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The intended use of the SDC3 HD Information Management System with Wireless Device Control Capability 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 SDC3 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 SDC3 HD Information Management System with Wireless Device Control Capability is a network compatible hardware platform that allows the users to control the state, selection, and settings of compatible connected endoscopic and general surgery devices both wired and wirelessly. The SDC3 HD Information Management System with Wireless Device Control Capability consists of the following: a. A SDC3 HD Information Management System console (Class I MDDS) 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 d. Connected OR Spoke (Class I MDDS)

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "SDC3 HD Information Management System with Wireless Device Control Capability". This submission argues for substantial equivalence to a predicate device (K160332).

Crucially, this document states that there are no performance studies or clinical trials conducted for this submission (K210584) because the changes are not related to design but to the indications for use, and a risk analysis concluded no new questions of safety and effectiveness were raised.

Therefore, I cannot provide details on the acceptance criteria, study design, sample sizes, expert ground truth establishment, or any other performance-related metrics as these studies were not performed for this 510(k) submission.

The document explicitly states:
"There are no design changes proposed nor necessary to support the change in indications for use. A risk analysis of the indications for use change concluded that the change in indications for use does not raise different questions of safety and effectiveness. Therefore, performance data are not necessary to evaluate the change in indications for use to a tool-type indications for use."

If performance data for the predicate device (K160332) were available, they would be in that submission's documentation. This document (K210584) only refers to a comparison of technological characteristics for substantial equivalence.

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