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The ULTRA SYSTEM SP™ is a reusable sterilization container system intended to allow sterilization of enclosed surgical instruments by health care providers in the STERRAD™ 50 and 100S Sterilizers and to maintain sterility of the enclosed instruments until they are used. Baskets are used with the container to feciliate placement of the enclosed surgical instruments. The maximum load is 8.35 pounds in the STERRAD™ 50 or 16.70 pounds in the STERRAD™ 100S. A maximum of Junens may be sterilized in each load.

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This letter is a 510(k) clearance for a sterilization wrap (specifically, a reusable sterilization container system), not an AI/ML device. Therefore, the detailed questions about acceptance criteria, study design, and performance metrics related to AI/ML devices are not applicable.

The document does not contain information about:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used (pathology, outcomes data, etc.).
• Sample size for training sets.
• How ground truth for training sets was established.

This is a regulatory clearance for a physical medical device, not a software or AI/ML product.

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