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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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The Aesculap Sterilcontainer is a reusable sterilization container system (consisting of a solid bottom, a perforated lid w/ filter retention plates, and disposable paper filters) 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 device and also maintain sterility of the enclosed device until used. This container has been validated with stainless steel lumens, hinged, and knurled instruments (stainless steel lumens of greater than 3 mm inner diameter or less than 400 mm in length). This container system is compatible for use in pre-vacuum (steam) flash sterilization. The SterilContainer System for includes accessories such as baskets, trays, and racks.

The Flash compatible 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 "Flash" prevacuum steam sterilization. The container is made from anodized aluminum and utilizes a disposable (single use) paper filter. The container system consists of a solid bottom, a perforated lid w/ filter retention plate, and disposable paper filter. Accessories such as trays, baskets, and racks can be used with it.

This 510(k) summary provides information on the Aesculap Sterilcontainer System (Flash Indication). The device is a reusable sterilization container system intended for use with "Flash" prevacuum steam sterilization.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the statement that the validation was conducted in accordance with "FDA quidance and available AAMI standards" and that the testing demonstrated "similar performance characteristics and prove efficacy of the Aesculap container" compared to a predicate device. Specific numerical acceptance criteria are not provided in this summary.

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 in the performance studies. It mentions that "The Aesculap Sterilcontainer system was fully validated... Additionally comparative testing was done on a predicate device." The provenance of the data (e.g., country of origin, retrospective or prospective) is not specified.

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

This information is not provided in the document. The validation was conducted "by a qualified testing laboratory," but details about expert involvement or qualifications are absent.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No, an MRMC comparative effectiveness study is not mentioned. The study focused on the performance of the device itself rather than human reader performance with or without AI assistance, as this is a physical medical device (sterilization container), not an AI-powered diagnostic tool.

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

Yes, in a conceptual sense, the performance study conducted for the sterilization container can be considered a standalone assessment of the device's ability to sterilize and maintain sterility. The device itself (the container) is the primary subject of the performance evaluation. There's no AI algorithm involved, so "standalone" here refers to the device's intrinsic mechanical/sterilization performance.

7. The Type of Ground Truth Used

The ground truth for this type of device would typically be established through microbiological testing (e.g., sterility testing using biological indicators or culture methods) to confirm the complete inactivation of microorganisms, and physical/chemical integrity testing to ensure the container maintains sterility under various conditions. While not explicitly detailed, the statement "fully validated... in accordance with FDA quidance and available AAMI standards" implies the use of such established scientific methods for ground truth.

8. The Sample Size for the Training Set

This information is not applicable. Sterilization containers are not "trained" in the way AI models are. Their performance is inherent in their design and manufacturing, and validated through physical and microbiological testing.

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

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

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