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The Aesculap SterilContainer™ S2 System is a reusable rigid 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 in the following sterilization modalities:

• Ethylene Oxide
• STERRAD 100NX DUO cycle
• . STERIZONE VP4

The Aesculap SterilContainer S2 System includes accessories such as silicone mats and organizers, stainless steel baskets, trays, holders, sterilization indicator cards and tamper proof locks.

The Aesculap SterilContainer S2 System is a reusable rigid container system intended for sterilization and storage of other medical devices. This container system is compatible for use in the following sterilization modalities:

• Ethylene Oxide ●
• STERRAD 100NX DUO cycle
• STERIZONE VP4 ●

The containers are perforated and made from anodized aluminum and utilize a single-use filter. The SterilContainer S2 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 a medical device (sterilization container system), not for an AI/ML powered device. As such, the concept of a "test set," "training set," "experts to establish ground truth," "adjudication method," or "MRMC comparative effectiveness study" does not apply to this type of device submission. The performance testing outlined is for sterilization efficacy, simulated use, material compatibility, and cytotoxicity, which are standard for sterilization container systems and do not involve AI/ML components.

Therefore, I cannot extract the information required by your prompt regarding AI/ML device acceptance criteria and study details from this document. The document describes the acceptance criteria and study that proves the device meets those criteria, but these are for a physical sterilization device, not an AI/ML algorithm.

If you are interested in the acceptance criteria and study for the sterilization container itself, I can provide that information based on the document.

However, assuming you are looking for the outlined AI/ML specific information, I must state that the document does not contain it.

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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. 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 maX Low Temperature Sterilization System Flexible Cycle.

The SterilContainer" S is a container system that will allow for sterilization and storage of medical devices. This container system can be used in the Amsco® V-PRO" maX Flexible Cycle. The SterilContainer" S rigid containers are made from non-anodized Aluminum and utilize disposable (single use) polypropylene filters. The SterilContainer" S includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper proof locks.

Here's an analysis of the acceptance criteria and study information provided for the SterilContainer™ S device, as described in the FDA 510(k) submission K151242:

This document primarily focuses on the performance data used to support substantial equivalence for a medical device (sterilization container system), not on an AI/ML powered device, which is indicated by the type of testing performed (e.g., sterilization efficacy, microbial challenge, material compatibility). Thus, many of the requested fields related to AI/ML studies (like expert consensus, adjudication methods, MRMC studies, or training set details) are not applicable or cannot be answered from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical targets in the same way an AI/ML study would (e.g., "sensitivity must be >90%"). Instead, it presents performance properties that were evaluated, and the results demonstrate the device met the necessary standards for sterilization and sterility maintenance.

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

• Sample Size for Test Set: The document does not specify a numerical "sample size" in terms of number of containers or tests for each performance property. It refers to "testing," "validations," and "studies" being conducted. For example, "100 cycles of processing" for material compatibility suggests a sample size of at least one container subjected to 100 cycles.
• Data Provenance: The studies were "conducted by a qualified testing laboratory." The country of origin is not specified, but the submission is to the U.S. FDA, suggesting the testing was performed to U.S. standards or by a lab recognized by the FDA. The studies are prospective in nature, as they involve actively performing tests (sterilization cycles, microbial challenges, material cycling).

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

This section is Not Applicable (N/A). This device is a sterilization container, not an AI/ML diagnostic system that requires expert interpretation for establishing ground truth. The "ground truth" for this device revolves around objective measurements of sterility, material integrity, and functionality based on standardized testing protocols.

4. Adjudication Method for the Test Set

This section is Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in human expert interpretations, which is not relevant for testing a physical sterilization device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This section is Not Applicable (N/A). MRMC studies are specific to evaluating the impact of AI on human reader performance for diagnostic tasks. This device is a sterilization container, not an imaging or diagnostic device.

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

This section is Not Applicable (N/A). This is not an algorithm or AI device. The device itself (the SterilContainer S and its components) is being evaluated for its standalone performance in sterilization and sterility maintenance. The performance data is standalone performance of the device.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective scientific and microbiological standards.

• Sterilization Efficacy: Measured by biological indicators (BI) overkill method and the achievement of a Sterility Assurance Level (SAL) of 10⁻⁶. This is a quantitative, laboratory-based measurement.
• Microbial Aerosol Challenge: Measured by the absence of microorganisms in the contents after exposure to a defined aerosol challenge.
• Sterility Maintenance: Measured by maintaining sterility over a 180-day period under simulated conditions.
• Material Compatibility: Measured by visual and functional assessment after repeated cycles.
• Simulated Use: Measured by the reproducible sterilization of a worst-case endoscope under defined conditions.

8. The Sample Size for the Training Set

This section is Not Applicable (N/A). This device is not an AI/ML algorithm that requires a "training set."

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

This section is Not Applicable (N/A). As there is no training set for an AI/ML algorithm, this question is not relevant to the provided device information.

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The SterilContainer S is a reusable sterilization container system (consisting of perforated lids with filter retention plates, and single use polypropylene filters) intended 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 V-PRO 60 Low Temperature Sterilization System's Lumen and Flexible Cycles. The SterilContainer S includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders. The Steril Container S was demonstrated to maintain the sterility of its contents for 180 days following successful sterilization.

The SterilContainer S 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 Steris V-PRO 60 Sterilization System. The SterilContainer Srigid containers are made from non-anodized Aluminum and utilize disposable (single use) polypropylene filters. The SterilContainer S includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper-evident locks.

The provided text describes the acceptance criteria and the study results for the SterilContainer™ S sterilization container system.

Here's the breakdown of the information requested:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

The document does not specify the exact sample size for each performance test (e.g., number of containers tested for sterilization efficacy, or event-related sterility maintenance). It uses terms like "a defined amount of aerosol microorganisms" or "a worst case dual channel flexible endoscope."

The data provenance is nonclinical testing performed by a "qualified testing laboratory." It does not provide information on the country of origin of the data or whether it was retrospective or prospective, as these terms are typically relevant for clinical studies involving human or animal subjects, not for device performance validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided as this is a nonclinical performance study of a sterilization container, not a diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" here is determined by objective measures (e.g., microbial growth, physical changes, sterility tests).

4. Adjudication method for the test set:

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, which is not relevant for this type of nonclinical device performance testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable and therefore not provided. The device described is a sterilization container, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.

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

This information is not applicable as the device is a physical sterilization container, not a software algorithm.

7. The type of ground truth used:

The ground truth used in this study is based on objective laboratory measurements and tests designed to assess:

• Microbial reduction and absence of growth: For sterilization efficacy and microbial aerosol challenge.
• Maintenance of sterility: For event-related sterility maintenance.
• Absence of visible or functional changes: For material compatibility.
• Successful sterilization under specified conditions: For simulated use.

This is not expert consensus, pathology, or outcomes data in the traditional sense, but rather defined physical and biological endpoints.

8. The sample size for the training set:

This information is not applicable as the device is a physical sterilization container and does not involve machine learning or 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 (no training set for a physical 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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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.

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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