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The Sterisystem Dry-Base Instrument Tray is intended to protect surgical instruments and facilitate the sterilization process by sterilant penetration and air removal. When used in conjunction with an FDA cleared sterilization wrap, sterility of the enclosed medical device is maintained until used.

The alone trays are not intended to maintain sterlity; they are intended to be used in conjunction with an FDA cleared sterilization wrap in order to maintain sterility of the enclosed devices.

The system has been validated for the use in the following sterilization cycle: Pre-Vacuum Steam Temperature: 132C (270F) Sterilization Time: 4 minutes Drying time: 30 minutes Maximum Weight: Up to 25lbs depending on the weight limit of the cleared sterilization wrap used.

Pre-Vacuum sterilized devices may be stored in a protective storage for up to 30 days provided integrity of the container is not comprised.

The Sterisystem Dry-Base Instrument Trays are reusable sterilization trays. The trays are not intended to maintain sterility by themselves. Prior to sterilization, the trays must be wrapped with an appropriate FDA-cleared sterilization wrap to provide a microbial barrier which allows sterilant to permeate throughout the interior of the loaded tray. The tray configurations are all trays and lids, available in various sizes. All trays are constructed of stainless steel metal meshbase and the lid are constructed of stainless steel and silicone. The tray and lid designs have a higher percentage of open cells than metal mesh allowing for complete permeation of sterilant. The trays have latches designed to fasten the lid onto the base.

This document describes the validation of the Sterisystem Dry-Base Instrument Tray for its intended use, which is to protect surgical instruments and facilitate sterilization when used with an FDA-cleared sterilization wrap.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sterilization Effectiveness: The study evaluated "Each sterilization wrap and tray tested." This implies a sample size of at least one of each configuration of the Sterisystem Dry-Base Instrument Tray in conjunction with a sterilization wrap. The precise number of trays and wraps tested is not explicitly stated as a single numeric value in the provided text.

• 30 Day Storage: "Maintenance of sterility was however evaluated on the subject device with a cleared sterilization for 30 days." Similar to sterilization effectiveness, the precise number of samples is not explicitly given.

• Cleaning Validation: "A manual and automated cleaning validation was performed." The number of devices subjected to this validation is not specified.

• Biocompatibility: "Biocompatibility testing was conducted on all materials used in construction of the subject device." The number of test articles or samples is not specified beyond "all materials."

• Life Cycle Testing: "Life cycle testing was performed." The number of cycles and devices tested is not specified.

• Data Provenance: The document does not specify the country of origin but implies that the tests were conducted by or on behalf of O&M Halyard, Inc. (Alpharetta, Georgia, USA). The studies appear to be prospective as they are specifically conducted to validate the performance of the device before market clearance.

3. Number of Experts and Qualifications:

The document does not mention the use of human experts to establish ground truth for the performance tests conducted (sterilization, cleaning, biocompatibility, life cycle). These tests typically rely on laboratory-based, objective measurements and established standards (e.g., Geobacillus stearothermophilus growth, chemical residue levels, cell lysis).

4. Adjudication Method:

Not applicable, as the evaluation methods are laboratory-based and objective, rather than subjective interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human interpretation of images or data is involved and the intent is to show how the device aids human readers. The Sterisystem Dry-Base Instrument Tray is a sterilization accessory, not a diagnostic device.

6. Standalone Performance:

Yes, a standalone (algorithm only without human-in-the-loop performance) evaluation was effectively done for the critical functions of the device. The various tests (sterilization efficacy, drying time, cleaning, biocompatibility, life cycle) determined the inherent performance characteristics of the physical device itself. The device's function is mechanical and chemical (facilitating sterilization), not based on an algorithm or human-in-the-loop diagnostic process.

7. Type of Ground Truth Used:

The ground truth used for the acceptance criteria and performance evaluation is primarily objective laboratory measurements and established scientific standards:

• Microbiological assays: For sterilization effectiveness (e.g., absence of Geobacillus stearothermophilus growth).
• Physical measurements/observations: For drying time, material integrity (life cycle testing), visual cleanliness (cleaning validation).
• Chemical/biological assays: For cleaning validation (residue levels) and biocompatibility (cell lysis, reactivity).
• Pre-defined acceptance limits: For all quantitative measures based on regulatory standards (e.g., ISO 10993 for biocompatibility) and industry best practices for sterilization.

8. Sample Size for the Training Set:

Not applicable. This device is a physical product (a sterilization tray), not an artificial intelligence or machine learning model that requires a "training set."

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

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

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