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The TSO3 Chemical Indicator is a process indicator intended for use by healthcare providers to accompany sterilization packs, containers, or trays intended to be sterilized in the TSO, Model 125L Sterilizer. It is intended to differentiate between unprocessed items and processed items. The color of the TSO; Chemical Indicator changes from a red to lighter than the peach reference color when exposed to ozone, a critical component of the TSO3 Model 125L Sterlizer sterilization process.

The TSO1 Chemical Indicator is a process indicalor strip intended to be used in the TSO--125L Ozone Sterilizer. The TSO3-125L Ozone Sterilizer uses Ozone vapor at low temperature and high humidity to destroy both spore-forming and nonspore-forming microorganisms. The routine use of CI's is considered to complement the employment of a biological indicator monitoring program. The TSO3 Chemical Indicator can be used to identify that an item has been processed through the TSO:-125L Ozone Sterilizer and that the Ozone was present. It does not imply that terminal sterilization occurred or to assure that the sterilization cvcle has been completed.

The TSO3 Chemical Indicator is comprised of a paper strip upon which a reactant chemical indicator ink is printed which is then overcoated with a clear finish to prevent the indicator ink from being damaged by handling or abrasion before, during or after use. The imprint consists of a red indicating ink circle located within a peach colored reference square. When the color of the indicator circle has changed to a color lighter than that of the surrounding peach colored reference square, the appropriate exposure to Ozone has taken place.

Acceptance Criteria and Device Performance for TSO3 Chemical Indicator

This document summarizes the acceptance criteria and study findings for the TSO3 Chemical Indicator, as presented in the provided 510(k) summary (K021161).

1. Acceptance Criteria and Reported Device Performance

The TSO3 Chemical Indicator is a process indicator intended to differentiate between unprocessed and processed items within the TSO3 Model 125L Ozone Sterilizer.

2. Sample Size and Data Provenance

The document does not explicitly state the specific sample sizes for each test conducted for the performance criteria. However, it mentions "Tests were conducted" and "CIs were processed" for various evaluations. The data provenance is not specified in terms of country of origin, but the applicant's address is in Quebec, Canada, and the contact agent is in New York, USA. The studies appear to be retrospective in the sense that they were conducted to demonstrate the performance of a developed device for regulatory submission.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of external experts for establishing ground truth regarding the performance of the chemical indicator. The evaluation of color change and other effects would have likely been performed by trained internal personnel (e.g., laboratory technicians, chemists, quality control staff) responsible for and knowledgeable in chemical indicator performance evaluation. No specific number or qualifications are provided.

4. Adjudication Method

No adjudication method is described. The assessment of color change and other physical/chemical properties would typically be objective measurements or visual assessments against a defined standard (e.g., the peach reference color).

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

No MRMC comparative effectiveness study was mentioned. This device is a chemical indicator, not an AI-powered diagnostic tool, so such a study would not be applicable.

6. Standalone (Algorithm Only) Performance

This question is not applicable. The TSO3 Chemical Indicator is a physical device that reacts to ozone exposure, not a software algorithm. Its performance is inherent to its physical and chemical properties in a standalone manner (without human interpretation beyond reading the color change).

7. Type of Ground Truth Used

The ground truth for the performance tests was based on:

• Physical/Chemical Reaction: The inherent property of the indicator ink to change color in the presence of a specific concentration of ozone.
• Established Test Protocols: Standardized laboratory tests to evaluate color stability under various conditions (chemical exposure, UV exposure, other sterilization methods) and cytotoxicity.
• Measurement of Ozone Concentration: Direct measurement of ozone dose (e.g., 70 mg/L) in the sterilization chamber.

8. Sample Size for the Training Set

This question is not applicable. The TSO3 Chemical Indicator is a physical device with a chemical reaction, not a machine learning model, so there is no "training set."

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

This question is not applicable as there is no training set for a chemical indicator.

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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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