Search Results

Sterisheet Sterilization Wraps are single use non-woven sterilization wraps intended to enclose medical devices that are to be sterilized at a healthcare facility. They are used in the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer.

Sterisheet Sterilization Wraps are single use, non-sterile sterilization wraps constructed from cellulose, synthetic fibers (polypropylene), and synthetic binders, with the addition of pigmentation. They are used to enclose medical devices that are to be sterilized by a healthcare provider in the 12 hour sterilization cycle at 20-29°C in an Anprolene AN75 Ethylene Oxide Gas Sterilizer. Devices must be wrapped following manufacturer's instructions. After completion of the sterilization process, Sterisheet Sterilization Wraps maintain sterility of the enclosed medical devices for at least 3 months.

The provided document is a 510(k) premarket notification for a medical device called "Sterisheet Sterilization Wrap." It is not a document describing a study of an AI/ML powered device, nor does it contain information about acceptance criteria and performance data for such a device.

The product in question is a physical sterilization wrap, and the performance testing mentioned relates to its physical properties, material compatibility, biocompatibility, shelf life, and its ability to allow sterilant penetration and maintain sterility. The "study that proves the device meets acceptance criteria" refers to bench tests of a physical product, not a study of an AI/ML algorithm's performance.

Therefore, I cannot answer your request as it pertains to an AI/ML device study. The document does not contain any of the information you requested regarding:

• A table of acceptance criteria and reported device performance for an AI/ML algorithm.
• Sample sizes for a test set (in the context of an algorithm).
• Data provenance (country, retrospective/prospective) for an algorithmic test set.
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods for an algorithmic test set.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth (expert consensus, pathology, outcomes data).
• Training set sample size or how its ground truth was established.

The document is solely a regulatory submission for a traditional medical device.

Ask a specific question about this device