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The Genesis Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used for a maximum of 180 days.

Containers are suitable for dynamic air re-vacuum) steam sterilization, immediate use pre-vacuum steam sterilization and 100% ethylene oxide sterilization when used as described in the instructions for use.

Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices during sterilization and storage of the container.

Data cards are used to recording a specific sterilization process load. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific external process indication indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are single use only.

The Genesis Reusable Rigid Container System is an assortment of rigid, reusable, stackable containers that are used to sterilize other medical devices and maintain sterility of these devices until used. The container system is comprised of a lid, bottom, filter, tamper evident arrows, and data cards. The container system houses baskets of varying depths and organizing accessory devices that are used to organize and to secure surgical instrumentation and/or other medical devices.

The provided document is a 510(k) premarket notification for a medical device (Genesis™ Reusable Rigid Sterilization Container System). It outlines the device's indications for use, comparison to a predicate device, and a summary of non-clinical performance tests.

Here's an analysis of the acceptance criteria and study information provided, focusing on the available details:

Description of Acceptance Criteria and Device Performance

The device under review is the Genesis™ Reusable Rigid Sterilization Container System. The primary function of this system is to enclose other medical devices for sterilization and maintain their sterility for up to 180 days. The acceptance criteria for this device revolve around demonstrating its efficacy in sterilization and maintaining sterility under various conditions.

The study presented focuses on non-clinical performance testing to validate the sterilization efficacy and dry time of the container system for specific sterilization modalities and contents.

1. Table of Acceptance Criteria and the Reported Device Performance:

Additional Performance Parameters and Conditions (from "Sterilization Parameters for the Genesis™ Reusable Rigid Container System by Modality" and "Accessories and Device Challenges by Sterilization Modality and Container Style" tables):

• Pre-conditioning Pulses: 3
• Exposure Time: 4 Minutes
• Dry Time Cycle: 30 minutes (Regular)
• Minimum Cool Time: 60 minutes (Regular)
• Stack Height: Max 3
• Total System Weight: 25 lbs.
• Lumen Devices: 2.68 mm x 450 mm (Qty 16), 1.37 mm x 242 mm (Qty 10), 3 mm x 400 mm (Qty 2) | Demonstrated efficacy for Solid and Perforated Bottom Containers, Stacking/Non-Stacking Baskets, various Lumen Devices (specified quantities), Devices with conjoined surfaces, Silicone Support Bars/Mats, Laparoscopic Racks, Optional Protective Plates. Materials include Metals, Polymers, Composites. (Performance is "Yes" for all listed components/configurations under these steam methods). |
  | 100% Ethylene Oxide | - EO Sterilant Conc: 100% EO, 725 mg/L
• Pre-Conditioning Time: 30 mins
• Temperature: 130°F (55°C)
• Exposure Time: 60 mins
• Relative Humidity: 50-80%
• Aeration: 8 hours @ 109.4°F (43°C)
• No stacking
• Total System Weight: 15 lbs.
• Lumen Devices: 3.0 mm x 400 mm (Qty 5) | Demonstrated efficacy for Perforated Bottom Containers (except CD2-10BDL and DINCD2-8B), Non-Stacking Baskets, Lumen Devices (specified quantity), Devices with conjoined surfaces, Silicone Support Bars, Laparoscopic Racks. Materials include Stainless Steel, Aluminum, Silicone, Radel. (Performance is "Yes" for listed components/configurations under EO). |

The document explicitly states: "The Genesis Reusable Rigid Container System has been validated to meet the established performance criteria." This indicates that for all the criteria mentioned in the tables, the device successfully demonstrated compliance through the stated non-clinical tests.

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

• The document mentions "Testing" for sterilization efficacy and dry time but does not specify the exact sample sizes (number of containers, number of cycles, number of biological indicators, etc.) for the test sets.
• Data provenance is not explicitly stated regarding country of origin or whether the tests were retrospective or prospective. Given it's a 510(k) submission for a medical device by a US-based company (CareFusion 2200 Inc, Vernon Hills, IL), and referring to an FDA guidance document (ST 77 2013), it is prospective testing conducted in a controlled laboratory setting, likely within the US.

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

• This document describes non-clinical performance testing of a sterilization container, not a diagnostic or AI-driven medical imaging device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of clinical interpretation (e.g., radiologists) is not applicable.
• The "ground truth" for sterilization efficacy is established by scientific principles and validated biological indicators (BI) and sterility assurance levels (SAL) as per recognized standards (ST 77 2013). The validation of dry time is based on the "absence of visible moisture." These are objective measurements rather than subjective expert consensus.

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

• As this is non-clinical performance testing, adjudication methods typically used for subjective clinical assessments are not applicable. The results are based on objective laboratory measurements and adherence to specified performance standards.

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:

• No, this is not applicable. The document is for a physical medical device (sterilization container), not an AI algorithm or a diagnostic tool involving human readers.

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

• No, this is not applicable. This document pertains to a physical sterilization container.

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

• The ground truth for the performance of the sterilization container is based on objective measurements of sterilization efficacy and dryness as defined by recognized industry standards (ST 77 2013).
  • For sterilization efficacy: achieving a 12 log reduction and a Sterility Assurance Level (SAL) of 10^-6 using biological indicators (overkill method).
  • For dry time: absence of visible moisture.

8. The sample size for the training set:

• Not applicable. This relates to a physical device evaluated through non-clinical performance testing, not an AI model that requires a training set.

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

• Not applicable. As indicated in point 8, there is no training set for this type of device evaluation.

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The Genesis Reusable Rugid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used for a maximum of 180 days.

Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization, immediate use pre-vacuum steam sterilization and 100% ethylene oxide sterilization when used as described in the instructions for use.

Reusable baskets and accessory ttems (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices during sterilization and storage of the container.

Data cards are used to record information a specific sterilization process load, Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evide a visual indication that the container system has not been madvertently opened prior to use. Each arrow contains a modality-specific external process indicator that serves as a visual ndication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are sungle use only.

The Genesis Reusable Rigid Container System is an assortment of rigid, reusable, stackable containers that are used to sterilize other medical devices and maintain sterility of these devices until used. The container system is comprised of a lid, bottom, filter, tamper evident arrows, and data cards.

The container system houses baskets of varying depths and organizing accessory devices that are used to organize and to secure surgical instrumentation and/or other medical devices.

Here's an analysis of the provided text regarding the Genesis Reusable Rigid Container System's acceptance criteria and the study proving it, formatted to address your specific points.

This document describes a medical device, a sterilization container system, and the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device. It does not contain information about an AI/ML powered device, therefore, some of your requested points related to AI/ML studies are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document specifies non-clinical performance testing. It does not provide explicit details on test sample sizes for each specific test (e.g., how many container cycles were tested for sterilization efficacy or dry time).

• Sample Size: Not explicitly stated as a number of distinct "cases" or "samples" for each test. The testing is reported as demonstrating the specified reductions or absence of moisture, implying a sufficient number of tests were conducted to validate the performance.
• Data Provenance: The document does not specify a country of origin for the data. The tests are non-clinical, likely conducted in a laboratory setting as part of the device manufacturer's validation process. The study is retrospective in the sense that the results are being reported for a previously conducted validation. It is not a prospective clinical trial.

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), not an AI/ML powered device requiring expert ground truth for interpretation or diagnosis. The "ground truth" for these tests comes from objective laboratory measurements (e.g., biological indicators for sterility assurance, measurement of moisture, chemical analysis for leaching).

4. Adjudication Method for the Test Set

This information is not applicable. Since this is non-clinical performance testing with objective measurements (e.g., lab analysis for sterility, visual inspection for moisture, chemical analysis for extractables), adjudication by human experts is not relevant. The results are directly measured against pre-defined scientific criteria.

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 system, not an AI/ML diagnostic or assistive technology. Therefore, no MRMC study or AI assistance evaluation was performed.

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 used for the performance testing is based on objective laboratory measurements and scientific standards:

• Sterilization Efficacy: Biological indicators (BI) and their ability to demonstrate a 12 log reduction and a sterility assurance level (SAL) of 10-6, which is aligned with industry standard ST 77 2013 (Containment Devices for Reusable Medical Device Sterilization).
• Dry Time: Absence of visible moisture, observed after the dry time cycle. This is an objective physical characteristic.
• Leaching of Colorants: Chemical evaluation to determine "significant levels" of extractable material, implying quantitative chemical analysis.
• Material Compatibility: The physical properties of the materials and their ability to withstand the sterilization processes without degradation or compromising the sterility of the enclosed devices.

8. The Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as this is not an AI/ML powered device. The device itself (the container system) is subjected to validation testing to ensure it meets performance requirements.

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

This information is not applicable as there is no training set for an AI/ML model.

Ask a specific question about this device

The Genesis Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used for a maximum of 180 days.

Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization, immediate use pre-vacuum steam sterilization and 100% ethylene oxide sterilization when used as described in the instructions for use.

Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices during sterilization and storage of the container.

Data cards are used to record information regarding a specific sterilization process load. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evident arrows provide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific external process indicator that serves as a visual indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are single use only.

The Genesis Reusable Rigid Container System is an assortment of rigid, reusable, stackable containers that are used to sterilize other medical devices and maintain sterility of these devices until used. The container system is comprised of a lid, bottom, filter, tamper evident arrows, and data cards. The container system houses baskets of varying depths and organizing.

Here's a summary of the acceptance criteria and study information for the Genesis Reusable Rigid Container System, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

The provided document describes non-clinical performance testing for the Genesis Reusable Rigid Container System.

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated. The document refers to "Testing" and "studies" but does not quantify the number of units or cycles tested for each characteristic.
   • Data Provenance: The studies are described as "non-clinical tests" and "Performance Test Summary-New Device". The manufacturer is CareFusion, based in McGaw Park, IL, USA. This suggests the data is likely from internal laboratory testing conducted by the manufacturer. It is prospective testing for the purpose of validating the new/modified device.

2. 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 the ground truth appears to be established through standardized methods for sterilization efficacy (biological indicators, microbial challenges) rather than expert consensus on observational data.

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

   • This information is not applicable as the ground truth is determined by objective laboratory measurements and standardized biological/microbial tests, not by human adjudication of subjective assessments.

4. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers assessing cases with and without AI assistance for diagnostic accuracy. The Genesis Reusable Rigid Container System is a sterilization container, not a diagnostic imaging device, so such a study would not be relevant.

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

   • Yes, implicitly. The reported performance data for sterilization efficacy, shelf life, and microbial challenge are "standalone" in the sense that they are objective measurements of the device's ability to perform its intended function (sterilization and maintaining sterility) without human intervention in the outcome assessment (beyond setting up the tests). The device itself is not an algorithm, but its function is evaluated without a human-in-the-loop interacting with its core sterilizing mechanism.

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

   • The ground truth is established through objective biological and microbiological testing standards. Specifically:
     • Sterilization Efficacy: Achieved a 12 log reduction and SAL of 10⁻⁶ using biological indicators (BI) and an overkill method, as per ST 77:2006.
     • Microbial Challenge: Demonstrated 100% negative growth following exposure to a specified concentration of Bacillus atrophaeus CFU via aerosol, also as per ST 77:2006.
     • Shelf Life: Sterility maintenance demonstrated over 180 days.

7. The sample size for the training set:

   • This information is not applicable. The device is a physical sterilization container, not a software algorithm that requires a training set. The performance is validated through physical and biological testing.

8. How the ground truth for the training set was established:

   • This information is not applicable as there is no training set for this device.

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