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The Switchpoint Infinity™ Control System is a medical device that is designed to allow direct control of the state, selection, and settings of room equipment, and audio/video equipment and indirect control through the Stryker Endoscopy Sidne™ System of the state, selection, and settings of surgical equipment in the operating room. The Switchpoint Infinity™ Control System is also an integrated voice, video, and data router and teleconferencing interface for the operating room. The intent of the Switchpoint Infinity™ Control System is to allow operating room personnel a center point for controlling all equipment and communication in surgery.

The Stryker Switchpoint Infinity™ Control System is indicated for use with the Stryker Endoscopy Sidne™ System [510(k) # K022393] and Sidne™ compatible endoscopic and general surgery devices. The users of Switchpoint Infinity™ Control System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, urologists, and any other surgeon whom requires the use of voice, video, or control in the operating room or a teleconferencing interface.

The Switchpoint Infinity™ Control System is a medical device that is designed to allow direct control of the state, selection, and settings of room equipment, and audio/video equipment and indirect control through the Stryker Endoscopy Sidne™ System of the state, selection, and settings of surgical equipment in the operating room. The Switchpoint Infinity™ Control System is also an integrated voice, video, and data router and teleconferencing interface for the operating room.

The provided text is a 510(k) summary for the Stryker Switchpoint Infinity™ Control System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria, a specific study proving device performance against those criteria, or details regarding ground truth, expert adjudication, or sample sizes related to performance evaluation.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance study data in the way a clinical trial or a standalone AI algorithm validation would.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and performance study details from the provided text.

The document states:

"The technological differences between the Stryker Switchpoint Infinity™ Control System and the predicate devices (Sidne™ System, Nurse's Assistant OR Control System, Switchpoint™ III, and KSEA Storz Communication Bus (SCB) Media Control™) do not raise new issues of safety and efficacy. Therefore, the Stryker Switchpoint Infinity™ Control System is substantially equivalent to the currently marketed Sidne™ System, Nurse's Assistant OR Control System, Switchpoint™ III, and KSEA Storz Communication Bus (SCB) Media Control™."

This declaration of substantial equivalence, along with conformity to voluntary standards (UL 60601-1, EN 60601-1-2), is the "proof" the device meets the safety and effectiveness requirements for 510(k) clearance, as opposed to a specific performance study with acceptance criteria.

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