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For use in right atrial electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The Constellation Multiple Electrode Recording and Pacing Catheter System is intended to acquire and display multiple electrograms simultaneously and to deliver physician generated pacing stimuli.

Constellation Catheters (Uncoated)
48mm Constellation, unipolar, uncoated: 8048 U
60mm Constellation, unipolar, uncoated: 8060 U
75mm Constellation, unipolar, uncoated: 8075 U
48mm Constellation, bipolar, uncoated: 8048 BU
60mm Constellation, bipolar, uncoated: 8060 BU
75mm Constellation, bipolar, uncoated: 8075 BU
Constellation Catheters (Coated)
48mm Constellation, unipolar, coated: 8048 C
60mm Constellation, unipolar, coated: 8060 C
75mm Constellation, unipolar, coated: 8075 C
48mm Constellation, bipolar, coated: 8048 BC
60mm Constellation, bipolar, coated: 8060 BC
75mm Constellation, bipolar, coated: 8075 BC
Sheaths
Straight: 961
Curved: 960 962
Pacing Switchbox
Standard Switchbox: 951
Cables
Universal, primary: 900
Universal, secondary: 901A 901B
Single spline, primary: 657
Single spline, secondary: 626

The provided document is a 510(k) clearance letter for a medical device (Constellation Multiple Electrode Pacing and Recording Catheter System and Accessories). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."

This means the device was cleared based on substantial equivalence to a predicate device, not on a study demonstrating it met specific acceptance criteria for performance, safety, or effectiveness. 510(k) clearance does not typically involve the submission of extensive clinical trial data or performance studies against predefined acceptance criteria in the same way a Premarket Approval (PMA) would.

Therefore, I cannot extract the requested information (performance table, sample sizes, ground truth details, MRMC study, etc.) from this document. The document's purpose is to grant market clearance based on substantial equivalence, not to describe the results of a performance study.

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