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Hydrotherapy; Relieve pain and itching.

Hydrotone-Thermal Capsule System

The provided document is a 510(k) clearance letter from the FDA for the Hydrotone-Thermal Capsule System. It confirms that the device is substantially equivalent to a legally marketed predicate device for the indicated uses. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter focuses on regulatory clearance, indicating the device can be marketed. It lists the "Indications for Use" as "Hydrotherapy; Relieve pain and itching." and provides contraindications. It does not include any performance metrics, study design, or results that would typically be found in a study demonstrating the device meets specific acceptance criteria.

Therefore, I cannot provide the requested information based on the given text. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test sets.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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Hydrotherapy - relieve pain and itching

Not Found

The provided document is a 510(k) premarket notification letter from the FDA regarding the Hydrotone device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or AI-related metrics.

Therefore, I cannot provide the requested information. The letter only states that the device is substantially equivalent to legally marketed predicate devices for the indicated use of "Hydrotherapy - relieve pain and itching."

Ask a specific question about this device