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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
• Default Cycle of the STERRAD®* 100S Sterilizer
• Standard and Advanced Cycles of the STERRAD NX and NX with . ALLClear Technology Sterilizers
• Standard, Flex Scope, Express and DUO Cycles of the STERRAD 100NX . and 100 NX with ALLClear Technology Sterilizers

*STERRAD and ALLClear are trademarks of Advanced Sterilization Products

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

• wrapped with a legally marketed sterilization wrap for use in the V-PRO ● or STERRAD Sterilization Systems. or
• . placed inside a legally marketed pouch for enclosing trays in the V-PRO or STERRAD Sterilization Systems.

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 and the following STERRAD Sterilizers and cycles. The trays are available in various sizes to accommodate the loads to be processed. The proposed trays are identical in design to the predicate Sterilization Tray (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 and sterilization mats are also described as accessories.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PRO-LITE Sterilization Tray:

The document (K183402) is not a multi-reader multi-case comparative effectiveness study nor does it describe a standalone algorithm performance study. It's a 510(k) premarket notification for a medical device (sterilization tray) aiming to demonstrate substantial equivalence to a predicate device. Therefore, questions related to AI-specific metrics, expert ground truth adjudication methods, and training set information are not applicable to this type of submission.

The study focuses on the physical and functional performance of the sterilization tray itself when used with specific sterilization systems.

Acceptance Criteria and Reported Device Performance

Additional Information Not Applicable to This Document:

2. Sample sizes used for the test set and the data provenance: This information is not provided in a way that relates to an "AI test set." The study involves physical testing of devices with sterilization cycles. The number of sterilization cycles and units tested for each criterion would be part of detailed test protocols, not typically summarized in this FDA 510(k) summary. Data provenance is not specified beyond being "non-clinical tests."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for this type of device is established through scientific and engineering tests (e.g., microbial log reduction for sterility, chemical analysis for residuals, functional testing for material compatibility).
4. Adjudication method for the test set: Not applicable. Decisions are based on objective measurement against defined criteria, not expert adjudication of subjective assessments.
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: Not applicable. This is not an AI device or an imaging device involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used: For "Demonstration of Effective Sterilant Penetration," the ground truth would be based on validated biological indicator (BI) testing (e.g., showing a 10^-6 or greater sterility assurance level, typically through half-cycle challenges). For "Drying and Aeration" it's chemical analysis (residual H2O2). For "Material Compatibility" it's functional assessment and integrity checks. For "Biocompatibility" it's laboratory assays (e.g., cytotoxicity tests). For "Cleaning," it's visual inspection and potentially tests for residual soil/protein.
8. The sample size for the training set: Not applicable. This is not an AI device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI device.

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