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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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The Aesculap Sterilcontainer System is intended to be used to enclose another medical devices and The Aesculab Stericontainer System is intended to allow sterilization on the enclosed medical devices and be sterilized by a heatincale provinced to and used. The Aesolapp Sterilismanner System has been also maintain sterliny of the enclosed devices) undridded. The Alocallar Concerner. validated for use in an ozone sterlization system (TSO3 125L) to include hinged devices an as small as 3mm (diameter) and 550 mm (length).

The Aesculap Sterilcontainer is designed as a container system that will allow for sterilization and storage of other medical devices. This container is designed to be compatible for use with ozone sterilization. The container is made from anodized aluminum and utilizes a disposable (sinqle use) paper filter.

The documentation describes the Aesculap Sterilcontainer System, intended for sterilization and storage of medical devices, specifically validated for use with ozone sterilization systems (TSO3 125L).

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 acceptance criteria for the Aesculap Sterilcontainer System, when used in an ozone sterilization cycle (TSO3 125L Sterilizer), are based on specific parameters for each phase of the sterilization cycle. The reported device performance is indicated by the "Actual values" achieved during the validation.

The "Actual values" reported fall within or match the "Typical values" (acceptance criteria) for all specified phases, demonstrating that the device meets the established parameters for ozone sterilization.

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

The document states, "The modified Aesculap Sterilcontainer system was fully validated for the additional indication of ozone sterilization by TSO3 in their model 125L sterilizer." It further mentions that this validation was "conducted in accordance with FDA guidance and available AAMI standards by qualified testing laboratories."

• Sample Size for Test Set: The document does not explicitly state the specific sample size used for the validation (e.g., number of containers, number of cycles, number of devices with lumened or hinged features tested). However, "fully validated" implies a sufficient number of tests to meet regulatory and standard requirements.
• Data Provenance: The data was generated by TSO3 in their 125L ozone sterilizer. The location of TSO3 is not specified but given the 510(k) submission to the FDA, it's implied that the testing was conducted to U.S. regulatory standards. The study is a prospective validation study as it specifically describes testing performed to ensure the device's compatibility with ozone sterilization.

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

This type of submission (medical device sterilization container) focuses on physical and biological efficacy rather than interpretative clinical outcomes. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense (e.g., radiologists interpreting images) is not directly applicable here.

• Number of Experts: Not applicable in the context of expert consensus for ground truth on a diagnostic task.
• Qualifications of Experts: The validation was performed by "qualified testing laboratories," implying personnel with expertise in microbiology, sterilization science, and engineering were involved in conducting the tests and analyzing the results, in accordance with FDA guidance and AAMI standards.

4. Adjudication Method (for the test set)

Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of data where disagreements need resolution. This is not directly relevant to the validation of a sterilization container's physical and biological performance. The "adjudication" in this context would be the adherence to predefined pass/fail criteria for sterility and container integrity, as outlined in the AAMI standards and FDA guidance.

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

• No MRMC study was done. This type of study assesses the impact of an AI tool on human clinician performance (e.g., diagnostic accuracy, reading time). The Aesculap Sterilcontainer System is a physical device used in a sterilization process, not a diagnostic AI tool. Therefore, an MRMC comparative effectiveness study is not applicable.

6. Standalone (Algorithm Only) Performance Study

• A standalone performance study was done in the sense that the performance of the Sterilcontainer System was evaluated independently within the specified ozone sterilization cycle. While not an "algorithm" in the software sense, the container's ability to maintain sterility and withstand the ozone process (i.e., its performance) was assessed in a standalone manner without human intervention influencing the sterilization outcome itself. The validation measured the physical parameters of the cycle and the sterility assurance level (which would typically involve biological indicators) within the container.

7. Type of Ground Truth Used

The ground truth for this sterilizer validation is based on:

• Physical Parameters: Confirmation that the sterilization cycle parameters (pressure, ozone concentration, temperature—though temperature is not explicitly listed, it's a standard parameter for such cycles) were met and maintained within acceptable ranges inside the container.
• Biological Efficacy: Although not explicitly detailed in this summary, "sterilization" validation inherently requires proving a certain level of microbial inactivation. This is typically demonstrated using biological indicators (BIs) placed within problematic areas of representative devices inside the container, confirming a Sterility Assurance Level (SAL) of 10^-6 or better. This would involve laboratory testing and microbiological assay.
• Integrity/Functionality: The container's ability to maintain sterility post-sterilization and its long-term compatibility with ozone processing would also be assessed.

8. Sample Size for the Training Set

• Not applicable. This is a hardware validation for a medical devicecontainer, not a machine learning or AI model. Therefore, there is no "training set" in the context of algorithm development.

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

• Not applicable. As there is no training set for an algorithm, there is no ground truth established for it. The "ground truth" for the device's acceptable performance is derived from established regulatory standards (FDA guidance) and industry standards (AAMI) for sterilization efficacy and medical device compatibility.

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