(146 days)
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
| Characteristic/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | 12 log reduction and a sterility assurance level (SAL) of 10-6 (using biological (BI) overkill method) | "Testing demonstrated a 12 log reduction and a sterility assurance level (SAL) of 10-6 using biological (BI) overkill method." (Page 9, "Performance Test Summary-New Device" table) |
| Dry Time (Pre-vacuum Steam) | Validated method of drying by absence of visible moisture | "Testing demonstrated validated method of drying by absence of visible moisture." (Page 9, "Performance Test Summary-New Device" table) |
| Leaching of Colorants | Did not produce significant levels of extractable material prior to or after multiple processing cycles | "Testing demonstrated that colored lids did not produce significant levels of extractable material prior to processing or after multiple processing cycles." (Page 9, "Performance Test Summary-New Device" table) |
| Materials Compatibility | Expanded to include intrinsically stable metals, composites, thermoplastics and thermosetting polymers with constant use temperatures above 135°C (compared to predicate's Stainless Steel, Aluminum, Silicone, Radel) | The "New/Modified Device" column for "Material Compatibility" explicitly states: "Intrinsically stable metals, composites, thermoplastics and thermosetting polymers with constant use temperatures above 135°C." (Page 9, "SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE" table). The test results confirm this expansion. |
| Sterilization Cycle Parameters | Specific parameters for Exposure Temp, Pre-conditioning Pulses, Exposure Time, Dry Time, Cool Time, Stack Height, and Total System Weight must be met for each modality (refer to pages 4 and 11). | The device is deemed suitable when used as described in the instructions for use, implying these parameters were met during validation. The tables on pages 4 and 11 list the specific parameters the device is validated for. |
| Container/Accessory Compatibility | Compatibility with various container types, baskets, lumen devices, occluded/mated challenges, and accessories (refer to pages 4, 5, 11, and 12). | The summary states, "The Genesis Reusable Rigid Container System has been validated to meet the established performance criteria." The extensive tables on pages 5 and 12 detail the specific configurations validated ("Yes" indicates compatibility). |
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.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).