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The PRO-LITE™ Sterilization Trays are used to contain medical devices for sterilization in the following cycles: Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-PRO® Low Temperature Sterilization Systems

Prior to placing in the Sterilizer, the trays must either be:

• · wrapped with a legally marketed sterilization wrap for use in the Sterilizers listed above or
• · placed inside a legally marketed pouch for enclosing trays in the Sterilizers listed above

The PRO-LITE Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed medical instruments.

The PRO-LITE Sterilization Trays contain medical devices for sterilization in the V-PRO Low Temperature Sterilization Systems: V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO maX 2, V-PRO 60 and V-PRO s2 Low Temperature Sterilization Systems. The trays are available in various sizes, outlined in Table 5-1, to accommodate the loads to be processed. The proposed trays are identical in design to the predicate Sterilization Trav (K172755) and are composed of a base and a lid. The lid includes clamping mechanisms designed to secure the lid onto the base. There are numerous holes in the base and lid for sterilant penetration. The tray is categorized as a cassette and requires complete enclosure in a legally-marketed sterilization wrap or pouch to maintain sterility of the enclosed devices. Both the base and the lid for the proposed tray are made of a mineral-filled polypropylene material.

Optional instrument organizers are provided as accessories to the trays and allow stabilization of various cylindrical medical devices during processing. Optional sterilization mats are provided as accessories to the trays. The mats, which are used to cushion and stabilize devices placed into the trays, are available in sizes as shown in Table 5-3 to fit the nine PRO-LITE Sterilization Trays. The mats are a diamond grid design with "fingers" that extend from each corner of the diamond and at the midpoint of each diamond side. The fingers cushion and stabilize instruments, helping to prevent the instruments from freely moving in the tray during packaging, sterilization and storage. The cushioning and stabilization qualities help protect delicate instruments placed into the trays.

The provided text describes the PRO-LITE Sterilization Tray and its performance in various sterilization cycles. There is no information about an AI/ML device in the document. Therefore, I cannot provide details on sample size for test and training sets, data provenance, number or qualifications of experts, adjudication methods, or MRMC comparative effectiveness studies, as these are not relevant to the described device.

However, I can provide the acceptance criteria and reported device performance based on the provided "Summary of Non-clinical Tests" table.

1. Table of Acceptance Criteria and 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)
This information is not provided in the document. The document describes the performance testing for a sterilization tray, which does not typically involve test sets, data provenance, or data types like those associated with AI/ML or clinical studies.

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 provided in the document and is not relevant to the type of device described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document and is not relevant to the type of device described.

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 provided in the document and is not relevant to the type of device described, which is a sterilization tray, not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document and is not relevant as it is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "Demonstration of Effective Sterilant Penetration" tests, the ground truth is implicitly defined by the ability to achieve "reproducible sterilization" of test articles/spaces under specified worst-case conditions. This is a direct measurement of sterility, likely using biological indicators or similar validated methods, rather than expert consensus or pathology in a clinical sense. For other tests like drying, material compatibility, biocompatibility, and cleaning, the ground truth involves objective measurements against established engineering and regulatory standards (e.g., residual hydrogen peroxide levels below acceptable levels, retention of functionality, non-cytotoxicity, visual cleanliness, etc.).

8. The sample size for the training set
This information is not provided in the document and is not relevant as it is not an AI/ML device.

9. How the ground truth for the training set was established
This information is not provided in the document and is not relevant as it is not an AI/ML device.

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