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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 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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