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The Vis-U-All Heat-Seal Pouch and Tubing have been qualified by STERIS Corporation as suitable for use by health care providers to enclose and seal other medical devices to be sterilized in the AMSCO V-Pro 1 Low Temperature Sterilizer. The system is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

The proposed Vis-U-All Heat Seal Pouch is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider by the AMSCO® V-PRO 1 Low Temperature Sterilization System. The purpose of this submission is to demonstrate the Vis-U-All Heat Seal Pouch is qualified for use in the AMSCO® V-PRO 1 Low Temperature Sterilizer. The 510(k) number for the AMSCO® V-PRO 1 Low Temperature Sterilizer is K062297 cleared on October 4, 2007.

The provided document is a 510(k) premarket notification for a medical device (Vis-U-All Heat Seal Pouch and Tubing), which is a sterilization wrap. It discusses the device's substantial equivalence to predicate devices and its intended use. However, it does not include detailed information on specific acceptance criteria and a study proving those criteria were met in the format requested.

The document states: "Performance testing of the Vis-U-All Heat Seal Pouch and Tubing demonstrated that the proposed pouch is qualified for use in the AMSCO® V-PRO 1 Low Temperature Sterilizer and is as safe, as effective, and performs the same as the predicate device." This is a general statement of compliance, not a detailed breakdown of acceptance criteria and performance data.

Therefore, I cannot fulfill your request for the specific table and study details (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types and establishment for training sets) because this information is not present in the provided text.

Based on the information given, I can only report that:

• Acceptance Criteria (Implied): The device must be "qualified for use in the AMSCO® V-PRO 1 Low Temperature Sterilizer" and demonstrate it is "as safe, as effective, and performs the same as the predicate device."
• Reported Device Performance: The device "demonstrated that the proposed pouch is qualified for use" and "is as safe, as effective, and performs the same as the predicate device."

All other requested details (sample sizes, expert qualifications, etc.) are not available in this document.

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