WEBVTT

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The five-ten K pathway clears a new device by showing substantial equivalence to one already on the market.

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Indications match. Technology matches. Performance matches. Safety matches.

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The framework was written for devices with fixed specifications. A I-enabled software has weights that change between releases. Substantial equivalence becomes ambiguous.

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Caventia pins the device to a specific model version, attaches the production performance evidence, and stabilizes the comparison.