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The MicroFlow Spacer (Frontal) is indicated for use as a postoperative spacer to maintain an opening to the frontal sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction.

The Relieva Stratus Pro MicroFlow Spacer (Frontal) is a device that maintains an opening at the target sinus for up to 14 days postoperatively. The device can be manually removed during an office follow-up visit.

The provided text describes a 510(k) premarket notification for a medical device, the Relieva Stratus Pro MicroFlow Spacer (Frontal). It highlights the device's purpose, classification, and a summary of its performance data. However, the document does not contain the detailed information requested regarding the acceptance criteria, specific study design, sample sizes, ground truth establishment, or multi-reader multi-case studies as would be expected for an AI/ML powered device.

The information provided is typical for a Class I medical device (manual surgical instrument for general use) where equivalence to a predicate device is established through demonstrating compliance with recognized standards and basic performance requirements. This is not a submission for an AI/ML-powered device.

Therefore, I cannot populate the requested table and sections with the information about acceptance criteria and study data for an AI/ML device because the provided text pertains to a traditional, non-AI medical device.

The "Performance Data" section explicitly states: "The Relieva Stratus Pro MicroFlow Spacer (Frontal) met all performance acceptance criteria." It then lists criteria related to sterilization, sterility assurance level, non-pyrogenicity, ethylene oxide residuals, shelf life, and package integrity, all of which are standard for a physical medical implant, not an AI algorithm.

Here's a breakdown of why I cannot fulfill the request specifically for AI/ML device evaluation criteria based on the provided text:

• No AI/ML Components: The device description ("maintains an opening at the target sinus for up to 14 days postoperatively") and its classification ("Manual surgical instrument for general use") clearly indicate it is a physical device, not an AI/ML algorithm.
• Performance Data Type: The "Performance Data" section discusses:
  • Sterilization (AAMI/ANSI/ISO 11135-1:2007)
  • Sterility Assurance Level (10-6)
  • Non-pyrogenicity (ANSI/AAMI ST72:2002)
  • Ethylene oxide residuals (ISO 10993-7:2008)
  • Shelf life (ASTM F1980-07)
  • Package integrity (ASTM F88-07A, ISTA 2A-08, and ASTM F2096-04)
    These are all physical and biological safety standards, not metrics or studies related to AI/ML prediction or diagnostic performance.
• Absence of AI-Specific Terminology: There is no mention of algorithms, models, datasets, training, testing, ground truth, accuracy, sensitivity, specificity, AUC, human readers, or any other terms associated with AI/ML device evaluation.

Conclusion: The provided document describes a Class I medical device in the context of a 510(k) submission, confirming its substantial equivalence to a predicate device based on standard performance tests for physical implants. It does not provide information relevant to the acceptance criteria or study design for an AI/ML-powered medical device.

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