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The EOGas 4 Ethylene Oxide Gas Sterilize is designed to sterilize reusable medical devices that are sensitive to moisture, heat, chemical corrosion, or radiation. The critical process parameters for the two available cycles are summarized below:

Table 1. EOGas 4 Ethylene Oxide Sterilizer cycle parameters

The differences between the two options are the length of EO gas exposure and the length of mandatory ventilation after gas exposure; the gas exposure is chosen based on the devices to be sterilized. The appropriate purge probe and process challenge device (PCD) must be used: EOGas 4 SteriTest for a 3-hour gas exposure, EOGas 4 Endo-SteriTest for a 6-hour gas exposure.

The EOGas 4 Ethylene Oxide Gas Sterilizer 3-hour gas exposure is used for surface sterilization of medical devices, including instruments with diffusion-restricted spaces (hinges or mated surfaces), as well as for the sterilization of endoscopes with working length shorter than 1100 mm as specified in the labeling. The EOGas 4 SteriTest PCD is used with the 3-hour gas exposure.

The EOGas 4 Ethylene Oxide Gas Sterilizer 6-hour gas exposure is used for sterilization of duodenoscopes and colonoscopes with working length longer than 1100 mm as specified in the labeling. The EOGas 4 Endo-SteriTest PCD is used with the 6-hour gas exposure.

The EOGas 4 Ethylene Oxide Gas Sterilizer, model AN4000.60 (115V) or AN4000.61 (230V), is intended to sterilize moisture, temperature, chemical corrosion, or radiation-sensitive reusable medical devices in healthcare facilities. The sterilant is a unit dose of 100% ethylene oxide contained in a cartridge, and the sterilization chamber is a gas-impervious flexible sterilization bag.

Here's a summary of the acceptance criteria and study information for the EOGas 4 Ethylene Oxide Gas Sterilizer, based on the provided document:

Acceptance Criteria and Device Performance

Study Information:

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

   • Minimum Sterilization Parameters: Performed to define and validate the endoscope loads. The results indicate successful inactivation of 6-Log BIs for "two duodenoscopes, two colonoscopes, or one colonoscope and one duodenoscope in each load." The exact number of each type of load tested isn't specified, but implies multiple runs for different combinations.
   • Half Dose Validation: "Consecutive half dose cycles and full dose cycles were performed." No specific number of cycles or endoscopes is provided.
   • Simulated-Use Testing: "Inactivated biological indicators were obtained in all cycles for all duodenoscope and colonoscope loads tested." Again, the exact number of cycles or endoscopes is not specified.
   • In-Use Testing: "Duodenoscopes and colonoscopes, used on patients... processed using the 6-hour EO exposure." No specific number of patient-used scopes is provided.
   • EO Residuals: Tested on "Olympus TJF-Q180V, TJF-Q160VF, TJF-Q190V, PJF-160, CF-Q180AL, Pentax ED34-i10T2, ED-3490TK duodenoscopes and EC-3490Li colonoscopes" and "Fujifilm ED-530XT and EC-600HL." This indicates testing on a variety of endoscope models.
   • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) submission for a medical device cleared in the U.S., the testing would typically be conducted to U.S. regulatory standards. "In-Use Testing" mentions "used in routine endoscopic procedures in a hospital or clinic setting," suggesting prospective collection of real-world use data.

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

   • This document describes performance testing of a sterilizer, where the "ground truth" is defined by the inactivation of biological indicators and the adherence to specified chemical and physical parameters. These are objective measures and do not typically involve human "experts" establishing a subjective ground truth, as would be the case for image interpretation or diagnosis. Therefore, no information on experts for ground truth is applicable or provided.

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

   • Not applicable. As noted above, the ground truth is based on objective laboratory measurements (biological indicator cultures, chemical concentrations, temperature, humidity, and residual levels), not a subjective human assessment requiring adjudication.

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

   • Not applicable. This document pertains to the validation of an ethylene oxide gas sterilizer, not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

   • Not applicable. This device is a sterilizer, not an algorithm. Its performance is evaluated through its physical and biological sterilization capabilities.

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

   • The ground truth for the sterilization efficacy tests is primarily established by:
     • Biological Inactivation: The complete inactivation of 6-Log Bacillus atrophaeus biological indicators, confirmed by culture methods.
     • Physical Parameters: Measurement of critical process parameters (EO concentration, temperature, relative humidity, time) meeting defined specifications.
     • Chemical Residuals: Measurement of ethylene oxide residuals meeting ANSI/AAMI/ISO 10993-7 requirements.
     • Sterility Testing: For in-use testing, sterility was confirmed by a flush method per USP, indicating no microbial growth.

7. The sample size for the training set:

   • Not applicable. This device is a physical sterilizer and does not involve AI or machine learning models that require a training set.

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

   • Not applicable, as no training set is used for this type of device validation.

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The Anprolene AN75 Ethylene Oxide Gas Sterilizer is intended for use in hospitals and other human healthcare settings. It is designed to sterilize reusable medical devices that are sensitive to moisture, heat, chemical corrosion, or radiation.

The 12 hour cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer is for surface sterilization of medical devices, including mated surfaces.

The Anprolene AN75 Ethylene Oxide Gas Sterilizers, model numbers AN75i (AN75.64 and AN75.65), AN75iX (AN75.84 and AN75.85), and AN75J (AN75.74 and AN75.75), are intended to sterilize moisture, temperature, chemical corrosion, or radiation-sensitive reusable medical devices in healthcare facilities. The sterilant is a unit dose of 100% ethylene oxide contained in a cartridge, and the sterilization chamber is a gas-impervious flexible sterilization bag. Each sterilization cycle is monitored using cumulative gas exposure measurement (AN87 Dosimeter), as well as a Bacillus atrophaeus biological indicator (AN2203) inserted into a process challenge device (AN7508.14 Anprolene SteriTest) that is integrated into the sterilizer.

This document describes the Anprolene AN75 Ethylene Oxide Gas Sterilizer, its indications for use, and a comparison to predicate devices, along with performance testing.

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 a numerical sample size for the "test set" in terms of specific units tested. However, it indicates:

• "The maximum loads of metal, fabric, and plastic devices that may be routinely sterilized in the Anprolene AN75 Ethylene Oxide Gas Sterilizer were defined and validated."
• "All validated maximum loads were processed without additional devices in the sterilizer."
• "The validation testing demonstrated that exposure to EO gas under the defined loads and physical parameters achieved a minimum sterility assurance level (SAL) of $10^{-6}$ for surfaces, including mated surfaces."
• "The effectiveness of the sterilization process for the loads was confirmed by successful sterilization in simulated-use testing using instruments with mated surfaces."

The data provenance is not explicitly mentioned (e.g., country of origin). The study appears to be prospective validation testing conducted by the manufacturer to demonstrate the sterilizer's performance according to established guidelines.

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 document. The "ground truth" for sterilization effectiveness is typically established through recognized biological indicators and laboratory analyses, rather than expert human assessment for individual sterilization cycles.

4. Adjudication Method for the Test Set

This information is not applicable as the "test set" involves objective performance metrics (e.g., SAL achievement, residual levels, physical parameters) rather than subjective assessments requiring 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

This is not applicable. The device is an ethylene oxide gas sterilizer, not an AI-assisted diagnostic or interpretative tool that would involve human readers.

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

This is not applicable. The device is a physical sterilizer, not an algorithm. The performance evaluation focuses on the sterilizer's ability to achieve sterility without human intervention on a per-cycle basis, beyond loading and operating the device following instructions.

7. The Type of Ground Truth Used

The ground truth used for assessing the sterilization effectiveness primarily relies on:

• Sterility Assurance Level (SAL) of $10^{-6}$: This is a widely accepted microbiological standard for sterilization, achieved through the inactivation of biological indicators.
• Inactivation of an EZTest®- Gas Biological Indicator: Specifically, the document mentions "successful inactivation of an EZTest®- Gas Biological Indicator in the Anprolene SteriTest process challenge device."
• AAMI/ANSI/ISO 10993-7: For process residue analysis, ground truth is based on meeting the requirements of this standard for ethylene oxide residuals.
• Physical Performance Specifications: For the sterilizer components, cartridges, and bags, ground truth is adherence to predetermined physical performance specifications (e.g., EO amount, concentration, temperature, relative humidity, electrical safety).

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical sterilizer and not an AI/machine learning model, so there is no "training set" in that context. The validation involves testing the physical device's performance under various conditions and loads.

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

This information is not applicable for the same reasons as point 8.

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The EOGas 4 Ethylene Oxide Gas Sterilizer is intended for use in hospitals and other human healthcare settings. It is designed to sterilize reusable medical devices that are sensitive to moisture, heat, chemical corrosion, or radiation.

The 3 hour cycle at 50°C in the EOGas 4 Ethylene Oxide sterilization of medical devices as well as for the sterilization of single-lumen flexible endoscopes.

The EOGas 4 Ethylene Oxide Gas Sterilizer, model AN4000.01 (115V) or AN4000.11 (230V), is intended to sterilize moisture, temperature, chemical corrosion, or radiation-sensitive reusable medical devices in healthcare facilities. The sterilant is a unit dose of 100% ethylene oxide contained in a cartridge, and the sterilization chamber is a gas-impervious flexible sterilization bag. Each sterilization cycle is monitored using cumulative gas exposure measurement (AN1087 Dosimeter), as well as a Bacillus atrophaeus biological indicator (AN2203) inserted into a process challenge device (AN7408.14 Andersen EOGas 4 Steritest) that is integrated into the sterilizer.

Here's a breakdown of the acceptance criteria and study information for the EOGas 4 Ethylene Oxide Gas Sterilizer, based on the provided document:

Acceptance Criteria and Reported Device Performance

• 24 lbs (11 kg) of metal instruments (with or without mated surfaces).
• 6.1 lbs (2.8 kg) of fabric.
• 7.0 lbs (3.2 kg) of plastic devices.
• Four 1.2 x 700 mm endoscopes or one 2 x 1100 mm endoscope. |
  | Process Challenge Device (PCD) Resistance: The resistance characteristics of the Andersen process challenge device (AN7408.14) must be greater than the same biological indicator (BI) placed in the worst-case location in each of the worst-case validation loads. | The resistance characteristics of the AN7408.14 are greater than the same BI placed in the worst-case location in each of the worst-case validation loads. |
  | Residuals (EO and ECH): Ethylene oxide (EO) or ethylene chlorohydrin (ECH) residuals remaining on even the most absorbent materials tested must meet the requirements of AAMI/ANSI/ISO 10993-7. | The majority of EO or ECH residuals met the requirements of AAMI/ANSI/ISO 10993-7. |
  | Electromagnetic Compatibility (EMC) and Electrical Safety: Verify compliance with requirements for EMC and electrical safety. | The device was tested to verify compliance with requirements for EMC and electrical safety. |
  | Physical Performance: EOGas 4 Ethylene Oxide Gas Sterilizer, EOGas cartridges, sterilization bags, and Humidichips must meet their performance specifications. | The device and accessories met their performance specifications. |
  | Cycle Specification Maintenance: The EOGas 4 sterilization system must achieve and maintain cycle specifications for EO concentration, temperature, time, and relative humidity. | The system achieved and maintained cycle specifications for EO concentration, temperature, time, and relative humidity. |
  | Repeatability and Reliability: The 3-hour cycle at 50°C must be repeatable and reliable under the indicated test load conditions. | The 3-hour cycle at 50°C was repeatable and reliable under the indicated test load conditions. |

Study Information

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

   • Test Set Sample Size:
     • Metal: 24 lbs (11 kg)
     • Plastic: 7.0 lbs (3.2 kg)
     • Fabric: 6.1 lbs (2.8 kg)
     • Single-lumen Endoscopes: One (1) ≥ 2.0mm ID ≤ 1100mm length OR Four (4) ≥ 1.2 mm ID ≤ 700 mm length.
     • The document states "All validated maximum loads were processed without additional devices in the sterilizer." This implies discrete tests for each load type.
   • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, the nature of equipment validation for FDA approval typically involves prospective, controlled laboratory testing.

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

   • The document does not specify the number or qualifications of experts used to establish the ground truth. Sterilization validation typically relies on established scientific methods (e.g., biological indicators, chemical indicators, physical monitors) rather than expert consensus on individual results, although experts would design and review the validation protocols.

3. Adjudication method for the test set:

   • The document does not describe an adjudication method in the context of human expert review. The "ground truth" for sterilization is determined by the inactivation of biological indicators and adherence to SAL, verified through laboratory methods.

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

   • No. This is a sterilization device, not an AI-powered diagnostic or imaging interpretation tool. Therefore, MRMC studies and AI assistance comparisons are not applicable.

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

   • Yes, effectively. The "standalone" performance in this context refers to the sterilizer's ability to achieve sterility without human intervention during the sterilization cycle itself. The validation testing described (achieving SAL of 10⁻⁶, effective sterilization of loads, meeting residuals, etc.) directly assesses the standalone performance of the device. Human operators perform pre-processing (cleaning, loading) and post-processing (unloading, aeration, biological indicator interpretation), but the sterilization process is automated by the device.

6. The type of ground truth used:

   • Biological Indicators (BIs): Specifically, Bacillus atrophaeus biological indicators (AN2203) are mentioned, inserted into a process challenge device (AN7408.14 Andersen EOGas 4 Steritest). The inactivation of these resistant microorganisms serves as the primary "ground truth" for sterility.
   • Simulated-use testing: This involved using instruments with mated surfaces and endoscope lumens, confirming effectiveness in conditions mimicking actual use.
   • In-use testing: Confirmed the ability of the cycle to sterilize single-lumen endoscopes used clinically in a hospital setting.
   • Chemical Analysis: Process residue analysis for EO and ECH residuals against AAMI/ANSI/ISO 10993-7 standards.
   • Physical Monitoring: Verification of EO concentration, temperature, time, and relative humidity.

7. The sample size for the training set:

   • This concept is not applicable here as this is not a machine learning or AI device. The validation involves testing against predefined loads and parameters, not "training" a model.

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

   • As this is not a machine learning device, the concept of a "training set" and its ground truth establishment does not apply. The device's performance is validated through direct empirical testing against established sterilization standards.

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The 3M™ Steri-Vac™ Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices in the following cycles:

Single or dual channel rigid and flexible scopes can be sterilized with non-lumened medical instruments in any of the GS sterilizer cycles provided the cycle parameters match the instructions. The load per cycle should not exceed 20 lumens.

The 3M Steri-Vac™ GS5 and 3M Steri-Vac™ GS8 models are traditional ethylene oxide (EO) sterilizers that use 100% EO cartridges in a vacuum vessel. The sterilizers use fully automated controls for cycle processing and error handling.

Here's an analysis of the provided text regarding the acceptance criteria and study for the 3M Steri-Vac Sterilizer/Aerator Models GS5 and GS8:

Acceptance Criteria and Device Performance for 3M Steri-Vac Sterilizer/Aerator Models GS5 and GS8

The device in question, the 3M Steri-Vac Sterilizer/Aerator, is an Ethylene Oxide (EO) gas sterilizer intended for sterilizing heat- and/or moisture-sensitive medical devices. The study to prove the device meets acceptance criteria is primarily based on performance testing against recognized consensus standards for EO sterilizers.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the AAMI ST24:1999/(R) 2009 standard, which outlines requirements for automatic, general-purpose ethylene oxide sterilizers. The reported device performance is based on efficacy and physical testing.

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

• Sample Size:
  • For efficacy testing (Empty Chamber, Simulated Load, Sterility Assurance): "three consecutive sterilization runs" for each test scenario, for both the GS5 and GS8 models. This means a minimum of 3 runs per model per scenario, so 3 runs x 2 models x 3 scenarios = 18 efficacy runs.
  • For physical testing (temperature, exposure time, RH): The number of runs is not explicitly stated, but it's implied that the controls were "demonstrated" to meet the criteria.
  • For safety and EMC testing: The sample size is not specified, but it implies a single device or a representative sample was tested for certification.
• Data Provenance: The data provenance is internal to 3M Health Care, as they conducted or commissioned the tests to demonstrate compliance with national and international standards. The country of origin for the data is not explicitly stated, but given the company location (St. Paul, MN, USA) and the standards used (AAMI, ISO, IEC, FCC), it's highly likely the testing was conducted in the United States or by labs accredited to these standards globally. The studies are prospective in nature, as they involve testing the performance of the manufactured devices against predefined criteria.

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

This type of device (sterilizer) performance evaluation does not typically rely on "experts" to establish a "ground truth" in the same way an AI diagnostic algorithm would. Instead, the ground truth is established by:

• Reference Standards: The AAMI ST24:1999/(R) 2009 standard itself defines the acceptable parameters and methodologies for assessing sterilizer performance, which represents a consensus of experts in sterilization science and engineering.
• Laboratory Procedures: The "ground truth" for sterilization efficacy is the complete inactivation of biological indicators (AAMI challenge test packs). This is determined by standard microbiological culture techniques, not by expert opinion. The "ground truth" for physical parameters (temperature, humidity, time) is measured by calibrated sensors and instruments.

Therefore, the concept of "number of experts used to establish ground truth" with specific qualifications like radiologists is not applicable to this type of device submission.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., image reading) where disagreement among readers needs to be resolved. This is not applicable to the performance testing of a sterilizer. The acceptance criteria are objective and measurable; either the device meets the specified inactivation levels or physical parameter ranges, or it does not. Discrepancies would lead to troubleshooting and re-testing, not adjudication of "expert opinions."

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 relevant for evaluating diagnostic aids or AI algorithms that assist human readers in tasks like image interpretation. The 3M Steri-Vac Sterilizer is a standalone medical device that performs a physical process (sterilization), not an AI system that assists human decision-making. Therefore, the concept of "how much human readers improve with AI vs. without AI assistance" is not applicable.

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

Yes, in a sense, a "standalone" study was done. The efficacy and physical performance testing of the sterilizer is inherently a standalone evaluation of the device's capability to perform its intended function without human intervention during the sterilization cycle. The device's performance (sterilization efficacy, parameter control) is assessed directly. There is no human-in-the-loop during the sterilization process being evaluated. Humans operate the device and interpret the results of the tests, but the device's performance in achieving sterilization is evaluated independently.

7. The Type of Ground Truth Used

The ground truth used is primarily based on:

• Biological Indicators (BIs): For efficacy testing, the ground truth for "sterilization" is the complete inactivation of highly resistant microbial spores (e.g., Bacillus atrophaeus) in AAMI challenge test packs, as evidenced by negative culture results after exposure to the sterilization cycle. This is a well-established microbiological method.
• Physical Measurements: For parameters like temperature, exposure time, and relative humidity, the ground truth is established by direct measurement using calibrated sensors and instruments, compared against the specified ranges in the AAMI ST24 standard.
• Safety and EMC Standards: For safety and electromagnetic compatibility, the ground truth is compliance with the specified international and national regulatory standards (e.g., IEC, FCC), verified by accredited testing laboratories.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. This is a hardware device (sterilizer), not an AI algorithm that learns from data. Therefore, there is no training set in the machine learning sense. The device is designed, engineered, and then tested against established performance standards.

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

As stated above, there is no training set for this device in the context of AI/machine learning. Therefore, the question of how its ground truth was established is not relevant. The device's design and operational parameters are based on scientific principles of ethylene oxide sterilization and engineering specifications, which are themselves derived from research and industry standards.

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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 Model 125L is an Ozone Sterilizer intended for use in the sterilization processing of reusable medical devices in health care facilities. The TSO3 Ozone Sterilizer, Movol 1252. is designed for sterilization of both metal and non-metal medical devices at low temperatires. The sterilization cycle operates at very low pressure and low temperature, consequently it is suitable for processing medical devices sensitive to heat and moisture.

The TSO3 Ozone Sterilizer, Model 125L, is designed to sterilize instruments and devices with diffusion-restricted spaces, such as the hinged portion of forceps and sciators.

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. Model 125L 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.

Here's an analysis of the provided text regarding the TSO3 Ozone Sterilizer, Model 125L, focusing on acceptance criteria and the supporting study:

Device Performance and Acceptance Criteria

The TSO3 Ozone Sterilizer, Model 125L, was tested for its ability to sterilize medical devices with extended lumens. The acceptance criterion for sterilization is the achievement of a Sterility Assurance Level (SAL) of 10^-6, which means the probability of a single viable microorganism remaining on an item after sterilization is 1 in a million.

The study demonstrated the device's ability to sterilize a range of stainless steel lumens.

Table of Acceptance Criteria and Reported Device Performance

Note: The document states, "Testing on lumens were conducted employing half cycle to demonstrate achievement of a sterility assurance level (SAL) of 10^-6." This "half cycle" method is a common and stringent approach to demonstrate an SAL, as it proves that even under reduced sterilization conditions (half of a full cycle), the target SAL can still be met, implying that a full cycle would provide an even greater margin of safety.

Study Details

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

• Sample Size: The document does not explicitly state the numerical sample size (number of lumens) used for the test set. It lists five distinct lumen configurations (combinations of internal diameter and length) that were tested. For each configuration, multiple tests would have been performed using biological indicators to establish the SAL.
• Data Provenance: The study was conducted by TSO3 Inc. in Quebec, Canada. The data is likely prospective as it describes specific validation testing performed to support the extended lumen claims.

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

• The document does not mention the use of human experts or an expert panel to establish ground truth for the test set in the context of sterilization efficacy. Sterilization efficacy studies typically rely on quantitative laboratory methods (e.g., biological indicators) rather than subjective expert assessment.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for subjective diagnostic assessments where discrepancies among human readers need resolution. For sterilization efficacy, the "ground truth" is determined by the inactivation of biological indicators, which is an objective measure.

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. This device is a sterilizer, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with or without AI assistance is irrelevant to this device.

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 intrinsically through its ability to inactivate microorganisms, not as an algorithm assisting a human. The "effectiveness" section explicitly describes validation testing of the process (sterilizer) using an "overkill" approach and biological indicators, which is a standalone assessment of the device's function.

7. The type of ground truth used:

• The ground truth for sterilization efficacy was established using biological indicators (B. stearothermophilus). These indicators contain a known population of highly resistant bacterial spores. The complete inactivation of these spores after sterilization, especially in a "half cycle" challenge, directly demonstrates the achievement of the required Sterility Assurance Level (SAL). This is an objective, laboratory-based method.

8. The sample size for the training set:

• Not applicable. This device is a sterilizer, not an AI model that requires a training set. The "validation testing" described refers to the testing of the physical device's performance, not the training of an algorithm.

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

• Not applicable, as there is no training set for an AI/algorithm in this context.

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The TSO1-Model 125L is an Ozone Sterilizer intended for use in the sterilization processing of reusable medical devices in Health Care Facilities. The TSO3 Model 125L Ozone Sterilizer is designed for sterilization of both metal and non-metal medical devices at low temperatures. The sterilization cycle operates at very low pressure and low temperatures, consequently it is suitable for processing medical devices sensitive to heat and moisture.

The TSO-125L Ocone Sterilizer is designed to sterilize instruments and devices with diffusion-restricted spaces, such as the hinged portion of forceps and scissors.

The TSO--125L Ozone Sterilizer is also designed to process medical devices having a single stainless steel lumen with:

• an inside diameter of 2 mm or larger and a length of 250 mm or shorter;

• an inside diameter of 3 min or larger and a length of 470 mm or shorter;

• an inside diameter of 4 mm or larger and a length of 600 mm or shorter.

Note: Testing conducted employing half cycle with a SAL of 10 with no survivors.

The packaging compatible with the TSO3-Model 125L Ozone Sterilizer are TSO3 sterilization pouch and rigid anodized aluminum containers using disposable cellulose filter paper.

TSO model 125L Ozone Sterilizer is intended to sterilize reusable medical devices that have been previously cleaned. Ozone is generated within the sterilizer to provide an efficient sterilant without the concerns for transporting, handling and disposing of toxic chemicals. The sterilization chamber has a capacity of 125 liters (4 cu. ft.). It requires medical grade oxygen, water and clectricity.

The Model 125L is equipped with a unique factory-programmed control system for processing reusable medical devices.

Processed medical instruments requires no aeration time at the end of the sterilization cycle. The TSO3 sterilization pouch and anodized aluminum sterilization containers are used as packaging for medical devices to be sterilized.

The TSO3 OZO-TEST™ self-contained Biological Indicator (B. stearothermophilus) is recommended for use in evaluating cycle performance. TSO3 Chemical Indicator is recommended for use to differentiate between processed and unprocessed loads and to indicate that the load has been exposed to the sterilization process.

Model 125L could be installed as a free standing unit or recessed behind a wall. No exhaust gas ventilation duct is required in a room that is adequately ventilated.

The provided document is a 510(k) premarket notification for a medical device, the TSO3-125L Ozone Sterilizer. It does not describe an AI medical device or a study involving human readers or AI assistance. Therefore, most of the requested information regarding AI device acceptance criteria, comparative effectiveness studies, and ground truth establishment for AI models cannot be extracted from this document.

However, I can provide information related to the device's effectiveness and safety as described in the document.

Acceptance Criteria and Device Performance (Based on provided document)

• inside diameter of 2 mm or larger and a length of 250 mm or shorter
• inside diameter of 3 mm or larger and a length of 470 mm or shorter
• inside diameter of 4 mm or larger and a length of 600 mm or shorter |
  | Biological Indicator Challenge | "Half cycle with a SAL of 10 with no survivors" using B. stearothermophilus (OZO-TEST™ self-contained Biological Indicator). |

Information Not Applicable or Not Found in the Document:

1. Sample size used for the test set and the data provenance: Not applicable. This document describes a sterilizer, not an AI model validated with a test dataset of medical images or patient encounters. The effectiveness testing references an "overkill" approach, which is a common method for sterilizer validation, but it doesn't specify a "test set" in the context of an AI model's performance.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would refer to results of sterility testing, which doesn't involve medical image interpretation by experts.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a sterilizer and does not involve human readers interpreting data with or without AI assistance.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a sterilizer, not an algorithm.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For sterility, the ground truth is typically the absence of viable microorganisms after processing. The document mentions using B. stearothermophilus biological indicators to evaluate cycle performance, implying a microbiological method for ground truth.
7. The sample size for the training set: Not applicable. No AI model is described.
8. How the ground truth for the training set was established: Not applicable. No AI model is described.

Summary of the Study:

The document describes the validation of the TSO3-125L Ozone Sterilizer. The primary "study" or validation approach mentioned for effectiveness is the "overkill" method, which is a standard microbiological approach for sterilizer validation to establish a Sterility Assurance Level (SAL). This method involves challenging the sterilizer with a high concentration of bacterial spores (specifically Geobacillus stearothermophilus, formerly Bacillus stearothermophilus, as per the OZO-TEST™ BI) to demonstrate its ability to sterilize across a wide range of conditions, thus ensuring a high probability of sterility for less challenging actual loads. The document states "half cycle with a SAL of 10 with no survivors," which is a common way to demonstrate a robust sterilization process.

The document emphasizes safety through compliance with electrical and mechanical standards and the use of risk analysis techniques (FTA-MIT and FMECA). Compatibility with specific medical device types (e.g., lumen dimensions) and packaging materials is also detailed through testing.

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The H & W Hospital Ethylene Oxide Sterilizer Control System is an accessory in the form of an electronic control system for the retrofit of existing sterilizers to provide operator and information monitoring capabilities of a personal computer (PC) together with the functional reliability, safety, and dependability of control obtained through the use of a programmable logic controller (PLC). The H & W Hospital Ethylene Oxide Sterilizer Control System is intended to retrofit existing Steris (Amsco) Eagle Model 2000 & 3000 series and Getinge (Castle) Model M/C 3500, 3600 or 4200 series Hospital EO Sterilizers only. The automated cycle performs in such a manner as to assure the repeatability of the process. The predetermined cycles duplicate the cycles provided by the original equipment manufacturer and are demonstrated to deliver the biological performance as stipulated in the consensus standard ANSI/AAMI ST-24.

This device is an accessory to an electronic ethylene oxide sterilizer control system. This control system is a modern, programmable logic controller (PLC)-based system with Personal Computer (PC) user interface. This accessory control system uses a PLC and a Visual Basic/Windows user interface. These two features, a PLC for control and a Windows -based user interface provide multiple advantages. First being the inherent safety and reliability of the PLC and second the operator's ease of use of the Windows "based user interface. This accessory control system kit is intended for the retrofit of existing sterilizers or for use on sterilizers remanufactured by original equipment manufacturers, third party remanufacturers or their licensees.

The provided text describes an ethylene oxide sterilizer control system, an accessory for existing sterilizers, and its compliance with standards and safety. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance with numerical metrics, nor does it detail a clinical study with elements like sample sizes, expert ground truth establishment, or multi-reader multi-case studies as typically expected for medical imaging or diagnostic AI devices.

The submission is for a control system for a sterilizer, not a diagnostic or imaging device, which explains the absence of the typical "study" information. The "study" here refers to validation against engineering and performance standards for sterilizers.

Here's an attempt to answer based on the provided text, highlighting the limitations due to the nature of the device and the available information:

Acceptance Criteria and Device Performance Study for H & W Hospital Ethylene Oxide Sterilizer Control System

The H & W Hospital Ethylene Oxide Sterilizer Control System is an electronic control system accessory designed to retrofit existing hospital ethylene oxide (EO) sterilizers. The primary objective is to maintain or improve the reliability, safety, and performance of the sterilizer, particularly its biological performance, according to established consensus standards.

Given that this is a control system for sterilizers and not a diagnostic or imaging device, the "acceptance criteria" and "study" details differ significantly from what would be expected for AI-powered diagnostic tools. The "performance" largely revolves around adherence to industry standards, safety regulations, and functional equivalence to predicate devices, rather than statistical metrics like sensitivity, specificity, or AUC from a clinical trial.

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 specify a "test set" in the context of data for an algorithm. Instead, the validation appears to be centered on the system itself when installed on existing sterilizers.

• The "test set" is implied to be actual sterilizers where the system is retrofitted and its performance validated on-site.
• Sample Size: Not explicitly stated as a number of devices. The validation process refers to "a sterilizer" (singular) but implies this process is to be followed for each retrofitted unit: "Performance is assured... by validating the performance of the system, on-site in a sterilizer with known and already defined characteristics."
• Data Provenance: This is an industrial control system, not a data-driven AI. "Data provenance" as typically understood (e.g., country of origin of patient data) is not applicable. The performance is validated against the physical characteristics and operational output of the sterilizer itself. The context is practical engineering validation rather than clinical data analysis.

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

This information is not explicitly provided. The "ground truth" for the biological performance is the successful sterilization outcomes as stipulated by consensus standard ANSI/AAMI ST-24. This standard itself is developed by experts in the field. The operational validation (on-site testing) would likely involve qualified technicians or engineers, but their number and specific qualifications are not detailed in this submission.

4. Adjudication method for the test set

Not applicable. There is no mention of "adjudication" in the context of panel reviews or conflict resolution for expert opinions, since the "test set" is the biological and mechanical performance of the sterilizer, measured against established standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This type of study is typically performed for diagnostic devices (e.g., medical imaging AI) to compare human reader performance with and without AI assistance. This device is an industrial control system accessory, not a diagnostic tool, so an MRMC study is not relevant or described.

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

The device is a control system, which functions "standalone" once programmed, but always within the context of physically controlling a sterilizer. The "algorithm" here refers to the PLC-based control logic, which operates independently to execute sterilization cycles. The validation focuses on whether these automated cycles achieve the required biological performance and safety standards, which is essentially its standalone or automated performance. Human interaction is primarily for monitoring and initiation through the PC interface.

7. The type of ground truth used

The primary ground truth is compliance with consensus standards and demonstrated biological performance as stipulated by ANSI/AAMI ST-24. This includes the successful inactivation of biological indicators, which is an objective measure of sterilization efficacy. Other ground truths include adherence to engineering and electrical safety standards (ASME, IEC).

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model in the sense of requiring a "training set" of data to learn from. Its logic is programmed based on engineering principles and industry standards, not data-driven model training.

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

Not applicable, as there is no "training set" in the context of machine learning. The "ground truth" for the design and programming of the control system is based on the requirements defined by the Product Development Life Cycle (PDLC) procedure, industry best practices, and the consensus standard ANSI/AAMI ST-24. These requirements are established by experts and regulatory bodies in the field of sterilization.

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This Premarket Notification is to expand the Indications for Use for the STERRAD 50 Sterilizer (K981625) and the STERRAD 100S Sterilizer (K991999) to include titanium as a compatible material and to expand the lumen sizes to include medical devices with only a single stainless steel lumen in the following configurations:

• An inside diameter of 1 mm or larger and a length of 125 mm or shorter
• An inside diameter of 2 mm or larger and a length of 250 mm or shorter .

The validation testing for these two new lumen sizes was conducted using a maximum of 10 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.

For information pertaining to previously cleared materials and lumen sizes, please reference K981625 and K991999.

The STERRAD® 50 & 100S Sterilizers are self-contained stand-alone systems of hardware and software designed to sterilize medical instruments and devices using a patented hydrogen peroxide gas plasma process. Hydrogen peroxide vapor is generated by injecting aqueous hydrogen peroxide into the vaporizer bowl where the solution is heated and transformed into a vapor, introducing the vapor into the process chamber under negative pressure and transforming the vapor into a gas plasma with radio frequency (RF) electrical energy.

The equipment (hardware and software) for the STERRAD® 50 & 100S Sterilizers is the same as that of the predicate devices. The hardware consists of a sterilization chamber onto which is mounted a variety of instruments and components, housed in a covered frame. The system also uses accessories such as disposable sterilant cassettes, reusable instrument trays, printer paper and ink cartridges.

Here's a breakdown of the acceptance criteria and the studies conducted for the STERRAD® 50 and STERRAD® 100S Sterilization Systems, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

                                                                   The In-Use testing demonstrated that the STERRAD® 50 and 100S Sterilization Systems were effective sterilizers of stainless steel lumen devices.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |

| No cytotoxicity or toxic residuals on processed materials | Cytotoxicity test results indicated that titanium materials processed did not induce in vitro cytotoxicity. Residues testing showed no toxic sterilant residuals. |

Note: SAL of 10^-6 means there is a one in a million chance of a non-sterile unit. SLR values of 6.0 or higher indicate a 6-log reduction in microbial population, which is a common standard for sterilization.

2. Sample Size and Data Provenance

• Test Set Sample Sizes:
  • Titanium Surface Sterilization: Not explicitly stated, but performed with "titanium materials representative of the materials commonly used in re-usable medical devices."
  • Lumen Sterilization: Not explicitly stated, but for the validation loads, a "maximum of 10 lumens per load" was used for the 1mm x 125mm and 2mm x 250mm lumens. The half-cycle validation tests used sufficient materials to demonstrate the SAL.
  • Tyvek-Mylar Pouched Device Sterilization: Not explicitly stated, but conducted with 1mm x 125mm and 2mm x 250mm stainless steel lumens in pouches.
  • Simulated Use Testing: Not explicitly stated how many devices, but used "devices representative of lumen claims."
  • In-Use Sterility Testing: Not explicitly stated how many devices, but used "Devices representative of lumen claims for the STERRAD® 50 Sterilization System" that were "used in routine surgeries at local hospitals."
• Data Provenance: Retrospective and prospective. The In-Use Sterility Testing involved devices "used in routine surgeries at local hospitals," suggesting data collected from real-world usage scenarios (retrospective element) which were then transported for prospective testing with the STERRAD systems. The other validation testing appears to be prospectively designed lab studies. No specific country of origin is mentioned beyond "local hospitals" for the in-use testing, implying a US-based context given the FDA submission.

3. Number of Experts and Qualifications for Ground Truth

• This information is not provided in the summary. The ground truth for sterilization is typically established through microbiological testing (e.g., demonstrating the death of a highly resistant test organism), rather than expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

• This information is not applicable as the studies are primarily microbiological challenge tests for sterilization efficacy, not human interpretation tasks requiring adjudication.

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

• No MRMC comparative effectiveness study was mentioned or performed. The device is a sterilizer, meaning its performance is assessed by its ability to render medical devices sterile, not by human interpretation or diagnosis. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this type of device.

6. Standalone Performance Study

• Yes, standalone performance studies were done. All the validation tests described (Surface Sterilization, Lumen Sterilization, Tyvek-Mylar Pouched Device Sterilization, Simulated Use Testing, In-Use Sterility Testing, Toxicity Testing) are assessing the algorithm/system-only performance of the STERRAD® 50 and 100S sterilizers without human intervention in the sterilization process itself. The "overkill" approach used in the validation testing directly assesses the system's ability to achieve a robust sterility assurance level.

7. Type of Ground Truth Used

• The primary ground truth used is microbiological evidence of sterility, specifically:
  • Inactivation of B. stearothermophilus endospores: This is a highly resistant bacterial spore used as a biological indicator to challenge sterilization processes. Its inactivation to a specific Sterility Assurance Level (SAL) (e.g., 10^-6) or log reduction (e.g., 6-log reduction) serves as the ground truth for effective sterilization.
  • Sterility Assessment: Direct assessment of the absence of viable microorganisms after processing.
  • Toxicity testing: Used to establish ground truth that no cytotoxic effects or toxic residuals remain.

8. Sample Size for the Training Set

• This information is not applicable. The STERRAD® Sterilization System is a physical-chemical sterilization device, not an AI/ML algorithm that is "trained" on data in the traditional sense. Its operation is based on pre-defined scientific principles of hydrogen peroxide gas plasma sterilization, not on learning from a dataset.

9. How Ground Truth for the Training Set Was Established

• This information is not applicable for the reasons stated above. The system's "operating parameters" or "settings" are developed through scientific and engineering principles, not through a "training set" with established ground truth. The validation studies described in the summary are designed to prove the device meets performance criteria, not to train it.

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