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The Aesculap SterilContainer System is a reusable sterilization container system 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 for 360 days. The SterilContainer System includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper proof locks.

The Aesculap SterilContainer is designed as a container system that will allow for sterilization and storage of other medical devices. This system consists of full, three-quarter, half, quarter, and extra long and wide body container system. There are a variety of accessories also available for this container system. This container is designed to be compatible for use in pre-vacuum steam, pre-vacuum immediate use steam and EtO sterilization. The container bottom is manufactured in anodized aluminum and has stainless steel handles on each end. There are two types of lids for the container bottom. There are anodized aluminum lids that have removable retention plates to hold the filter and a stainless steel latch on each end to lock the lid only to the container bottom. There are also Prime Line lids available for use that are manufactured in the material commonly known as Radel R. The PrimeLine lids have a reusable filter system. The reusable filter is for Pre-vac steam and Immediate Use steam sterilization only.

The provided text describes the Aesculap SterilContainer System for sterilization. Here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" with pass/fail thresholds in a formal table separate from the performance results. Instead, it presents the validated sterilization cycle parameters and states that the device was "fully validated" according to FDA and AAMI standards. The reported device performance is that it meets these validated parameters and achieves a 360-day event-related shelf life.

• Pre-vacuum steam (270°F, 4 min. exposure, 30 min. dry)
• Pre-vacuum immediate use steam (270°F, 3 min. (non-porous) / 4 min. (porous) exposure)
• Ethylene Oxide (130°F, 60 min exposure, ≥ 50% RH, 725 mg/L gas pressure) | Achieved: "fully validated for pre-vacuum steam, pre-vacuum immediate use steam, and EtO sterilization processes." |
  | Shelf Life | Maintain sterility for 360 days. | Achieved: "360 days of event related shelf life testing has been conducted." |
  | Compatibility | Compatible with specified lids, filters, and accessories for each sterilization method. | Achieved: Detailed tables provided for compatibility across various configurations and accessories. |
  | Max Load Weight | Accommodate maximum load weights of 25 pounds or less (AAMI/AORN recommendation). | Achieved: "Max total weight 25 pounds." |
  | Vent to Volume Ratio | Meet predetermined standards for the "worst case vent to volume ratio" to ensure sterilization. | Achieved: "This container represents the worst case vent to volume ratio for the SterilContainer System," and validation was successful. |
  | Reuse Testing | Maintain performance after repeat sterilization cycles. | Achieved: "100 cycles minimum" for container, "2,200 cycles (lid)" for reusable filter. |

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

The document does not explicitly state the numerical sample size used for the test set in terms of number of containers or cycles. However, it does state:

• "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications 510(k)'s' for Aesculap SterilContainer was completed on this new three-quarter size 8" (187mm) container of the worst case vent to volume ratio..."
• The testing was conducted by "a qualified testing laboratory."

Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given that it's a 510(k) submission for a new device, the testing would inherently be prospective in nature, specifically designed to validate the new device.

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

This type of information is not applicable to this submission. The "ground truth" for sterilization efficacy is established through standardized biological and physical indicator tests, not expert consensus on medical images or patient outcomes. The testing was performed in a laboratory setting per established standards (FDA and AAMI).

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 refer to a process where multiple human reviewers independently assess data (e.g., medical images) and disagreements are resolved by an expert panel. Sterilization and shelf-life testing relies on objective, measurable scientific and engineering principles (e.g., microbial kill, barrier integrity), not subjective human interpretation 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

Not applicable. This is a medical device for sterilization, not an AI-powered diagnostic or assistive tool for human readers/clinicians, so an MRMC study is not relevant.

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

This refers to the performance of a device on its own, without human intervention in its function during testing. In this context, the device (the SterilContainer) was tested in a standalone manner as its primary function is to achieve and maintain sterility independently when subjected to specified sterilization cycles. The performance data presented (sterilization cycle parameters met, 360-day shelf-life) reflects the container's inherent capabilities.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for sterilization efficacy is typically established through:

• Biological Indicators (BIs): Contain a known number of highly resistant microorganisms (e.g., bacterial spores). A successful sterilization cycle renders the BI sterile, demonstrating microbial kill.
• Chemical Indicators (CIs): React to one or more sterilization parameters with a visible change in color or state.
• Physical Monitoring: Readings from sterilizer gauges, thermometers, pressure recorders, and timers confirm that the physical parameters (temperature, pressure, time) of the cycle were met.
• Barrier Integrity Testing: For shelf-life, tests ensure the container maintains a sterile barrier over time, often involving microbial ingress challenges or visual inspection for damage.

The document implicitly refers to these methods by stating: "These validations were conducted in accordance with FDA and AAMI standards by a qualified testing laboratory." These standards prescribe the use of BIs, CIs, and physical monitoring for sterilization efficacy, and specific tests for packaging integrity and shelf-life.

8. The Sample Size for the Training Set

Not applicable. Training sets are relevant for machine learning or AI models. This device is a physical container, and its performance is evaluated through conventional engineering and microbiological testing, not by training an algorithm.

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

Not applicable, for the same reason as point 8.

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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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