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ArjoWrap 47/100 and ArjoWrap 47/88 models are single use, non-sterilization wraps intended to be used by healthcare facilities to wrap other medical devices for terminal sterilization by steam or ethylene oxide. ArjoWrap 47/100 and ArjoWrap 47/88 maintain the sterility of the enclosed devices until they are used.

ArjoWrap 47/100 and ArjoWrap 47/88 are not recommended for any type of irradiation sterilization.

ArjoWrap is a sterilization wrap to be used by healthcare facilities to wrap other medical devices for terminal sterilization by steam or ethylene oxide. The ArjoWrap product is composed of two materials and will be offered two different weights. Each weight will be markcted in twelve sizes.

This 510(k) summary does not contain the information required to populate the acceptance criteria and study details. This document is a premarket notification for a sterilization wrap (ArjoWrap) and focuses on demonstrating substantial equivalence to a predicate device (Sterisheet Sterilization Wrap).

The provided text details:

• Device Description: ArjoWrap is a sterilization wrap made of two materials, available in two weights and twelve sizes.
• Intended Use: For wrapping other medical devices for terminal sterilization by steam or ethylene oxide, maintaining sterility until use. Not for irradiation sterilization.
• Substantial Equivalence: Claimed based on equivalent intended use, manufacturing materials, operating principles, and physical, operational, and biological specifications compared to the predicate device K931202.

Crucially, there is no mention of:

• Specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, or performance metrics for a diagnostic device).
• Any performance study with a test set, ground truth, or expert review. This type of submission (for a sterilization wrap) typically relies on material properties testing and comparative analysis to a predicate device rather than clinical performance studies involving interpretation by experts.
• Algorithms, AI assistance, or human-in-the-loop performance. This is a medical device (sterilization wrap), not an AI/ML diagnostic or assistive tool.

Therefore, I cannot fill out the requested table and study details from the provided text. The submission type and device being described do not generate the kind of information asked for in your prompt (which is typically related to AI/ML diagnostic or image interpretation devices).

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