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The Grumpy Innovation PORTARE System is intended to endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is intended to provide visualization via a monitor. The endoscope is intended for use in a hospital or clinical environment. It is intended for use in adults.

The Grumpy Innovation PORTARE System is a flexible endoscope with steerable navigation and a built-in image and video processing system that wirelessly transmits images and video to a tablet application. The PORTARE System is comprised of a:
• Sterile, single-use disposable endoscope handle, steering mechanism, and steerable insertion tube with chip-on-tip camera and LED light source.
• Reusable module comprising the primary circuit board with wireless unit and rechargeable battery.
• Tablet viewer that runs a software application.

The reusable module attaches to the single-use disposable endoscope handle to create a functional endoscope.

The provided FDA 510(k) clearance letter and summary for the PORTARE System (FA-001) does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria, in the context of an AI/ML-driven medical device performance evaluation.

The document primarily focuses on establishing substantial equivalence to a predicate device for a flexible nasopharyngoscope system. The performance tests listed are non-clinical and relate to the physical, optical, mechanical, software, electrical, and biocompatibility aspects of the device, typical for hardware and software components of an endoscope.

Therefore, I cannot provide the requested information, which typically applies to AI/ML device performance studies. The document explicitly states:

"Performance Data – Clinical: Not applicable"

This confirms that no clinical performance study, which would typically involve human subjects and outcome measures against a pre-defined ground truth, was conducted or submitted for this particular clearance, at least not in a way that would generate acceptance criteria and performance metrics for an AI component.

If the PORTARE system did include an AI component, the provided document does not detail its performance characteristics or the study design used to validate it.

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