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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)

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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