Search Results

The Aesculap Sterilcontainer S is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and disposable polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. This container has been validated with stainless steel lumens, hinged, and knurled instruments. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use with the STERRAD 200, STERRAD NX (Standard cycle and Advanced cycle), and STERRAD 100NX (Standard cycle and Flex cycle). The Sterilcontainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.

The Sterilcontainer S is recommended for surface and lumens:

STERRAD 200, stainless steel lumens ≥ 3mm I.D. x ≤ 400mm L STERRAD NX standard cycle, stainless steel lumens ≥ 2mm I.D. x ≤ 400mm L STERRAD NX advanced cycle, stainless steel lumens ≥ 1mm I.D. x ≤ 500mm L STERRAD 100NX standard cycle, stainless steel lumens ≥ 0.7mm I.D. x ≤ 500mm L STERRAD 100NX flex cycle, porous lumens (flexible endoscope) ≥ 1mm I.D. x ≤ 850mm L

30 days of shelf life testing has been conducted for the Sterilicontainer S.

The attached tables identify which products may be sterilized in which STERRAD sterilization cycle.

The Aesculap Sterilcontainer S 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 the STERRAD sterilization processes [200, NX (Standard cycle and Advanced cycle), and 100NX (Standard cycle and Flex cycle). The container is made from non-anodized Aluminum and utilizes a disposable (single use) polypropylene filter. The Sterilcontainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.

Here's an analysis of the acceptance criteria and study information for the Aesculap Sterilcontainer S, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not explicitly state a numerical sample size for the "test set" in terms of how many containers or sterilization cycles were performed. Instead, it refers to "validation" of various container sizes with a specific number of lumens per container system (e.g., "5 stainless steel lumens per container system" for full, ¾, ½, and ¼ sizes, and "2 stainless steel lumens per container system" for Extra Long Mini). For the 100NX flex cycle, it states "1 PTFE/PE lumen per container system." This suggests that the "sample size" is the combination of container types and the specified number of lumens.
• Data Provenance: The document explicitly states the validation was conducted by "a qualified testing laboratory." The country of origin for the data is not specified. The study is implicitly prospective as it's a validation study for a new device to demonstrate its performance against predefined criteria.

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 document. The validation appears to rely on objective measures of sterilization efficacy rather than expert subjective assessment.

4. Adjudication Method for the Test Set

• This information is not applicable as the nature of the study (sterilization container validation) does not involve human expert adjudication of results but rather objective measurements of sterility and physical compatibility.

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

• This information is not applicable. The device is a sterilization container, not an AI-powered diagnostic tool, so an MRMC study related to human reader performance with or without AI is irrelevant.

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

• This information is not applicable. The device is a physical sterilization container, not an algorithm.

7. The Type of Ground Truth Used

• The ground truth in this context would be objective laboratory measurements of sterility (e.g., absence of microbial growth on biological indicators, successful chemical indicator changes, maintenance of barrier properties, and lumen patency) and physical compatibility (e.g., fitness for use within the specified STERRAD sterilizers). The document implies validation against "FDA guidance and available AAMI standards," which would define the methods and criteria for establishing sterility.

8. The Sample Size for the Training Set

• This information is not applicable. The Aesculap Sterilcontainer S is a physical device, 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 point 8.

Ask a specific question about this device

The Aesculap Sterilcontainer S 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 of the enclosed device until used. This container system is compatible for use with the V-PRO 1 and V-PRO Plus Systems.

The Sterilcontainer S is recommended for surface and lumens:

≥ 1mm internal diameter and ≤ 125 mm in length > 2mm internal diameter and < 250 mm in length ≥ 3mm internal diameter and ≤ 400 mm in length

Lumen Cycle - The maximum number of lumens per load is 20 lumens.

The Aesculap Sterilcontainer S 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 the V-PRO 1 and V-PRO 1 Plus sterilization systems. The container is made from non-anodized Aluminum and utilizes a disposable (single use) polypropylene filter.

The provided text describes the Aesculap Sterilcontainer S, a reusable sterilization container system. However, it does not contain the detailed acceptance criteria or the specific study data that comprehensively demonstrates the device meets acceptance criteria in the format requested.

The document is a 510(k) summary and FDA communication, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study report.

Here's a breakdown of what can be extracted and what information is missing based on your request:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

The provided document, a 510(k) summary and FDA clearance letter, confirms that the Aesculap Sterilcontainer S was validated for use with V-PRO 1 and V-PRO 1 Plus Sterilization Systems. This validation was conducted in accordance with FDA guidance and available AAMI standards, implying that the device met the performance requirements outlined in those standards for sterilization containers. However, the exact acceptance criteria and detailed performance results are not explicitly stated in this document.

For example, a sterilization container system would typically need to demonstrate:

• Sterilization Efficacy: The container must allow for effective sterilization of enclosed devices (e.g., achieving a sterility assurance level (SAL) of $10^{-6}$ for specified cycles).
• Maintenance of Sterility: The container must maintain the sterility of the enclosed devices for a specified period (e.g., 6 months, 1 year).
• Material Compatibility: The container materials must be compatible with the sterilization process (e.g., V-PRO hydrogen peroxide plasma) without degradation or leaching.
• Physical Integrity: The container must maintain its physical integrity after repeated sterilization cycles.
• Filter Performance: The single-use polypropylene filter must effectively facilitate gas exchange while maintaining the sterile barrier.

The document states: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications 510(k)'s' for Aesculap Sterilcontainer S was completed. The Aesculap Sterilcontainer S was fully validated for V-PRO 1 and V-PRO 1 Plus Sterilization Systems. This validation was conducted in accordance with FDA guidance and available AAMI standards by a qualified testing laboratory."

This indicates a study was performed, but the specifics are not provided. Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.

Missing Information:

The provided text does not contain the following information required for your detailed request:

1. A table of acceptance criteria and the reported device performance: The document only generally states that "All required testing...was completed" and the device was "fully validated," implying it met relevant criteria, but no specific values or thresholds are given.
2. Sample size used for the test set and the data provenance: There is no mention of the number of containers or cycles tested, nor the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This type of study (related to physical sterilization efficacy) typically does not rely on human experts for ground truth in the same way an AI diagnostic device would. Ground truth would be established through biological indicator testing, chemical indicator evaluation, and sterility testing performed by qualified microbiology labs. The number and qualifications of such laboratory personnel are not mentioned.
4. Adjudication method for the test set: Not applicable for this type of device performance testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable, as this is a physical medical device, not an AI diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
7. The type of ground truth used: While the text doesn't specify, for sterilization validation, ground truth would typically come from:
   • Biological Indicator (BI) testing: Using highly resistant spores to confirm killing.
   • Chemical Indicator (CI) changes: To visually confirm that sterilant conditions were met.
   • Sterility Testing: Incubation of processed items to ensure no microbial growth.
   • Physical Parameter Monitoring: Recording and verification of cycle parameters (temperature, pressure, time, sterilant concentration).
     The document only states "fully validated," which implies these methods were used but does not detail them.
8. The sample size for the training set: Not applicable, as this is a physical medical device, not an AI system that requires a "training set."
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text confirms that performance testing and validation were conducted for the Aesculap Sterilcontainer S to demonstrate its compatibility and efficacy with V-PRO 1 and V-PRO 1 Plus sterilization systems, in accordance with FDA guidance and AAMI standards. However, it does not offer the granular detail concerning specific acceptance criteria, study sizes, methodologies, or ground truth establishment that your request specifies for an AI/diagnostic device.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device