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The humidifier chambers for the SCT 3000 are indicated for use with the SCT 3000 unit and to hold water required to humidify the air being delivered to patients.

The humidifier chambers offered for use with the SCT 3000.

• • Adult low flow humidifier chamber
• • Adult extended run humidifier chamber
• • Pediatric low compressible volume humidifier chamber
• • Adult hi flow humidifier chamber

This looks like a 510K submission for humidifier chambers, not an AI/ML medical device. As such, the requested information about acceptance criteria, clinical study designs, ground truth establishment, and AI performance metrics is not applicable to this document.

The document states:

• "Performance Testing: None applicable" - This explicitly indicates no specific performance tests were deemed necessary beyond comparison to predicate devices, which implies no formal clinical studies or detailed performance metrics were conducted or required.
• The entire submission focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than novel performance claims.

Therefore, I cannot extract the requested information from this document.

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