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Gemini Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of such content for 180 days following sterilization. Gemini Sterilization Wrap is validated for use in steam or STERRAD® sterilization processes in the following sterilization modes and cycles.

• . Pre-vacuum steam cycles
  • 0 4 Minutes Exposure at 270°F/132°C with minimum 20 minutes dry time
• Gravity steam cycles ●
  • 30 Minutes Exposure at 250°F/121°C with minimum 20 minutes dry time ಂ
• STERRAD® Sterilization ●
  • STERRAD® 100NX, Flex cycle o
  • STERRAD® 100NX, Standard cycle 0
  • STERRAD® 100NX, Express cycle O
  • STERRAD® 100S, Standard cycle O
  • STERRAD®NX, Advanced cycle O
  • STERRAD® NX, Standard cycle O

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This document is a 510(k) clearance letter from the FDA for a medical device called "Gemini Sterilization Wrap." It approves the device for marketing and outlines its intended use. There is no information provided in this document regarding acceptance criteria, device performance, or any studies conducted on the device. Therefore, I am unable to answer most of your questions based on the provided text.

The document only states the following:

1. Acceptance Criteria and Device Performance:

• No acceptance criteria or reported device performance for Gemini Sterilization Wrap are mentioned in this document. The FDA letter grants substantial equivalence based on the provided indications for use and classification, but it does not detail specific performance metrics or studies.

The following information is NOT available in the provided document:

• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth establishment.
• Adjudication method for the test set.
• MRMC comparative effectiveness study or its effect size.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on the regulatory approval of the "Gemini Sterilization Wrap" after reviewing its 510(k) submission, confirming its substantial equivalence to a predicate device, and listing its intended uses and applicable sterilization methods.

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