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The Heart Stabilizer Pad is used on an appropriate heart stabilizer unit for coronary bypass surgery. It provides a mechanical means for immobilization of the anastomotic site on a beating heart and provides coronary artery isolation and occlusion by compression.

Pilling Weck Surgical Stabilizer Removable Pads

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study proving the device meets those criteria in the format requested.

The document is a 510(k) clearance letter from the FDA for a device called "Pilling Weck Surgical Stabilizer Removable Pads." This letter primarily:

• Confirms that the device is substantially equivalent to legally marketed predicate devices.
• States its regulatory class (Class I) and product code.
• Outlines the general regulatory requirements that apply to the device, such as GMP regulations, registration, and prohibitions against misbranding and adulteration.
• Provides the "Indications for Use" for the device.

It does not include:

• Specific acceptance criteria (e.g., performance metrics, thresholds).
• Details of any specific study (clinical or analytical) conducted to demonstrate device performance against such criteria.
• Information regarding sample sizes, data provenance, ground truth establishment, expert qualifications, or comparative effectiveness studies.

Therefore, I cannot populate the table or answer the specific questions about the study details based on the provided text.

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