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The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.

The STERIZONE® VP4 Sterilizer (VP4) is a self-contained stand-alone device, using vaporized hydrogen peroxide and ozone in a multiphase process. The VP4 offers a single sterilization cycle intended for general instruments, flexible endoscopes (including single, dual, and multi-channel devices), and rigid-channel devices (including single-channel and doublechannel rigid endoscopes).

Lumen claims for the VP4 have been expanded to include double and multiple-channel devices with no more than four channels.

Here's a breakdown of the acceptance criteria and the study details for the STERIZONE® VP4 Sterilizer, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device's performance in terms of its ability to achieve sterility under various load conditions and its compliance with safety standards. The core acceptance criterion for effectiveness is demonstrating a Sterility Assurance Level (SAL) of 10⁻⁶.

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

• Sample Size: The test set for effectiveness involved nine separate validation loads. The specific number of individual medical devices or biological indicators within each load is implied to be sufficient to demonstrate SAL 10⁻⁶ for the represented device types and geometries, but a precise count of individual items is not given.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the study was retrospective or prospective. However, given that it's a 510(k) submission to the U.S. Food & Drug Administration (FDA) by a company (TSO3 Inc.) located in Quebec, Canada, it's reasonable to infer that the studies were conducted by or on behalf of TSO3 Inc., likely in Canada or a facility compliant with regulatory standards for such testing. The validation studies appear to be prospective, designed specifically to demonstrate the effectiveness of the sterilizer for the expanded claims.

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

This information is not explicitly provided in the document. The determination of sterility (ground truth for effectiveness) in such studies is typically established through the "overkill" approach using biological indicators (BIs) with a known high resistance to the sterilization process. The expertise involved would be in microbiology and sterilization sciences, ensuring proper BI preparation, inoculation, exposure, and recovery methods that align with standards like ANSI/AAMI/ISO 14937. However, no specific number of experts or their qualifications are mentioned.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. Sterilization validation studies using biological indicators do not involve human "adjudication" in the sense of multiple experts reviewing results like in diagnostic imaging studies. The outcome (sterility or growth) of biological indicators is a direct, objective measure interpreted by microbiological methods.

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 results, sometimes with AI assistance. The STERIZONE® VP4 Sterilizer is a medical device for sterilization, which has objective performance metrics (sterility, safety) and does not involve human readers interpreting device output in a comparative effectiveness setting as described.

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

Yes, the effectiveness study of the STERIZONE® VP4 Sterilizer is inherently a standalone performance evaluation. The device's primary function is to perform sterilization independently. The "performance validation testing" described directly assesses the sterilizer's ability to achieve a Sterility Assurance Level (SAL) of 10⁻⁶ without human intervention or interpretation during the sterilization process itself. The study confirms that the sterilizer, as a standalone automated system, effectively sterilizes the specified medical devices.

7. The Type of Ground Truth Used:

The ground truth used for effectiveness was based on microbiological challenge testing, specifically:

• Biological Indicators (BIs): The "overkill" approach typically involves using biological indicators with a high concentration of resistant microorganisms (e.g., bacterial spores like Geobacillus stearothermophilus) placed in the most challenging locations within the test load.
• Achievement of SAL 10⁻⁶: The ground truth is confirmed by showing the complete inactivation of these highly resistant microorganisms, demonstrating a sterility assurance level of 1 viable microorganism in a million.

8. The Sample Size for the Training Set:

This information is not applicable and therefore not provided. The STERIZONE® VP4 Sterilizer is a physical device that performs a sterilization process, not an AI/machine learning algorithm that requires a "training set" of data in the computational sense. Its performance is validated through defined physical and microbiological challenges.

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

This information is not applicable for the reasons stated in point 8. The device's operational parameters and design are based on established scientific principles of sterilization, engineering, and validated through performance testing rather than training on a data set.

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The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and nonmetal reusable medical devices in health care facilities.

The single pre-set cycle of the STERIZONE® VP4 Sterilizer uses hydrogen peroxide and ozone. The injection of vaporized hydrogen peroxide is followed by the injection of ozone, with residual hydrogen peroxide to form hydroxyl radicals.

Sterilization efficacy was demonstrated using a representative sample of one or more device types and packaging, in nine separate validation loads, as described in Table 1. The load to be processed should be maintained between 20℃ to 26℃ (68°F to 78°F). Total load weight shall not exceed 75 lb, inclusive of the containers/packaging weight but excluding the 25 1b loading rack.

The STERIZONE® VP4 Sterilizer is a versatile low temperature sterilizer using two sterilants (vaporized hydrogen peroxide [H₂O₂] and ozone [O₃]) in a multi-phase process to sterilize reusable medical instruments up to a maximum load of 75 lb. In contrast to the sterilization processes using H2O2 only and having multiple cycles, the STERIZONE® VP4 Sterilizer enables the sterilization of a wider range of instruments and load configuration with only one preset cycle. The dynamic system to distribute the sterilant ensures an adequate supply of the sterilant through multiple successive pulsed injections that adapt to the different load conditions (size, weight and temperature). The STERIZONE® VP4 Sterilizer offers a unique preset sterilization cycle (Cycle 1) to sterilize a wide range of loads consisting of general instruments, flexible endoscopes with one channel, double channels and multi-channels, and devices with rigid and semi-rigid channels, including rigid endoscopes with single or double channels.

This document is a 510(k) premarket notification for the STERIZONE® VP4 Sterilizer, specifically addressing an air vent option (K173694) in comparison to a previously cleared version (K153689). The primary focus of the document is to demonstrate substantial equivalence, rather than providing a detailed report of the original validation study for the sterilizer's efficacy.

Therefore, many of the requested details about a study proving the device meets acceptance criteria, such as specific performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment, are not explicitly provided for the overall sterilizer efficacy. The document focuses on showing that the change (air vent option) does not negatively impact performance or safety.

However, based on the provided text, here is an attempt to address your questions where information is available:

1. A table of acceptance criteria and the reported device performance

The document primarily discusses sterilization efficacy as the overarching performance goal. The "acceptance criteria" for sterilization efficacy is implicitly achieving sterilization, meaning a biological indicator showing no growth. The reported "device performance" is that sterilization efficacy was demonstrated.

The document outlines the types of devices and loads used in validation studies but doesn't provide specific numerical outcomes for sterilization efficacy (e.g., Sterility Assurance Level, or SAL, achieved). It states that the device is "intended for use in terminal sterilization of cleaned, rinsed, and nonmetal reusable medical devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The sterilization efficacy was demonstrated using a "representative sample of one or more device types and packaging, in nine separate validation loads" (as described in Table 1). The specific number of individual devices or biological indicators within each load is not detailed in this summary.
• Data Provenance: Not explicitly stated as retrospective or prospective, but validation studies for medical devices are typically prospective. The company (TSO3 Inc.) is based in Quebec, Canada, suggesting the studies could have been performed there or internationally.

3. 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 information is not provided in the document. For sterilization efficacy, the "ground truth" is typically established by the growth or non-growth of biological indicators (e.g., spore strips) after exposure to the sterilization process, followed by incubation. This is a scientific and microbiological assessment, not usually based on expert consensus in the way image interpretation might be.

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

Not applicable in the context of sterilization efficacy studies as described. The outcome (sterile or not sterile) is determined by objective microbiological testing methods using biological indicators, not human adjudication.

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

Not applicable. The STERIZONE® VP4 Sterilizer is a medical device for sterilization, not an AI-assisted diagnostic tool or an imaging device. Therefore, MRMC studies are not relevant to its evaluation.

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

This question is not applicable to a physical sterilizer device. Its performance is inherent to its mechanical and chemical processes, not an algorithm.

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

For sterilization efficacy, the ground truth is established by biological indicator (BI) testing. This involves placing a known quantity of highly resistant microorganisms (e.g., Geobacillus stearothermophilus spores) in challenge devices within the sterilization load. After the sterilization cycle, these BIs are retrieved and incubated. No growth of the test organism indicates successful sterilization (a negative BI result).

Additionally, physicochemical monitoring, such as chemical indicators (CIs) or physical parameters measured by the device itself, would also be used as part of the total validation of the sterilization process.

8. The sample size for the training set

Not applicable. This document describes the validation of a physical sterilizer, not a machine learning algorithm.

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

Not applicable. This document describes the validation of a physical sterilizer, not a machine learning algorithm.

Additional Information from the Document Regarding the Validation Study:

• Validation Loads: Nine distinct validation loads were used, described in Table 1 (pages 3, 4, 7). These loads varied in terms of medical instrument geometries (e.g., clamp, serrated surface, hinged, lumens, scopes), packaging types (wrapped plastic tray, aluminum tray, pouch, rigid containers), and total weight. They included both general medical instruments and flexible and rigid endoscopes with varying channel diameters and lengths.
• Load Conditions: The load to be processed must be maintained between 20℃ to 26℃ (68°F to 78°F). Total load weight shall not exceed 75 lb, inclusive of containers/packaging, but excluding the 25 lb loading rack.
• Sterilization Method: Uses hydrogen peroxide and ozone, forming hydroxyl radicals.
• Cycle: A single pre-set cycle ("Cycle 1").
• The overall conclusion is that the updated device (with the air vent option) is "substantially equivalent" to the predicate device, implying that the established sterilization efficacy of the predicate is maintained.
• Biocompatibility testing was also performed, verifying that residual sterilants were within acceptable criteria, demonstrating biological safety.

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The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.

The single pre-set cycle of the STERIZONE® VP4 Sterilizer uses hydrogen peroxide and ozone. The injection of vaporized hydrogen peroxide is followed by the injection of ozone, which reacts with residual hydrogen peroxide to form hydroxyl radicals.

Sterilization efficacy was demonstrated using a representative sample of one or more device types and packaging, in seven separate validation loads, as described in Table 1. The load to be processed should be maintained between 20℃ to 26℃ (68°F to 78°F). Total load weight shall not exceed 75 lbs, inclusive of the containers/packaging weight but excluding the 25 Ibs loading rack.

The STERIZONE® VP4 Sterilizer (VP4) is a self-contained stand-alone device, using vaporized hydrogen peroxide and ozone in a multiphase process. The VP4 offers a single sterilization cycle intended for general instruments, single-channel flexible endoscopes, and rigid-channel devices including single-channel and double-channel rigid endoscopes.

The VP4 has been modified in order to make it compliant with the European Directive on the Restriction Of use of certain Hazardous Substances also known as « RoHS ». In addition, device software has been modified to include a maintenance mode, among other small changes. Finally, a new sensor has been adopted for monitor and control of chamber pressure.

Here's a breakdown of the acceptance criteria and study information for the STERIZONE® VP4 Sterilizer, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the demonstration of a sterility assurance level (SAL) of 10^-6, which is a standard for sterilization effectiveness. The "overkill" approach used in testing suggests that the device's performance exceeds this minimum requirement.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The test set for demonstrating sterilization efficacy consisted of a "representative sample of one or more device types and packaging, in seven separate validation loads." The details of these loads are provided in Table 1 (pages 2-3 and 5-6). For example:
  • Load 1: General medical instruments (e.g., clamp, serrated surface, box-lock) – 11 lb load.
  • Load 3: Three single-channel flexible endoscopes + eight general medical instruments – 23 lb load.
  • Load 4: Up to 15 rigid or semi-rigid channeled instruments + two general medical instruments – 19 lb load.
  • Load 7: General medical instruments – 75 lb load.
• Data Provenance: The document (page 4) states the applicant's name and address as TSO3 Inc., Quebec, QC, Canada. This indicates the testing and data likely originated from Canada, although the exact location of the testing facility is not specified. The study is prospective as it involves performance validation testing of the STERIZONE® VP4 Sterilizer to demonstrate its effectiveness.

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

This information is not provided in the document. The study focuses on the physical and biological efficacy of a sterilizer, not on interpretation by human experts. The "ground truth" for sterilization is typically established through standard microbiological methods (e.g., biological indicators, culturing) demonstrating the absence of viable microorganisms.

4. Adjudication Method for the Test Set

This is not applicable as the study does not involve subjective human assessment requiring adjudication. The assessment of sterilization efficacy is based on objective biological and physical measurements.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, often with and without AI assistance. The STERIZONE® VP4 Sterilizer is a sterilization device, and its performance is evaluated by its ability to sterilize, not by human interpretation of its output.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

Yes, a standalone performance study was done. The document explicitly states: "The modified STERIZONE® VP4 Sterilizer underwent performance validation testing using the « overkill » approach to demonstrate the effectiveness of the process." This describes the algorithm (sterilization process) acting independently to achieve sterility. The efficacy is demonstrated by achieving a 10^-6 SAL, inherently a standalone performance metric.

7. Type of Ground Truth Used

The ground truth used for demonstrating sterilization efficacy is microbiological (biological indicators). The "overkill approach" and "achievement of a sterility assurance level (SAL) of 10^-6" directly refer to the statistical probability of a single viable microorganism remaining after sterilization, which is determined through testing with highly resistant bacterial spores (biological indicators).

8. Sample Size for the Training Set

This information is not explicitly provided in the document. The document describes verification and validation testing for the modified device, but does not detail a separate "training set" in the context of machine learning. The term "training set" is usually associated with AI/ML model development. While the device contains software, the efficacy testing described is typical for a medical device sterilizer, where robust physical and biological challenge tests are performed, rather than machine learning model training.

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

As no explicit "training set" in the machine learning sense is described, this information is not applicable. The ground truth for the performance validation (test set equivalent) was established through microbiological methods using biological indicators to confirm sterility, typically following established standards for sterilization validation.

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