(198 days)
The Siemens SC9000/SC9015 Series Surgical Display Controller is indicated for use in an environment where patient care is provided by healthcare professionals (e.g. surgeons and other operating room personnel). It will be used whenever the professional determines that parameters and functions generated by the SC 9000/9015 Bedside Monitor should be displayed on a remote terminal.
The SC900/9015 Series Surgical Display Controller enables SC9000/9015 monitoring to be displayed on a Siemens 15 inch Remote Display or on a standard video display.
The provided text is a 510(k) summary for the Siemens SC9000/SC9015 Series Surgical Display Controller. This document aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a study.
Therefore, the input does not contain the information required to answer the questions about acceptance criteria and a study proving those criteria are met. The device is a "Medical Cathode-Ray Tube Display," and its submission to the FDA is based on substantial equivalence to an existing device (Siemens SC9000/9015 Series SC9015 Display), meaning extensive performance studies as requested are typically not required, especially for a display unit.
Here's a breakdown of why the requested information is not available in the provided text:
- Acceptance Criteria and Reported Device Performance: This device is a display controller. The primary performance criterion would be its ability to accurately display information from the bedside monitor. This is handled by a claim of "substantial equivalence" rather than a detailed performance study with specific metrics.
- Sample Size, Ground Truth, Adjudication, MRMC studies, Standalone performance, Training set details: These are all elements typically involved in performance studies for diagnostic or analytical devices (e.g., AI algorithms, new sensors). A display controller's evaluation focuses on its technical specifications (e.g., resolution, refresh rate, compatibility) and safety, which are generally demonstrated through engineering and compatibility testing, not clinical studies with patients/experts/ground truth as described in your questions.
- The document explicitly states: "Assessment of clinical performance data for equivalence: Not applicable; device is substantially equivalent to predicate device."
In summary, the provided 510(k) summary is not designed to present a performance study with the types of details requested. It relies on demonstrating that the new device is essentially the same as a previously cleared device.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.