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The SterilContainer S System is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and single use polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. This container system has been validated with flexible endoscopes and accessories, cables, and camera heads. 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 100NX DUO Cycle. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, filters, indicator cards, locks, and instrument holders.

Validation testing for event related sterility maintenance has been conducted for up to 365 days.

The SterilContainer™S System is a container system that will allow for sterilization and storage of medical devices. This container system can be used in the STERRAD 100NX DUO Sterilization System. The SterilContainer" S System rigid containers are made from nonanodized Aluminum and utilize disposable (single use) polypropylene filters. The SterilContainer" S System includes accessories such as mats, baskets, trays, instrument holders, organizers, filters, indicator cards and tamper proof locks.

The provided document is a 510(k) summary for the SterilContainer S System for use in the STERRAD 100NX DUO Cycle. It describes non-clinical performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, 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

The document does not explicitly state the numerical sample sizes for each test in the non-clinical performance data section. However, it indicates that:

• "Testing demonstrated a 12 log reduction..." for Sterilization Efficacy.
• "No growth was observed from three different injection doses for load configuration 1, 2 and 3 respectively" for Inactivation Kinetics. This suggests at least three instances were tested.
• "Validation testing for event related sterility maintenance has been conducted for up to 365 days."

The data provenance is presented as "Non-Clinical Performance Data" and states that "These validations were conducted by a qualified testing laboratory." The document does not specify the country of origin of the data or whether it was retrospective or prospective, but clinical trials are not mentioned, which typically implies laboratory-based, prospective testing.

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

This information is not applicable as the document describes non-clinical performance testing of a medical device (sterilization container system) rather than an AI/ML-driven diagnostic or therapeutic. The "ground truth" here is based on quantitative microbiological and physical performance metrics, not expert human interpretation.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above.

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 is not applicable as the device is not an AI/ML-driven system nor is it related to image interpretation or human reader performance.

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

This is not applicable as the device described is a physical sterilization container system, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests is based on objective, quantitative measurements and established scientific principles for sterilization and sterility maintenance, including:

• Microbiological assays: Such as measuring log reduction of G. stearothermophilus (biological indicator) to establish a Sterility Assurance Level (SAL).
• Physical integrity testing: To assess the container's ability to maintain a sterile barrier over time.
• Chemical compatibility: Ensuring materials do not degrade or interfere with the sterilization process.

This is distinct from expert consensus, pathology, or outcomes data which are relevant for diagnostic or therapeutic devices.

8. The Sample Size for the Training Set

This is not applicable as the device is not an AI/ML system requiring a training set. The "testing" in this context refers to validation studies for the physical device.

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

This is not applicable as there is no training set for this type of device.

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The SterilContainer S System is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and single use polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. This container system has been validated with stainless steel and Teflon 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 TS03 Sterizone VP4 Low Temperature Sterilization System. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.

The SterilContainer™ S System is a container system that will allow for sterilization and storage of medical devices. This container system can be used in the TS03 Sterizone VP4 Low Temperature Sterilization System. The SterilContainer" S System rigid containers are made from non-anodized Aluminum and utilize disposable (single use) polypropylene filters. The SterilContainer" S System includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper proof locks.

This documentation describes the regulatory clearance of the SterilContainer™ S System by Aesculap, Inc. as a reusable sterilization container system. The validation studies demonstrate its effectiveness and safety.

Here's an analysis of the provided text in the context of acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a separate table. However, the "Performance Properties" table (page 7) implicitly outlines the performance requirements that the device needed to meet for clearance.

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

• Sterilization Efficacy/Lethality Study: Performed in triplicate on the Aesculap rigid container. The specific number of containers per replicate is not stated. The data provenance is not explicitly mentioned as country of origin but is implied to be from a "qualified testing laboratory" (page 7) in support of US FDA clearance. It is a prospective study as tests were conducted specifically for this clearance.
• Bacterial Filtration Efficiency: The "evaluation" suggests a test set, but the sample size for filters or test runs is not specified.
• Event Related Sterility Maintenance: Not specified for individual containers, but the study simulated "hospital sterile package handling and storage conditions" over 180 days.
• Material Compatibility/Reuse Test: The device was subjected to 100 cycles of processing.
• Biocompatibility: The "study" evaluated the polypropylene filters, but the sample size of filters tested is not specified.
• Aerosol Microbial Challenge: Not specified.

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

This document describes the mechanical and biological performance of a medical device (sterilization container), not a diagnostic or AI-based device that relies on human interpretation for "ground truth". Therefore, the concept of "experts used to establish ground truth" based on interpretation is not applicable in this context. The "ground truth" for these tests is based on objective, standardized laboratory measurements and methods (e.g., microbial growth, visual inspection, filtration efficiency).

4. Adjudication Method for the Test Set:

Not applicable, as "adjudication method" often refers to resolving discrepancies among human readers or interpreters. The tests here are objective performance measurements.

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

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and AI assistance can be evaluated for its impact on their performance. This document is about a sterilization container system, which does not involve human interpretation in the same way.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

Not applicable. This device is a physical container and doesn't involve any algorithm or AI for "standalone performance."

7. Type of Ground Truth Used:

The ground truth for the performance tests relies on:

• Microbial Challenge Testing: Demonstrating a log reduction of Geobacillus stearothermophilus spores and achieving a specific Sterility Assurance Level (SAL).
• Physical and Functional Testing: Visual inspection for material integrity, flow rate/filtration measurements for barrier function, and functional checks after repeated cycles.
• Chemical Testing: Biocompatibility assessment of materials.
• Time-based Stability: Maintaining sterility over a defined storage period.

These are all objective, laboratory-based measurements defined by established standards for medical device sterilization.

8. Sample Size for the Training Set:

Not applicable. This document describes the validation of a physical medical device. There is no AI or machine learning component that would require a "training set." The listed studies are for device validation, not model training.

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

Not applicable, as there is no training set for an AI/ML model for this device.

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The SterilContainer S System is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and single-use polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. This container system has been validated with hinged, and knurled instruments. It is intended to allow sterilization of the enclosed device and also maintain sterlity of the enclosed device until used. This container system is compatible for use with STERRAD 100NX EXPRESS Cycle. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.

Testing has been completed on the SterilContainer S Full size container to maintain the sterility of its contents for 360 days following successful sterilization.

Testing has been completed on the SterilContainer S 1/2 size container to maintain the sterility of its contents for 30 days following successful sterilization.

The validated chamber load for the SterilContainer S Full and Half sizes in the STERRAD 100NX EXPRESS Cycle consisted of one SterilContainer S placed on the bottom shelf in an otherwise empty chamber.

The SterilContainer S System is a container system that will allow for sterilization and storage of medical devices. This container system is for use in low-temperature sterilization technology such as with the STERRAD 100NX EXPRESS Cycle. The SterilContainer S System rigid containers are made from non-anodized Aluminum and utilize disposable (single use) polypropylene filters. The SterilContainer S System includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper-evident locks.

This document describes a 510(k) premarket notification for a medical device, the "SterilContainer S System", and focuses on demonstrating its substantial equivalence to a predicate device. This is a regulatory filing, not a clinical study, and therefore the acceptance criteria and study data provided are for performance validation rather than clinical efficacy.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific numerical sample sizes for each test. For example, it doesn't say "X number of containers were tested for sterilization efficacy." However, it describes the type of testing performed:

• Sterilization Efficacy: "a half cycle validation."
• Whole Package Microbial Aerosol Challenge: "exposure to a defined amount of aerosol microorganisms."
• Event Related Sterility Maintenance: Mentions "30 or 360 day event related storage" and "100 cycles of processing."
• Biocompatibility: Mentions "Cytotoxicity testing" and "A Hemolysis study."

The data provenance is not specified regarding country of origin. The studies are prospective in nature, as they involve performing tests on the device to validate its performance according to defined protocols.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is a technical performance validation of a sterilization container, not a diagnostic device requiring expert interpretation of images or clinical outcomes. Therefore, the concept of "experts used to establish ground truth" in the clinical sense (e.g., radiologists) is not applicable here. The "ground truth" for these tests would be established by the adherence to recognized industry standards (e.g., ISO, ASTM) and microbiology principles for sterility and biological safety, as performed by a "qualified testing laboratory."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As noted above, this is a technical device validation following standardized protocols, not a clinical study involving human interpretation that would require an adjudication method for ground truth.

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 device is a sterilization container, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.

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

Not applicable. This device does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device validation is based on accepted scientific and industry standards for sterility, microbial barrier performance, material durability, and biocompatibility.

• Sterilization Efficacy: No microbial growth after sterilization and challenge, achieving a specified sterility assurance level (SAL).
• Whole Package Microbial Aerosol Challenge: No microbial ingress or contamination of contents.
• Event Related Sterility Maintenance: Maintenance of sterility for specified durations (30 or 360 days) and no degradation after repeated use (100 cycles).
• Biocompatibility: Meeting the criteria for non-cytotoxicity (per ISO 10993-5) and non-hemolysis (per ASTM F756 and ISO 10993-4).

These are objectively verifiable measurements and observations against established benchmarks, not subjective expert consensus or pathology.

8. The sample size for the training set

Not applicable. This device does not utilize machine learning or AI algorithms, and therefore does not have a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

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