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The use of the Connected OR Hub with Device and Voice Control system is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the Connected OR Hub with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

The Connected OR Hub with Device and Voice Control is a medical device that allows the surgeon to control the state, selection, and settings of any compatible device attached to it. It also has operating room documentation functionalities (Class I device function) to electronically capture, transfer, store and display medical device data independently of the functions or parameters of the connected medical device. The Connected OR Hub with Device and Voice Control consists of the following: a. A Connected OR Hub console (MDDS device) b. A Device control package (contains an optional software upgrade and a handheld Infrared (IR) remote control) - Class II c. A Voice control package (contains an optional software upgrade and a headset and base station) - Class II

The provided document is a 510(k) premarket notification for a medical device called "Connected OR Hub with Device and Voice Control." It does not contain any performance study data or acceptance criteria related to AI or algorithm performance.

The document primarily focuses on establishing substantial equivalence to a predicate device (Stryker Connected OR Hub with Device and Voice Control, K181258). It highlights that the proposed device has "no significant design changes" and that a "risk analysis of the indications for use change concluded that the change in indication for use does not raise new issues of safety and effectiveness." Therefore, the document explicitly states: "Therefore, performance data are not necessary to evaluate the change in indications to a tool type indication."

As a result, I cannot provide the information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. This information is absent from the provided text.

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