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The KARL STORZ UDEL Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in STERRAD and steam sterilization systems as indicated table. The system may be used with flexible endoscopes with lumen diameters ≥ 1.2mm and a maximum length of 845mm. KARL STORZ UDEL Sterilization Trays must be used in conjunction with an FDA cleared sterilization wrap or container.

The KARL STORZ UDEL Sterilization Trays are intended only for use to encase specific KARL STORZ reusable medical devices for sterilization in steam and specified STERRAD Sterilization System cycles. The sterilization trays are not intended to maintain sterility by themselves. Prior to sterilization, the trays must be double-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, available in various sizes, are designed to encase specific KARL STORZ medical devices, such as fiber optic light cable, flexible endoscopes, and camera heads. Some of the trays are specifically molded to fit and accommodate KARL STORZ light cables, flexible endoscopes, camera heads and rigid telescopes, allowing the instruments to be arranged in an organized manner when placed in the tray. All systems consist of a Udel plastic base and Udel plastic lid. Lids are attached to the trays with assembled hardware. Baskets are injection molded and trays are thermoformed from Udel polysulfone polymer (sourced from Solvay Specialty Polymers), which is compatible with all indicated sterilization modes.

The sterilization trays are constructed with a perforated lid and base to allow for permeation of sterilant during sterilization. Some of the tray configurations are simply molded into the form of a mesh. The trays have latches designed to fasten the lid onto the base. Other tray components include silicone holders and mats (depending on the tray type) to secure instruments and provide protection of the medical devices in the sterilization tray. The holders and mats are manufactured from silicone material, which is also compatible with all sterilization modes.

The provided text describes the acceptance criteria and a summary of non-clinical testing for the KARL STORZ UDEL Sterilization Trays. The device is a medical device sterilization tray, and the testing focuses on its efficacy in various sterilization methods and its material stability.

Here's a breakdown of the requested information based on the provided text:

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 generally refers to "worst case tray configurations" being used for testing. However, specific sample sizes for individual tests are not provided in the summary. The data provenance is not specified (e.g., country of origin, retrospective/prospective). The studies are "non-clinical testing" conducted to establish efficacy.

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 information is not applicable to this type of device and study. The "ground truth" for sterilization efficacy is typically established through standardized biological indicators and laboratory analysis to determine the Sterility Assurance Level (SAL), not by human expert consensus in the way clinical diagnostic devices are evaluated. Similarly, for cleaning and material stability, the "ground truth" is determined by objective measurements against established chemical and physical standards.

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

This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where there might be disagreement in assessments. The testing described here involves objective laboratory measurements and adherence to 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

An MRMC comparative effectiveness study is not applicable to this device. This device is a sterilization tray, not an AI-powered diagnostic tool that involves human readers.

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

This information is not applicable. This device is not an algorithm or an AI system. Its performance is evaluated through its physical properties and interaction with sterilization processes.

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

The "ground truth" for the tests is derived from:

• Sterilization efficacy: Achieved Sterility Assurance Level (SAL) of 10^-6, which is an industry standard based on the inactivation of biological indicators. This is determined through microbiological testing.
• Cleaning efficacy: Quantitative measurements of residual protein and hemoglobin on the device surface after cleaning, compared against established limits in standards like AAMI TIR 30.
• Material stability: Assessment of the material's physical integrity after a specified number of sterilization cycles, likely through visual inspection, mechanical testing, or other material science methods, against an internal protocol and AAMI TIR 12.
• Dry time: Objective measurement of the time required for the device to be completely dry after sterilization.

8. The sample size for the training set

This information is not applicable. The device is a physical product, not a machine learning model, so there is no "training set."

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

This information is not applicable for the same reason as point 8.

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