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

Containers are suitable for various STERRAD and V-PRO low temperature sterilization modalities 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™ Low Temperature Container System is an assortment of rigid, reusable, stackable containers that are used to enclose 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 describes the Genesis™ Low Temperature Reusable Rigid Sterilization Container System, detailing its indications for use and performance data to support its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document provides details of the tests performed but does not explicitly state the exact sample sizes for each test set. For instance:

• Aerosol Challenge: "Containers subjected to an aerosol challenge test with an exposure of 1.0 - 5.0 x 10^6 CFU. Agar vessels placed in each container sample..." implies multiple container samples were used, but the specific number is not given.
• Cycled Aerosol / Limits of Reuse: "After 100 simulated full use cycles or the equivalent followed by an aerosol challenge test with an exposure of 1.0 - 5.0 x 10^6 CFU. Agar vessels placed in each container sample..." again implies multiple samples over 100 cycles, but the number of distinct items tested is not specified.
• Simulated Use: "no recovery of viable challenge organism...from the lumens on the test device after processing within a worst case Genesis Container as part of a worst case cycle simulated use container validation load." This suggests a focus on "worst-case" scenarios, likely involving a limited number of "test devices" and container configurations, but the exact count isn't in the provided text.
• Shelf Life / Package Integrity: "All sample devices remained sterile...following exposure to a full sterilization cycle and weekly rotation events at a 180 day storage duration" implies multiple "sample devices" but the number is not provided.
• Biocompatibility: "Blood hemolysis testing demonstrated that any accessories used..." does not specify the number of accessories or tests performed.

The data provenance is not specified regarding country of origin; however, the context of an FDA 510(k) submission implies testing conducted under relevant regulatory standards. The studies described are prospective in nature, as they involve performing specific tests (e.g., sterilization cycles, aerosol challenges, simulated use, shelf-life studies) to validate performance criteria for the device.

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

The document describes non-clinical performance tests, not clinical studies involving human experts for ground truth establishment. The "ground truth" for these tests is based on objective scientific measurements (e.g., presence/absence of microbial growth, sterility assurance levels, material property changes) as defined by established standards like ANSI AAMI ST 77 2013 and ISO 10993-4 2009. Therefore, there were no human experts establishing ground truth in the way one might for diagnostic imaging.

4. Adjudication Method for the Test Set:

Not applicable, as this is a non-clinical device performance study based on objective measurements against defined standards, not an assessment requiring human interpretation or adjudication for ground truth.

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

No. This document pertains to the performance validation of a sterilization container system, which is a physical medical device, not an AI or diagnostic imaging system. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance:

No. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

The ground truth used in these studies is objective, measurable criteria defined by recognized scientific standards and validated laboratory methods. This includes:

• Microbiological Negativity: Absence of microbial growth (biological indicators, indicator organisms in aerosol challenge) to establish sterility.
• Sterility Assurance Level (SAL): Quantitative measure (10^-6) of sterilization effectiveness.
• Physical and Mechanical Integrity: Maintaining filter properties (BFE, tear strength, burst strength), container integrity.
• Biocompatibility: Demonstrating no harmful interactions with blood (hemolysis testing).

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device undergoing performance validation, not a machine learning model requiring a training set.

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

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

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