen peroxide sterilizers. The sterilizers have one or more of 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 Systems are intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities. The V-PRO Sterilizers uses VAPROX HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The four preprogrammed 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.

This document describes the V-PRO Low Temperature Sterilization Systems, specifically the V-PRO 1, V-PRO 1 Plus, V-PRO maX, and V-PRO maX 2 models. The information provided focuses on their indications for use and the validation studies conducted to prove their effectiveness.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes two main tests to demonstrate the device meets acceptance criteria for sterilization efficacy. The acceptance criteria for biological indicators (BIs) are generally defined by a "total kill endpoint," meaning no microbial growth after sterilization, which is achieved at a specific sterilant injection weight. The "simulated use test" acceptance criteria are that the sterilizer cycles successfully sterilize medical devices under worst-case conditions.

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

The document doesn't explicitly state a "test set" in the context of a typical AI/ML study (e.g., number of images, cases). Instead, it refers to "validation loads" and "lumen sizes" for sterilization efficacy testing.

• Validation Loads: Various validation loads are described depending on the specific cycle (Non Lumen, Flexible, Lumen) and device model.

  • V-PRO 1 Plus and V-PRO maX (Non Lumen Cycle): Two instrument trays for a total weight of 50 lbs (22.7 kg).
  • V-PRO maX (Flexible Cycle, Configuration 1): Two flexible endoscopes, each packaged into a tray with a silicone mat and light cord.
  • V-PRO maX (Flexible Cycle, Configuration 2): One flexible endoscope in a tray with a silicone mat and light cord, plus an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg).
  • V-PRO 1, V-PRO 1 Plus, V-PRO maX (Lumen Cycle): A maximum of 20 lumens per load. The validation studies used a load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg).
  • V-PRO maX 2 (Non Lumen Cycle): Two instrument trays for a total weight of 50 lbs (22.7 kg).
  • V-PRO maX 2 (Fast Non Lumen Cycle): One pouched instrument tray for a total weight of 11 lbs (5 kg).
  • V-PRO maX 2 (Flexible Cycle, Configuration 1): Two flexible endoscopes, each packaged into a tray with a silicone mat and light cord.
  • V-PRO maX 2 (Flexible Cycle, Configuration 2): One flexible endoscope in a tray with a silicone mat and light cord, plus an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg).
  • V-PRO maX 2 (Lumen Cycle): A maximum of 20 lumens per load. The validation studies used a load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg).

• Data Provenance: The document does not specify the country of origin of the data. The studies are described as "validation studies" and "non-clinical performance tests," implying they were conducted prospectively to validate the sterilization claims of the device.

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 context of sterilization validation, "ground truth" is typically established through microbiological methods (e.g., culturing biological indicators to confirm sterility or lack thereof) rather than expert interpretation of medical images or case data. Therefore, the concept of "experts" in the traditional sense of clinical opinion is not directly applicable to this type of device validation. The "experts" would likely be microbiologists or validation engineers.

4. Adjudication Method for the Test Set:

Not applicable. As described above, the "ground truth" for sterilization efficacy is typically determined by objective microbiological culture results (growth/no growth of biological indicators), not by subjective expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. These devices are sterilizers, and their performance is evaluated based on direct microbiological efficacy, not on the improvement of human reader performance using AI assistance. The document explicitly states the studies are "non-clinical performance tests."

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

This question is not applicable in the context of this device. The V-PRO systems are sterilization machines, not AI algorithms designed to assist human interpretation. Their "standalone" performance is the validation of their sterilization efficacy without human intervention in the sterilization process itself. The software controls the sterilization cycle, and its performance is part of the overall device validation.

7. The Type of Ground Truth Used:

The ground truth for these validation studies is primarily:

• Microbiological Sterility (Biological Indicators): The "total kill endpoint verification" test indicates the use of biological indicators (BIs) which contain a known number of resistant microorganisms (e.g., Geobacillus stearothermophilus spores). Sterility is achieved when no growth of these microorganisms is detected after processing.
• Physical and Chemical Parameters: The document mentions "critical process parameters" such as "Time, Chamber Temperature, Vaporizer Temperature, Chamber Pressure Prior to Injection, Sterilant Injection Weight." These parameters are controlled and monitored to ensure the cycle performs optimally, contributing to the "ground truth" that appropriate conditions for sterilization were met.

8. The Sample Size for the Training Set:

This information is not provided, and the concept of a "training set" in the context of machine learning is not directly applicable to these physical sterilization devices. The physical properties and mechanisms of sterilization are based on established scientific principlesvalidated through controlled experiments, not through training an algorithm on a dataset. The formulation of the VAPROX HC Sterilant and the design of the sterilization cycles are based on research and development, not on a machine learning training set.

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

Not applicable, as there is no mention of a "training set" for an AI/ML algorithm within the provided text for these sterilization devices. The "ground truth" for the development and validation of these sterilizers is based on established methods in microbiology and validated sterilization principles (e.g., D-value determination, overkill methods) which define what constitutes a sterile condition and how to achieve it.

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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.

Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle and Fast Non Lumen Cycle.

The Non Lumen Cycle can sterilize: †

Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid and flexible endoscopes.

t: The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).

The Fast Non Lumen Cycle can sterilize: *

Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid and flexible endoscopes.

• The validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg).

The Flexible Cycle can sterilize:

Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations:

1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain either:

• · A single lumen that is ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length
• · Or two lumens with:
  • One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
  • And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length

• The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).

2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments. ++ The flexible endoscope may contain either:

• A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length

• Or two lumens with:

• One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
• And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length.

** The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg).

The Lumen Cycle can sterilize: †

Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:

• Single channeled devices with a stainless lumen that is > 0.77 mm ID and ≤ 500 mm in length
• Dual channeled devices with stainless lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length
• · Triple channeled devices with stainless lumens that are either:
  • ≥ 1.2 mm ID and ≤ 275 mm in length

  • 1.8 mm ID and

The V-PRO maX 2 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 Amsco V-PRO 1, Amsco V-PRO 1 Plus, V-PRO maX and V-PRO 60 Sterilizers.

As with the predicate device (K162413), the V-PRO maX 2 Sterilizer has three preprogrammed cycles (the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycle) with a fourth added (the Fast Non Lumen Cycle). The V-PRO maX 2 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 maX 2 Sterilizer uses VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Its four preprogrammed 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 describes the V-PRO® maX 2 Low Temperature Sterilization System, a medical device for sterilizing instruments. It is a 510(k) premarket notification, indicating it is intended to be substantially equivalent to a predicate device, not a new type of device requiring extensive clinical trials for efficacy. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to performance tests demonstrating substantial equivalence to the predicate device and the general efficacy of the sterilization process.

Here's an breakdown based on your request, interpreting "acceptance criteria" as the required successful outcomes of the performance tests for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document primarily discusses device performance and sterilization efficacy, not diagnostic accuracy where "test sets" of patient data are typically used. Instead, the "test set" here refers to the biological indicators (BIs) and test loads used in the sterilization efficacy studies.

• AOAC Sporicidal Test: "All 720 carriers processed using 3 lots of EOSL sterilant were sterile." This implies a total of 720 biological indicators (carriers).
• Other Efficacy Tests (D-value, Total Kill, 1/2 Cycle Verification, Simulated Use, In Use): These tests involve specific "validation loads" and "worst-case conditions."
  • Non Lumen Cycle: Validation load of two instrument trays for a total weight of 50 lbs (22.7 kg).
  • Fast Non Lumen Cycle: Validation load of one pouched instrument tray for a total weight of 11 lbs (5 kg).
  • Flexible Cycle (Load Config 1): Two flexible endoscopes, each packaged into a tray with silicone mat and light cord.
  • Flexible Cycle (Load Config 2): One flexible endoscope in a tray with silicone mat and light cord, plus an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg).
  • Lumen Cycle: A maximum of 20 lumens per load, using a validation load of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg).
  • "Patient-soiled, clinically-cleaned, medical instruments" were used for the in-use test.

Data Provenance: The studies were conducted by the device manufacturer (STERIS Corporation) internally as part of their premarket notification for the Food and Drug Administration (FDA) in the USA. These are laboratory and simulated/actual use tests, not human data. The context implies these are prospective tests designed to prove the device's performance.

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

This information is not applicable in the context of device sterilization validation. "Ground truth" for sterilization is established by scientific principles of microbial inactivation (e.g., whether biological indicators containing a known number of resistant spores are killed), rather than expert consensus on interpretive tasks. The methodology for assessing sterility (e.g., incubation of biological indicators) relies on established microbiological techniques.

4. Adjudication Method for the Test Set:

Not applicable. Sterility tests involve objective outcomes (growth or no growth of microorganisms). There is no "adjudication" in the sense of resolving disagreements between human readers, as for an AI diagnostic tool.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and AI might assist in that interpretation. This document is about a sterilization device, which does not involve human interpretation of output in that manner.

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

The device itself is a "standalone" sterilizer. Its performance is evaluated purely on its ability to sterilize medical instruments, without human intervention in the sterilization process once initiated. The tests performed (e.g., AOAC Sporicidal Test, D-value determination) are indeed standalone assessments of the device's efficacy. There is no "human-in-the-loop" concept for the primary function of sterilization.

7. The Type of Ground Truth Used:

The ground truth used for these performance tests is microbiological eradication/inactivation.

• For the AOAC Sporicidal Test, D-value, and Total Kill Endpoint, the ground truth is the absence of viable microorganisms (specifically, highly resistant bacterial spores like Geobacillus stearothermophilus). This is determined by standard microbiological culture techniques (e.g., incubating biological indicators and observing for growth).
• For the "In Use Test," the ground truth for successful sterilization of patient-soiled instruments would similarly be the absence of microbial growth from processed items.
• For biocompatibility and material compatibility, the ground truth is established through standardized cytotoxicity assays and visual / functional assessment of materials following repeated processing.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical sterilizer and not an AI/machine learning model that undergoes "training." Its operational parameters are designed and validated based on scientific principles of sterilization, not statistical inference from a training dataset derived from "training examples."

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

Not applicable, as there is no "training set" in the context of this traditional device validation.

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