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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. 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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The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems, with VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and are thus suitable for processing medical devices sensitive to heat and moisture.

The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle can sterilize:(a)

• Lumened and non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
• Medical devices, including single, dual and triple channeled rigid endoscopes, with the following configurations: (a)
  • o single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length
  • o dual channeled devices with stainless steel lumens that are > 0.77 mm ID and 2.8 mm ID and 1 mm ID and 1 mm ID and

The V-PRO 1 Plus and V-PRO maX Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Devices that meet the criteria described within the indications for use and composed of compatible materials are placed within the sterilization chamber and the appropriate cycle selected through the graphic user interface. The preprogrammed cycles all utilize a conditioning phase which prepares the chamber, a sterilize phase in which loaded devices are exposed to the sterilizing agent, VHP, at low pressure and an aeration phase to remove residual hydrogen peroxide. 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 V-PRO 1 Plus Low Temperature Sterilization System provides two cycle options, Lumen and Non Lumen. The sterilizer contains a 136 L welded aluminum chamber with two shelves for device loading, an onboard printer to provide cycle printouts, a cup interface where the VAPROX HC cups are loaded, a display for the graphic user interface and the components necessary to achieve the desired cvcle parameters (injection cylinder, vaporizer, vacuum pump and catalytic converter). The side panels of the sterilizer are composed of stainless steel.

The V-PRO maX Low Temperature Sterilization System provides three cycle options, Lumen, Non Lumen and Flexible. The sterilizer contains a 136 L welded aluminum chamber with two shelves for device loading, an onboard printer to provide cycle printouts, a cup interface where the VAPROX HC cups are loaded, a display for the graphic user interface and the components necessary to achieve the desired cycle parameters (injection cylinder, vacuum pump and catalytic converter). The side panels of the sterilizer are composed of plastic.

The purpose of this pre-market notification is to modify the maximum load weight for the Non Lumen Cycle from 19.65 to 50 lbs, to add titanium diffusion-restricted areas to the indications for use of the Non Lumen Cycle, and to remove the term "reusable" from indications for use statement.

The FDA 510(k) summary for the V-PRO® 1 Plus and V-PRO® maX Low Temperature Sterilization Systems describes performance testing to support the substantial equivalence claim. Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the "PASS" result in the context of sterilization, meaning the device successfully sterilized the test articles under specified conditions. The document acts as a summary, so detailed quantitative acceptance criteria (e.g., specific log reduction of microorganisms) are not explicitly stated in this high-level summary but are inherent to sterilization validation.

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state a numerical sample size for the test set in terms of the number of items sterilized in total. However, it provides details on the load configurations used in the validation studies:

• Lumen Cycle: Maximum of twenty (20) lumens per load, using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.
• Non Lumen Cycle: Validation load consisting of two instrument trays for a total weight of 50 lbs. (This is a modification from the previous 19.65 lbs of two instrument trays and two pouches).
• Flexible Cycle (Config 1): Two flexible endoscopes (with light cord/mat) with no additional load.
• Flexible Cycle (Config 2): One flexible endoscope (with light cord/mat) and additional non-lumened instruments (instrument tray and one pouch) for a total load weight of 24.0 lbs.

The data provenance is not explicitly stated as retrospective or prospective, nor is a country of origin identified for the data. Given it's a pre-market notification for a medical device by the STERIS Corporation (Mentor, OH, USA), it is highly likely the studies were prospective, conducted by the manufacturer, and likely performed in the USA or under relevant international standards.

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

The document does not mention the use of human experts to establish ground truth for the test set. Sterilization validation typically relies on objective measures, primarily biological indicators (BIs) containing highly resistant bacterial spores (e.g., Geobacillus stearothermophilus) and chemical indicators (CIs). The "ground truth" for sterilization is the complete inactivation of these spores, indicated by no growth.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth for sterilization is objective (growth/no growth of biological indicators), not based on human interpretation or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a sterilization system, not an AI-assisted diagnostic or interpretive device that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is a standalone system. The "algorithm" here is the pre-programmed sterilization cycle, and its performance is assessed directly against the ability to sterilize. There is no human intervention in the sterilization process itself; the human selects the cycle and loads the sterilizer. The performance data presented (e.g., ½ Cycle Modified Total Kill Endpoint Verification, Simulated Use Test) are indeed standalone performance of the device without human interpretation of the sterilization outcome itself.

7. Type of Ground Truth Used

The primary ground truth for sterilization efficacy is the inactivation of biological indicators (BIs). The document explicitly mentions:

• "reproducibly sterilized under worst case ½ cycle conditions" for STERIS VERIFY® V24 Self-Contained Biological Indicator (SCBI).
• "all SCBIs were negative for growth under worst case full cycle conditions."

Additionally, chemical indicators (CIs) are used to confirm exposure to the sterilant, showing "complete color change."

8. Sample Size for the Training Set

Not applicable. This device is a physical sterilizer and its associated pre-programmed cycles, not a machine learning model that requires a "training set" in the conventional AI sense. The "training" of the cycles would refer to the developmental and engineering process of determining optimal parameters, which involves a different type of experimental design and validation than data-driven machine learning model training.

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

Not applicable, for the same reasons as point 8. The "ground truth" for developing the sterilizer's parameters (e.g., sterilant injection, exposure time, pressure, temperature) would have been established through extensive empirical experimentation and adherence to sterilization standards (e.g., AAMI, ISO) to achieve a validated Sterility Assurance Level (SAL) of 10^-6 or better. This involves progressively testing parameters with biological indicators to determine the minimum conditions required for sterility.

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