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The DOLPHIN® II Fluid Management System provides low viscosity liquid distension of the uterus for hysteroscopy, and monitors intrauterine pressure, fluid use and fluid deficit.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the DOLPHIN® II Fluid Management System. This type of document primarily addresses the substantial equivalence of a new device to a legally marketed predicate device, rather than providing details of a de novo study proving new acceptance criteria.

Therefore, the input does not contain the information requested in the prompt, such as:

• A table of acceptance criteria and reported device performance.
• Details of a study (sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance).
• Information about ground truth (type, establishment).
• Training set details.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This indicates that the approval is based on equivalence to existing devices, not on a new study that establishes a device's performance against specific acceptance criteria for a novel functionality.

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