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The STERIZONE® VP4 Test Pack is intended to be used for routine monitoring of the STERIZONE® VP4 Sterilizer cycle (Cycle 1) and for the performance validation of the STERIZONE® VP4 Sterilizer system.

The STERIZONE® VP4 Test Pack is a Process Challenge Device (PCD) designed to have greater resistance than the worst-case sterilization load of the STERIZONE® VP4 Sterilizer. The STERIZONE® VP4 Test Pack is intended to simulate products to be sterilized and to constitute a defined challenge to the sterilization process and used to assess the effective performance of the process.

The STERIZONE® VP4 Test Pack (subject device) is composed of a Self-contained Biological Indicator (the Terragene's Bionova® BT96), a 10 mL syringe and its plunger, and a diffusion restrictor. A STERIZONE® CI+ Chemical Indicator is also added, external to the syringe, to allow differentiating processed from unprocessed test packs. All components of the Test Pack are single-use, disposable items.

The provided text describes the performance testing of the STERIZONE® VP4 Test Pack (subject device) which uses the Terragene Bionova® BT96 biological indicator, compared to a predicate device that used a different biological indicator. The goal was to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the numerical sample size for the test set (e.g., number of test packs, number of sterilization cycles). It mentions "all the limit parameter loads tested" for half-cycle survivability and "partial cycles" for increased resistance, implying multiple runs, but no specific number.

The data provenance is from bench testing ("Performance Testing - Bench") conducted by TSO3 Inc. (now part of Stryker) for this 510(k) submission. The location of the testing is not specified, but the submitter is TSO3 Inc. in Québec, Canada and Stryker in Portage, Michigan, USA. The nature of the study is prospective, as it's performance testing for a new device qualification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. For biological indicators, the ground truth is typically established by the growth or non-growth of spores, which is a direct biological outcome, not subject to expert interpretation in the same way as, for example, a medical imaging diagnosis.

4. Adjudication method for the test set:

This information is not applicable and therefore not provided. The results of biological indicator testing (growth or no growth) are objective and do not require adjudication by multiple experts.

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:

This information is not applicable as the device is a sterilization process indicator, not an AI-powered diagnostic tool for human readers.

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

This information is not applicable. The device is not an algorithm, but a physical biological indicator used in a sterilization process. Its performance is inherent to its design and biological response, not an algorithm's output.

7. The type of ground truth used:

The ground truth used is biological growth/non-growth of Geobacillus stearothermophilus spores. This is a direct measure of the effectiveness of the sterilization process in inactivating microorganisms.

8. The sample size for the training set:

This information is not applicable. The STERIZONE® VP4 Test Pack is a physical device, not a machine learning model, so there is no training set in the context of AI/ML. The device's resistance characteristics are determined through experimental validation, not by "training" an algorithm.

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

This information is not applicable as there is no training set. The performance is assessed against established standards for biological indicators.

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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 nine separate validation loads, as described in Table 1 [refer to continuation pages 2 - 4 of this form]. 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 lb 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, flexible endoscopes (including single, dual, and multichannel devices), and rigid-channel devices (including single-channel and double-channel rigid endoscopes). The changes to the sterilizer are component changes that were made to extend the of the hydrogen peroxide vaporization block. These changes include: 1] anodization of the hydrogen peroxide vaporization block, and 2] a reduction of the stabilizer concentration in the hydrogen peroxide solution.

This document describes the non-clinical testing and validation of the STERIZONE® VP4 Sterilizer, specifically focusing on changes to the hydrogen peroxide vaporization block and the hydrogen peroxide solution. The primary goal of the study was to demonstrate that the modified device maintains the same safety and effectiveness as its predicate (K173694).

Here's an analysis based on the provided text:

1. Acceptance Criteria and Reported Device Performance:

The primary acceptance criterion is that the modified STERIZONE® VP4 Sterilizer achieves a Sterility Assurance Level (SAL) of 10⁻⁶ using an overkill approach. It also needed to meet various safety and performance standards.

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

• Sample Size for Test Set: The sterilizer underwent "nine separate validation loads" as described in Table 1 (pages 3-4 and reiterated on page 7). Each load represented specific types of medical instruments, geometries, and packaging. The text does not specify the exact number of individual items or biological indicators within each load, but it refers to the use of "directly inoculated medical devices."
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. However, based on the applicant's address (TSO3 Inc., Québec, QC G1P 3S5 Canada) and the FDA submission, the testing likely occurred in a controlled lab environment, most likely in Canada or the US, as part of a prospective validation study for regulatory submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• This document is for a sterilizer device, not an AI or imaging device that requires diagnostic interpretation by human experts. Therefore, the concept of "experts establishing ground truth for a test set" in the context of radiological reads or similar scenarios is not applicable here.
• The "ground truth" for a sterilizer's performance is established by microbiological testing (e.g., biological indicators, inoculated devices) and subsequent culturing to verify the absence of viable microorganisms. The expertise lies in microbiology, sterilizer validation, and engineering, rather than clinical interpretation.

4. Adjudication Method for the Test Set:

• Not applicable as this is a sterilizer validation study, not a study involving human reader interpretation or adjudication of diagnostic findings. The results are quantitative (sterility assurance level) and determined by laboratory methods.

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

• Not applicable. This is a study on a sterilization device, not an AI-assisted diagnostic tool for human readers. No human readers are involved in the "performance" of the sterilizer itself.

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

• This concept is applicable to the STERIZONE® VP4 Sterilizer itself. The device performs its sterilization function autonomously once initiated. The validation studies performed were standalone performance studies of the device's ability to achieve sterility without human intervention in the sterilization process, only in its operation.
• The study demonstrated the device's ability to achieve an SAL of 10⁻⁶ on its own.

7. Type of Ground Truth Used:

• The ground truth for sterility was established through microbiological methods, specifically:
  • Directly inoculated medical devices: Devices were purposely contaminated with known resistant microorganisms (likely bacterial spores, given the "overkill" approach for sterilization validation).
  • Biological Indicators: Although not explicitly stated as "biological indicators," the "overkill approach" and "half-cycle testing" strongly imply the use of standardized biological indicators or highly resistant microbial challenges to demonstrate the SAL.
  • Absence of viable microorganisms: The success criterion for sterility is the complete inactivation of these microbial challenges, confirming an SAL of 10⁻⁶.

8. Sample Size for the Training Set:

• Not applicable. This is a physical device (sterilizer) undergoing validation, not an AI algorithm that requires a training set. The device's operation is based on established physical and chemical principles, not machine learning from data.

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

• Not applicable, as there is no "training set" in the context of an algorithm. The device's design and operational parameters are based on scientific understanding of sterilization processes, extensive R&D, and adherence to relevant standards for medical device manufacturing and sterilization.

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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 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.

This document describes the STERIZONE® VP4 Sterilizer, a device for terminal sterilization of reusable medical devices. The primary purpose of the submission is to expand the lumen claims for flexible endoscopes.

Here's an analysis of the provided text for acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion for this device is the achievement of a sterility assurance level (SAL) of 10^-6. The reported device performance indicates that this SAL was achieved.

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

The test set consisted of nine separate validation loads, as described in Table 1 (pages 2-3 and 5-6). Each load contained a representative sample of one or more device types and packaging. The specific contents of each validation load are detailed, including various surgical instruments and different types of endoscopes (single-channel flexible, multi-channel flexible, rigid, and semi-rigid channeled instruments).

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data. However, given that this is a premarket notification to the FDA, it is highly likely that the data was generated prospectively as part of the device's validation testing. The applicant's address in Canada suggests the studies may have been conducted there or in collaboration with Canadian institutions, but this is not explicitly stated.

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

This type of device validation (sterilization) does not typically involve human experts establishing "ground truth" in the way that image interpretation for diagnostics would. Instead, the ground truth for sterilization effectiveness is established through microbiological testing. For this device, the "overkill" approach was used, involving directly inoculated medical devices. The performance is measured by the complete killing of highly resistant microorganisms (e.g., bacterial spores as biological indicators). Therefore, experts in microbiology and sterilization validation would design and oversee these tests, but the "truth" is an objective, measurable outcome (sterility). The document does not specify the number or specific qualifications of such experts, but it is implied that these studies were conducted by qualified personnel in accordance with established standards (ANSI/AAMI/ISO 14937).

4. Adjudication Method for the Test Set

Not applicable. As described above, the effectiveness of a sterilizer is determined by objective microbiological testing, not by expert adjudication of various interpretations.

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

No. This is a sterilization device, not an imaging or diagnostic device that requires human interpretation. Therefore, an MRMC study is not relevant.

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

Yes, the effectiveness testing described is a standalone performance evaluation of the STERIZONE® VP4 Sterilizer. The device's ability to sterilize medical instruments to a specified SAL is assessed independently of human intervention during the sterilization cycle itself. The testing focused purely on the physical and chemical processes of the sterilizer.

7. The Type of Ground Truth Used

The ground truth used is microbiological proof of sterility, specifically demonstrating a Sterility Assurance Level (SAL) of 10^-6. This is achieved by challenging the sterilizer with a high number of highly resistant microorganisms (typically bacterial spores as biological indicators) directly inoculated onto medical devices. The complete inactivation of these microorganisms after a half-cycle exposure ensures that a full cycle would achieve the required SAL.

8. The Sample Size for the Training Set

Not applicable in the conventional sense of machine learning. This device is a physical sterilizer and its performance is based on well-understood physical/chemical principles, not a machine learning model that requires a "training set." The "training" for such a device would be its engineering design and optimization, which is not described in terms of a data set.

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

Not applicable. As explained in point 8, there isn't a "training set" with associated ground truth in the context of this physical device. The device's design and parameters are established through engineering principles, scientific understanding of sterilization, and iterative testing/optimization based on microbiological efficacy.

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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 Sterilization chamber has a capacity of 4.4 cu. ft. (125 liters). It requires oxygen (94% pure and greater), electricity and the 125-280 Solution™ containing 50% hydrogen peroxide by weight. Both hydrogen peroxide and ozone are used in a multiphase process.

The STERIZONE® VP4 Sterilizer is equipped with a factory-programmed control system offering a unique sterilization cycle.

Processed medical instruments are ready to use immediately after the cycle ends; no aeration is required.

Polypropylene non-woven wrapping material, non-woven polyethylene (Tyvek™) with polyester/LDPE transparent film pouches, and vaporized hydrogen peroxide compatible aluminium containers using disposable polypropylene filters, are used as packaging for medical devices to be sterilized. Plastic and metal trays are also suitable packaging means when combined with polypropylene wraps.

A self-contained biological indicator containing spores of G. stearothermophilus, incorporated into a test pack, is recommended to monitor cycle performance.

The STERIZONE® VP4 Sterilizer could be installed as a free standing unit or recessed behind the wall.

No exhaust gas ventilation duct is required as long as the room is adequately ventilated.

The document is a 510(k) premarket notification for the STERIZONE® VP4 Sterilizer, which is intended for terminal sterilization of reusable medical devices in healthcare facilities. It provides information regarding the device's indications for use, its sterilization process, safety and effectiveness testing, and a comparison to predicate devices to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents "Performance Requirements for Effectiveness" and "Performance Requirements for Safety" for the STERIZONE® VP4 Sterilizer, along with the results.

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

The "Effectiveness" validation was demonstrated using a "representative sample of one or more device types and packaging, in seven separate validation loads" (Table 1 and 2, pages 2-3 and 7-8). Each load contained various medical instruments representing different geometries and packaging types. The specific number of individual devices or biological indicators within each load is not explicitly stated as a "sample size" in the way it might be for a clinical trial. Instead, the "overkill" approach mentions inoculating medical devices with 10^6 microorganisms, implying a high concentration of test organisms rather than a large count of unique physical samples being tested. This type of testing is generally prospective, designed specifically for validation. The country of origin of the data is not explicitly stated, but the applicant's address is in Quebec, Canada, suggesting Canadian provenance for at least some of the underlying work.

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

This type of sterilization efficacy testing does not typically rely on human expert consensus for "ground truth" in the same way as, for example, image interpretation. The ground truth for sterilization is established through microbiological testing (e.g., demonstrating the eradication of 10^6 microorganisms, achieving a sterility assurance level (SAL) of 10^-6), and chemical analysis for residue. The document does not specify the number or qualifications of experts involved in analyzing these microbiological and chemical results, as these are standardized laboratory procedures.

4. Adjudication Method for the Test Set:

Not applicable in the context of sterilization device validation. Adjudication methods like "2+1" are used in studies involving subjective human interpretation, such as clinical image reading. Sterilization efficacy is determined by objective microbiological and chemical tests.

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 outputs, often looking at how AI assistance changes their performance. For a sterilizer, the focus is on the device's inherent ability to achieve sterility, not on human interpretation of data.

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

Yes, the effectiveness testing describes the standalone performance of the STERIZONE® VP4 Sterilizer. The entire study focuses on the device's ability to sterilize medical devices on its own, independent of human intervention during the sterilization cycle once initiated. The "half-cycle validation testing," "simulated-use testing," and "in-use testing" all evaluate the device's performance directly.

7. The Type of Ground Truth Used:

The primary ground truth used for effectiveness testing is microbiological efficacy, specifically demonstrating a sterility assurance level (SAL) of 10^-6, which means a probability of one non-sterile item in a million. This is achieved through controlled inoculation of medical devices with a known quantity (10^6) of highly resistant microorganisms (e.g., Geobacillus stearothermophilus spores) and verifying their eradication after sterilization. Secondary ground truths include chemical analysis to ensure the absence of toxic residues and by-products.

8. The Sample Size for the Training Set:

This document does not describe a "training set" in the context of machine learning. The STERIZONE® VP4 Sterilizer is not an AI/ML device in the sense of requiring a training set of data for an algorithm to learn from. The "training" for a sterilization device would be the engineering design, development, and iterative testing that precedes the final validation studies.

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

Not applicable, as the device is not an AI/ML device that requires a training set and corresponding ground truth. The "ground truth" during the development and design phases would be based on established principles of microbiology, chemistry, and engineering for effective and safe sterilization.

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The STERIZONE® BI+ Self-contained Biological Indicator (SCBI) is intended for routine monitoring of the STERIZONE® VP4 Sterilizer, which offers a single pre-set sterilization cycle ("Cycle 1"). The SCBI should only be used in a Test Pack configuration to monitor Cycle 1. The SCBI placed within the STERIZONE® VP4 Test Pack monitors exposure to both vaporized hydrogen peroxide (H2O2 or VHP) and ozone (O3) which are both used in the STERIZONE® VP4 Sterilizer. The STERIZONE® VP4 Test Pack is intended to have equivalent to greater resistance than worst case devices and loads in any load configuration.

The STERIZONE® BI+ Self-contained Biological Indicator (TSO3 product code 42602) consists of at least 106 Geobacillus stearothermophilus viable spores, known to be the reference microorganism for the STERIZONE® VP4 Sterilizer sterilization process, grouped on a stainless steel carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. The presence of G. stearothermophilus spores is detected by a visual color change (media turns yellow). The yellow color change indicates bacterial growth. No change of color indicates that the process achieved the conditions necessary to kill at least 1 × 106 viable spores of G. stearothermophilus (6 logs) on the SCBI inoculated stainless steel carrier. The final readout of a negative result (media remains purple) is made after 18 hours of incubation when using a dry-bath type incubator.

The STERIZONE® VP4 Test Pack is a device composed of the STERIZONE® BI+ Selfcontained Biological Indicator (TSO3 product code 42602, including crusher), a 10 mL syringe and its plunger, and a diffusion restrictor (sold in the form of a kit - TSO3 product code: 44020). A STERIZONE® CI+ Chemical Indicator (TSO3 product code 43810) is also added, external to the syringe, to allow differentiating processed test packs. All components of the Test Pack are single-use, disposable items.

The provided document describes the STERIZONE® BI+ Self-contained Biological Indicator and STERIZONE® VP4 Test Pack and includes a summary of nonclinical performance tests.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for each of the nonclinical tests. It only lists the tests performed and their results. The data provenance is not specified (e.g., country of origin, retrospective/prospective). These were likely laboratory-based studies conducted by the manufacturer, TSO3 Inc., in Québec, Canada.

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

This information is not provided in the document. The tests performed are objective, laboratory-based assays (e.g., population counts, growth inhibition) that do not typically rely on human expert consensus for ground truth establishment in the way clinical diagnostic devices might.

4. Adjudication Method for the Test Set

This information is not applicable and is not provided in the document. The tests are scientific measurements or observations with clear pass/fail criteria, not subjective interpretations requiring adjudication.

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. This type of study is typically used for diagnostic devices where human readers interpret medical images or data. The STERIZONE® BI+ Biological Indicator is a sterilization process indicator evaluated through laboratory performance tests.

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

The device itself is a physical biological indicator, not a software algorithm. Therefore, the concept of "standalone (algorithm only)" is not applicable. The performance evaluation is based on the biological and chemical responses of the indicator to sterilization conditions.

7. The Type of Ground Truth Used

The ground truth for these nonclinical tests is based on established scientific principles and standards for biological indicators and sterilization efficacy.

• Viable population assay: Ground truth is the measured number of viable spores, compared against a specified range (e.g., $\ge1 \times 10^6$ viable spores).
• Growth inhibition: Ground truth is the observation of microbial growth/no growth in the presence/absence of carrier materials and pack materials.
• Reduced incubation time/stability of biological read/positive controls: Ground truth is the presence or absence of spore growth within specified timeframes or under specific conditions.
• BI validation in the STERIZONE® VP4 process & Test Pack performance evaluation: Ground truth is the kill of a specified log reduction of Geobacillus stearothermophilus spores (6 logs) under defined sterilization conditions (half-cycle vs. full cycle).

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI. The tests described are validation tests for the physical device's performance characteristics. Development and optimization of the biological indicator would have involved internal testing, but this is not detailed as a "training set."

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

As there is no "training set" in the AI/ML sense, this question is not applicable. The device's performance is established through direct physical and biological testing against known sterilization challenges, rather than through a learning algorithm trained on data.

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The STERIZONE® CI+ Chemical Indicator is a single-use process indicator intended to distinguish between processed and unprocessed packaged medical devices to be sterilized using the STERIZONE® VP4 Sterilizer. The device is intended for use only with the STERIZONE® VP4 Sterilizer, which has a single sterilization cycle ("Cycle 1"). Critical process parameters for Cycle 1 are summarized in Table 1.

The red stripe chemical indicator is located above the peach-colored stripe labeled as the "REFERENCE". After exposure to the Cycle 1 of the STERIZONE® VP4 Sterilizer, the chemical indicator color changes from red to peach-Reference color (or lighter).

The STERIZONE® CI+ Chemical Indicator (CI+) is a Class 1 process indicator that conforms to ANSI/AAMI/ISO 11140-1: 2005(R)2010, and is intended to only be used with the STERIZONE® VP4 Sterilizer. The single pre-set cycle (Cycle 1) of the STERIZONE® VP4 Sterilizer utilizes vaporized hydrogen peroxide and ozone in a multiphase process, to rapidly sterilize a variety of reusable medical devices.

The CI+ chemical indicator consists of a polymeric material strip on which an indicator ink, a reference color and a varnish coating have been deposited. The CI+ provides a visual indication that a sterilization load has been exposed to the STERIZONE® VP4 Sterilizer Cycle 1. The indicator works by means of a chemical reaction, which results is a recognizable color change from red to peach (or lighter).

The provided text describes the STERIZONE® CI+ Chemical Indicator and its assessment for substantial equivalence to a predicate device. It explicitly states that "Performance testing was conducted to demonstrate the functionality of the STERIZONE® CI+ Chemical Indicator and general conformance with the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as detailed in ANSI/AAMI/ISO 11140-1:2005(R)2010."

However, the document does not describe a study involving an AI device or algorithm. The "device" in question is a chemical indicator that changes color. Therefore, most of the requested information regarding AI device-specific criteria (like sample sizes for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable or cannot be extracted from this text.

I will provide the acceptance criteria and performance as described for the chemical indicator, and note where the requested information is not relevant to this type of device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes and Data Provenance for Test Set:
The document does not specify specific sample sizes (e.g., number of indicators tested) for each non-clinical test.
Data provenance (country of origin, retrospective/prospective) is not mentioned for these tests, which are laboratory-based functionality tests for a chemical indicator, not typically tied to patient data.

3. Number and Qualifications of Experts for Ground Truth (Test Set):
Not applicable. This device is a chemical indicator with a physical color change. Its performance is assessed by physical and chemical tests against a standard, not by human expert interpretation in the same way an AI diagnostic tool would be.

4. Adjudication Method for Test Set:
Not applicable for the reasons stated above. The "ground truth" for a chemical indicator is its physical response to sterilization parameters as defined by industry standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a chemical indicator, not an AI system. There are no "human readers" to improve with "AI assistance" in this context.

6. Standalone (Algorithm Only) Performance Study:
Not applicable. This device is a passive chemical indicator, not an algorithm.

7. Type of Ground Truth Used:
The ground truth used for evaluating the STERIZONE® CI+ Chemical Indicator is based on industry standards and physical/chemical properties. Specifically, performance is assessed against the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as detailed in ANSI/AAMI/ISO 11140-1:2005(R)2010. The color change (red to peach or lighter) triggered by exposure to the STERIZONE® VP4 Sterilizer's Cycle 1 is the intended functional ground truth.

8. Sample Size for Training Set:
Not applicable. This is a manufactured chemical indicator, not an AI model that requires a training set.

9. How Ground Truth for Training Set Was Established:
Not applicable. As above, no training set or AI model is involved.

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TSO3 125L Ozone Sterilizer is intended for use in the sterilization processing of reusable medical devices in health care facilities. TSO 125L Ozone Sterilizer is designed for sterilization of both metal and non-metal medical devices at low temperatures.

TSO3 125L Ozone Sterilizer has the ability to sterilize successfully packaged rigid and flexible lumen medical devices, including single and multi channel flexible endoscopes such as fiberoptic and video endoscopes.

TSO3 Ozone Sterilizer, model 125L is intended to sterilize medical devices that has been previously cleaned.

The sterilization chamber has a capacity of 125 liters (4.3 cu. ft.).

It requires USP grade oxygen, water and electricity. TSO3 Sterilizer could be installed as a free standing unit or recessed behind the wall. No exhaust gas ventilation duct is required as long as the room is adequately ventilated. By-products are oxygen and low humidity water vapor.

Model 125L is equipped with a unique factory-programmed control system.

Non-woven wrapping material or pouches and anodized aluminum containers are used as packaging for medical devices to be sterilized.

OZO-TEST® self-contained Biological Indicators (B. stearothermophilus) are recommended for use in evaluating cycle performance.

TSO3 Chemical Indicators are available for this process.

No aeration is needed following the sterilization cycle. The sterilized items are cool to the touch and can be removed immediately and used, or stored for future use.

The provided text describes the TSO3 Ozone Sterilizer, Model 125L, and its validation for sterilizing flexible endoscopes. However, it does not contain a typical "acceptance criteria" table with specific quantitative metrics (like sensitivity, specificity, accuracy) and corresponding performance outcomes for an AI/device, as it's a sterilizer, not a diagnostic or AI-powered medical device.

Based on the information provided, here's a breakdown of the requested elements adapted for this type of device:

Acceptance Criteria and Study for TSO3 Ozone Sterilizer, Model 125L

The primary acceptance criterion for a sterilizer is to achieve a sufficient Sterility Assurance Level (SAL), typically 10^-6, meaning a one-in-a-million probability of a non-sterile item. The study demonstrates effectiveness through an "overkill" approach and validated test cycles.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of distinct "cases" in the way a diagnostic device would have patient samples. Instead, the study involved:
  • Testing with flexible endoscopes: "single and multi channel flexible endoscopes such as fiberoptic and video endoscopes." Specific types evaluated include: Colonoscope, Gastroscope, Broncho videoscope, Choledofiberscope, and Ureteroscope.
  • A specific test load configuration was used for qualification testing: 2 multi-channel and 1 single-channel flexible endoscope, plus 14 medical devices packaged in TSO3 Sterilization Pouches, and a Process Challenge Device.
  • Biological Indicators (B. stearothermophilus) were used to evaluate cycle performance, though the number of indicators per test is not specified.
• Data Provenance: The study was conducted as a validation of a medical device sterilizer, implying laboratory and simulated-use testing. The document is a 510(k) submission to the FDA for a device manufactured by TSO3 Inc. in Québec, Canada. The document itself does not specify a country of origin for the "data" in terms of patient population or retrospective/prospective clinical data, as this is a device effectiveness study, not a clinical trial. It is a prospective validation study.

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

This information is not provided in the document. For a sterilizer, "ground truth" is typically established by microbiological testing (e.g., negative growth of biological indicators after processing), not by expert consensus on visual or diagnostic interpretation.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers assess a case and their disagreements need resolution. This is not applicable to a sterilizer performance study.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and an AI system might assist them. The TSO3 Ozone Sterilizer is a medical device sterilizer, not an AI-powered diagnostic tool.

6. Standalone Performance Study

• Yes, a standalone study was done. The "Effectiveness" section states that "Ozone Sterilizer validation testing... was performed using the 'overkill' approach to demonstrate the effectiveness of the process." This demonstrates the performance of the algorithm/device (the sterilizer itself) without human intervention in the sterilization process (beyond loading/unloading).
  • The study included:
    • Full cycle validation testing in simulated use conditions.
    • Half-cycle validation testing.
    • In-use testing.

7. Type of Ground Truth Used

The ground truth used was microbiological evidence and validated laboratory sterility testing. This is inferred from:

• The use of the "overkill" approach to demonstrate effectiveness.
• The goal of achieving a Sterility Assurance Level (SAL) of 10^-6.
• The recommendation for using OZO-TEST® self-contained Biological Indicators (B. stearothermophilus) to evaluate cycle performance. This implies the absence of viable microorganisms is the ground truth.

8. Sample Size for the Training Set

This information is not applicable / not provided. Sterilizers are not "trained" in the way AI algorithms are. Their design and validation are based on engineering principles and microbiological test standards.

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

This information is not applicable / not provided for the same reason as point 8. The device's operational parameters are factory-programmed based on scientific validation and engineering design, not through a "training set" with established ground truth.

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The TSO3 Ozone Sterilization Wrap is a single-use, non-sterile device. It is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device, and also to maintain sterility of the enclosed device until used. This wrap is intended for use with TSO3 Ozone Sterilization process.

The TSO3 Ozone Sterilization Wrap is a single-use, non-sterile device. It is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device, and also to maintain sterility of the enclosed device until used. This wrap is intended for use in the TSO3 Ozone Sterilization process.

The TSO3 Ozone Sterilization Wrap is a 2 layer laminate consisting of an ePTFE membrane and a 100% Polyethylene/Polyester (PE/PET) bi-component nonwoven backer.

The TSO3 Ozone Sterilization Wrap is a single-use, non-sterile device intended to enclose a medical device for sterilization and maintain its sterility until use, specifically with the TSO3 Ozone Sterilization process.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set for the sterilization performance and shelf-life sterility studies. It only mentions that "sterilization performance studies and shelf-life sterility tests were conducted."

For biocompatibility testing, it states that "A skin irritation test was performed by an independent laboratory to demonstrate that the final product does not induce any biocompatibility hazard." The specific sample size for this test is not provided in the summary.

The provenance of the data (country of origin, retrospective/prospective) is not specified in the provided text.

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 given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done as this device is a sterilization wrap, not an AI-assisted diagnostic tool where human readers would be involved in interpreting results. Therefore, there is no effect size of human readers improving with AI assistance.

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

This is not applicable as the device is a physical sterilization wrap, not an algorithm.

7. Type of Ground Truth Used

• For Effectiveness (Sterilization Performance and Shelf-life Sterility): The ground truth would likely be established by microbiological testing, confirming the absence of viable microorganisms after sterilization and during the shelf-life. The document states "all acceptance criteria were met," implying these tests confirmed the desired outcome.
• For Biocompatibility (Skin Irritation, Cytotoxicity, Sensitization): The ground truth was established by laboratory testing according to ISO 10993 standard, part 1. This involves observing biological responses (e.g., cell viability, skin reactions) to the device materials.

8. Sample Size for the Training Set

This information is not applicable as the device is a physical product, not an AI model that requires a training set.

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

This information is not applicable for the same reason as above.

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