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Tyvek Sterilization Pouches with Chevron Seal are intended to enclose medical devices that are to be sterilized in a single pouch configuration at a healthcare facility. They are used in 3-hour and 6-hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.

Tyvek Sterilization Pouches with Chevron Seal are constructed from an uncoated Tyvek backing of fine, continuous, high-density polyethylene fibers, with front material consisting of a clear, laminated polyethylene terephthalate / low density polyethylene (LDPE) or LDPE-ethylene-vinyl acetate copolymer film. The pouches are used to enclose medical devices that are to be sterilized by a healthcare provider in 3-hour and 6-hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. Following manufacturer's instructions, devices are inserted into Tyvek Sterilization Pouches and sealed. The self-seal pouch permits sealing of the pouch without heatsealing equipment, whereas the heat-sealable pouches must be heat sealed prior to the cycle. Andersen Sterilizers' AN85 EO Indicators, when placed on the outside of the sterilization pouches. indicate EO exposure and offer a convenient way to differentiate pouches that have been processed in EO sterilization cycles from unprocessed units. The color of the AN85 EO Indicators changes from yellow-green to blue after exposure to EO. After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for 6 months.

The provided document is a 510(k) premarket notification for a medical device (Tyvek Sterilization Pouches with Chevron Seal), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria and performance metrics for a novel AI/ML-driven device.

Therefore, the requested information about acceptance criteria, study design, sample sizes, expert involvement, MRMC studies, standalone performance, and ground truth establishment for an AI/ML device is not applicable to this document.

This submission is for a physical product (sterilization pouches) and details non-clinical performance testing related to its material properties, sterilization efficacy, and shelf life, not an AI/ML algorithm.

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