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Vichy Shower is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.

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The provided document is a 510(k) clearance letter from the FDA for a device called "Vichy Shower." This letter confirms that the device is substantially equivalent to a predicate device and can be marketed.

However, the document does not contain the kind of information requested in the prompt regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for AI/ML device evaluation. The Vichy Shower is a hydrotherapy device, not an AI/ML-driven diagnostic or treatment device, therefore, the requested information is not applicable to this submission.

To clarify, the prompt asks for details typically found in submissions for AI/ML-enabled medical devices, which require extensive clinical validation studies to demonstrate safety and effectiveness. The Vichy Shower falls under a different regulatory pathway where substantial equivalence to existing devices is the primary criterion for market clearance, and typically does not involve the types of studies described in the prompt.

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Relieve pain and itching, as an aid in the healing process of inflamed and traumatized tissue, and serve as a settting for removal of contamined tissue.

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This document is a 510(k) premarket notification acceptance letter from the FDA for a device called "Equinoxe Spa Tub." It declares the device substantially equivalent to a legally marketed predicate device.

The letter does not contain information about specific acceptance criteria, device performance, or any studies conducted. It focuses on regulatory approval based on substantial equivalence. Therefore, I cannot provide the requested table or answer the study-related questions based on this document.

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