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The Coretech Compression System RHB3003 is a sequential compression device which is intended for treatment of patients with the following conditions:

• Lymphedema
• Venous stasis ulcers
• Venous insufficiency
• Peripheral edema

The device is safe for both home and hospital use.

The Coretech Compression System RHB3003 (Coretech RHB3003) is a compression device that delivers sequential compression to the affected upper and lower extremity of patients with lymphedema, chronic edema, peripheral edema, venous insufficiency and venous stasis ulcers.

This device helps direct and move excess fluid from an impaired lymphatic region to healthy regions, where fluid can be absorbed and processed naturally by the body. The Coretech RHB3003 controller is used to inflate the connected garment chambers. The air chambers inflate and deflate repeatedly and orderly to create circular pressure on the affected limb. The air inflates from the distal end to the proximal end of the patient. This helps to promote the flow of blood and lymph and improves microcirculation. The pressure can be adjusted to avoid discomfort to the patient and deflates as one cycle.

This document is a 510(k) clearance letter for the Vive Health Coretech Compression System (model RHB3003). It confirms that the device is substantially equivalent to a predicate device for its indicated uses. However, the provided document does not contain the detailed acceptance criteria and study information requested.

The letter mentions that various types of testing were completed to support the substantial equivalence determination, including:

• Electrical safety and electromagnetic compatibility (EMC) testing
• Software verification and validation testing
• Mechanical bench testing (covering start/stop, inflation/deflation, cycle time, operating modes, pressure calibration, operating/treatment time, pressure accuracy, burst pressure/garment integrity, firmware/software integration, and noise performance)
• Packaging Validation

Crucially, the document states: "The technological comparison and performance testing together demonstrate that Coretech RHB3003 has a similar safety and effectiveness profile as the predicate device." It does not, however, numerically report acceptance criteria or the specific device performance against these criteria. It only lists the types of tests conducted.

Therefore, I cannot populate the table or provide specific answers to the detailed questions regarding sample sizes, ground truth establishment, expert qualifications, or MRMC studies for this device based on the provided text. The document is an FDA clearance letter, not a detailed technical report of the studies themselves.

In summary, the requested information (acceptance criteria, reported performance, sample sizes, ground truth details, expert involvement, and MRMC studies) is NOT present in the provided FDA 510(k) Clearance Letter.

If you have a different document (e.g., the actual test reports or a summary of the performance data submitted to the FDA), I would be able to extract that information.

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